Though Pfizer Inc.’s work on a PD-1-targeting antibody has trailed far behind that of its fellow big pharmas, the company could be the first to market in treatment-naïve, high-risk non-muscle invasive bladder cancer on the back of solid phase III data showing subcutaneously administered sasanlimab hit its endpoint of event-free survival. Pfizer anticipates meeting with regulatory agencies to discuss potential filings for what could be the first new treatment for that NMIBC population in decades.
Vir Biotechnology Inc.’s 2024 deal with Sanofi SA is starting to look like a pretty savvy move. The company, which picked up three clinical-stage dual-masked T-cell engagers (TCEs) and rights to the platform technology as part of a pipeline overhaul, reported phase I data for TCE programs targeting HER2 and PSMA that indicated promising efficacy with a low prevalence of the cytokine toxicity that has hampered other TCE programs.
Its lead program might have hit a safety snag, but Bioage Labs Inc.’s longevity data platform caught the attention of Novartis AG, which agreed to pay $20 million up front in a collaboration to identify drug targets for aging-related diseases. Taking into account potential long-term research, development and commercial milestones, the agreement could bring in up to an additional $530 million.
A year after manufacturing issues resulted in a complete response letter for cosibelimab, the U.S. FDA approved Checkpoint Therapeutics Inc.’s drug, branded Unloxcyt, as the first anti-PD-L1 antibody for use in metastatic or locally advanced cutaneous squamous cell carcinoma patients who are not candidates for curative surgery or curative radiation.
Disappointing readouts from separate phase II studies in atopic dermatitis sank shares of Q32 Bio Inc. and Anaptysbio Inc., as their respective antibody candidates failed to impress in a highly competitive space.
Cervomed Inc. executives said they intend to scrutinize low plasma drug concentrations that appeared to spoil results from the phase IIb Rewind-LB trial testing neflamapimod in patients with dementia with Lewy bodies.
Less than three months after going public via a $227.7 million IPO, shares of Bioage Labs Inc. (NASDAQ:BIOA) took a hit Dec. 9, losing 77% of their value, as safety concerns prompted the company to halt its phase II trial testing oral obesity candidate azelaprag. The Strides study, launched in July, had been testing azelaprag, an oral apelin receptor agonist licensed from Amgen Inc., as a monotherapy and in combination with GLP-1/GIP therapy Zepbound (tirzepatide, Eli Lilly and Co.) in obesity.
Shares of Relmada Therapeutics Inc. (NASDAQ:RLMD) plummeted 77% to close at 63 cents Dec. 4 after a pre-planned interim analysis prompted the independent data monitoring committee to conclude the phase III Reliance II study testing REL-1017 in major depressive disorder is likely to fail, leaving the future of the NMDA receptor channel blocker in doubt while the company looks ahead to an earlier-stage psilocybin-based program targeting metabolic disease.
Following a late-cycle review meeting with the U.S. FDA in September and the agency’s decision to skip the advisory committee meeting, expectations were high heading toward the PDUFA date for Applied Therapeutics Inc.’s priority NDA for govorestat in galactosemia. So the complete response letter issued by the FDA just ahead of the Nov. 28 PDUFA date, citing deficiencies in the clinical application, caught nearly everyone off guard.
In the largest collaboration of 2024, Sarepta Therapeutics Inc. and Arrowhead Pharmaceuticals Inc. entered a sprawling global licensing deal that includes a swath of clinical and preclinical candidates targeting rare genetic diseases. Under the terms, Sarepta gains access to existing and potential future compounds derived from the RNAi platform developed by Arrowhead, with the latter eligible for payments potentially exceeding $11 billion.
