Corcept Therapeutics to Announce Fourth Quarter and Full-Year 2025 Financial Results, Provide Corporate Update and Host Conference Call

Corcept Therapeutics to Announce Fourth Quarter and Full-Year 2025 Financial Results, Provide Corporate Update and Host Conference Call

REDWOOD CITY, Calif.–(BUSINESS WIRE)–
Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced it will report fourth quarter and full-year 2025 financial results and provide a corporate update on February 24, 2026. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

Conference Call Information

Participants must register in advance of the conference call by clicking here.Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller.

Additionally, a listen-only webcast will be available by clicking here.

A replay of the call will be available on the Investors / Events tab of Corcept.com.

About Corcept Therapeutics

For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.

Investor inquiries:

[email protected]

Media inquiries:

[email protected]

www.corcept.com

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Neurology Diabetes Genetics Clinical Trials Biotechnology Health Pharmaceutical General Health Oncology

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Medifast Announces Fourth Quarter and Full Year 2025 Financial Results

Medifast Announces Fourth Quarter and Full Year 2025 Financial Results

BALTIMORE–(BUSINESS WIRE)–Medifast (NYSE: MED), the health and wellness company known for its science-backed, coach-guided lifestyle system, today reported results for the fourth quarter and full year ended December 31, 2025.

Fourth Quarter 2025

  • Revenue of $75.1 million, with revenue per active earning coach of $4,664

  • Independent active earningcoaches of 16,100

  • Net loss of $18.1 million, or $1.65 per diluted share (“EPS”), which includes the tax provision charge to establish a non-cash valuation allowance on the Company’s deferred tax balance of $12.1 million (or $1.10 per diluted share)

  • Cash, cash equivalents, and investment Securities of $167.3 million and no debt

Full Year 2025

  • Revenue of $385.8 million

  • Net loss of $18.7 million, or $1.70 per diluted share, which includes the tax provision charge to establish a non-cash valuation allowance on the Company’s deferred tax balance of $12.1 million (or $1.10 per diluted share)

“As we enter 2026, Medifast is moving from defining its business transformation strategy to executing on a new path to growth, leading to profitability as we become wholly focused on optimal metabolic health,” said Dan Chard, Chairman and Chief Executive Officer of Medifast.

“In the fourth quarter, we saw coach productivity turn positive year-over-year for the first time since 2022, which has historically been a lead indicator of broader improvement. We also saw a significant increase in coach-led meetings, an indication our coach base is energized and dialed-in to the opportunities ahead. Our foundational work of the past two years has established a direction for future growth, and with these plans in place, we are reinstating annual guidance as we execute against the path we are on to become a metabolic health company.”

Fourth Quarter 2025 Results

Fourth quarter 2025 revenue decreased 36.9% to $75.1 million from $119.0 million for the fourth quarter of 2024 primarily driven by a decrease in the number of active earning coaches. The total number of active earning coaches decreased 40.6% to 16,100 compared to 27,100 for the fourth quarter of 2024. The decrease in the number of active earning coaches was driven by continued pressure with client acquisition reflecting broader challenges in the operating environment, including rapid adoption of GLP-1 medications for weight loss. The average revenue per active earning coach was $4,664, compared to $4,391 for the fourth quarter last year, an increase of 6.2% which was driven by greater alignment of the company’s network of coaches, prioritizing productive coaches and efficient coach network structures.

Gross profit decreased 40.9% to $52.1 million from $88.2 million for the fourth quarter of 2024. The decrease in gross profit was primarily due to lower revenue. The company’s gross profit as a percentage of revenue was 69.4% compared to 74.1% in the fourth quarter of 2024. The decrease in gross profit as a percentage of revenue was primarily driven by the loss of leverage on fixed costs of 420 basis points and a one-time restructuring charge of 40 basis points.

Selling, general, and administrative expenses (“SG&A”) decreased 31.5% to $59.9 million compared to $87.5 million for the fourth quarter of 2024. The decrease in SG&A was primarily due to a $18.6 million decrease in coach compensation due to lower sales volumes and a decrease in the number of active earning coaches, a $5.8 million decrease in company-led marketing related expenses, and a $4.2 million decrease resulting from the realignment of the employee base to lower revenue levels, partially offset by a $1.9 million increase due to a one-time restructuring charge and a $1.6 million increase in coach events costs. As a percentage of revenue, SG&A increased 630 basis points year-over-year to 79.8% of revenue, as compared to 73.5% for the fourth quarter of 2024. The increase in SG&A as a percentage of revenue was primarily due to 370 basis points of loss of leverage on fixed costs, a 300 basis point increase for increased coach event costs, and a 250 basis point increase due to a one-time restructuring charge, partially offset by 440 basis points of reduced company-led marketing related expenses.

Loss from operations was $7.8 million compared to income from operations of $0.7 million in the prior year period. As a percentage of revenue, loss from operations was 10.4% for the fourth quarter of 2025 compared to income from operations of 0.6% in the prior-year period due to the factors described above impacting revenue and SG&A expenses.

Other income increased 151.1% to $1.4 million from $0.6 million for the fourth quarter of 2024. The increase in other income was primarily due to unrealized losses on the investment in LifeMD common stock in the prior period. The company sold its investment in LifeMD during the three months ended June 30, 2025.

