TEVA Gets FDA Nod for Uzedy Label Expansion in Bipolar I Disorder

Teva Pharmaceutical Industries Limited TEVA recently announced that the FDA has approved expanded use of its branded product, Uzedy (risperidone).The regulatory body has now approved Uzedy (50 mg, 75 mg and 100 mg) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of adults with bipolar I disorder (BD-I).Uzedy extended-release injectable suspension, a long-acting subcutaneous atypical antipsychotic injection, is already approved in the United States for the treatment of schizophrenia.The FDA’s review supporting Uzedy’s approval for the treatment of BD-I included prior findings on the safety and efficacy of earlier risperidone formulations approved for BD-I, along with data from two pivotal phase III studies evaluating the efficacy, long-term safety and tolerability of Uzedy in patients with schizophrenia.TEVA’s Price PerformanceYear to date, shares of Teva have declined 9.1% against the industry’s 2.2% rise.Image Source: Zacks Investment ResearchTEVA’s Top-Line Growth Thrives on New Branded DrugsIn the first half of 2025, Uzedy’s sales soared 134% year over year to $93 million, with total sales expected to be between $190 million and $200 million for the year.The approval for the BD-I indication is likely to boost Uzedy sales further in 2025 and beyond.Per the company, BD-I is linked to poor long-term outcomes and a significantly higher risk of death compared to the general population, mainly due to suicide and cardiovascular disease.Teva has been witnessing continued market share growth of its newest branded drugs, including Uzedy, Austedo and Ajovy.Austedo sales rose 29% year over year in the first half of 2025 to $891 million. Teva expects Austedo annual revenues to be more than $2.5 billion by 2027 and exceed $3 billion by 2030. Ajovy sales rose 34% year over year in the first half of 2025 to $117 million.Teva has also made decent progress with its branded pipeline, which includes olanzapine, a long-acting subcutaneous injectable for treating schizophrenia and duvakitug, its anti-TL1A therapy for inflammatory bowel diseases, ulcerative colitis (UC) and Crohn’s disease (CD).Teva has partnered with Sanofi SNY for duvakitug to maximize the value of the asset. Teva and Sanofi will equally share the development costs globally. Sanofi plans to advance duvakitug into phase III studies for both UC and CD later in the fourth quarter of 2025. Teva expects to file a new drug application to seek approval for olanzapine later in the fourth quarter of 2025.Teva anticipates generating more than $5 billion in revenues from its branded products by 2030.TEVA's Zacks Rank & Stocks to ConsiderTeva currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks in the biotech sector are Allogene Therapeutics ALLO and Chemomab Therapeutics CMMB, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.In the past 60 days, estimates for Allogene Therapeutics’ 2025 loss per share have narrowed from $1.02 to 96 cents. Loss per share estimates for 2026 have narrowed from 98 cents to 86 cents during the same period. ALLO stock has lost 42.3% year to date.Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 14.03%.In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 54.7% year to date.Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 26.25%.Radical New Technology Could Hand Investors Huge GainsQuantum Computing is the next technological revolution, and it could be even more advanced than AI.While some believed the technology was years away, it is already present and moving fast. Large hyperscalers, such as Microsoft, Google, Amazon, Oracle, and even Meta and Tesla, are scrambling to integrate quantum computing into their infrastructure.Senior Stock Strategist Kevin Cook reveals 7 carefully selected stocks poised to dominate the quantum computing landscape in his report, Beyond AI: The Quantum Leap in Computing Power.Kevin was among the early experts who recognized NVIDIA's enormous potential back in 2016. Now, he has keyed in on what could be "the next big thing" in quantum computing supremacy. Today, you have a rare chance to position your portfolio at the forefront of this opportunity.See Top Quantum Stocks Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report Teva Pharmaceutical Industries Ltd. (TEVA): Free Stock Analysis Report Allogene Therapeutics, Inc. (ALLO): Free Stock Analysis Report Chemomab Therapeutics Ltd. Sponsored ADR (CMMB): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks