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BioCardia Submits Request for Clinical Data Review Meeting with Japan PMDA To Discuss Approval Pathway for CardiAMP® Cell Therapy in Ischemic Heart Failure
Globenewswire· 2025-07-24 21:00
SUNNYVALE, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that it submitted its CardiAMP autologous cell therapy investigational heart failure treatment for clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This milestone marks a significant step toward potential regulatory approval in Japan, a key market for adva ...
Roche Diagnostics showcases science-driven leadership and innovation at ADLM 2025
Prnewswire· 2025-07-24 21:00
Lead With Us -- a promise for innovative partnerships, better insights, faster support, and improved healthcare outcomes.INDIANAPOLIS and CHICAGO, July 24, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) will showcase its science-driven leadership in diagnostics at the 2025 Association for Diagnostics & Laboratory Medicine (ADLM) Scientific Meeting and Clinical Lab Expo, held July 28–31 in Chicago. Roche will spotlight its commitment to delivering the right test at the right time — empowering clinic ...
Windtree Therapeutics Announces Up To $520 Million in New Funding to Amplify BNB Cryptocurrency Treasury Strategy
Globenewswire· 2025-07-24 21:00
Up to $700 Million Committed to BNB Acquisitions, Reinforcing Innovative Crypto Treasury Strategy Ninety Nine Percent of the proceeds from both issuances to be used to buy BNB WARRINGTON, Pa., July 24, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company diversifying its portfolio through strategic initiatives, today announced it has entered into a Common Stock Purchase Agreement for up to $500 million to establish an equity line of cre ...
Pierre Fabre Pharmaceuticals Inc. Announces FDA Acceptance and Priority Review of the Biologics License Application (BLA) for Tabelecleucel for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
Prnewswire· 2025-07-24 20:57
First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatmentEBV+ PTLD is an ultra-rare, acute, and potentially deadly blood malignancy that occurs after hematopoietic cell transplant (HCT) or solid organ transplant (SOT) when T-cell activity is impaired by immunosuppressionTabelecleucel has a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026 and w ...
Gain Therapeutics to Present at BTIG Annual Virtual Biotechnology Conference
GlobeNewswire News Room· 2025-07-24 20:53
BETHESDA, Md., July 24, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next-generation of allosteric small molecule therapies, today announced that the Company’s management team will participate in a fireside chat and one-on-one meetings at BTIG’s Annual Virtual Biotechnology Conference, being held Tuesday, July 29th through Wednesday, July 30th. Fireside Presentation Details Date ...
The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Sarepta Therapeutics, Inc.(SRPT) Shareholders
Prnewswire· 2025-07-24 20:45
NEW YORK, July 24, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Sarepta Therapeutics, Inc. (NASDAQ: SRPT).Shareholders who purchased shares of SRPT during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/sarepta-loss-submission-form/?id=157768&from=4CLASS PERIOD: June 22, 2023 to J ...
Abivax announces trading resumption of its ordinary shares on Euronext Paris
Globenewswire· 2025-07-24 20:40
Abivax announces trading resumption of its ordinary shares on Euronext Paris PARIS, France, July 24, 2025 – 02:30 p.m. (CEST) – Abivax SA (Euronext Paris: FR0012333284 – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases, announced the trading resumption of its ordinary shares on the regulated market of Euronext Paris a ...
Abivax Announces Pricing of $650M (€554M) Public Offering of American Depositary Shares
Globenewswire· 2025-07-24 20:40
Abivax Announces Pricing of $650M (€554M) Public Offering of American Depositary Shares PARIS, France, July 24, 2025 – 2:30 p.m. (CEST) – Abivax SA (Euronext Paris: FR0012333284 – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases, today announces the pricing of its previously announced underwritten public offering of 1 ...
Minovia Therapeutics Announces Interim Data from Phase 2 Trial in Pearson Syndrome Demonstrating No Treatment-Related Serious Adverse Events and Preliminary Signal for Efficacy Measured by Growth
Globenewswire· 2025-07-24 20:15
Data presented at the UMDF meeting highlighting first three of expected six subjects and two compassionate use patients provide encouraging results supporting continuation of trialHAIFA, Israel, July 24, 2025 (GLOBE NEWSWIRE) -- Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical-stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age-related decline, announces positive interim results of the ongoing Phase 2 trial of the Company’s lead investigati ...
REPL STOCK NEWS: Replimune Group, Inc. (NASDAQ:REPL) is Facing a Securities Fraud Investigation – Investors with Losses are Notified to Contact BFA Law
GlobeNewswire News Room· 2025-07-24 20:07
NEW YORK, July 24, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Replimune Group, Inc. (NASDAQ: REPL) for potential violations of the federal securities laws. If you invested in Replimune, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases-investigations/replimune-group-class-action-lawsuit. Why is Replimune being Investigated? Replimune is a clinical-stage biotechnology company focused on developin ...