Newco Idel Therapeutics GmbH has closed a €9 million (US$10.4 million) seed round to advance the development of a technology for delivery of cytotoxic drugs directly into the cytosol of tumor cells.
Apparently put off by data with a higher dose, investors in Wave Life Sciences Inc. backed away after the company rolled out data from the phase I portion of its first-in-human Inlight trial evaluating 250 mg of WVE-007, an INHBE GalNAc-siRNA prospect, in otherwise healthy overweight or obese adults.
Maze Therapeutics Inc. continues its journey toward a pivotal program after sharing positive top-line data from the phase II Horizon study with MZE-829, an oral, small-molecule, dual-mechanism APOL1 inhibitor, in patients with broad APOL1-mediated kidney disease (AMKD).
The U.S. FDA approved Corcept Therapeutics Inc.’s oral, selective glucocorticoid receptor antagonist, Lifyorli (relacorilant), nearly four months ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. A short time after the agency approved Lifyorli, it cleared Denali Therapeutics Inc.’s Avlayah (tividenofusp alfa) under the accelerated approval pathway for mucopolysaccharidosis II, also called Hunter syndrome, ahead of the April 5 PDUFA date.
Only a few months after reporting what it called “unprecedented” phase I data for its BCR-ABL1 tyrosine kinase inhibitor in chronic myeloid leukemia, Terns Pharmaceuticals Inc. agreed to an acquisition by Merck & Co. Inc. valued at about $6.7 billion. For Terns, the deal validates the decision last year to switch focus from its metabolic pipeline to oncology and, for Merck, it’s the latest move as the big pharma looks to shore up its offerings ahead of patent expirations for cancer blockbuster drug Keytruda (pembrolizumab).
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).
RSS
