Another shoe dropped on Oncopeptides AB when the U.S. FDA issued an alert July 28 citing trial data showing an increased risk of death with the company’s only marketed drug, Pepaxto, used in combination with dexamethasone to treat multiple myeloma. The agency said it’s continuing to evaluate the Ocean trial results and may hold a public meeting to discuss the safety findings and explore the continued marketing of Pepaxto (melphalan flufenamide), which was granted accelerated approval in February as a fifth-line treatment for relapsed or refractory multiple myeloma.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axon, Biogen, Cerecor, Effector, Eisai, Entasis, Grunenthal, Infinity, Merck, Redx, Relmada, Xylocor.

New data on the addition of Infinity Pharmaceuticals Inc.'s oral PI3K-gamma inhibitor, eganelisib, to PD-(L)1 in both urothelial and triple-negative breast cancer patients appeared to evidence benefits for the combination. Benefit for company shares (NASDAQ:INFI), however, was nowhere to be seen, as they fell 31.5% to $1.52 on July 27. In a same-day earnings report, the Cambridge, Mass.-based company said it had a cash balance of $97.3 million to fund further development of the drug and filed to raise the maximum amount of capital it may raise in future sales of its shares.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Allegro Ophthalmics, Cassava, Da Volterra, GNT, Inmune, Iveric, Lee's, Radius, Sorrento, Synaptogenix, Tarsus, Tonix, Virios.

As amyotrophic lateral sclerosis continues to make headlines, candidates bearing varied approaches proliferate and the indication likely allows for multiple players, given the prospect of a combo regimen.

Shionogi & Co. Ltd. started a phase I trial in Japan for S-217622, its orally administered 3CL protease inhibitor for treating COVID-19. Should the drug be approved by Japanese regulators, it would be the first Japanese-developed COVID-19 treatment to be approved in the country.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abeona, Acticor, Adverum, Aurion, Denali, F-star, Immunicum, Innovent, Kyowa Kirin, Mediwound, NGM, Synlogic.

Alzamend Neuro Inc.’s positive preclinical data for AL-002 sent the company’s stock (NADAQ:ALZN) more than 70% higher before the market opened July 23. The Tampa, Fla.-based biopharma is researching a mutant-peptide sensitized cell for treating Alzheimer’s disease. The positive data came from a GLP toxicology study using a transgenic mouse model.