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,...
Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.
The company announced positive data from two Phase III trials testing the cholesterol-lowering medicine.
The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
In this week's episode: Sanofi’s Blueprint buy; AstraZeneca’s breast cancer resistance results at ASCO; BMS and BioNTech’s big bispecific deal; Kymera’s Dupixent in a pill; and Degron’s CEO on pipeline and strategy.
Otsuka bested Vera on Phase III immunoglobulin A nephropathy data for proteinuria, but analysts wonder if the difference is especially meaningful.
The company presented Phase I data for CART-EGFR-IL13Rα2, showing patient responses in the notoriously hard-to-treat and deadly brain cancer.
