Aldeyra Therapeutics Inc. CEO Todd Brady said that, with new data from a crossover trial with reproxalap in dry eye disease (DED), the question of “approvability has been put to bed,” and the company plans a pre-NDA meeting with U.S. FDA in the third quarter of this year.
Areteia Therapeutics Inc. has launched to put its lead candidate, dexpramipexole, an oral treatment for eosinophilic asthma, through a phase III trial. Areteia was created by Knopp Biosciences LLC, which has put the small-molecule eosinophil maturation inhibitor through a phase II study, and also by Population Health Partners. Areteia has both the development and commercial rights to dexpramipexole.
Novo Nordisk A/S announced positive clinical data for its two hemophilia therapies and said each is shaping up to fill unmet needs in what is an increasingly competitive market.
Seven fatalities that could be related to hemorrhagic events in Macrogenics Inc.’s phase II trial of the monoclonal antibody enoblituzumab for treating head and neck cancer has led to the study’s closure.
Wall Street cheered a potential, long hoped-for breakthrough in idiopathic pulmonary fibrosis (IPF), and shares of Pliant Therapeutics Inc. (NASDAQ:PLRX) closed at $23, up $14.12, or 159%, after investors learned of positive phase IIa data with PLN-74809. The trial met its primary and secondary endpoints, proving PLN-74809, a dual integrin alpha-V/beta-1/6 antagonist, well-tolerated with a favorable pharmacokinetic (PK) profile. Exploratory efficacy endpoints measured changes in forced vital capacity (FVC) and quantitative lung fibrosis (QLF) imaging, and the drug turned up a dose-dependent treatment effect on FVC and QLF vs. placebo over 12 weeks of treatment. Serum biomarkers were examined, too.
The recent win in Japan by Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. with oral heat shock protein 90 inhibitor Jeselhy (pimitespib) put gastrointestinal stromal tumors (GIST) at center stage. Jeselhy was cleared for GIST cases that have progressed after chemotherapy. A handful of companies line the runway with candidates meant to defeat the resistance that GIST often develops to approved tyrosine kinase inhibitors.
Attention has turned to Cytomx Therapeutics Inc.’s CX-2029 candidate after the company held up its program with the CD166-directed antibody-drug conjugate CX-2009, based on phase II data in patients with hormone receptor-positive/HER2-non-amplified breast cancer.
Three serious adverse events have led the U.S. FDA to place a clinical hold on Diamedica Therapeutics Inc.’s phase II/III study of DM-199, a synthetic form of human tissue kallikrein-1 for treating acute ischemic stroke. The blood pressure in three participants dropped to a significantly low level shortly after receiving an I.V. dose of the therapy. All three bounced back to normal within minutes of stopping the I.V.
More than two years after the U.S. FDA shocked Intercept Pharmaceuticals Inc. with its rejection of obeticholic acid to treat fibrosis due to nonalcoholic steatohepatitis (NASH), the company has announced data it said will form the basis of a NDA refile in the disease for which there is no approved therapy.
Treating sooner in the disease course – “hit them hard, hit them early,” as CEO Tahir Mahmood put it – may change outcomes for the better with AMT-101, the candidate from Applied Molecular Transport Inc. (AMT) tested in a combo trial against ulcerative colitis (UC), officials said during a conference call with investors.
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