A year ago, BioWorld published a special series on the women’s health drug development ecosystem, showing that while women make up half of the population, venture capital investment and life sciences partnerships in the space – specifically those deals supporting innovations for conditions primarily affecting women – pale in comparison to efforts addressing diseases more men experience. That appears to be changing, according to an updated look of BioWorld data, supported by findings in the Silicon Valley Bank 2025 Innovation in Women’s Health Report published in April, and Clarivate’s Nov. 13 release of its latest Companies to Watch 2025 report, Rediscovering women’s health.
Phase II data being presented at the American Association for the Study of Liver Diseases annual meeting indicate drug development in the field of metabolic dysfunction-associated steatohepatitis (MASH) is making steady progress.
Eli Lilly and Co.’s amylin receptor agonist, eloralintide, showed impressive weight loss and improved tolerability in phase II results reported at ObesityWeek 2025, setting the stage for a phase III trial to start next month. The once-weekly drug demonstrated superior mean weight reductions from 9.5% to 20.1% vs. only 0.4% for placebo over 48 weeks, with all treatment arms meeting the primary endpoint, mean percent change in body weight from the average baseline of 240.5 lbs. (109.1 kg).
Pfizer Inc. upped its original $7.3 billion September offer to buy Metsera Inc., but the obesity specialist maintained that a now-improved unsolicited bid by semaglutide developer Novo Nordisk A/S is superior.
Detailed Viktoria-1 results of Celcuity Inc.’s gedatolisib positions the pan-PI3K/mTORC1/2 inhibitor as a top contender for second-line treatment of HR+/HER2- PIK3CA wild-type advanced breast cancer – a multibillion-dollar indication in need of new treatments.
Success by nearly all measures with Praxis Precision Medicines Inc.’s essential tremor phase III candidate, ulixacaltamide, drove the company’s stock up significantly and provided solid data for an NDA filing planned for early 2026.
Two biopharma companies launched within the past year raised top amounts in series B financings for 2025, seeking to advance their therapeutic candidates for cardiovascular diseases and obesity.
Eight years after Novartis AG gained U.S. FDA approval of the first CAR T therapy, Kymriah (tisagenlecleucel), for B-cell acute lymphoblastic leukemia, developers are advancing prospects that could significantly impact another disease space outside of cancer – autoimmunity. The efforts are getting a swirl of attention, with Bristol Myers Squibb Co. (BMS) announcing Oct. 10 that it would offer $1.5 billion in cash to buy three-year-old privately held Orbital Therapeutics Inc., including its lead, next-generation CAR T-cell therapy OTX-201, which is designed to reprogram cells in vivo for autoimmune diseases.
Among severe insulin-deficient diabetes patients, 12 weeks of 100-mg, once-daily dosing of Biomea Fusion Inc.’s icovamenib lowered hemoglobin A1c by 1.8% from placebo at the 52-week timepoint, an increased benefit over and above what was seen at 26 weeks.
In a deal that could bring more than $2.1 billion in payments to Arbor Biotechnologies Inc., 90-year-old Chiesi Group gained exclusive and global rights to develop and commercialize ABO-101 for primary hyperoxaluria type 1, an ultra-rare disease caused by a mutation in the AGXT gene, as well as an option to go after a limited number of additional targets.
