California American Water Encourages Customers to Follow Safety Tips

California American Water Encourages Customers to Follow Safety Tips

PACIFIC GROVE, Calif.–(BUSINESS WIRE)–
Safety is of paramount importance to California American Water, for our customers and our employees. California American Water has implemented, and regularly monitors, safety measures ranging from providing safe, clean, and reliable water service, to keeping our workers, customers and the communities we serve safe.

Recently California American Water has been made aware of scammers posing as utility workers, going door to door, asking permission to enter customers’ homes in Monterey County. In the rare event that a California American Water employee asks for access to a home, they will always identify themselves as an employee, display a company ID badge, and provide clear identification and purpose of the visit. Some important tips to help avoid scams are:

  • Ask for proper identification such as a company ID and a driver’s license. Do not open the door to anyone who cannot provide these forms of identification.

  • Thoroughly inspect the ID badge. The front of a California American Water ID badge will display the person’s picture and the company logo. Customers may contact the company to confirm the identity of employees before allowing them onto their property.

  • Check the person’s vehicle. All California American Water vehicles have the company’s logo clearly displayed.

Following these simple tips can prevent scammers from accessing residents’ homes and helping keep them and their families safe.

California American Water would like to wish our customers a happy and safe holiday season and a prosperous 2025.

About American Water

American Water (NYSE: AWK) is the largest regulated water and wastewater utility company in the United States. With a history dating back to 1886, We Keep Life Flowing® by providing safe, clean, reliable and affordable drinking water and wastewater services to more than 14 million people with regulated operations in 14 states and on 18 military installations. American Water’s 6,500 talented professionals leverage their significant expertise and the company’s national size and scale to achieve excellent outcomes for the benefit of customers, employees, investors and other stakeholders.

For more information, visit amwater.com and join American Water on LinkedIn, Facebook, X (formally Twitter) and Instagram.

About California American Water

California American Water, a subsidiary of American Water, provides high-quality and reliable water and wastewater services to approximately 700,000 people. For more information, visit www.californiaamwater.com and follow California American Water on LinkedIn, Facebook, X, and Instagram.

Josh Stratton

831-435-6015

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Utilities Energy

MEDIA:

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BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: VOXX International Corporation (Nasdaq – VOXX), Penns Woods Bancorp, Inc. (Nasdaq – PWOD), Staffing 360 Solutions, Inc. (Nasdaq – STAF), Adams Resources & Energy, Inc. (NYSE American – AE)

BALA CYNWYD, Pa., Dec. 20, 2024 (GLOBE NEWSWIRE) — Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ([email protected]) or Marc Ackerman ([email protected]) at 855-576-4847. There is no cost or financial obligation to you.

VOXX International Corporation (Nasdaq – VOXX)

Under the terms of the Merger Agreement, VOXX will be acquired by Gentex Corporation (Nasdaq – GNTX) for $7.50 per share in cash. The investigation concerns whether the VOXX Board breached its fiduciary duties to shareholders by failing to conduct a fair process, including whether Gentex is paying fair value to shareholders of the Company.

Additional information can be found at https://www.brodskysmith.com/cases/voxx-international-corporation-nasdaq-voxx/.

Penns Woods Bancorp, Inc. (Nasdaq – PWOD)

Under the terms of the agreement, Penns Woods will merge with Northwest Bancshares, Inc. (“Northwest”) (Nasdaq – NWBI). Northwest will acquire Penns Woods in an all-stock transaction. Penns Woods shareholders will be entitled to receive 2.385 shares of Northwest common stock for each share of Penns Woods common stock they own upon the effective time of the merger. Based on Northwest’s closing stock price of $14.44 as of December 16, 2024, the transaction consideration is valued at $34.44 for each share of Penns Woods. The investigation concerns whether the Penns Woods Board breached its fiduciary duties to shareholders by failing to conduct a fair process, including whether the deal offers fair value to the Company’s shareholders.

Additional information can be found at https://www.brodskysmith.com/cases/penns-woods-bancorp-inc-nasdaq-pwod/.

Staffing 360 Solutions, Inc. (Nasdaq – STAF)

Under the terms of the agreement, Staffing 360 will be acquired by Atlantic International Corp. (“Atlantic”) (OTC – ATLN). Staffing 360 shareholders will receive 1.202 Atlantic shares for each Staffing 360 share. Atlantic and Staffing 360 shareholders will own approximately 90% and 10%, respectively, of the combined company on a fully diluted basis. The investigation concerns whether the Staffing 360 Board breached its fiduciary duties to shareholders by failing to conduct a fair process, including the dilution of the Company’s shareholders in the combined company.

Additional information can be found at https://www.brodskysmith.com/cases/staffing-360-solutions-inc-nasdaq-staf/.

Adams Resources & Energy, Inc. (NYSE American – AE)

Under the terms of the agreement, Adams will be acquired by an affiliate of Tres Energy LLC (“Tres Energy”). Adams stockholders will receive $38.00 per share in cash in a deal with an enterprise value of $138.9 million. The investigation concerns whether the Adams Board breached its fiduciary duties to shareholders by failing to conduct a fair process, including whether Tres Energy is paying fair value to shareholders of the Company.

Additional information can be found at https://www.brodskysmith.com/cases/adams-resources-energy-inc-nyse-american-ae/.

Brodsky & Smith is a litigation law firm with extensive expertise representing shareholders throughout the nation in securities and class action lawsuits. The attorneys at Brodsky & Smith have been appointed by numerous courts throughout the country to serve as lead counsel in class actions and have successfully recovered millions of dollars for our clients and shareholders. Attorney advertising. Prior results do not guarantee a similar outcome.



