Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology 2025 Kidney Week as a late-breaking clinical trialIn Group 1 (n=24), kidney function stabilized in patients randomized to receive two rilparencel injections (one in each kidney). The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference was stat ...

Candel Therapeutics (CADL) announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational adenovirus immunotherapy candidate, CAN-2409 (aglatimagene besadenovec), for treating newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk of the disease.The RMAT tag was granted based on positive data from a phase III study, which evaluated the safety and efficacy of CAN-2409+prodrug (valacyclovir)+standard of care (SOC) radiation ...

– SLE and LN registrational discussions with FDA anticipated in 3Q25; systemic sclerosis registrational discussions with FDA anticipated in 4Q25 – – New clinical data on rese-cel in myositis, SLE / LN and systemic sclerosis to be presented in three oral sessions at the EULAR 2025 Congress in June – – Two subtype specific cohorts with ~15 patients each added to the ongoing RESET-Myositis™ trial – As of March 31, 2025, the Company had cash and cash equivalents of $131.8 million, per our Form 10-Q being filed ...

Fate Therapeutics (FATE) reported a loss of 32 cents per share for the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of 39 cents. The company had reported a loss of 47 cents per share in the year-ago period.The company earned collaboration revenues of $1.6 million, which surpassed the Zacks Consensus Estimate of $1 million. Revenues declined 15.8% on a year-over-year basis. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)Revenues in the first quarter we ...

- This RMAT designation is based on data from 3 clinical studies demonstrating the potential benefit of AAV-GAD as a one-time treatment for Parkinson’s disease - RMAT designation includes the benefits of the Fast Track and Breakthrough Therapy designations, allows frequent regulatory interactions with the FDA, and potential routes to accelerated approval and Priority Review LONDON and NEW YORK, May 09, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage gen ...

SAN DIEGO, April 14, 2025 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical- stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)- derived off-the-shelf cellular immunotherapies to patients, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to FT819, an investigational, off-the-shelf, iPSC-derived CAR T-cell therapy in Phase 1 clinical development for the t ...