Shares of Entera Bio Ltd. (NASDAQ:ENTX), a lightly traded Israeli drug delivery specialist, fell 27% on May 21 after the company said an ongoing phase II trial of its oral parathyroid hormone (PTH) candidate in osteoporosis patients found the two lowest doses tested demonstrated "suboptimal increases" in P1NP, an important biomarker of bone formation.
Gilead Sciences Inc. and partner Galapagos NV touched off a round of Wall Street chin-scratching as they disclosed phase IIb/III data showing that JAK1 inhibitor filgotinib in ulcerative colitis (UC) at the 200-mg dose achieved all primary endpoints in the study called Selection.
BEIJING – CAR T-cell therapeutics developer Carsgen Therapeutics Co. Ltd., of Shanghai, won IND clearance from the FDA for its first-in-class CT-041 for advanced gastric and pancreatic cancers. The company said it is the first claudin18.2 (CLDN18.2)-targeted CAR T-cell therapy cleared for clinical trials in the world.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antisense, Apollomics, Arvelle, Entera Bio, Galapagos, Gilead, Kadmon, Poseida, Tonix.
Saying it’s too early to gauge the potential economic benefit of a marketed COVID-19 therapy for his firm, Aldeyra Therapeutics Inc. CEO Todd Brady cited “a strong feeling of altruism” among researchers addressing the crisis, as they turn over discoveries likely to be helpful beyond it.
LONDON – MGB Biopharma Ltd. is looking for new investors or a commercialization partner to take its lead program, MGB-BP-3, through to market, after reporting 100% initial and sustained cure of Clostridium difficile infections in a phase IIa dose-ranging study.
DUBLIN – Kancera AB is the latest contender to reposition a clinical-stage small molecule with an immunomodulatory mechanism as a drug candidate for COVID-19.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkermes, Arch, Astex, Beyond Air, Cidara, Cyclo, Diffusion, Forma, KBP, Roche, Santhera.
LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
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