INVESTIGATION ALERT (NASDAQ: SEZL): DiCello Levitt LLP Is Investigating Investor Claims Against Sezzle Inc. and Encourages SEZL Investors with Losses to Contact the Firm

SAN DIEGO, Dec. 20, 2024 (GLOBE NEWSWIRE) — DiCello Levitt LLP announces that it is investigating whether Sezzle Inc. (“Sezzle” or the “Company”) (NASDAQ: SEZL) complied with federal securities laws. The Firm’s investigation focuses on whether the Company violated the federal securities laws and issued false and/or misleading statements and/or failed to disclose information required to be disclosed to investors.

Investors who purchased Sezzle securities and those with information about the allegations are encouraged to obtain additional information and assist the Firm’s investigation by contacting DiCello Levitt attorneys Brian O’Mara or Ruben Peña by calling (888) 287-9005 or at [email protected].

No Case Has Been Filed and No Class Has Been Certified. Until a case is filed and a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice.

Investigation Details:

Sezzle is a technology-enabled payments company that offers flexible financing option to consumers and merchants through a ‘Buy Now, Pay Later’ service. Approximately 52% of Sezzle’s revenue for the third quarter of fiscal year 2024 came from “transaction income,” which includes, among other things, merchant processing fees and consumer fees. In the same period, Sezzle derived 33% of its revenue from its two “subscription” offerings.

On December 18, 2024, Hindenburg Research published a critical research report titled “Sezzle: A Failing ‘Buy Now, Pay Later’ Platform Playing Short Term Tricks As Insiders Cash Out Via Stock Sales And Margin Loans,” alleging, among other things, that it found “Sezzle is borrowing expensive capital to make extremely risky loans through a struggling platform that is rapidly losing customers and merchants” and, at the same time, “insiders are selling stock or cashing out through a massive margin loan.” According to the report, Hindenburg Research claims that “Sezzle borrows at a 12.65% interest rate to lend to extremely high-risk consumers” with bad credit despite its merchant and customer base declining by 51% and 20% since 2021. The report further states that Sezzle is actively “boosting its near-term subscription numbers” by “enrolling users into recurring monthly subscriptions without their awareness.” After extensive research, Hindenburg Research has concluded that Sezzle’s optimistic revenue numbers are obtained using short-term strategies to give the Company’s insiders an opportunity to cash out over $71 million in stock.

In response to the Hindenburg Research report, shares of Sezzle plunged to trade as low as $225 per share on December 18, 2024, falling more than 28% (or more than $90) from its close on December 17, 2024.

About DiCello Levitt:

At DiCello Levitt, we are dedicated to achieving justice for our clients through class action, business-to-business, public client, whistleblower, personal injury, civil and human rights, and mass tort litigation. Our lawyers are highly respected for their ability to litigate and win cases – whether by trial, settlement, or otherwise – for people who have suffered harm, global corporations that have sustained significant economic losses, and public clients seeking to protect their citizens’ rights and interests. Every day, we put our reputations – and our capital – on the line for our clients.

DiCello Levitt has achieved top recognition as Plaintiffs Firm of the Year and Trial Innovation Firm of the Year by the National Law Journal, in addition to its top-tier Chambers and Benchmark ratings. The New York Law Journal also recently recognized DiCello Levitt as a Distinguished Leader in trial innovation. For more information about the Firm, including recent trial victories and case resolutions, please visit www.dicellolevitt.com

Attorney Advertising. Prior results do not guarantee a similar outcome.

Media Contact

Amy Coker
4747 Executive Drive, Suite 240
San Diego, CA 92121
619-963-2426
[email protected]



INVESTIGATION ALERT (NASDAQ: ADBE): DiCello Levitt LLP Is Investigating Investor Claims Against Adobe, Inc. and Encourages ADBE Investors with Losses to Contact the Firm

SAN DIEGO, Dec. 20, 2024 (GLOBE NEWSWIRE) — DiCello Levitt LLP announces that it is investigating whether Adobe, Inc. (“Adobe” or the “Company”) (NASDAQ: ADBE) violated the federal securities laws, issued false and/or misleading statements, and/or failed to disclose information required to be disclosed to investors.

Investors who purchased Adobe securities from September 2022 to the present and those with information about the allegations are encouraged to obtain additional information and assist the firm’s investigation by contacting DiCello Levitt attorneys Brian O’Mara or Hani Farah by calling (888) 287-9005 or emailing [email protected].

No Case Has Been Filed and No Class Has Been Certified. Until a case is filed and a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice.

Investigation Details:

Adobe is one of the largest software companies in the world, offering software products used by creative professionals, businesses, and other consumers. DiCello Levitt is investigating whether the Company made false and misleading statements regarding Adobe’s efforts to monetize artificial intelligence (“AI”).   

On December 11, 2024, Adobe announced financial results for fiscal year (“FY”) 2024 and issued disappointing guidance for FY 2025. In response to the announcement, more than a dozen securities analysts cut their price targets for Adobe stock due to the Company’s apparent failure to monetize AI. For example, UBS wrote that “Adobe’s been pushing an AI narrative for 2 years now and we still see no evidence of monetization.” Similarly, KeyBanc Capital Markets stated that “[t]he results in the quarter were more of the same that has vexed investors throughout 2024,” adding that “AI monetization continues to get kicked further and further down the road.”

On this news, the price of Adobe common stock fell $75.30 per share, from a closing price of $549.93 per share on December 11, 2024, to a closing price of $474.63 per share on December 12, 2024, a decline of 13.7% on heavy volume.