The effective tax rate was negative 183.9% for the fourth quarter of 2025 compared to 37.3% in the prior-year period, primarily due to establishing a $12.1 million non-cash valuation allowance against the Company’s deferred tax assets in the current period.

In the fourth quarter of 2025, net loss was $18.1 million, or $1.65 loss per diluted share, based on approximately 11.0 million shares of common stock outstanding. In the fourth quarter of 2024, net income was $0.8 million, or $0.07 per diluted share, based on approximately 10.9 million shares of common stock outstanding. The $12.1 million non-cash valuation allowance represents $1.10 of current period loss on a per share basis.

Full Year Fiscal 2025 Results

For the fiscal year ended December 31, 2025, revenue decreased 36.0% to $385.8 million compared to revenue of $602.5 million in 2024. Net loss for 2025 was $18.7 million, or $1.70 loss per diluted share, based on approximately 11.0 million shares outstanding. This compares to 2024 net income of $2.1 million, or $0.19 per diluted share, based on approximately 11.0 million shares outstanding. The $12.1 million non-cash valuation allowance represents $1.10 of current period loss on a per share basis.

Capital Allocation and Balance Sheet

The company’s balance sheet remains strong with cash, cash equivalents, and investment securities of $167.3 million and no interest-bearing debt as of December 31, 2025, compared to $162.3 million in cash and cash equivalents and no debt at December 31, 2024. Working capital as defined as current assets less current liability as of December 31, 2025 was 158.7 million, compared to $150.2 million of working capital at December 31, 2024.

Outlook

The company expects first quarter 2026 revenue to be in the range of $65 million to $80 million and first quarter 2026 loss per share to range from $0.15 to $0.70. The company expects full year 2026 revenue to be in the range of $270 million to $300 million and full year 2026 loss per share to range from $1.55 to $2.75.

Conference Call Information

The conference call is scheduled for today, Tuesday, February 17, 2026 at 4:30 PM ET. The call will be broadcast live over the Internet, hosted on the Investor Relations section of Medifast’s website at www.MedifastInc.com or directly at https://viavid.webcasts.com/starthere.jsp?ei=1749244&tp_key=cd37227dbd and will be archived online and available through May 17, 2026. In addition, listeners may dial (201) 389-0879 to join via telephone.

A telephonic playback will be available from February 17, 2026 at 7:30 PM ET through Tuesday, February 24, 2026 at 11:59 PM ET. Participants can dial (412) 317-6671 and enter passcode 13758136 to hear the playback.

About Medifast®:

Medifast (NYSE: MED) is the health and wellness company known for its science-backed, coach-guided lifestyle system. Designed to help address the challenges of metabolic dysfunction, the company’s holistic approach integrates personalized plans, scientifically developed products and a framework for habit creation — all supported by a dedicated network of independent coaches.

Driven to improve metabolic health through advanced science and comprehensive behavioral support, Medifast has introduced Metabolic Synchronization™, a breakthrough science that reverses metabolic dysfunction through a targeted reset. Research demonstrates the company’s comprehensive system activates strong and targeted fat burn to enhance metabolic health and body composition by reducing visceral fat, preserving lean mass and protecting muscle integrity.

Backed by more than 40 years of clinical heritage, Medifast continues to advance its mission of Lifelong Transformation, Making Healthy Lifestyle Second Nature®. For more information, visit Medifastinc.com.

MED-F

Forward Looking Statements

Please Note: This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified by use of phrases or terminology such as “intend,” “anticipate,” “expect” or other similar words or the negative of such terminology. Similarly, descriptions of Medifast’s objectives, strategies, plans, goals, outlook or targets contained herein are also considered forward-looking statements. These statements are based on the current expectations of the management of Medifast and are subject to certain events, risks, uncertainties and other factors. Some of these factors include, among others, Medifast’s inability to maintain and grow the network of independent coaches; industry competition and new weight loss products, including weight loss medications such as GLP-1s, or services; Medifast’s health or advertising related claims by clients; Medifast’s inability to continue to develop new products; effectiveness of Medifast’s advertising and marketing programs, including use of social media by coaches; effectiveness of the Company’s strategic pivot towards metabolic health; the departure of one or more key personnel; Medifast’s inability to protect against online security risks and cyberattacks; competitors use of artificial intelligence to make their offer more competitive; risks associated with Medifast’s direct-to-consumer business model; disruptions in Medifast’s supply chain; product liability claims; adverse publicity associated with Medifast’s products; the impact of existing and future laws and regulations on Medifast’s business; fluctuations of Medifast’s common stock market price; increases in litigation; actions of activist investors; the consequences of other geopolitical events, overall economic and market conditions and the resulting impact on consumer sentiment and spending patterns; and Medifast’s ability to prevent or detect a failure of internal control over financial reporting. Although Medifast believes that the expectations, statements and assumptions reflected in these forward-looking statements are reasonable, it cautions readers to always consider all of the risk factors and any other cautionary statements carefully in evaluating each forward-looking statement in this release, as well as those set forth in its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and other filings filed with the United States Securities and Exchange Commission, including its quarterly reports on Form 10-Q and current reports on Form 8-K. All of the forward-looking statements contained herein speak only as of the date of this release.

