Teva and Medincell's NDA for Long-Acting Olanzapine Accepted by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 21 2026
0mins
Should l Buy TEVA?
Source: seekingalpha
- NDA Acceptance: Teva and Medincell announced that the FDA has accepted their New Drug Application for the long-acting antipsychotic olanzapine, TEV-'749, which aims to provide a more convenient treatment option for schizophrenia patients.
- Clinical Trial Validation: The NDA is supported by data from the Phase 3 SOLARIS trial, demonstrating that patients receiving TEV-'749 do not require post-administration monitoring, significantly reducing treatment burdens while aligning with the safety profile of existing olanzapine formulations.
- Addressing Market Needs: Teva's Chief Medical Officer Eric Hughes emphasized that the lack of viable long-acting olanzapine formulations has limited treatment options for patients, and the introduction of TEV-'749 will fill this care gap and enhance patient quality of life.
- Regulatory Collaboration Outlook: Teva looks forward to collaborating with the FDA on the review of TEV-'749, which, if approved, will offer a once-monthly subcutaneous injection, simplifying the current three-hour monitoring requirement and improving treatment convenience.
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Analyst Views on TEVA
Wall Street analysts forecast TEVA stock price to rise
11 Analyst Rating
10 Buy
1 Hold
0 Sell
Strong Buy
Current: 29.440
Low
29.00
Averages
35.71
High
40.00
Current: 29.440
Low
29.00
Averages
35.71
High
40.00
About TEVA
Teva Pharmaceutical Industries Ltd is a Israeli-based pharmaceutical company. The Company operates through three segments: North America, Europe and International Markets. Each business segment manages entire product portfolio in its region, including generics, specialty and over-the-counter (OTC) products. In addition to these three segments, The Company has other activities, primarily the sale of active pharmaceutical ingredients (API) to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through its affiliate Medis.
About the author

Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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