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Deals:
Roche-backed Chugai offered up to $250 million to develop antibodies against age-related disease targets identified by Pfizer-allied Gero‘s AI-driven drug discovery process.
Beam Therapeutics bought a private startup for just under $7 million in stock, plus another $89 million in potential milestone payments.
The private equity firm Carlyle Group will sell up to 10% of its stake in India’s Piramal Pharma.
Sage Therapeutics talked with 43 “counterparties” over the course of last year and early 2025 before agreeing to be purchased by Supernus Pharmaceuticals.
Gilead Sciences announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) to supply lenacapavir—Gilead’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP).
Samsung Electronics is acquiring U.S.-based Xealth.
Concentra Biosciences is buying CAR-T therapy developer Cargo Therapeutics and shutting it down.
HeartBeat.bio and biotx.ai signed a license and technology access agreement to identify novel targets in heart failure.
Amarna Therapeutics and NorthX Biologics finalized an agreement to advance Nimvec AM510 gene therapy toward clinical trials for Type 1 Diabetes.
Merck acquired Verona Pharma for $10 billion.
FDA:
The FDA approved KalVista Pharmaceuticals’ sebetralstat to treat acute hereditary angioedema attacks in patients 12 years and older after informing the company that it would not meet its June 17 PDUFA date due to resource restraints.
Thermo Fisher Scientific announced the U.S. Food and Drug Administration (FDA) has approved the Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer as an in vitro diagnostic (IVD) assay for use as a companion diagnostic (CDx) for Dizal’s ZEGFROVY (sunvozertinib) and in tumor profiling.
Dizal said that its EGFR inhibitor sunvozertinib has been approved by the FDA for certain types of lung cancer.
Mendaera announced it has received 510(k) clearance from the FDA for its Focalist handheld robotics system.
Longeveron announced U.S. FDA approval of IND application for a Phase 2 pivotal registration study evaluating Laromestrocel as a treatment of Pediatric Dilated Cardiomyopathy (DCM).
Eton Pharmaceuticals announces FDA acceptance of new drug application for ET-600 (Desmopressin Oral Solution).
J&J Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo.
The FDA granted fast track designation for Trethara’s TRE-515 in combination with radiation therapy for the treatment of metastatic castration resistant prostate cancer.
Funding rounds:
Renasant Bio gained $54.5 million in a seed round backed by Atlas Ventures, 5AM Ventures, OrbiMed, and Qiming Venture Partners to launch into the kidney disease space.
Layoffs:
4D Molecular Therapeutics announced it is downsizing its current staff by 25% in an effort to realign resources.
Oncternal Therapeutics announced that it is shutting down and only retaining one employee: Craig Jalbert, who will act as its CEO, treasurer, and only member of the board of trustees.
BlueRock Therapeutics is laying off around 50 employees across all of its locations.
Industry news:
Organon’s endometriosis-related pain drug is being discontinued after it failed to improve pelvic pain in a Phase II trial.
Novartis’ Cosentyx fails to meet endpoints in GCA study.
In response to a challenge from Bayer Healthcare, BBB National Programs’ National Advertising Division determined that Olly PBC provided a reasonable basis for claims made for its Lovin’ Libido dietary supplement related to desire, drive, arousal, satisfaction and lubrication.
Apogee Therapeutics said its atopic dermatitis candidate has the potential to offer a more convenient alternative to Sanofi/Regeneron’s Dupixent or Eli Lilly’s Egblyss.
Cogent Biosciences reported that its experimental drug reduced the symptoms of a chronic immune disorder called indolent systemic mastocytosis.
Healthylife, Woolworths Group’s digital health platform, appointed Bread Agency as its social media agency of record.