MEDIFAST, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

(U.S. dollars in thousands, except per share amounts & dividend data)

 

 

Three months ended December 31,

 

Year ended December 31,

 

2025

 

2024

 

2025

 

2024

 

 

 

 

 

 

 

 

Revenue

$

75,096

 

$

119,003

 

$

385,788

 

$

602,463

Cost of sales

 

22,956

 

 

30,784

 

 

110,601

 

 

157,840

Gross profit

 

52,140

 

 

88,219

 

 

275,187

 

 

444,623

 

 

 

 

 

 

 

 

Selling, general, and administrative

 

59,943

 

 

87,510

 

 

289,400

 

 

441,745

 

 

 

 

 

 

 

 

Income (loss) from operations

 

(7,803)

 

 

709

 

 

(14,213)

 

 

2,878

 

 

 

 

 

 

 

 

Other income

 

 

 

 

 

 

 

Interest income

 

1,420

 

 

953

 

 

5,516

 

 

4,804

Other income (expense)

 

1

 

 

(387)

 

 

3,058

 

 

(3,895)

 

 

1,421

 

 

566

 

 

8,574

 

 

909

 

 

 

 

 

 

 

 

Income (loss) from operations before income taxes

 

(6,382)

 

 

1,275

 

 

(5,639)

 

 

3,787

 

 

 

 

 

 

 

 

Provision for income taxes

 

11,737

 

 

475

 

 

13,033

 

 

1,696

 

 

 

 

 

 

 

 

Net income (loss)

$

(18,119)

 

$

800

 

$

(18,672)

 

$

2,091

 

 

 

 

 

 

 

 

Earnings (loss) per share – basic

$

(1.65)

 

$

0.07

 

$

(1.70)

 

$

0.19

 

 

 

 

 

 

 

 

Earnings (loss) per share – diluted

$

(1.65)

 

$

0.07

 

$

(1.70)

 

$

0.19

 

 

 

 

 

 

 

 

Weighted average shares outstanding

 

 

 

 

 

 

 

Basic

 

10,991

 

 

10,938

 

 

10,981

 

 

10,930

Diluted

 

10,991

 

 

10,983

 

 

10,981

 

 

10,963

MEDIFAST, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

(U.S. dollars in thousands, except par value)

 

 

December 31, 2025

 

December 31, 2024

ASSETS

 

 

 

Current Assets

 

 

 

Cash and cash equivalents

$

89,303

 

$

90,928

Inventories, net

 

20,228

 

 

42,421

Investments

 

77,970

 

 

71,416

Income taxes, prepaid

 

5,116

 

 

Prepaid expenses and other current assets

 

9,066

 

 

9,639

Total current assets

 

201,683

 

 

214,404

 

 

 

 

Property, plant and equipment – net of accumulated depreciation

 

31,230

 

 

37,527

Right-of-use assets

 

7,232

 

 

11,155

Other assets

 

7,828

 

 

9,667

Deferred tax assets, net

 

 

 

11,460

 

 

 

 

TOTAL ASSETS

$

247,973

 

$

284,213

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

Current Liabilities

 

 

 

Accounts payable and accrued expenses

$

38,359

 

$

56,494

Income taxes payable

 

 

 

1,485

Current lease obligations

 

4,603

 

 

6,182

Total current liabilities

 

42,962

 

 

64,161

 

 

 

 

Lease obligations, net of current lease obligations

 

6,091

 

 

9,943

Total liabilities

 

49,053

 

 

74,104

 

 

 

 

Commitments

 

 

 

 

 

 

 

Stockholders’ Equity

 

 

 

Common stock, par value 0.001 per share: 20,000 shares authorized; 10,991 and 10,938 issued and outstanding at December 31, 2025 and December 31, 2024

 

11

 

 

11

Additional paid-in capital

 

40,406

 

 

33,136

Accumulated other comprehensive income

 

234

 

 

180

Retained earnings

 

158,269

 

 

176,782

Total stockholders’ equity

 

198,920

 

 

210,109

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

247,973

 

$

284,213

 

Investor Contact:

Medifast, Inc.

Steven Zenker

[email protected]

(443) 379-5256

KEYWORDS: United States North America Maryland

INDUSTRY KEYWORDS: Research Vitamins/Supplements Fitness & Nutrition Alternative Medicine Lifestyle Health Consumer General Health Science

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Pega to Present at Upcoming Investor Conferences

Pega to Present at Upcoming Investor Conferences

WALTHAM, Mass.–(BUSINESS WIRE)–Pegasystems Inc. (NASDAQ: PEGA), The Enterprise Transformation Company™, today announced that Ken Stillwell, COO and CFO, Pega, will be presenting at the following upcoming investor conferences:

Archives of the presentations will be available from the Investors page of Pega’s website for a limited time.

About Pegasystems

Pega provides the leading AI-powered platform for enterprise transformation. The world’s most influential organizations trust our technology to reimagine how work gets done by automating workflows, personalizing customer experiences, and modernizing legacy systems. Since 1983, our scalable, flexible architecture has fueled continuous innovation, helping clients accelerate their path to the autonomous enterprise. Ready to Build for Change®? Visit www.pega.com.