About DiCello Levitt:

At DiCello Levitt, we are dedicated to achieving justice for our clients through class action, business-to-business, public client, whistleblower, personal injury, civil and human rights, and mass tort litigation. Our lawyers are highly respected for their ability to litigate and win cases – whether by trial, settlement, or otherwise – for people who have suffered harm, global corporations that have sustained significant economic losses, and public clients seeking to protect their citizens’ rights and interests. Every day, we put our reputations – and our capital – on the line for our clients.

DiCello Levitt has achieved top recognition as Plaintiffs Firm of the Year and Trial Innovation Firm of the Year by the National Law Journal, in addition to its top-tier Chambers and Benchmark ratings. The New York Law Journal also recently recognized DiCello Levitt as a Distinguished Leader in trial innovation. For more information about the firm, including recent trial victories and case resolutions, please visit www.dicellolevitt.com.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Media Contact

Amy Coker
4747 Executive Drive, Suite 240
San Diego, CA 92121
619-963-2426
[email protected]



INVESTOR ALERT: Shareholder Class Action Lawsuit Filed Against MGP Ingredients, Inc. (NASDAQ: MGPI); DiCello Levitt LLP Encourages Investors with Losses to Discuss Their Options with Counsel

SAN DIEGO, Dec. 20, 2024 (GLOBE NEWSWIRE) — A class action lawsuit has been filed on behalf of all persons and entities who purchased or otherwise acquired MGP Ingredients, Inc. (NASDAQ: MGPI) (“MGPI” or the “Company”) common stock between May 4, 2023 through October 30, 2024 (the “Class Period”), charging the Company and certain of its current and former senior executives with violations of the federal securities laws (collectively, “Defendants”).  

MGPI investors have until February 14, 2025 to seek appointment as lead plaintiff of the MGPI class action lawsuit.


If you purchased or acquired MGPI common stock between May 4, 2023 through October 30, 2024, and suffered substantial losses
, and you wish to obtain additional information or serve as lead plaintiff in this lawsuit, you may submit your information and contact us here: https://dicellolevitt.com/securities/mgpi/.

You can also contact DiCello Levitt attorneys Brian O’Mara or Ruben Peña by calling (888) 287-9005 or emailing [email protected].   Those who inquire by email are encouraged to include their mailing address, telephone number, and the number of shares purchased.

No Class Has Been Certified.   Until a class is certified, you are not represented by counsel unless you retain one.   You may select counsel of your choice.

Case Allegations

MGPI is an American distilled spirits producer that manufactures, distills, and sells alcoholic beverages such as tequila, bourbon, rye, and other whiskeys, as well as grain-neutral spirits such as vodka and gin under different brand names and under its own labels.

The MGPI lawsuit alleges that Defendants issued false and misleading statements and/or concealed material adverse facts concerning MGPI’s business, operations, and prospects during the Class Period. Specifically, Defendants repeatedly advertised a strong demand and “normal” inventory levels in MGPI’s brown goods (i.e., American whiskies and tequila), when consumption of such goods had slowed and there was an oversupply in MGPI’s products. Further, Defendants assured investors that the Company was better positioned than its competitors, and would not be impacted, as MGPI had already initiated actions to decrease the risk of lower consumption and product oversupply, but in reality, it had not.

The truth began to emerge on October 17, 2024, when MGPI reported its preliminary financial results for the third quarter of fiscal 2024. In the related press release, the Company announced its sales were expected to decline 14% from the prior year’s third quarter, and explained that “[s]oft alcohol spirits category trends and elevated industry-wide whiskey inventories are putting greater than expected pressure on our brown goods business.

On this news, the price of MGPI stock fell by $24.07 per share, or nearly 30%, to close at $57.50 per share three trading days later.

Then, on October 31, 2024, MGPI provided more details when Defendants pointed to “the softening American whiskey category trends and elevated industry-wide barrel inventories” as the source of its troubles, requiring the Company “to further lower [its] net aging whiskey put away, scale down [its] whiskey production, and optimize [its] cost structure to mitigate lower production volumes.” These statements were followed by the Company announcing it was “significantly reducing [its] brown goods production to better align with demand in 2025.”

On this news, the price of MGPI stock declined by $8.27 per share, or nearly 15%, to close at $49.04 per share on October 31, 2024.

About DiCello Levitt

At DiCello Levitt, we are dedicated to achieving justice for our clients through class action, business-to-business, public client, whistleblower, personal injury, civil and human rights, and mass tort litigation. Our lawyers are highly respected for their ability to litigate and win cases – whether by trial, settlement, or otherwise – for people who have suffered harm, global corporations that have sustained significant economic losses, and public clients seeking to protect their citizens’ rights and interests. Every day, we put our reputations – and our capital – on the line for our clients.

DiCello Levitt has achieved top recognition as Plaintiffs Firm of the Year and Trial Innovation Firm of the Year by the National Law Journal, in addition to its top-tier Chambers and Benchmark ratings. The New York Law Journal also recently recognized DiCello Levitt as a Distinguished Leader in trial innovation. For more information about the Firm, including recent trial victories and case resolutions, please visit www.dicellolevitt.com

Attorney Advertising. Prior results do not guarantee a similar outcome.

Media Contact

Amy Coker
4747 Executive Drive, Suite 240
San Diego, CA 92121
619-963-2426
[email protected]



Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients as Young as 2 Years Old

BOSTON, Dec. 20, 2024 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for IMCIVREE® (setmelanotide) to include children as young as 2 years old. IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long-term in patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency.

