Shares of Ovid Therapeutics soared in trading after the company announced pharma giant Takeda signed a licensing agreement valued at $856 million to secure global rights to the investigational medicine soticlestat for the treatment of two forms of rare epilepsy.
Oyster Point’s New Drug Application (NDA) for the dry eye disease therapy OC-01 was accepted for FDA regulatory review on the back of positive Phase III data.
Amicus Therapeutics announced topline results from the Phase III PROPEL pivotal trial of AT-GAA (cipaglucosidase alfa and miglustat) for late-onset Pompe disease.
AstraZeneca reported that the company’s Phase III KESTREL trial of Imfinzi (durvalumab) failed to meet the primary endpoint of improving overall survival compared to the EXTREME treatment regimen, which was chemotherapy plus cetuximab, a standard of care.
Bristol Myers Squibb announced positive data from POETYK PSO-2, the second Phase III trial of deucravacitinib for moderate to severe plaque psoriasis, evaluated against placebo and Amgen’s Otezla (apremilast).
BeiGene announced topline data for tislelizumab for esophageal squamous cell carcinoma (ESCC), the anti-PD-1 monoclonal antibody’s fourth positive Phase III trial.
Pfizer announced in a statement that the prespecified non-inferiority criteria for a post-marketing safety study of the rheumatoid arthritis drug Xeljanz (tofacitinib) were not met, but the company remains hopeful that future analyses of the study will be more promising.
Roche announced topline data from two identical Phase III trials (TENAYA and LUCERNE) of faricimab in neovascular or “wet” age-related macular degeneration (nAMD), with both studies hitting their primary endpoint.
Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival for adults with previously treated, high-risk chronic lymphocytic leukemia (CLL) compared to ibrutinib.
An investigational oral MK2 inhibitor from clinical-stage biopharmaceutical company Aclaris Therapeutics was safe and associated with promising reductions in inflammatory markers in a 12-week, Phase II study of patients with moderate to severe rheumatoid arthritis (RA).