All trademarks are the property of their respective owners.

Press Contact:

Lisa Pintchman

VP, Corporate Communications

[email protected]

617-866-6022

Investor Contact:

Peter Welburn

VP, Corporate Development & Investor Relations

[email protected]

617-498-8968

KEYWORDS: California Massachusetts United States North America

INDUSTRY KEYWORDS: Professional Services Data Management Data Analytics Technology Software Consulting Artificial Intelligence

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United Rentals Named One of America’s Best-Managed Companies

United Rentals Named One of America’s Best-Managed Companies

Company Selected to Management Top 250 Presented by Wall Street Journal

STAMFORD, Conn.–(BUSINESS WIRE)–
United Rentals, Inc. (NYSE: URI), the world’s largest equipment rental company, has been again selected to The Wall Street Journal’s Management Top 250 list. The ranking, developed by the Drucker Institute and published by The Wall Street Journal, identifies America’s most effectively managed publicly-traded companies based on comprehensive performance metrics.

The Best-Managed Companies ranking measures corporate management effectiveness by examining performance in five areas: customer satisfaction, employee engagement and development, innovation, social responsibility and financial strength. It is based on an analysis of 34 data inputs provided by 15 third-party sources. Notably, United Rentals ranked #3 in customer satisfaction among the 668 companies assessed, #36 in employee engagement and #96 in financial strength.

“We’re honored by this recognition, which is driven by the hard work of our 28,000-plus team members,” said Matthew Flannery, President and Chief Executive Officer, United Rentals. “This ranking underscores our commitment to our customers, our people, and the communities we serve, while creating long-term value for all stakeholders.”

Information on career opportunities can be found on the United Rentals Careers website.

About United Rentals

United Rentals, Inc. is the largest equipment rental company in the world. The company has an integrated network of 1,663 rental locations in North America, 41 in Europe, 45 in Australia and 19 in New Zealand. In North America, the company operates in 49 states and every Canadian province. The company’s approximately 28,500 employees serve construction and industrial customers, utilities, municipalities, homeowners and others. The company offers a fleet of equipment for rent with a total original cost of $22.48 billion. United Rentals is a member of the Standard & Poor’s 500 Index, the Barron’s 400 Index and the Russell 3000 Index® and is headquartered in Stamford, Conn. Additional information about United Rentals is available at unitedrentals.com.

Elizabeth Grenfell

Vice President, Investor Relations

O: (203) 618-7125

[email protected]

KEYWORDS: Connecticut United States North America

INDUSTRY KEYWORDS: Commercial Building & Real Estate Construction & Property Human Resources Publishing Communications Professional Services Interior Design Building Systems Architecture Residential Building & Real Estate

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agilon health to Participate in Upcoming Conferences

agilon health to Participate in Upcoming Conferences

WESTERVILLE, Ohio–(BUSINESS WIRE)–
agilon health, inc. (NYSE: AGL), the trusted partner empowering physicians to transform health care in our communities, today announced that its management team will participate in a fireside chat at the following conferences:

  • 46th Annual Cowen Health Care Conference on Monday, March 2, 2026. A live webcast will be available on the company’s investor relations website at 10:30am ET.

  • Jefferies Healthcare Services Innovation & Technology Summit on Monday, March 9, 2026 at 10:00am ET. A webcast of this event will not be available due to the event format.

  • 28th Annual Barclays Global Healthcare Conference on Tuesday, March 10, 2026. A live webcast will be available on the company’s investor relations website at 1:30pm ET

Interested investors and other parties may listen to replays or a simultaneous webcast of the presentation as applicable by visiting the “Events & Presentations” section of agilon health’s investor relations website at https://investors.agilonhealth.com. Replays will be available for on-demand listening shortly after the completion of the presentation.

About agilon health

agilon health is the trusted partner empowering physicians to transform health care in our communities. Through our partnerships and purpose-built platform, agilon is accelerating at scale how physician groups and health systems transition to a value-based Total Care Model for their senior patients. agilon provides the technology, people, capital, process, and access to a peer network of approximately 2,200 primary care physicians (PCPs) that allow its physician partners to maintain their independence and focus on the total health of their most vulnerable patients. Together, agilon and its physician partners are creating the healthcare system we need – one built on the value of care, not the volume of fees. The result: healthier communities and empowered doctors. agilon is the trusted partner in approximately 30 diverse communities and is here to help more of our nation’s leading physician groups and health systems have a sustained, thriving future. For more information visit www.agilonhealth.com and connect with us on LinkedIn.