BBS and POMC, PCSK1 and LEPR deficiencies are rare melanocortin-4 receptor (MC4R) pathway diseases with hallmark characteristics that include hyperphagia, or pathological, insatiable hunger and impaired satiety accompanied by persistent and abnormal food-seeking behaviors, and early-onset obesity. IMCIVREE is the first and only precision medicine to target impairment of the hypothalamic MC4R pathway, a root cause of hyperphagia and obesity due to BBS and POMC, PCSK1 and LEPR deficiencies in adults and children as young as 2 years old in the United States, as well as Europe.

“It’s important to understand that rare MC4R pathway diseases differ from general obesity as the insatiable hunger these patients experience is pathologic and a result of impairment to a pathway in the brain. With this insatiable hunger, most patients develop early-onset obesity before the age of 5,” said Ilene Fennoy, MD, MPH, pediatric endocrinologist, obesity specialist and professor of Pediatrics at Columbia University Medical Center. “Obesity in childhood, if untreated, can lead to a greater risk of severe and long-term health complications, making early intervention to treat obesity critical. With this expanded indication for IMCIVREE, patients now can receive a much needed, targeted treatment that we believe can address a root cause of their obesity at a very young age.”

Results from clinical trials demonstrate that setmelanotide delivers significant and sustained reductions in measures of weight and hunger. Results from the Phase 3 VENTURE trial were published in the peer-reviewed journal The Lancet Diabetes & Endocrinology in November 2024. The most common adverse events are skin hyperpigmentation, injection site reactions, diarrhea, nausea and headache.

“Today’s approval is welcome news for the BBS community and others with rare MC4R diseases who struggle with hyperphagia,” said Tim Ogden, President of the Bardet Biedl Syndrome Foundation. “Many children with BBS feel hungry or think about food regardless of how much or how recently they’ve eaten, leaving families to deal with children sneaking or stealing food, which makes daily life extremely stressful. Parents have enough to worry about and manage when their child has a multi-systemic syndrome like BBS and IMCIVREE can be an important tool for their obesity.”

“Rhythm is focused on ensuring patients with these rare genetic diseases that are present at birth and manifest early in life have access to IMCIVREE as soon as possible,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. “We remain steadfast in our commitment to continue rapidly advancing care and precision medicines that address the root cause of rare neuroendocrine diseases.”

IMCIVREE initially received approval from the FDA in November 2020 for patients 6 years old and older with POMC, PCSK1 or LEPR deficiencies and approval in June 2022 for use in patients with BBS. IMCIVREE has also received marketing authorization from the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) for use in patients as young as 2 years of age.

BBS, which is diagnosed clinically, affects approximately 4,000 to 5,000 people in the U.S. People living with BBS may experience insatiable hunger, also known as hyperphagia, and severe obesity beginning early in life. BBS also may be associated with cognitive impairment, polydactyly, renal dysfunction, hypogonadism, and visual impairment. POMC, PCSK1 and LEPR deficiency obesities, caused by biallelic variants in the POMC,PCSK1 or LEPR genes, affect approximately 600 to 2,500 people in the United States.

About Rhythm Pharmaceuticals

Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists LB54640 and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.

Setmelanotide Indication

In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the European Union and the United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Limitations of Use

Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:

  • Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign
  • Other types of obesity not related to BBS or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity

Contraindication

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression, suicidal ideation and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation, darkening of pre-existing nevi, development of new melanocytic nevi and increase in size of existing melanocytic nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol preserved drugs.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.

Please see the full Prescribing Information for additional Important Safety Information.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical progress, potential regulatory submissions, approvals and timing thereof of setmelanotide and other product candidates; the potential benefits of any of our products or product candidates for any specific disease indication, in any particular patient population, or at any dosage, including the potential benefits of setmelanotide for pediatric patients with BBS or POMC, PCSK1, or LEPR deficiency; expectations surrounding potential clinical trial results, regulatory submissions and approvals; our business strategy and plans, including regarding commercialization of setmelanotide in the United States; and the timing of any of the foregoing . Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our ability to successfully commercialize setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants, and to attract, retain and motivate qualified personnel, and general economic conditions, and the other important factors discussed under the caption “Risk Factors” in Rhythm’s Quarterly Report on  Form 10-Q for the three months ended September 30, 2024 and other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Corporate Contact:

David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
[email protected]

Media Contact:

Sheryl Seapy
Real Chemistry
(949) 903-4750
[email protected]  



U.S. FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer

U.S. FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer

  • BRAFTOVI in combination with cetuximab and mFOLFOX6 is the first and only combination regimen with targeted therapy approved for use as early as first-line for patients with metastatic colorectal cancer with a BRAFV600E mutation
  • Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the Phase 3 BREAKWATER trial

NEW YORK–(BUSINESS WIRE)–
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.i The indication was approved based on a statistically significant and clinically meaningful improvement in response rate and durability of response in treatment-naïve patients treated with BRAFTOVI in combination with cetuximab and mFOLFOX6 from the Phase 3 BREAKWATER trial. Continued approval for this indication is contingent upon verification of clinical benefit. This accelerated approval is among the first in the industry to be conducted under the FDA’s Project FrontRunner, which seeks to support the development and approval of new cancer drugs for advanced or metastatic disease.

“Historically, treatment options have been limited and outcomes poor for patients diagnosed with metastatic colorectal cancer with BRAF mutations,” said Scott Kopetz, M.D., Ph.D., FACP, Professor and Deputy Chair of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and co-principal investigator of the BREAKWATER trial. “As the first and only combination regimen featuring a BRAF-targeted therapy for this patient population, usable even in first-line treatment, the encorafenib regimen has demonstrated high response rates that are rapid and durable. This represents an encouraging sign of continued disease control and a source of renewed hope for patients.”

