Calithera Biosciences Inc.’s in-licensing deal to take ownership of a pair of oncology assets from Takeda Pharmaceutical Co. Ltd. may be on its way to paying off, perhaps especially with regard to the oral Syk/FLT3 inhibitor mivavotinib, formerly known as CB-659/TAK-659.
Alkermes plc’s recent update on sales of the schizophrenia drug Lybalvi (also indicated for bipolar I disorder) along with positive phase III data from Karuna Therapeutics Inc. from tests of Karxt (xanomeline plus trospium) shone more light on the troublesome indication, where Cerevel Therapeutics Holdings Inc. is advancing emraclidine in what could be a registrational phase II study.
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) took up the matter of Oncopeptides AB’s long-storied multiple myeloma (MM) drug, Pepaxto (melphalan flufenamide), and briefing documents ahead of the meeting – which provided little cause for optimism – proved predictive of ODAC’s vote. Shares of Oncopeptides (Stockholm:ONCO) have dropped more than 64% over the past five days as investor jitters worsened.
About four months after starting its search for strategic alternatives, Sesen Bio Inc. disclosed an all-stock merger with privately held cell-therapy specialist Carisma Therapeutics Inc., a move that sent shares (NASDAQ:SESN) down 22 cents, or 32.7%, to close at 45 cents. Sesen stockholders are expected to own about 41.7% of the combined firm, and Carisma the remainder.
Shares of Renovacor Inc. (NYSE:RCOR) closed at $2.18, up 28 cents, or 14.7%, on word that Rocket Pharmaceuticals Inc. is acquiring the firm in an all-stock transaction valued at $53 million. Rocket, of Cranbury, N.J., said “compelling” preclinical data generated by Cambridge, Mass.-based Renovacor validates an AAV-based transgene replacement strategy for BLC2 athanogene 3 dilated cardiomyopathy.
The May 2014 approval of Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab) brought welcome news in the form of an important mechanism of action for patients with ulcerative colitis and Crohn’s disease, but also means a burdensome course of administration – 30 minutes’ worth of infusion every six weeks, a drawback that other developers are trying to remedy. Standouts among the up-and-comers are Morphic Holding Inc., with an oral candidate that works through the same mechanism of action as Entyvio, and Protagonist Therapeutics Inc.
As therapeutics development in Alzheimer’s disease (AD) is broadening its search for therapeutic targets, one of the alternatives to amyloid-β, or at least to its direct targeting by monoclonal antibodies, that is coming into focus is triggering receptor expressed on myeloid cells 2 (TREM2). From a drug development standpoint, amyloid-β remains a mystery. Scientific evidence clearly suggests that amyloid misprocessing is an underlying factor in the development of AD, and it is certainly a reasonable hypothesis that reducing amyloid plaque should fight the disease.
Novartis AG rolled out positive phase III data Sept. 13 with Cosentyx (secukinumab), its interleukin-17A (IL-17A) inhibitor for hidradenitis suppurativa, offering more evidence for the approach taken up by a handful of biopharma firms.
The bad news in March 2022 from Takeda Pharmaceutical Co. Ltd. regarding Natpara, its recombinant human parathyroid hormone for hypoparathyroidism (HPT), served to generate more interest in the already bubbling space, where a handful of players large and small own prospects at various clinical stages.
Bristol Myers Squibb Co. (BMS) dodged a black-box warning on the label of just-approved Sotyktu (deucravacitinib), but hurdles lie ahead for the first-in-class, oral, allosteric tyrosine kinase 2 inhibitor. Designed to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, Sotyktu is priced as $75,000 per year, and will become available during September, BMS said.