Investor Contacts

Evan Smith, CFA

SVP Investor Relations

[email protected]

Megan Cagle

[email protected]

Media Contacts

Stephanie Law

Senior Director, Marketing & Communications

[email protected]

KEYWORDS: United States North America Ohio

INDUSTRY KEYWORDS: Managed Care General Health Health Practice Management

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NovaBridge Doses First Patient in Global, Randomized Phase 2 Study of Givastomig Combined with Immunochemotherapy in Patients with 1L Metastatic Gastric Cancer

  • Global, randomized Phase 2 study to evaluate the addition of givastomig, a CLDN18.2 x 4-1BB bispecific antibody (8 mg/kg and 12 mg/kg) to standard of care immunochemotherapy in patients with first line (1L) metastatic gastric cancer
  • Major milestone builds on positive Phase 1b combination data demonstrating that givastomig produced, best-in-class potential efficacy in 1L HER2-negative, metastatic gastric cancer patients in combination with nivolumab and chemotherapy (mFOLFOX6)
  • Phase 1b results showed that patients treated with givastomig experienced an objective response rate (ORR) of 75%, median progression free survival (mPFS) of 16.9 months and 82% six-month landmark PFS
  • Gastric cancer represents a $12 billion market opportunity by 2030
  • Top line results from the Phase 2 study are expected in 2027

ROCKVILLE, Md., Feb. 17, 2026 (GLOBE NEWSWIRE) — NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, today announced enrollment of the first patient in the global Phase 2 randomized combination study evaluating givastomig, a Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy (mFOLFOX6) in patients with HER2-negative, 1L metastatic gastric cancer. Positive Phase 1b data position givastomig to be a potential best-in-class CLDN18.2-directed therapy for gastric cancer with a projected $12 billion market opportunity by 20301. Top line Phase 2 results are expected in 2027.

“We are pleased to be advancing givastomig one step closer towards commercialization, with the initiation of the global randomized Phase 2 study. The study builds on the compelling Phase 1b givastomig results, showing robust efficacy and favorable overall tolerability, and demonstrating a potential marked improvement relative to historical benchmarks for the standard of care. The Phase 2 study is designed to confirm these results in a broader setting and validate givastomig as a potential best in class therapy for 1L metastatic gastric cancer, with the potential for broad utilization across CLDN18.2 levels in PD-L1 positive patients,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. “We expect to present results from this study in 2027. In addition, we expect to present updated results from the Phase 1b dose expansion study in the second half of this year.”

“We continue to be encouraged by givastomig’s high response rate across a wide range of Claudin 18.2 and PD-L1 expression levels. The depth and duration of responses achieved with combination therapy coupled with the tolerability enabled the swift enrollment in the Phase 1b study and provides a strong basis to move to the next stage of development,” said Samuel J. Klempner, MD, Associate Professor of Medicine at Mass General Brigham Cancer Institute. “We are hopeful that, with continued positive clinical results, givastomig will ultimately become a standard of care for gastric and esophageal cancer.”

“Initiation of the Phase 2 study marks a pivotal moment for NovaBridge as we transition to a mid-stage clinical Company. Compelling Phase 1b efficacy and safety data validate givastomig’s potential as a premier CLDN18.2-directed therapy for gastric cancer and beyond. The strong and durable response data underscore our conviction in givastomig’s significant commercial potential,” said Sean Fu, PhD, MBA, Chief Executive Officer of NovaBridge. “We remain focused on developing novel, differentiated therapies that can transform the treatment of patients worldwide and believe that givastomig will be a cornerstone of our future growth.”

About the Givastomig Phase 1b Dose Escalation and Expansion Combination Study in 1L Gastric Cancer

The Phase 1b dose expansion data (per the January 6, 2026 press release and corporate presentation) showed that givastomig, dosed at 8 mg/kg every two weeks (Q2W) and 12 mg/kg Q2W, produced:

  • Robust efficacy, with 75% ORR (77% ORR observed at 8 mg/kg, 73% ORR observed at 12 mg/kg, n=52 evaluable)
  • Responses observed across a wide range of PD-L1 and CLDN18.2 expression levels
  • Durable responses with 16.9-month mPFS and an 82% 6-month landmark PFS rate (n=53 evaluable)
  • With good overall tolerability in combination with immunochemotherapy, without dose dependent toxicity

Detailed Phase 1b expansion data are expected to be presented at a major medical conference in H2 2026

About the Global, Randomized Phase 2 Study of Givastomig in the Setting of 1L Gastric Cancer

The Phase 2 global, randomized study is evaluating the safety and efficacy of givastomig, used in combination with nivolumab and mFOLFOX6, as 1L therapy in patients with CLDN18.2-positive gastric cancer, including gastroesophageal cancer (GEC), gastroesophageal junction cancer (GEJ), gastroesophageal adenocarcinoma (GEA), with CLDN18.2 levels of ≥1+ immunohistochemistry (IHC) intensity on ≥1% of cells, and PD-L1 expression ≥1. The study is expected to enroll approximately 180 patients (randomized equally to 8mg/kg givastomig, 12 mg/kg givastomig or nivolumab+mFOLFOX6). The primary endpoint is progression free survival (PFS); secondary endpoints include objective response rate (ORR), overall survival (OS), duration of response (DoR) and disease control rate (DCR). The study will enroll patients globally.

Sources:

  1. Markets include U.S., five E.U. countries, and Japan by 2030 for potential sales based on Data Monitor Biomed Tracker

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

About NovaBridge

NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. The Company combines deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need.

The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, Claudin 18.2 x 4-1BB bispecific antibody, and VIS-101, a second-in-class, potentially best-in-class bifunctional biologic, targeting VEGF-A and ANG2.

Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. The product candidate is being evaluated in a global, randomized Phase 2 study, following the recent announcement of positive topline results from a Phase 1b, multi-center, open label study in first line gastric cancer. The Company is also collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors. Additionally, NovaBridge owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody that targets adenosine-driven immunosuppression in cancer.

