Amgen, Inc.

Amgen receives approval from Japan’s MHLW for TEPEZZA to treat thyroid eye disease. The treatment involves eight infusions, with initial and subsequent doses at 10mg/kg and 20mg/kg respectively. The approval is based on the Phase III OPTIC-J trial, which showed 89% improvement in proptosis at week 24. A second Phase III trial is ongoing in Japan for chronic TED with low CAS.

Kyowa Kirin announces Phase 3 ROCKET HORIZON trial of rocatinlimab met co-primary endpoints: vIGA-AD 0/1 with ≥ 2-point reduction and EASI-75 at week 24, with significant differences from placebo for all key secondary endpoints. Rocatinlimab, targeting OX40 receptor, aims to be a T-cell rebalancing therapy for moderate to severe atopic dermatitis.

Amgen's Phase 3 trials for uplizna and rocatinlimab met key endpoints, potentially expanding treatment options and revenue growth. Uplizna targets CD19 to improve myasthenia gravis symptoms, while rocatinlimab shows promise in treating atopic dermatitis. Amgen also won a legal battle against Regeneron, allowing Pavblu's development. Wall Street rates AMGN with a Moderate Buy consensus, projecting 2.54% upside potential.

First patient dosed with CONV01-α in Phase II trial for metastatic castration-resistant prostate cancer. Richard Messmann, MD appointed as Chief Medical Officer. Novo Holdings invests $40 million in Series A extension to advance radiopharmaceutical development at Convergent Therapeutics.

Amgen's antibody drugs for eczema and myasthenia gravis showed success in Phase 3 trials but did not outperform existing treatments.

Amgen shares fell 3% post-market after reporting Phase 3 data for Uplizna and rocatinlimab.

Amgen announces TEPEZZA® (teprotumumab) approval by Japan's MHLW for active Thyroid Eye Disease, marking the first approval in Asia. TEPEZZA is the only approved treatment in Japan for active TED, with a Phase 3 trial ongoing for chronic TED. The approval is based on the OPTIC-J study, showing 89% improvement in proptosis with TEPEZZA versus 11% with placebo.

Regeneron shares dropped 5% after a judge denied its request to block Amgen from launching a biosimilar of its drug Eylea, called Pavblu. This ruling contrasts with previous injunctions granted by the same judge against other biosimilars, suggesting Pavblu may not infringe on Regeneron's patent. Regeneron has filed an appeal.

New entrants challenge Novo Nordisk and Eli Lilly in the $200 billion GLP-1 market, with 68% of sales from weight loss by 2031. Novo and Lilly expected to retain 70% of the market but are viewed as overvalued. Next-gen obesity drugs from Roche, Amgen, Pfizer, AstraZeneca, Boehringer, and others will disrupt the market, pressuring pricing. Novo and Lilly's next-gen pipelines also advancing. Public and private firms accelerating obesity drug development through acquisitions and innovative startups.