Following the World Health Organization’s escalation of mpox to a public health emergency of international concern on Aug. 14 and the emergence of what appears to be a more severe strain of the orthopoxvirus, the spotlight has focused on a handful of companies working on vaccines and antivirals. Shares of Geovax Labs Inc., Emergent Biosolutions Inc. and Tonix Pharmaceuticals Inc. were all trading up Aug. 19.
Following the World Health Organization’s escalation of mpox to a public health emergency of international concern on Aug. 14 and the emergence of what appears to be a more severe strain of the orthopoxvirus, the spotlight has focused on a handful of companies working on vaccines and antivirals. Shares of Geovax Labs Inc., Emergent Biosolutions Inc. and Tonix Pharmaceuticals Inc. were all trading up Aug. 19.
Executives of ARS Pharmaceuticals Inc. are anticipating a quick switch for severe allergy patients following the U.S. FDA approval of Neffy (epinephrine nasal spray 2 mg), marking the first needle-free treatment option.
Speculation about potentially wider meaning among developers of psychedelic drugs was reignited after the complete response letter (CRL) from the U.S. FDA to Lykos Therapeutics Inc. for midomafetaminecapsules, which the company wants to use in combination with psychological intervention to treat post-traumatic stress disorder (PTSD). CEO Amy Emerson called the FDA move “deeply disappointing,” adding that San Jose, Calif.-based Lykos plans to request a meeting with the FDA to ask for reconsideration.
Concerns of lower-than-expected efficacy, which prompted AN2 Therapeutics Inc. to pause enrollment in the phase III portion of the phase II/III trial earlier this year, turned out to be well-founded, as top-line data proved disappointing for epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease. As a result, the company is dropping the program and restructuring.
The possibility of a 2025 approval looks to be off the table for Actinium Pharmaceuticals Inc.’s Iomab-B, at least in the U.S. In a move that H.C. Wainwright analyst Joseph Pantginis dubbed “a major surprise,” the FDA has requested a head-to-head study demonstrating overall survival before it will consider approving the radiotherapy candidate for use in patients with active relapsed or refractory acute myeloid leukemia.
Vir Biotechnology Inc.’s focus will look a little different for the latter half of 2024, as the San Francisco-based firm disclosed a restructuring that will cut about a fourth of its workforce and phase out programs targeting influenza and COVID-19 as well as vaccines developed using its T-cell-based viral vector platform.
The disappointments continue for Fibrogen Inc., which is terminating work on its once-promising anti-CTGF monoclonal antibody, pamrevlumab, after reporting missed endpoints in two late-stage pancreatic cancer studies, and cutting its workforce by about 75%.
Cognition Therapeutics Inc. said it is moving to the next stage of clinical testing with oral, small-molecule candidate CT-1812, despite phase II efficacy results falling short of statistical significance in patients with mild to moderate Alzheimer’s disease and sending shares of the Purchase, N.Y.-based company (NASDAQ:CGTX) falling 44%, or $1.04, to close July 29 at $1.33.
In one of the largest venture rounds for biopharma in 2024, Cardurion Pharmaceuticals Inc. closed a $260 million series B financing, with funds slated to advance and expand its pipeline for potentially first-in-class drugs targeting cardiovascular disease, including two programs in phase II development.
