Risperidone

Plus, news about Avidity, Biophytis, the Novo Nordisk Foundation, ADC Therapeutics and Apogee Therapeutics: 💸 SystImmune to get $250M from Bristol Myers Squibb: The milestone payment is the result of the first patient being dosed in a Phase 2/3 trial for izalontamab brengitecan in some patients with triple-negative breast cancer. The companies inked a deal in 2023 worth up to $7.1 billion to develop iza-bren outside of China. — Jaimy Lee 🏛 FDA approves Teva’s Uzedy for bipolar I disorder: The subcutaneous drug can now be marketed as a maintenance treatment for adults with the disorder. Uzedy, which was first approved in 2023 to treat schizophrenia, brought in $117 million in sales last year. — Jaimy Lee 🗂️ Avidity Biosciences pushes back FDA filing: The RNA medicines company now plans to submit a BLA for del-zota in the first quarter of 2026 and not before the end of this year, as it previously said. The decision is to “ ensure the FDA receives additional data” with regard to CMC. The San Diego biotech is developing an experimental medicine for Duchenne patients whose gene mutations are amenable to exon 44 skipping. The company last month raised $690 million in an offering. The Financial Times reported in August that Novartis was considering an acquisition of Avidity. — Kyle LaHucik 💼 Biophytis to start joint venture and sarcopenia trial: A consortium of investors, including the Chinese conglomerate Ronghui Renhe Life Technology, plans to form a Hong Kong-based joint venture with the company. The investors are expected to fork over up to $20 million over the next two years to fund the first late-stage trial of Biophytis’ MAS receptor activator, BIO101, in sarcopenia. The trial is expected to recruit up to 932 patients in Europe and Asia and is set to start next year. The joint venture will exclusively sell BIO101 in China, Japan, and Korea if it is approved. — Elizabeth Cairns 🦠 New AI platform for pathogen surveillance gets funding: The Novo Nordisk Foundation is giving up to DKK 200 million ($31 million) to help build new “infrastructure” at the Technical University of Denmark that’s called the Global Pathogen Analysis Platform. The platform will be used to track and analyse infectious diseases using bioinformatics and artificial intelligence. It will also have “partner nodes” at the University of Copenhagen, Statens Serum Institut in Copenhagen and Imperial College London. — Anna Brown 💰 ADC Therapeutics’ $60M PIPE: The company is selling 11.3 million shares at $4.00 apiece to support the commercialization of Zynlonta, which was approved by the FDA in 2021. The private placement was led by TCGX. — Jaimy Lee 💵 Apogee Therapeutics ended up raising $345 million in its public offering, up from the $300 million it targeted. — Jaimy Lee

The once-a-month extended-release injectable suspension incorporates Medincell’s copolymer technology. Credit: PhotobyTawat/Shutterstock.com. Teva Pharmaceuticals and Medincell have gained approval from the US Food and Drug Administration (FDA) for Uzedy (risperidone), a once-a-month extended-release injectable suspension to treat adult patients with bipolar I disorder (BD-I). The medication has been approved for use as a standalone treatment or as an addition to lithium or valproate therapies for maintenance treatment of the disorder. The US regulator’s clearance for Uzedy is supported by a combination of current clinical data and model-informed drug development (MIDD) techniques. These methods capitalise on the established efficacy and safety profiles of previously approved risperidone formulations indicated for BD-I. The agency also considered Uzedy’s tolerability, efficacy and extended safety data in schizophrenia treatment, substantiated by the pivotal Phase III RISE and SHINE studies. Uzedy received FDA approval in 2023 to treat schizophrenia in adults. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Teva US Commercial executive vice-president Chris Fox stated: “Adults living with BD-I experience debilitating manic and depressive symptoms, and today’s FDA approval of Uzedy provides a new long-acting formulation of risperidone that may help address existing unmet needs and treatment gaps. “This expanded indication for Uzedy builds on its success in adults living with schizophrenia and demonstrates Teva’s dedication to developing innovative medicines for complex mental health conditions that place a heavy burden on individuals and their caregivers.” Uzedy is a long-acting risperidone formula, incorporating Medincell’s copolymer technology, SteadyTeq, which ensures a consistent release of the medication. Therapeutic blood levels are achieved within six to 24 hours following a single administration. With the FDA’s approval, Uzedy now offers three monthly dosing options for BD-I patients: 50mg, 75mg and 100mg. In August 2025, Teva’s Ajovy received the agency’s approval for label expansion, marking it as the first migraine prevention medication for specific paediatric groups. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now