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 Performance

Year to date, shares of Teva have declined 9.1% against the industry’s 2.2% rise.

TEVA’s Top-Line Growth Thrives on New Branded Drugs

In 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 Consider

Teva 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%.

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