VIS-101 targets VEGF-A and ANG-2 to provide more potent and durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). VIS-101 is currently completing a randomized, dose-ranging Phase 2a study for wet AMD. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia.

For more information, please visit www.novabridge.com and follow us on LinkedIn.

Forward Looking Statements

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. NovaBridge may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the strategy, clinical development, plans, results, safety and efficacy of givastomig and VIS-101 and its other drug candidates; the strategic and clinical development of NovaBridge’s drug candidates, including givastomig, ragistomig, uliledlimab, and VIS-101; anticipated clinical milestones and results, and related timing. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: the Company’s ability to demonstrate the safety and efficacy of its drug candidates; the Company’s ability to enroll patients and complete clinical studies on the timelines contemplated; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the Company’s drug candidates; the Company’s ability to achieve commercial success for its drug candidates, if approved; the Company’s ability to obtain and maintain protection of intellectual property for its technology and drugs; the Company’s reliance on third parties to conduct drug development, manufacturing and other services; the Company’s limited operating history and the Company’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and those risks more fully discussed in the “Risk Factors” section in the Company’s annual report on Form 20-F filed with the SEC on April 3, 2025 as well as the discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to the Company. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.

NovaBridge Investor & Media Contacts

PJ Kelleher
LifeSci Advisors
+1-617-430-7579
[email protected]

NovaBridge Biosciences
+1-240-745-6330
[email protected]



Clearwater Paper Announces Participation in Bank of America Global Agricultural and Materials Conference

Clearwater Paper Announces Participation in Bank of America Global Agricultural and Materials Conference

SPOKANE, Wash.–(BUSINESS WIRE)–
Clearwater Paper Corporation (NYSE: CLW) today announced upcoming participation in the Bank of America 2026 Global Agricultural and Materials Conference on February 25, 2026, in Ft Lauderdale, FL.

President and Chief Executive Officer Arsen Kitch will participate in two presentations: a panel discussion beginning at approximately 11:15 a.m. Eastern Time and a fireside chat beginning at approximately 3:30 p.m. Eastern Time. He and Senior Vice President and Chief Financial Officer Sherri Baker will also be available for one-on-ones and small group investor meetings that day.

About Clearwater Paper Corporation

Clearwater Paper is a premier independent supplier of paperboard packaging products to North American converters. Headquartered in Spokane, Wash., our team produces high-quality paperboard that provides sustainable packaging solutions for consumer goods and food service applications. For additional information, please visit our website at www.clearwaterpaper.com.

Investor Contact:

Sloan Bohlen

Solebury Strategic Communications

509.344.5906

[email protected]

Media Contact:

Virginia Aulin

Clearwater Paper Corporation

509.344.5967

[email protected]

KEYWORDS: Florida Washington United States North America

INDUSTRY KEYWORDS: Forest Products Packaging Natural Resources Manufacturing

MEDIA:

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Leonardo DRS Awarded Contracts for the Missile Defense Agency SHIELD IDIQ

Leonardo DRS Awarded Contracts for the Missile Defense Agency SHIELD IDIQ

DRS brings rapid design and manufacturing strength to accelerate innovation for the warfighter

ARLINGTON, Va.–(BUSINESS WIRE)–
Leonardo DRS, Inc. (Nasdaq: DRS) announced today it was awarded multiple contracts for the Missile Defense Agency (MDA) Scalable Homeland Innovative Enterprise Layered Defense (SHIELD) indefinite-delivery/indefinite-quantity (IDIQ) contract with a ceiling of $151 billion. These contracts encompass a broad range of work areas that allow for the rapid delivery of innovative capabilities to the warfighter with increased speed and agility.

Leonardo DRS is a leading U.S. defense technology company with operations across the country, rapidly designing, manufacturing, and delivering diverse, innovative, integrated technologies that advance next-generation air and missile defense capabilities across all domains. Backed by deep mission expertise and a nationwide industrial footprint, we help customers accelerate capability—from concept through production and sustainment—to meet evolving threats with speed, scale, and reliability.

“Leonardo DRS has a proven track record of moving quickly to develop, integrate, and successfully deliver leading edge technologies and real-world mission capabilities that support some of the most critical needs of the U.S. military,” said John Baylouny, President and CEO of Leonardo DRS. “We stand ready today to answer the call with our next-generation air and missile defense capabilities and deliver proven performance at speed to help the Missile Defense Agency and the warfighter outpace rapidly evolving threats.”

This IDIQ contract award positions Leonardo DRS to compete for future task orders throughout the contract’s period of performance.

About Leonardo DRS

Leonardo DRS, Inc. (Nasdaq: DRS) is at the forefront of developing transformative defense technologies using its proven agility and delivering innovative solutions for U.S. national security customers and allies worldwide. We specialize in rapidly providing high-performance, multi-domain capabilities across next-generation advanced sensing, network computing, force protection, and electric power and propulsion. Our reputation as a trusted provider is built on a continuous focus on practical innovation, delivering quality, and meeting our customers’ most demanding mission requirements. For further information on our complete range of capabilities, visit www.LeonardoDRS.com.

