San Francisco Bay Area researchers from UC Berkeley, UC San Francisco and Stanford University have combined their technologies to create Azalea Therapeutics Inc., a company focused on editing cells in vivo.
With strong phase II data in hand from its trial testing EVO-756 in chronic inducible urticaria (CIndU) – hives triggered by a specific cause – Evommune Inc. priced its IPO of about 9.3 million shares at $16 each, granting underwriters a 30-day option to buy as many as about 1.4 million more. Proceeds are expected to total $150 million, and shares of the firm (NYSE:EVMN) came out of the gate strong, closing Nov. 6 at $20.23, up 26%.
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).
Hailing it as a win-win and a historic step forward in fighting chronic disease, the Trump administration announced pricing agreements Nov. 6 with Eli Lilly and Co. and Novo Nordisk A/S that will expand the availability of the companies’ weight loss drugs by cutting prices and, for the first time, providing coverage for the drugs in obesity through Medicare and Medicaid.
The U.S. FDA’s attempts to harmonize with other nations on quality management received a dose of good news recently when the International Organization for Standards decided to stand pat on ISO 13485, which also leaves the FDA’s Quality Management System Regulation intact.
The U.S. CMS has confirmed that it will cover renal denervation as a treatment for hypertension in a final coverage memo that largely mirrors the July 2025 draft. One key difference, however, is that Medicare beneficiaries are eligible for RDN after only six weeks of optimized medical therapy, half the three-month waiting period described in the draft.
Celltrion Inc. scored a hat-trick of deals to license new antibody candidates, including a $744 million deal with Kaigene Inc. Nov. 3, and a near $500 million deal with Mustbio Co. Ltd. Oct. 31.
Centessa Pharmaceuticals plc’s unremarkable third-quarter 2025 earnings report was greatly overshadowed by an early readout from its orexin receptor 2 (OX2R) agonist program in narcolepsy, particularly promising phase IIa data demonstrating ORX-750’s efficacy across a group of sleep disorders, though investors seek further data to differentiate Centessa’s program from potential competitors such as Takeda Pharmaceutical Co. Ltd.’s oveporexton and Alkermes plc’s alixorexton.
The U.S. FDA’s complete response letter (CRL) for Biohaven Ltd.’s lead asset, troriluzole, to treat spinocerebellar ataxia has prompted a wave of downstream changes at the company. There will be a roughly 60% cutback in annual R&D spending, not including personnel, as Biohaven focuses on three other late-stage clinical programs.
Impulse Dynamics Inc. snared an affirmative Medicare coverage policy for its Optimizer cardiac contractility modulation (CCM) system, giving the company sole possession of the U.S. marketplace for this therapy at least for the time being.
RSS
