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Tag: drug application

IRON Investor News: If You Have Suffered Losses in Disc Medicine, Inc. (NASDAQ: IRON), You Are Encouraged to Contact The Rosen Law Firm About...

NEW YORK, June 05, 2026 (GLOBE NEWSWIRE) --

WHY: Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of Disc Medicine, Inc. (NASDAQ: IRON) resulting from allegations that Disc Medicine may have issued materially misleading business information to the investing public.

NRx Pharmaceuticals, Inc. Announces Closing of $22.3 Million Public Offering of Common Stock and Including Exercise of the Underwriters’ Option

Offering was led by B Group Capital with significant participation from, among others, Columbia Threadneedle Investments, Corbets Capital, Venture 76, and Mossrock Capital
Offering was led by B Group Capital with significant participation from, among others, Columbia Threadneedle Investments, Corbets Capital, Venture 76, and Mossrock Capital

World’s First CLDN18.2 ADC for Regulatory Review: Innovent Biologics Announces IBI343 (arcotatug tavatecan) Met Primary Endpoint in International Phase 3 Study in Advanced Refractory...

SAN FRANCISCO and SUZHOU, China, June 4, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and...

Celcuity Inc. Announces Pricing of Upsized Public Offering of 0.250% Convertible Senior Notes Due 2032

MINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (“Celcuity” or the “Company”), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced the pricing of its upsized underwritten public offering of $500,000,000 aggregate principal amount of its 0.250% convertible senior notes due 2032 (the “Convertible Notes”). The aggregate principal amount of the offering was increased from the previously announced offering size of $400,000,000.

Antengene to Present First Preclinical Data on ATG-207 (αCD3-TGF-β Bifunctional Fusion Protein) at EULAR 2026

SHANGHAI and HONG KONG, June 3, 2026 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) , a leading innovative, commercial-stage global biotech company dedicated...

Pomerantz Law Firm Announces the Filing of a Class Action Against Biohaven Ltd. and Certain Officers – BHVN

NEW YORK, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Biohaven Ltd. (“Biohaven” or the “Company”) (NYSE: BHVN) and certain officers. The class action, filed in the United States District Court for the District of Connecticut, and docketed under 25-cv-01120, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Biohaven securities between March 24, 2023 and May 14, 2025, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 sand Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

Novo Nordisk A/S: Wegovy® approved in the US for the treatment of MASH

Bagsværd, Denmark, 15 August 2025 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved an additional indication for Wegovy® (semaglutide 2.4 mg) based on a supplemental New Drug Application (sNDA) for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in combination with a reduced calorie diet and increased physical activity.

Cingulate Provides Management Team Update

Jennifer Callahan, Chief Financial Officer, appointed Interim CEO

Everest Medicines Announces Acceptance of the New Drug Application for VELSIPITY® by the Taiwan Food and Drug Administration for the Treatment of Moderately to...

SHANGHAI, Aug. 14, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing...

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reschedules Second Quarter 2025 Financial Results Release to August 19, 2025

Conference Call 8:00am ET, Wednesday August 20, 2025 WILMINGTON, Del., Aug. 13, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a...

Applied Therapeutics Reports Second Quarter 2025 Financial Results

- CMT-SORD program advances; meeting scheduled with the FDA in Q3 2025 to discuss govorestat for the treatment of CMT-SORD

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Unicycive Therapeutics, Inc. – UNCY

NEW YORK, Aug. 09, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ: UNCY).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.

Arvinas Announces FDA Acceptance of the New Drug Application for Vepdegestrant for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer

– Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant –

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