The company plans to submit an NDA for reproxalap for dry eye disease based on the results and hailed the crossover trial design as unique in the therapeutic area.
Aldeyra Therapeutics, Inc. believes it has the data it needs to file for US Food and Drug Administration approval of reproxalap for dry eye disease following successful completion of a Phase III study that met co-primary endpoints for ocular redness and tear production, and that the data position reproxalap well to compete in the dry eye market.
The company announced the clinical trial results on 12 July, about six months after its initial Phase III trial, TRANQUILITY,...
The oral BTK inhibitor impresses in a Phase II trial for IgG4-related disease.
The company has established the efficacy of its biologic Saphenlo in systemic lupus erythematosus but is now investing across modalities to stay ahead of rivals.
The first Phase III data for the CD38-targeting antibody is expected in 2027 in antibody-mediated rejection in kidney transplant patients, followed by other indications.
The FDA has paused Gilead’s HIV trials of GS-1720 and GS-4182 over safety concerns. The company’s upcoming PrEP PDUFA looks to be unaffected.
The FDA has paused Gilead’s HIV trials of GS-1720 and GS-4182 over safety concerns. The company’s upcoming PrEP PDUFA looks to be unaffected.
Merck and Lilly are among the leading pharma players using space-based research to power drug development. From reusable satellites to process drugs in low earth orbit to biomanufacturing labs experts discuss R&D opportunities in the starry canvas above.
Series B cash will be used to advance its Stargardt disease gene therapy.
