Shares of Forte Biosciences Inc. (NASDAQ:FBRX) touched a 52-week low, diving 82.3% to close at $5.06 on Sept. 3 after its sole candidate, FB-401, failed to make a statistically significant difference in improving the severity of atopic dermatitis. The result, contrasting starkly with a smaller positive trial, led CEO Paul Wagner to announce the company would quit development of the FDA fast-tracked asset, licensed from the U.S. National Institute of Allergy and Infectious Diseases.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adamis, Assembly, Can-Fite, Connect, Inmune, Pfizer, Quantum, Quest, Takeda.
After seeing elevated alanine transaminase (ALT) levels consistent with drug-induced hepatotoxicity in its phase II study of ABI-H2158, Assembly Biosciences Inc. decided to discontinue development of the chronic hepatitis B virus (HBV) infection therapy.
Astellas Pharma Inc. has halted further dosing of the experimental X-linked myotubular myopathy (XLMTM) gene therapy AT-132 (resamirigene bilparvovec) after one participant in the ongoing Aspiro study experienced a serious adverse event (SAE) of abnormal liver function.
“Now it’s all about time to market,” Bavarian Nordic A/S CEO Paul Chaplin said as the company disclosed positive results from the phase IIa study with its respiratory syncytial virus (RSV) vaccine, MVA-BN RSV. “We’re looking at designs [for phase III] that give us the fastest approval possible” in the competitive space, he said, adding that the previously envisioned two-season setup “has gone out the window” with the latest findings.
LONDON – One in seven children and young people who have COVID-19 go on to develop symptoms of Long COVID, according to the first cut of data from a large national study involving 6,804 participants ages 11 to 17 who had PCR tests between January and March this year.
The race to develop better antivirals for COVID-19 is heating up after Pfizer Inc. and Merck & Co. Inc. pushed ahead with clinical development of late-stage candidates, while Rigel Pharmaceuticals Inc. announced encouraging midstage data.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Adial, Amarin, Axerovision, Bayer, Curevac, Genentech, Gennova, Gensight, GSK, HDT, J&J, Nocion, Pharmaxis, Poseida, Roche, Senhwa, SK Bioscience, Tauriga.