Sage Therapeutics

GSK and Pfizer see US RSV vaccine sales decline; Sage discontinues Alzheimer’s drug post late-stage trial failure.

Sage Therapeutics' experimental drug dalzanemdor (SAGE-718) failed to significantly improve cognition in a mid-stage Alzheimer’s trial, leading the company to halt further development for the disease. The drug, which targets glutamate receptors, has also failed in Parkinson’s disease studies, prompting low expectations for its upcoming Huntington’s trial. Sage’s stock has declined, and the company faces financial challenges after recent setbacks in drug development.

City Therapeutics aims to lead RNAi-based medicine by improving siRNA engineering, with a $135 million Series A funding and a clinical development plan starting in 2025, led by RNAi pioneers.

The Phase 2 LIGHTWAVE Study found no significant difference in cognitive improvement with dalzanemdor (SAGE-718) vs. placebo in Alzheimer’s patients. Dalzanemdor was well-tolerated, with no new safety concerns. Sage Therapeutics will not pursue further development for Alzheimer’s but expects to report Phase 2 DIMENSION Study results for Huntington’s Disease later this year.

Sage Therapeutics navigates the launch of Zurzuvae for postpartum depression, facing financial challenges and pipeline risks. Zurzuvae's initial success suggests market potential but slow development tempers short-term expectations. Sage's high expenses require over $950 million in sales for profitability, exceeding Zurzuvae's estimated peak sales of $350-400 million. The pipeline, particularly Dalzanemdor for Huntington's and Alzheimer's, is crucial for long-term prospects, with Phase II results in 2024 pivotal. Financial projections show revenue growth but uncertain profitability, emphasizing cost management and successful commercialization. Sage operates in a competitive CNS market, with Zurzuvae's market penetration and Dalzanemdor's success critical for its future.

J&J's Talvey shows promise in multiple myeloma trials; FDA advisory committee votes against cancer immunotherapy use in certain digestive tract cancers; AbbVie's acquisition of Cerevel Therapeutics yields positive Parkinson's drug results; Roche's Gazyva succeeds in lupus nephritis Phase 3 study; Biogen terminates agreement with Sage Therapeutics over failed essential tremor drug; Enanta Pharmaceuticals' EDP-323 shows rapid antiviral effect against RSV.

Shionogi submitted a New Drug Application in Japan for zuranolone, a treatment for major depressive disorder, based on Phase 3 data. Zuranolone showed rapid efficacy in MDD symptoms, potentially addressing the need for fast-acting therapies in Japan's 5 million depression patients.

Senator Bernie Sanders will lead a Senate HELP Committee hearing on Ozempic and Wegovy prices, focusing on price controls despite R&D costs and potential harm to medical innovation. The hearing aims to address the high cost of these diabetes medicines, but critics argue it overlooks the significant R&D investments required and the broader implications for future drug development.

Bragar Eagel & Squire, P.C. reminds investors of class actions against Sage Therapeutics, Outset Medical, Allarity Therapeutics, and Super Micro Computer. Lead plaintiff deadlines are set for October 28, 2024, for Sage and Outset, November 12, 2024, for Allarity, and October 29, 2024, for Super Micro. The complaints allege misleading statements and omissions regarding product effectiveness and regulatory compliance.