Kintor Pharmaceutical Ltd.’s topical androgen receptor antagonist, pyrilutamide (KX-826), met the primary endpoint in a pivotal phase III trial in male androgenetic alopecia, and the company will soon file an NDA with China’s National Medical Products Administration.

What one analyst called an “intriguing” overall survival signal in phase III results has Karyopharm Therapeutics Inc. planning to meet with the U.S. FDA about a would-be sNDA filing for Xpovio (selinexor) in myelofibrosis (MF).

Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.

Attacking attention deficit hyperactivity disorder (ADHD) from two different angles, thanks to a new asset just brought aboard, should help Collegium Pharmaceutical Inc. protect its revenue stream in the pesky and widespread condition. Stoughton, Mass.-based Collegium disclosed its pact March 19 with Corium Therapeutics Holdings LLC for the former to buy the latter’s Azstarys (serdexmethylphenidate and dexmethylphenidate).

Facing increasing competition to PI3Kα inhibitor Piqray (alpelisib) in breast cancer, Novartis AG looks to bolster its pipeline with next-generation programs, including phase I/II-stage candidate SNV-4818, by way of a potential $3 billion deal with Synnovation Therapeutics LLC.

Kintor Pharmaceutical Ltd.’s topical androgen receptor antagonist, pyrilutamide (KX-826), met the primary endpoint in a pivotal phase III trial in male androgenetic alopecia, and the company will soon file an NDA with China’s National Medical Products Administration.

With the U.S. FDA’s approval of GSK plc’s ileal bile acid transporter (IBAT) inhibitor, Lynavoy (linerixibat), patients with primary biliary cholangitis no longer need off-label treatments for a debilitating internal itch symptom called cholestatic pruritus.

Further weight loss details are yet to come this year, but Eli Lilly and Co. scored positive top-line results in Transcend-T2D-1, a phase III trial evaluating the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise in type 2 diabetes (T2D).

Atrogi AB is making a bid for a slice of the obesity market and has dosed the first overweight subjects with ATR-258, an oral therapy it says mimics the effects of exercise, driving loss of fat whilst sparing muscle.

It’s déjà vu all over again for Aldeyra Therapeutics Inc., which disclosed its third complete response letter (CRL) for dry eye disease candidate reproxalap, with the U.S. FDA citing a lack of substantial and consistent evidence of efficacy.