Forward-Looking Statements

This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Those statements reflect current expectations, assumptions and estimates of future performance and economic conditions. The company cautions investors that any forward-looking statements which include contract values, contract performance and our development and production of products are subject to risks and uncertainties that may cause actual results and future trends to differ materially from those matters expressed in or implied by such forward-looking statements.

Leonardo DRS Investor Relations Contact

Steve Vather

Senior Vice President, Corporate Development (M&A) and Investor Relations

+1 703 409 2906

[email protected]

Leonardo DRS Media Contact

Carrie Robinson

Vice President, Marketing and Corporate Communications

+1 321 266 7691

[email protected]

KEYWORDS: United States North America Virginia

INDUSTRY KEYWORDS: Other Defense Contracts Hardware Technology Defense Other Manufacturing Security Satellite Government Technology Aerospace Manufacturing Military

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Voya Equity Closed End Funds Declare Distributions

Voya Equity Closed End Funds Declare Distributions

SCOTTSDALE, Ariz.–(BUSINESS WIRE)–
Voya Investment Management, the asset management business of Voya Financial, Inc. (NYSE: VOYA), announced today the distributions on the common shares of five of its closed-end funds: Voya Global Advantage and Premium Opportunity Fund (NYSE: IGA), Voya Global Equity Dividend and Premium Opportunity Fund (NYSE: IGD), Voya Infrastructure, Industrials and Materials Fund (NYSE: IDE), Voya Asia Pacific High Dividend Equity Income Fund (NYSE: IAE), and Voya Emerging Markets High Dividend Equity Fund (NYSE: IHD).

With respect to each Fund, the distribution will be paid on March 16, 2026, to shareholders of record on March 2, 2026. The ex-dividend date is March 2, 2026. The distribution per share for each Fund is as follows:

Fund

Distribution Per Share

Monthly Distributions

 

Voya Global Equity Dividend and Premium Opportunity Fund (NYSE: IGD)

$0.050

Voya Asia Pacific High Dividend Equity Income Fund (NYSE: IAE)

$0.065

Voya Emerging Markets High Dividend Equity Fund (NYSE: IHD)

$0.055

Voya Global Advantage and Premium Opportunity Fund (NYSE: IGA)

$0.085

Voya Infrastructure, Industrials and Materials Fund (NYSE: IDE)

$0.100

The following table sets forth an estimate of the sources of each Fund’s February distribution and its cumulative distributions paid this fiscal year to date. Amounts are expressed on a per common share basis and as a percentage of the distribution amount.

Data as of 1/31/2026
Estimated Sources Tax YTD1 Estimated Tax YTD Percentages
of Current Distribution Estimated Sources of Distribution of Distribution

 

Per Share

Net Investment

LT

ST

Return of

Per Share

Net Investment

LT

ST

Return of

Net Investment

LT

ST

Return of

Distribution Income Gains Gains Capital Distribution Income Gains Gains Capital Income Gains Gains Capital
IGA (FYE 2/28)

0.085

0.009

0.000

0.000

0.076

0.085

0.009

0.000

0.000

0.076

10.0%

0.0%

0.0%

90.0%

IGD (FYE 2/28)

0.050

0.005

0.000

0.000

0.045

0.050

0.005

0.000

0.000

0.045

11.0%

0.0%

0.0%

89.0%

IDE (FYE 2/28)

0.100

0.000

0.018

0.000

0.082

0.100

0.000

0.018

0.000

0.082

0.0%

18.0%

0.0%

82.0%

IHD (FYE 2/28)

0.055

0.000

0.000

0.000

0.055

0.055

0.000

0.000

0.000

0.055

0.0%

0.0%

0.0%

100.0%

IAE (FYE 2/28)

0.065

0.000

0.000

0.000

0.065

0.065

0.000

0.000

0.000

0.065

0.0%

0.0%

0.0%

100.0%

 
1 The Fund’s tax year is January 1, 2026 to December 31, 2026.

Set forth in the tables below is information relating to each Fund’s performance based on its net asset value (NAV) for certain periods.

Data as of 1/30/2026 Annualized Cumulative

 

Distribution

Rate

Tax YTD

Distribution

NAV

5-Year

Return on NAV

Tax

Distribution Rate

on NAV1

Tax YTD

Return on NAV

Tax YTD

Distribution Rate

on NAV1

IGA (FYE 2/28)

0.085

0.085

10.55

11.14%

9.67%

2.13%

0.81%

IGD (FYE 2/28)

0.050

0.050

6.26

10.75%

9.58%

2.12%

0.80%

IDE (FYE 2/28)

0.100

0.100

13.51

12.66%

8.88%

5.71%

0.74%

IHD (FYE 2/28)

0.055

0.055

7.31

8.87%

9.03%

7.82%

0.75%

IAE (FYE 2/28)

0.065

0.065

8.46

8.72%

9.22%

6.42%

0.77%

 
1 As a percentage of 12/31/2025 NAV

You should not draw any conclusions about the Funds’ investment performance from the amount of this distribution or from the terms of the Funds’ Plan. The Funds’ estimate that it has distributed more than its income and net realized capital gains; therefore, a portion of your distribution may be a return of capital. A return of capital may occur, for example, when some or all of the money that you invested in the Funds is paid back to you. A return of capital distribution does not necessarily reflect the Funds’ investment performance and should not be confused with ‘yield’ or ‘income.’ The amounts and sources of distributions reported in this Section 19(a) Notice are only estimates and are not being provided for tax reporting purposes. The actual amounts and sources of the amounts for tax reporting purposes will depend upon the Funds’ investment experience during the remainder of its fiscal year and may be subject to changes based on tax regulations. The Funds will send you a Form 1099-DIV for the calendar year that will tell you how to report these distributions for federal income tax purposes.