The ongoing BREAKWATER trial is evaluating BRAFTOVI plus cetuximab with or without chemotherapy (mFOLFOX6) in previously untreated mCRC patients who harbor a BRAF V600E mutation. It is the only Phase 3 trial for a BRAF-targeted therapy regimen in first-line BRAF V600E-mutant mCRC. The trial met one of the dual primary endpoints of confirmed overall response rate (ORR), with a statistically significant improvement over standard of care: ORR 61% (95% confidence interval [CI]: 52, 70) for BRAFTOVI in combination with cetuximab and mFOLFOX6 compared with ORR 40% (95% CI: 31, 49) for chemotherapy, with or without bevacizumab (p=0.0008).1 The median duration of response (DoR) was 13.9 months (95% CI: 8.5, not estimable) for the BRAFTOVI combination regimen versus 11.1 months (95% CI: 6.7, 12.7) for chemotherapy, with or without bevacizumab.1 The Phase 3 BREAKWATER trial is ongoing, and results from the full dataset will be presented at upcoming medical meetings.

“For more than a decade, Pfizer has been a pioneer in delivering targeted therapies for molecular-driven cancers. With today’s accelerated approval of the BRAFTOVI regimen, patients with metastatic colorectal cancer with a BRAF V600E mutation now have a first-line treatment option, which contains a targeted therapy specifically for a mutation that is driving their cancer,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President, Pfizer. “This milestone adds to our legacy of developing innovative medicines in BRAF tumors, some of the hardest-to-treat cancers. We look forward to continuing to expand our portfolio, including the exploration of a next-generation brain-penetrant BRAF inhibitor.”

The safety profile of BRAFTOVI in combination with cetuximab and mFOLFOX6 in the BREAKWATER trial was consistent with the known safety profile of each respective agent. No new safety signals were identified. The most common adverse reactions (≥25%) were peripheral neuropathy, nausea, fatigue, rash, diarrhea, decreased appetite, vomiting, hemorrhage, abdominal pain, and pyrexia.1 Among patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6, 12% experienced an adverse reaction that resulted in permanent discontinuation of BRAFTOVI; the most common adverse reactions (≥1%) included elevated lipase levels.

“Finding out that your cancer has spread can be a frightening time for those with colorectal cancer and their loved ones. The prognosis for those receiving a metastatic colorectal cancer diagnosis has improved slightly in recent years, but the same cannot be said for those with a BRAF mutation who unfortunately face an especially aggressive disease and worse outcomes,” said Michael Sapienza, Chief Executive Officer of the Colorectal Cancer Alliance. “Today’s approval of the first combination regimen including a BRAF-targeted therapy for BRAFV600E-mutant metastatic colorectal cancer, which can be used for previously untreated patients, offers new promise for the community and marks an important step forward in our collective mission to end this disease.”

This application was granted priority review, used the Real-Time Oncology Review (RTOR) pilot program, and was conducted under Project Orbis, with application reviews ongoing for Project Orbis partners, including Canada and Brazil. The BREAKWATER data are also being discussed with other regulatory authorities around the world to support potential future additional license applications for the BRAFTOVI combination regimen in this indication. This accelerated approval follows the previous FDA approval for BRAFTOVI in combination with cetuximab for adults with mCRC with a BRAF V600E mutation after prior therapy.

About Colorectal Cancer (CRC)

CRC is the third most common type of cancer in the world, with approximately 1.8 million new diagnoses in 2022.2 Overall, the lifetime risk of developing CRC is about 1 in 23 for men and 1 in 25 for women.3 In the U.S. alone, an estimated 152,810 people will be diagnosed with cancer of the colon or rectum in 2024, and approximately 53,000 are estimated to die from the disease each year.4 For 20% of those diagnosed with CRC, the disease has metastasized, or spread, making it harder to treat.5

BRAF mutations are estimated to occur in 8-10% of people with mCRC and represent a poor prognosis for these patients.6 The BRAF V600E mutation is the most common BRAF mutation and the risk of mortality in CRC patients with the BRAF V600E mutation is more than double that of patients with no known mutation present.6,7 Despite the high unmet need in BRAF V600E-mutant mCRC, prior to today there were no approved biomarker-driven therapies specifically indicated for people with previously untreated BRAF V600E-mutant mCRC.8,9

About BREAKWATER

BREAKWATER is a Phase 3, randomized, active-controlled, open-label, multicenter trial of BRAFTOVI with cetuximab, alone or in combination with chemotherapy, in participants with previously untreated BRAF V600E-mutant mCRC. In the Phase 3 portion of the study, patients were randomized to receive BRAFTOVI 300 mg orally once-daily in combination with cetuximab (discontinued after randomization of 158 patients), BRAFTOVI 300 mg orally once-daily in combination with cetuximab and mFOLFOX6 (n=236), or mFOLFOX6, FOLFOXIRI, or CAPOX each with or without bevacizumab (control arm) (n=243).

The dual primary endpoints are ORR and progression-free survival (PFS), as assessed by blinded independent central review (BICR). Key secondary endpoints include DoR as assessed by BICR, time to response by BICR, overall survival, and safety.

About BRAFTOVI® (encorafenib)

BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including CRC.

Pfizer has exclusive rights to BRAFTOVI in the U.S., Canada, Latin America, Middle East, and Africa. Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel and Pierre Fabre has exclusive rights to commercialize the product in all other countries, including Europe and Asia (excluding Japan and South Korea).

U.S. INDICATION AND USAGE

BRAFTOVI® (encorafenib) is indicated, in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

BRAFTOVI is indicated, in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.

IMPORTANT SAFETY INFORMATION

Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 for recommended dosing and additional safety information.

