Pharmaceutical Industry Roundup: Amgen's Setback, Regeneron's Dividend, and Biotech Advancements

In a week of significant developments across the pharmaceutical landscape, major players faced both challenges and milestones. From clinical holds to historic financial moves, the industry continues to evolve rapidly.

Amgen Faces Obstacle in Obesity Drug Development

Amgen, a leading biotechnology company, has encountered a setback in its obesity research program. The Food and Drug Administration (FDA) has placed a clinical hold on a study involving AMG 513, an injectable obesity treatment. While the company has not disclosed the specific reasons for the hold, executives have assured investors that they do not believe the issue is related to the drug itself.

This development poses a "speed bump" for Amgen's obesity research and development efforts, according to Raymond James analyst Gary Nachman. The company is currently in discussions with the FDA to determine a path forward to reopen the study. Meanwhile, Amgen continues its late-stage testing of another obesity drug, MariTide, highlighting the company's commitment to this therapeutic area despite the current challenge.

Regeneron Marks Historic Milestone with First Dividend

In a significant move, Regeneron Pharmaceuticals has announced its first-ever dividend payment in its 37-year history. The biotech giant will institute a quarterly cash dividend of $0.88 per share, a decision that has surprised industry analysts and investors alike.

Baird analyst Brian Skorney described the move as a "positive surprise" that could potentially expand Regeneron's investor base. However, he noted that this development did not entirely offset concerns about soft sales of the company's key products, Eylea and Dupixent. Christopher Raymond of Piper Sandler interpreted the dividend as a "clear vote of confidence" from Regeneron's leadership team, particularly notable during what he termed a "commercial lull."

Advancements in Vaccine and Radiopharmaceutical Development

Valneva, a specialty vaccine company, has received approval from UK regulators for its chikungunya vaccine, Ixchiq. This marks the fourth regulatory clearance for the vaccine, following approvals in the US, Europe, and Canada. Valneva is also anticipating approval in Brazil this year, which would represent a significant milestone as the first endemic country to authorize the vaccine.

In the radiopharmaceutical space, AdvanCell has successfully raised $112 million in a Series C financing round. The Australia-based company, founded in 2019, is developing therapies containing alpha-emitting radionuclides like Pb-212. AdvanCell's lead treatment, ADVC001, is currently in a Phase 1/2 study for metastatic prostate cancer. The substantial funding, led by prominent investors including SV Health Investors and Sanofi Ventures, will support manufacturing expansion and pipeline advancement.

Industry Restructuring and Strategic Shifts

Turnstone Biologics has announced the discontinuation of its cancer cell therapy program, TIDAL-01. This decision comes as part of a broader strategic review that may lead to a sale or merger of the company. The move follows a significant restructuring in October 2023, when Turnstone laid off 60% of its staff and reorganized its executive team to focus solely on the TIDAL-01 program. The company is now exploring various strategic alternatives as it navigates this challenging period.