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Today, a brief rundown of news involving Amgen and Regeneron, as well as updates from Valneva, Turnstone Biologics and AdvanCell that you might have missed.
The Food and Drug Administration has put an obesity study run by Amgen on clinical hold, the company disclosed Tuesday in its fourth quarter earnings. The study is testing an injectable medicine called AMG 513. Amgen didn’t share the reason for the hold, but executives told investors that they don’t believe it’s related to the medicine itself. Still, the news is a “speed bump” for Amgen’s obesity R&D, wrote Raymond James analyst Gary Nachman in a note to clients. The company, which is in late-stage testing with another obesity drug called MariTide, hasn’t disclosed how AMG 513 works. Discussions are underway on a “path forward” to reopen the study, Amgen said. — Ned Pagliarulo
For the first time in its 37-year history, Regeneron Pharmaceuticals will return capital to its shareholders via a dividend. The biotech instituted a quarterly cash dividend of $0.88 per share on Tuesday, alongside announcing fourth quarter earnings. Baird analyst Brian Skorney called the move a “positive surprise” that could help expand Regeneron’s investor base, but added in a client note that it didn’t entirely distract from soft sales of Eylea and Dupixent, the company’s two most important products. Christopher Raymond, an analyst at Piper Sandler, told clients the dividend was a “clear vote of confidence” from Regeneron’s executive team “in midst of a commercial lull.” — Ned Pagliarulo
Regulators in the U.K. have approved Valneva’s chikungunya vaccine for adults. The clearance is the shot’s fourth, following OKs in the U.S., Europe and Canada. Valneva also expects to gain approval this year in Brazil, which would be the first country where chikungunya, a mosquito-borne viral disease, is endemic. Clinical testing of the live-attenuated vaccine, called Ixchiq, showed immunization led to an immune response that can last several years. — Ned Pagliarulo
Turnstone Biologics is ending further development of its cancer cell therapy program TIDAL-01, laying off staff and reducing spending as part of a review of “strategic alternatives” that could end in a sale or merger. TIDAL-01 was in a Phase 1 study testing Turnstone’s tumor-infiltrating lymphocyte therapy. The company made TIDAL-01 its sole focus back in October, when it laid off 60% of its staff and reshuffled its executive team. — Ned Pagliarulo