WARNINGS AND PRECAUTIONS

New Primary Malignancies: New primary malignancies, cutaneous and non-cutaneous, can occur. In BEACON CRC (previously treated BRAF V600E mutation-positive mCRC), cutaneous squamous cell carcinoma (cuSCC), including keratoacanthoma (KA), occurred in 1.4% of patients with CRC, and a new primary melanoma occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC) skin papilloma was reported in 2.6%, basal cell carcinoma in 1.3%, squamous cell carcinoma of skin in 0.9%, keratoacanthoma in 0.4% and malignant melanoma in situ in 0.4% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Dose modification is not recommended for new primary cutaneous malignancies. Based on its mechanism of action, BRAFTOVI may promote malignancies associated with activation of RAS through mutation or other mechanisms. Monitor patients receiving BRAFTOVI for signs and symptoms of non-cutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive non-cutaneous malignancies. Monitor patients for new malignancies prior to initiation of treatment, while on treatment, and after discontinuation of treatment.

Tumor Promotion in BRAF Wild-Type Tumors: In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation using an FDA-approved test prior to initiating BRAFTOVI.

Cardiomyopathy: Cardiomyopathy manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ejection fraction, has been reported in patients. Assess left ventricular ejection fraction (LVEF) by echocardiogram or multi-gated acquisition (MUGA) scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. The safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal (LLN). Patients with cardiovascular risk factors should be monitored closely. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hepatotoxicity: Hepatotoxicity can occur. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), the incidence of Grade 3 or 4 increases in liver function laboratory tests in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6 was 2.2% for alkaline phosphatase, 1.3% for ALT, and 0.9% for AST. Monitor liver laboratory tests before initiation of BRAFTOVI, monthly during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hemorrhage: In BEACON CRC (previously treated BRAF V600E mutation-positive mCRC), hemorrhage occurred in 19% of patients receiving BRAFTOVI in combination with cetuximab; Grade 3 or higher hemorrhage occurred in 1.9% of patients, including fatal gastrointestinal hemorrhage in 0.5% of patients. The most frequent hemorrhagic events were epistaxis (6.9%), hematochezia (2.3%), and rectal hemorrhage (2.3%).In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), hemorrhage occurred in 30% of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6; Grade 3 or 4 hemorrhage occurred in 3% of patients. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Uveitis: Uveitis, including iritis and iridocyclitis, has been reported in patients treated with BRAFTOVI. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

QT Prolongation: BRAFTOVI is associated with dose-dependent QTc interval prolongation in some patients. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), an increase of QTcF >500 ms was measured in 3.6% (8/222) of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms.

Embryo-Fetal Toxicity: BRAFTOVI can cause fetal harm when administered to pregnant women. BRAFTOVI can render hormonal contraceptives ineffective. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose.

Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with cetuximab, or in combination with cetuximab and mFOLFOX6. Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 for additional risk information.

Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the final dose.

Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility.

ADVERSE REACTIONS

BREAKWATER Trial (previously untreated BRAF V600E mutation-positive mCRC)

  • Serious adverse reactions occurred in 38% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Serious adverse reactions in >3% of patients included intestinal obstruction (3.5%) and pyrexia (3.5%).
  • Fatal gastrointestinal perforation occurred in 0.9% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6.
  • Most common adverse reactions (≥25%, all grades) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab) were peripheral neuropathy (62% vs 53%), nausea (51% vs 48%), fatigue (49% vs 38%), rash (31% vs 4%), diarrhea (34% vs 47%), decreased appetite (33% vs 25%), vomiting (33% vs 21%), hemorrhage (30% vs 18%), abdominal pain (26% vs 27%), and pyrexia (26% vs 14%).
  • Most common laboratory abnormalities (≥10%, grade 3 or 4) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab) were: increased lipase (51% vs 25%), decreased neutrophil count (36% vs 34%), decreased hemoglobin (13% vs 5%), decreased white blood cell count (12% vs 7%), and increased glucose (11% vs 2%).

BEACON CRC Trial (previously treated BRAF V600E mutation-positive mCRC)

  • Most common adverse reactions (≥25%, all grades) in the BRAFTOVI with cetuximab arm compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were: fatigue (51% vs 50%), nausea (34% vs 41%), diarrhea (33% vs 48%), dermatitis acneiform (32% vs 43%), abdominal pain (30% vs 32%), decreased appetite (27% vs 27%), arthralgia (27% vs 3%), and rash (26% vs 26%).
  • Other clinically important adverse reactions occurring in <10% of patients who received BRAFTOVI in combination with cetuximab was pancreatitis.
  • Most common laboratory abnormalities (all grades) (≥20%) in the BRAFTOVI with cetuximab arm compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were: anemia (34% vs 48%) and lymphopenia (24% vs 35%).

DRUG INTERACTIONS

Strong or moderate CYP3A4 inhibitors: Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose.

Strong CYP3A4 inducers: Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers.

Sensitive CYP3A4 substrates: Avoid the coadministration of BRAFTOVI with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. If the coadministration cannot be avoided, see the CYP3A4 substrate product labeling for recommendations.

Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI.

Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval.

View the full Prescribing Information. There may be a delay as the document is updated with the latest information. It will be available as soon as possible. Please check back for the updated full information shortly.

About Pfizer Oncology

At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice

The information contained in this release is as of December 20, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about the BRAFTOVI® (encorafenib) plus cetuximab and mFOLFOX6 combination and a new indication in the U.S. for thetreatment of patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, including their potential benefits and discussions with other regulatory authorities to support potential future additional license applications for the BRAFTOVI combination regimen in this indication, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BRAFTOVI plus cetuximab and mFOLFOX6; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications may be filed in any additional jurisdictions for BRAFTOVI plus cetuximab and mFOLFOX6 for the treatment of patients with metastatic CRC with a BRAF V600E mutation or in any jurisdictions for any other potential indications for BRAFTOVI; whether and when any such other applications may be approved by regulatory authorities, which will depend on a myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether BRAFTOVI plus cetuximab and mFOLFOX6 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BRAFTOVI or BRAFTOVIplus cetuximab and mFOLFOX6; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Erbitux® is a registered trademark of Eli Lilly and Company and Merck KGaA, Darmstadt, Germany.