Past performance is no guarantee of future results. Investment return and principal value of an investment will fluctuate, and shares, when redeemed, may be worth more or less than their original cost. Current performance may be lower or higher than the performance data quoted.

Shares of closed-end funds often trade at a discount from their net asset value. The market price of Fund shares may vary from net asset value based on factors affecting the supply and demand for shares, such as Fund distribution rates relative to similar investments, investors’ expectations for future distribution changes, the clarity of the Fund’s investment strategy and future return expectations, and investors’ confidence in the underlying markets in which the Fund invests. Fund shares are subject to investment risk, including possible loss of principal invested. No Fund is a complete investment program and you may lose money investing in a Fund. An investment in a Fund may not be appropriate for all investors. Before investing, prospective investors should consider carefully the Fund’s investment objective, risks, charges and expenses.

Certain statements made on behalf of the Funds in this release are forward-looking statements. The Funds’ actual future results may differ significantly from those anticipated in any forward-looking statements due to numerous factors, including but not limited to a decline in value in equity markets in general or the Funds’ investments specifically. Neither the Funds nor Voya Investment Management undertake any responsibility to update publicly or revise any forward-looking statement.

This information should not be used as a basis for legal and/or tax advice. In any specific case, the parties involved should seek the guidance and advice of their own legal and tax counsel.

About Voya® Investment Management

Voya Investment Management manages approximately $360 billion as of December 31, 2025 in assets across public and private fixed income, equities, multi-asset solutions and alternative strategies for institutions, financial intermediaries and individual investors, drawing on a 50-year legacy of active investing and the expertise of 300+ investment professionals. Voya IM has cultivated a culture grounded in a commitment to understanding and anticipating clients’ needs, producing strong investment performance, and embedding diversity, equity and inclusion in its business.

SHAREHOLDER INQUIRIES: Shareholder Services at (800) 992-0180; voyainvestments.com

CONTACT: Kris Kagel, (800) 992-0180

KEYWORDS: United States North America Arizona

INDUSTRY KEYWORDS: Banking Asset Management Professional Services Finance

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FirstEnergy Ohio Utilities’ PIPP RFP Auction: Information Session for Prospective Bidders on Wednesday, February 18, 2026

FirstEnergy Ohio Utilities’ PIPP RFP Auction: Information Session for Prospective Bidders on Wednesday, February 18, 2026

BOSTON–(BUSINESS WIRE)–CRA International, Inc. (NASDAQ: CRAI), a worldwide leader in providing economic, financial, and management consulting services, today announced that an RFP auction process will be conducted for FirstEnergy Corp.’s (NYSE: FE) Ohio subsidiaries – Ohio Edison, The Illuminating Company and Toledo Edison – to procure full requirements service for their Percentage of Income Payment Plan (PIPP) customers. The winning PIPP supplier will be obligated to serve all of the PIPP load for the 12-month delivery period June 2026 through May 2027.

The PIPP RFP auction process will be managed by PIPP RFP Manager CRA International, Inc. d/b/a Charles River Associates.

The Information Session for prospective bidders is scheduled for Wednesday, February 18, 2026. Instructions to join the Webinar session are available on the PIPP RFP Auction Information Website at firstenergypipprfp.com. PIPP Supplier Applications from prospective bidders will be accepted starting February 19 and are due no later than March 4. Bids from Registered Bidders will be submitted on March 16.

Additional information about the auction process can be found at the Information Website at firstenergypipprfp.com.

About CRA’s Energy Practice

CRA’s Energy Practice provides global strategic, economic, commercial, and regulatory advice on today’s energy ecosystem and the energy transition. CRA’s Energy experts have extensive experience in auction and market design, implementation, monitoring, and participation. More information about CRA’s Energy Practice is available at www.crai.com/industries/energy/.

About Charles River Associates (CRA)

Charles River Associates® is a global consulting firm specializing in economic, financial, and management consulting services. CRA advises clients on economic and financial matters pertaining to litigation and regulatory proceedings, and guides corporations through critical business strategy and performance-related issues. Since 1965, clients have engaged CRA for its unique combination of functional expertise and industry knowledge, and for its objective solutions to complex problems. Headquartered in Boston, CRA has offices throughout the world. Detailed information about Charles River Associates, a registered trade name of CRA International, Inc., is available at www.crai.com. Follow us on LinkedIn and Facebook.

Media Relations

Charles River Associates

[email protected]

416-825-1595

Nicholas Manganaro

Sharon Merrill Advisors

[email protected]

617-542-5300

KEYWORDS: United States North America Massachusetts Ohio

INDUSTRY KEYWORDS: Consulting Energy Professional Services Legal Utilities

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