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Saturday, September 5, 2026

Tag: drug application

Cidara Announces Proposed Public Offering of Common Stock

SAN DIEGO, June 23, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (“Cidara”) (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced its plans to commence an underwritten public offering, subject to market and other conditions, to issue and sell $250.0 million of shares of its common stock. All of the shares are being offered by Cidara. In connection with the proposed offering, Cidara expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock sold in the public offering. There can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of UroGen Pharma Ltd. – URGN

NEW YORK, June 23, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.

Sana Biotechnology Announces Positive Six-Month Clinical Results from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression

Groundbreaking First-in-Human Study Establishes Potential to Treat Type 1 Diabetes by Transplanting Insulin-Secreting Cells Without Immunosuppression

Sephience™ (sepiapterin) Granted Marketing Authorization by the European Commission for the Treatment of Children and Adults Living with Phenylketonuria (PKU)

 – Broad label inclusive of all ages and disease severities –  – Launch to be initiated in Germany – WARREN, N.J., June 23, 2025 /PRNewswire/ -- PTC Therapeutics, Inc....

Jyong Biotech Ltd. Announces Closing of $20 Million Initial Public Offering

New Taipei City, Taiwan, June 18, 2025 (GLOBE NEWSWIRE) -- Jyong Biotech Ltd. (Nasdaq: MENS) (the “Company”), a science-driven biotechnology company based in Taiwan committed to developing and commercializing innovative and differentiated new drugs (plant-derived) mainly specializing in the treatment of urinary system diseases, with an initial focus on the markets of the U.S., the EU and Asia, today announced the closing of its initial public offering (the “Offering”) of 2,666,667 ordinary shares (the “Ordinary Shares”) at a public offering price of $7.5 per share for aggregate gross proceeds of approximately $20 million, before deducting underwriting discounts and other offering expenses. The Ordinary Shares commenced trading on Nasdaq Global Market on June 17, 2025, under the ticker symbol “MENS”. The Offering closed on June 18, 2025.

Chronic Hepatitis B Market–The US to Have the Lion’s Share Among the 7MM, Predicts DelveInsight

The chronic hepatitis B market size is predicted to surge owing to the increasing prevalence of the disease globally and rising awareness about early...

Jyong Biotech Ltd. Announces Pricing of $20 Million Initial Public Offering

New Taipei City, Taiwan, June 16, 2025 (GLOBE NEWSWIRE) -- Jyong Biotech Ltd. (the “Company”), a science-driven biotechnology company based in Taiwan committed to developing and commercializing innovative and differentiated new drugs (plant-derived) mainly specializing in the treatment of urinary system diseases, with an initial focus on the markets of the U.S., the EU and Asia, today announced the pricing of its initial public offering (the “Offering”) of 2,666,667 ordinary shares (the “Ordinary Shares”) at a public offering price of $7.50 per share. The Company expects to receive aggregate gross proceeds of approximately $20 million, before deducting underwriting discounts and other offering expenses. The Ordinary Shares have been approved for listing on the Nasdaq Global Market and are expected to commence trading on June 17, 2025 under the ticker symbol “MENS”. The Offering is expected to close on June 18, 2025, subject to the satisfaction of customary closing conditions. In addition, the Company has granted the underwriters an option (the "Over-Allotment Option"), within 45 days from the date of the final prospectus, to purchase up to an additional 400,000 Ordinary Shares at the public offering price, less underwriting discounts, to cover the Over-Allotment Option, if any.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Red Cat, Reckitt, UroGen and Fortrea and Encourages Investors...

NEW YORK, June 16, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Reckitt Benckiser Group plc (OTC:RBGLY), UroGen Pharma Ltd. (NASDAQ:URGN), Red Cat Holdings, Inc. (NASDAQ: RCAT) and Fortrea Holdings Inc. (NASDAQ:FTRE). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

PolyPid Secures $26.7 Million Through Warrant Exercise Following Successful SHIELD II Phase 3 Trial Results

PETACH TIKVA, Israel, June 17, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that following its recently announced successful SHIELD II phase 3 topline results, it has secured additional funding through the exercise of warrants with aggregate gross proceeds of $26.7 million. The Company anticipates that with this additional funding, PolyPid’s runway would be extended beyond anticipated FDA approval of D-PLEX₁₀₀.

NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) and HOPE Therapeutics, Inc. Announce Strategic Investor Relations Partnership with astr partners

WILMINGTON, Del., June 16, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, and HOPE...

ArkBio’s New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA

SHANGHAI, June 15, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) has officially accepted...

DRI Healthcare Trust Comments on FDA Delay for KalVista Pharmaceuticals’ Sebetralstat PDUFA Goal Date Due to FDA Resourcing Constraints

- FDA decision anticipated within four weeks - TORONTO, June 13, 2025 /CNW/ - DRI Healthcare Trust (TSX: DHT.UN) (TSX: DHT.U) (the "Trust") today announced KalVista Pharmaceuticals...

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) and HOPE Therapeutics, Inc. to Present at H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference

WILMINGTON, Del., June 12, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, and HOPE...

Kelun-Biotech’s Novel CLDN18.2 ADC SKB315 IND in Combination with Tagolizumab Receives NMPA Approval for the First-Line Treatment of Gastric/Gastro-oesophageal Junction Cancer

CHENGDU, China, June 11, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") today announced that the Company has received a clinical trial notice...

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