A year after Alkermes plc announced it would divide its oncology and neuroscience efforts into two separate businesses, the Dublin-based company spun out Mural Oncology plc with $275 million in funding and the lead solid tumor candidate nemvaleukin alfa. Shares of Mural (NASDAQ:MURA) will begin trading Nov. 16. “We’re very excited,” Mural’s CEO Caroline Loew told BioWorld. “We’ve got two major clinical datapoints in the next 18 months.” Registrational readouts for nemvaleukin alfa, an interleukin-2 (IL-2) cytokine, are expected in the first quarter of 2025 from a phase III trial in platinum-resistant ovarian cancer and a phase II trial in mucosal melanoma.

Adcom’s focus on chronic cough drug could shape future of the space

The U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee has a lot to discuss Friday, but only one voting question: Does the evidence demonstrate that Merck & Co. Inc.’s gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained chronic cough? While chronic cough represents a large market, it’s also a new territory for companies that are pioneering monitoring devices, algorithms and therapies. Since gefapixant is the furthest along in the pipeline, how the FDA perceives its safety and efficacy data, as well as the validity of monitoring devices used to generate that data, could serve as guidance for other products in the pipeline.

PPM heats up as Wall Street awaits developers’ data; Reneo to report next month

The primary mitochondrial myopathy (PMM) space has begun to percolate seriously, with a number of developers approaching inflection points. Of particular interest is Reneo Pharmaceuticals Inc., due to roll out data from a pivotal study next month with REN-001 (mavodelpar), a selective peroxisome proliferator-activated receptor delta agonist. Others busy in PMM include Stealth Biotherapeutics Inc. and Astellas Pharma Inc.

Gilead’s Kite invests $285M more, expands Arcellx CAR T deal to include lymphoma

If there had been any lingering market concerns following the temporary partial clinical hold earlier this year for Arcellx Inc.’s multiple myeloma CAR T-cell therapy, CART-ddBCMA, they were likely put to rest as partner Gilead Sciences Inc.’s Kite unit expanded the scope of the firms’ late 2022 collaboration to include lymphomas. At the same time, Kite exercised its option to negotiate a license for Arcellx’s ARC-Sparx program, ACLX-001, in multiple myeloma.

FDA chides Otsuka for making false or misleading claims in Rexulti advertising

The FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement. The FDA first approved Rexulti (brexpiprazole) in 2015 for adults with schizophrenia and as adjunctive therapy to antidepressants for adults with major depressive disorder; it was later cleared in May 2023 as the first FDA-approved drug for agitation in Alzheimer’s dementia.

Jeffries says health care M&A activity expected to rise next year

Senior leaders and investors in the health care sector expect mergers and acquisitions (M&A) activity to continue to pick up next year but this will be corporate led rather than private equity, according to a report by global investment bank Jefferies. At the same time, many executives remained concerned about the lack of funding in the sector as it was identified as the number one threat.

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