Shares of Forte Biosciences Inc. (NASDAQ:FBRX) dove to a 52-week low, falling 81.4% by midday 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 an earlier 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.

Compelled by data, FDA approves Impel’s migraine nasal spray

The FDA has approved Trudhesa (dihydroergotamine mesylate [DHE]; INP-104) from Impel Neuropharma Inc. for treating acute migraine headaches with or without aura in adults. Trudhesa, a nasal spray (0.725 mg per spray), has a commercial launch date planned for early October, according to Impel. The therapy’s NDA was approved Sept. 3, ahead of its Sept. 6 PDUFA date. The Seattle-based company’s stock (NASDAQ:IMPL) took giant step Sept. 3 as shares were up 15% at midday. The approval was based in part on results from a phase III, open-label, pivotal study, which the company said is the largest longitudinal study ever conducted using DHE with a nasal spray delivery.

European Commission and Astrazeneca end legal row over COVID vaccine supplies

The European Commission and Astrazeneca plc have ended their legal row over COVID-19 vaccines, while also reaching an agreement over supplies of remaining shots to Europe. The settlement brings to an end an unseemly row over vaccine supply, which further soured relations between the EU and U.K. following Brexit. U.K.-based Astrazeneca had a contract to supply 300 million shots of its vaccine to the EU but hit speed bumps when trying to get its European manufacturing operations up and running earlier this year.

Regulatory environment increasingly busy; NMEs on track with 2020

While the volume of regulatory data is above this point last year by more than 17%, the proportion of COVID-19-related news is nearly the same, as is the number of U.S.-approved new molecular entities (NMEs). BioWorld tracked 221 regulatory items of news in August, 215 in July and 280 in June, bringing the year total to 1,817, compared with 1,548 by this point in 2020. The number of items is already greater than the full years of 2019 (1,698) and 2018 (1,624) and an increase of 61% and 85%, respectively, over where each year stood at the end of August. Pandemic-focused regulatory news dropped to about 11.4% in June and 13.5% in July, but it rose to 16.3% in August, just as the number of COVID-19 cases and deaths began to climb in the U.S. as the Delta variant circulated. In total, 15.1% of all regulatory data collected by BioWorld in 2021 is focused on COVID-19 vaccines and therapeutics, up slightly from 14.5% last year.

Innovent acquires KRAS G12C candidate from Genfleet in $312M deal

Innovent Biologics Inc. has inked a $312 million licensing deal for the development and commercialization of Genfleet Therapeutics Inc.’s KRAS G12C inhibitor, GFH-925, in mainland China, Hong Kong, Macau and Taiwan. Innovent also has additional option-in rights for global development and commercialization.

Holiday notice

BioWorld's offices will be closed in observance of Labor Day in the U.S. No issue will be published Monday, Sept. 6.

Also in the news

Arctic Vision, Ardelyx, Astrazeneca, Cassava Sciences, Chardan Healthcare Acquisition 2, Felix, Forte, Impel Neuropharma, Locate, Neuren, Oncopeptides, Pharmabcine, Renovacor, Sorrento, Supernus