References

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1 BRAFTOVI (encorafenib) Prescribing Information. Array BioPharma, Inc.; December 2024

2 American Cancer Society. Global Cancer Facts & Figures 5th Edition. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-2024.pdf. Last accessed: December 2024.

3 American Cancer Society. Key Statistics for Colorectal Cancer. Available at: https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html. Last accessed: December 2024.

4 American Cancer Society. Cancer Facts & Figures 2024. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf. Last accessed: December 2024.

5 Ciardiello F, Ciardiello D, Martini G, et al. Clinical management of metastatic colorectal cancer in the era of precision medicine. CA Cancer J Clin. 2022;72:372–40.

6 Djanani A, Eller S, Öfner D, et al. The role of BRAF in metastatic colorectal carcinoma-past, present, and future. Int J Mol Sci. 2020;21(23):9001.

7 Safaee Ardekani G, Jafarnejad SM, Tan L, et al. The prognostic value of BRAF mutation in colorectal cancer and melanoma: a systematic review and meta-analysis. PloS ONE. 2012;7(10):e47054.

8 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Colon Cancer. V.5.2024 © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed December 2024. To view the most recent and complete version of the guideline, go online to NCCN.org.

9 Cervantes A, Adam R, Roselló S, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(1):10–32.

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INDUSTRY KEYWORDS: Research FDA Clinical Trials Biotechnology Health Pharmaceutical General Health Science Oncology

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Beyond, Inc. Announces Sale of Corporate Headquarters Closing

Company On Track to Deliver $65 Million Annualized Fixed Cost Reduction 

Company to Maintain Presence in Salt Lake City

MIDVALE, Utah, Dec. 20, 2024 (GLOBE NEWSWIRE) — Beyond, Inc. (NYSE:BYON), owner of Bed Bath & Beyond, Overstock, Zulily, and other online retail brands designed to unlock your family’s and home’s potential (“the Company”), today announced that it has completed the transaction with Salt Lake County to sell the Company’s corporate headquarters located in Midvale, Utah on December 20, 2024. The sale of the corporate headquarters aligns with the Company’s strategic plan to reduce debt and fixed costs, free up capital for new growth opportunities, and generate cash flow.

“I am pleased to report we have delivered almost 90% of our $65 million annualized fixed cost expense reduction while making sequential progress on our critical business KPIs, with meaningful improvement in December,” said Adrianne Lee, Chief Financial and Administrative Officer. “We have leased new office space in the Salt Lake City area to serve as our corporate headquarters, which is well-suited for the current and evolving needs of our business and will reduce our fixed cost expense base.”

The sale of the corporate headquarters includes a lease-back to the Company, by which the Company can continue to use and occupy a 5,000 square foot data center. The Company intends to use the proceeds from the sale to fully pay off its associated mortgage obligations, with the remainder to fund operations.


About Beyond


Beyond, Inc. (NYSE:BYON), based in Midvale, Utah, is an ecommerce expert with a singular focus: connecting consumers with products and services that unlock their families’ and homes’ potential. The Company owns Overstock, Bed Bath & Beyond, Baby & Beyond, Zulily, and other related brands and associated intellectual property. Its suite of online shopping brands features millions of products for various life stages that millions of customers visit each month. Beyond regularly posts information about the Company and other related matters on the Newsroom and Investor Relations pages on its website, Beyond.com.

Beyond, Bed Bath & Beyond, Welcome Rewards, Zulily, Overstock and Backyard are trademarks of Beyond, Inc. Other service marks, trademarks and trade names which may be referred to herein are the property of their respective owners.


Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements include all statements other than statements of historical fact, including but not limited to statements regarding the timing and use of lease-back, and our use of proceeds from the sale of our corporate headquarters. Additional information regarding factors that could materially affect results and the accuracy of the forward-looking statements contained herein may be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 23, 2024, on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on October 25, 2024, and in our subsequent filings with the SEC.

 

Contact Information
 
Investor Relations & Public Relations
[email protected]
[email protected]
 
 



DAT: November truckload volumes lagged robust October

DAT: November truckload volumes lagged robust October

BEAVERTON, Ore.–(BUSINESS WIRE)–
After gaining momentum throughout the year, last month spot truckload freight volumes retreated to their lowest point since January, said DAT Freight & Analytics, which operates the DAT One freight marketplace and DAT iQ data analytics service.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241220897542/en/

DAT: November truckload volumes lagged robust October (Photo: DAT Freight & Analytics)

DAT: November truckload volumes lagged robust October (Photo: DAT Freight & Analytics)

The DAT Truckload Volume Index (TVI) declined for all three equipment categories compared to October:

  • Van TVI: 246, down 18%

  • Refrigerated TVI: 204, down 11%

  • Flatbed TVI: 242, down 23%

The TVI was higher year over year only for reefer freight, up 7% compared to November 2023. The van and flatbed TVI were down 1% and 5%, respectively.

“Shippers moved so much freight into the U.S. earlier this year, ahead of potential tariffs and port strikes, that we didn’t see the volumes we might expect in November,” said Ken Adamo, DAT Chief of Analytics. “The exception was reefer freight. The late Thanksgiving gave grocers a few extra shipping days for fresh and frozen goods.”

