Vivoryon Therapeutics NV said it will conduct an in-depth analysis after reporting top-line data showing the phase IIb European Viviad study testing its oral small molecule, varoglutamstat, in patients with early Alzheimer’s disease missed statistical significance on the primary endpoint measuring changes in cognition over time. Investors, however, opted for a more immediate reaction, sending company shares (Euronext Amsterdam:VVY) plunging 90% March 4, to close at €0.80 (US87 cents)
OSE Immunotherapeutics SA disclosed a $713 million deal with Abbvie Inc. for preclinical-stage monoclonal antibody OSE-230, a potentially first-in-class therapy for treating a range of inflammatory diseases, while Idorsia Ltd. found a partner for two phase III-stage assets in Viatris Inc., as dealmaking continues strong in 2024.
Allecra Therapeutics GmbH secured U.S. FDA approval for its beta-lactam/beta-lactamase inhibitor combination, Exblifep (cefepime/enmetazobactam), in complicated urinary tract infections, including pyelonephritis, in patients 18 years and older.
To understand the focus of startup Insamo Inc., one need look no further than its name, which co-founder and CEO Timothy Craven described as “portmanteau of ‘internally satisfied molecules,’” highlighting its efforts to create orally administered and membrane-permeable cyclic peptides across a range of disease areas.
In the end, Minerva Neurosciences Inc. NDA submission wasn’t able to overcome the U.S. FDA’s concerns regarding data for dual 5-HT2A/sigma 2 antagonist roluperidone. The agency issued a complete response letter (CRL) for the application, which had been seeking approval as the first treatment specifically targeting negative symptoms of schizophrenia.
With a regulatory filing expected later this year for gepotidacin based on positive data in uncomplicated urinary tract infections, GSK plc reported that the potentially first-in-class oral antibiotic hit its endpoints in a phase III trial in uncomplicated urogenital gonorrhea, the sexually transmitted disease facing a rise in incidence rate and increased antibiotic resistance.
The good news is that the U.S. FDA’s complete response letter (CRL) for Venatorx Pharmaceuticals Inc.’s intravenous antibiotic combination, cefepime-taniborbactam, in complicated urinary tract infections (cUTIs) requested no additional clinical testing. The bad news is the inevitable delay for a drug Venatorx and partner Melinta Therapeutics Inc. are aiming to position as a much-needed option for the fight against drug-resistant gram-negative infections.
To understand the focus of startup Insamo Inc., one need look no further than its name, which co-founder and CEO Timothy Craven described as “portmanteau of ‘internally satisfied molecules,’” highlighting its efforts to create orally administered and membrane-permeable cyclic peptides across a range of disease areas.
Roughly 35 years after early patient data suggested the potential of tumor-infiltrating lymphocytes (TIL) in cancer, Iovance Biotherapeutics Inc. received U.S. FDA approval for lifileucel, marking both the first autologous TIL cell therapy for commercial use and the first one-time cell therapy for a solid tumor cancer. Branded Amtagvi, lifileucel is cleared for use in patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor
Getting a drug successfully through clinical development in amyotrophic lateral sclerosis (ALS) continues to be an elusive task, with Denali Therapeutics Inc. and partner Sanofi SA reporting the latest failure in the progressive neurodegenerative disease.