Spot reefer rate strengthened ahead of the holiday

The national average spot rate for reefer freight increased 6 cents to $2.45 a mile, the most since January. The van rate was unchanged at $2.02 and the flatbed rate fell 5 cents to $2.37.

The van linehaul rate averaged $1.64 a mile, up 1 cent compared to October. The reefer rate was $2.04, up 7 cents, and the flatbed rate slipped 3 cents to $1.93. Rates are about 5% higher year over year.

Contract rates dipped but show signs of strength

National average contract rates were changed little last month:

  • Contract van rate: $2.40 per mile, down 1 cents but 11 cents lower year over year

  • Contract reefer rate: $2.74 a mile, unchanged and down 18 cents year over year

  • Contract flatbed rate: $3.03 a mile, down 1 cent and 11 cents lower than last year

At 0.3%, the DAT iQ New Rate Differential (NRD) for van freight was above zero for the third month in a row for the first time since Spring 2022. The NRD measures changes in the contract market by comparing rates entering the market to those exiting; a positive NRD signals a tightening market and higher rates for shippers.

“The NRD suggests that truckload pricing for contract freight is moving higher,” Adamo said. “We don’t expect bold changes quickly, but all indications point to steady rate growth into the first half of 2025.”

About the DAT Truckload Volume Index

The DAT Truckload Volume Index reflects the change in the number of loads with a pickup date during that month. A baseline of 100 equals the number of loads moved in January 2015, as recorded in DAT RateView, a truckload pricing database and analysis tool with rates paid on an average of 3 million monthly loads.

DAT benchmark spot rates are derived from invoice data for hauls of 250 miles or more with a pickup date during the month reported. Linehaul rates subtract an amount equal to an average fuel surcharge.

About DAT Freight & Analytics

DAT Freight & Analytics operates both the largest truckload freight marketplace and truckload freight data analytics service in North America. Shippers, transportation brokers, carriers, news organizations, and industry analysts rely on DAT for market trends and data insights based on more than 400 million annual freight matches, and a database of $150 billion in annual freight market transactions.

Founded in 1978, DAT is a business unit of Roper Technologies (Nasdaq: ROP), a constituent of the Nasdaq 100, S&P 500, and Fortune 1000. DAT is headquartered in Beaverton, Ore. Visit dat.com for more information.

DAT Contact

Georgia Jablon

[email protected] / [email protected]

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DAT: November truckload volumes lagged robust October (Photo: DAT Freight & Analytics)

APPLIED THERAPEUTICS BREAKING NEWS: BFA Law Announces that Applied Therapeutics, Inc. has been Sued for Securities Fraud – Investors with Losses Urged to Contact the Firm (NASDAQ:APLT)

NEW YORK, Dec. 20, 2024 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Applied Therapeutics, Inc. (NASDAQ: APLT) and certain of the Company’s senior executives for potential violations of the federal securities laws.

If you invested in Applied Therapeutics, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc.

Investors have until February 18, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in Applied Therapeutics securities. The case is pending in the U.S. District Court for the Southern District of New York and is captioned Alexandru v. Applied Therapeutics, Inc.et al., No. 24-cv-09715.

What is the Lawsuit About?

Applied Therapeutics is a clinical-stage biopharmaceutical company specializing in the development of novel drug candidates against validated molecular targets in rare diseases. The Company’s lead drug candidate, govorestat, is a central nervous system penetrant Aldose Reductase Inhibitor for the treatment of CNS rare metabolic diseases, including Galactosemia.

During the relevant period, the Company stated that its New Drug Applications submitted to regulators for govorestat were “supported by rapid and sustained reduction in galactitol, which resulted in a meaningful benefit on clinical outcomes across pediatric patients, alongside a favorable safety profile.” Applied Therapeutics also assured investors that its tests were “performed properly” and that the Company “felt good about the quality of the data,” stating that it “took really extensive steps” and “actually videotaped” and had “master trainers” review all of the performances of the 10-meter walk-run test—the primary endpoint of the Company’s Phase III INSPIRE study for govorestat.

The Stock Declines as the Truth is Revealed

On November 27, 2024, Applied Therapeutics issued a press release stating that the FDA issued a Complete Response Letter for the NDA for govorestat. The Complete Response Letter stated that the FDA completed its review of the application and determined that it was unable to approve the NDA due to “deficiencies in the clinical application.”

This news caused the price of Applied Therapeutics stock to fall more than 80% over the course of multiple trading days, from a closing price of $10.21 per share on November 26, 2024 to a closing price of $1.75 per share on December 2, 2024.

Then, on December 2, 2024, Applied Therapeutics revealed that it received a warning letter from the FDA relating to its govorestat study discussing “issues related to electronic data capture” and “a dosing error in the dose-escalation phase of the study resulting in slightly lower levels than targeted in a limited number of patients[.]”

This news caused the price of Applied Therapeutics stock to fall more than 26% over the course of multiple trading days, from a closing price of $1.75 per share on December 2, 2024 to a closing price of $1.29 per share on December 5, 2024.

Click here for more information:

https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc

.

What Can You Do?

If you invested in Applied Therapeutics you may have legal options and are encouraged to submit your information to the firm.

All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.

Submit your information by visiting:


https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc

Or contact:
Ross Shikowitz
[email protected]
212-789-3619

Why Bleichmar Fonti & Auld LLP?

Bleichmar Fonti & Auld LLP is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs’ Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.’s Board of Directors (pending court approval), as well as $420 million from Teva Pharmaceutical Ind. Ltd.

For more information about BFA and its attorneys, please visit https://www.bfalaw.com.


https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc

Attorney advertising. Past results do not guarantee future outcomes.