Teva Pharm - TEVA STOCK NEWS

Teva Pharmaceuticals (NYSE: TEVA) announced the FDA's acceptance of its supplemental Biologics License Application (sBLA) for AJOVY® (fremanezumab) to expand its use to pediatric episodic migraine prevention in patients aged 6-17 years weighing 45kg or more.

The application is supported by positive Phase 3 SPACE trial results, which showed statistically significant improvements in reducing monthly migraine and headache days versus placebo. If approved, AJOVY would become the first calcitonin gene-related peptide (CGRP) antagonist for both adult migraine prevention and pediatric episodic migraine prevention.

AJOVY, initially approved in the U.S. in 2018 for adult migraine prevention, is currently the only anti-CGRP treatment available in both quarterly and monthly dosing options. The treatment is also approved in Europe, Canada, Australia, and Japan.

Teva Pharmaceuticals has announced promising results from their Phase 3 SOLARIS trial survey for TEV-'749, a once-monthly subcutaneous long-acting injectable treatment for schizophrenia. The survey revealed high satisfaction rates among participants:

• Over 92% of patients were satisfied with the initiation regimen and dosing schedule
• 87% of nurses and 72% of physicians expressed satisfaction with the treatment
• 78.6% of patients preferred subcutaneous over intramuscular injection

The study included 70 patients, 24 nurses, and 11 physicians. Notable findings showed that 90% of patients would prefer an LAI without post-injection monitoring, and 72.9% favored a single-injection initiation regimen. The data was presented at the 2025 SIRS Congress in Chicago, highlighting TEV-'749's potential as a new treatment option for schizophrenia using MedinCell's SteadyTeq™ technology.

Teva Pharmaceutical Industries (NYSE and TASE: TEVA) has announced its upcoming first quarter 2025 financial results release and conference call schedule. The company will publish its Q1 2025 financial results press release on Wednesday, May 7, 2025, at 7:00 a.m. ET, followed by a conference call and live webcast at 8:00 a.m. ET the same day.

Interested participants must register in advance to obtain local or toll-free phone numbers and personal pins. The webcast will be accessible through Teva's investor relations website, with a replay available within 24 hours after the call conclusion.

Teva Pharmaceutical Industries (NYSE and TASE: TEVA) has announced the release of its Q1 2025 Aide Memoire, now available on the company's investor relations webpage. The document is designed to assist in financial modeling of quarterly results, incorporating previous performance data, management commentary on business outlook, and select third-party source information.

The company has indicated its intention to provide this information regularly towards the end of each quarter going forward.

Teva Pharmaceutical Industries (NYSE and TASE: TEVA) has announced its upcoming participation in two major healthcare investor conferences this March. Richard Francis, Teva's President and CEO, will be presenting at the Barclays 27th Annual Global Healthcare Conference on Tuesday, March 11, 2025, at 8:00 am ET, followed by the Leerink Partners Global Healthcare Conference on Wednesday, March 12, 2025, at 8:40 am ET.

Investors and interested parties can access live webcasts of both presentations through Teva's Investor Relations website. Archived versions will be made available within 24 hours after each live discussion concludes.

Teva Pharmaceuticals has awarded $2 million in new mental health care grants across 11 free and charitable clinics in Alabama, Mississippi, and Texas. This funding is part of a larger $4 million commitment launched in 2022 through the Community Routes initiative. Each clinic will receive $75,000 to expand mental health services in underserved communities.

The program's previous two years have shown significant impact, reaching over 63,000 beneficiaries, conducting 24,617 patient screenings for mental health conditions, and training more than 2,800 community members. The clinics also organized 131 community events to expand mental health education and services.

The 2025 grant recipients include facilities across three states, focusing on initiatives such as integrating behavioral health services into primary care, implementing screening tools, and developing culturally competent services. Key priorities include creating sustainable mental health service models and establishing standardized screening protocols, particularly for depression and anxiety treatment.

Teva Pharmaceuticals (NYSE: TEVA) and Medincell announced the FDA's acceptance of a supplemental New Drug Application (sNDA) for UZEDY®, their extended-release injectable suspension, for treating bipolar I disorder (BP-I) in adults. The application leverages existing clinical data for UZEDY and previous findings of safety and efficacy from past risperidone formulations.

UZEDY is currently approved in the US as a subcutaneous long-acting injectable for schizophrenia treatment in adults, administered every one or two months. The drug's efficacy and safety were previously evaluated in two Phase 3 studies: the RISE Study and the SHINE Study. If approved for BP-I, Teva will handle commercialization, with Medincell receiving royalties on net sales.

Teva Pharmaceuticals (NYSE and TASE: TEVA) and Medincell announced the FDA's acceptance of a supplemental New Drug Application (sNDA) for UZEDY as a maintenance treatment for bipolar I disorder (BP-I) in adults. UZEDY is currently approved as a subcutaneous long-acting injectable for schizophrenia treatment, administered every one or two months.

The sNDA leverages existing UZEDY clinical data and previous findings of safety and efficacy from past risperidone formulations approved for BP-I treatment. If approved, Teva will lead commercialization, with Medincell eligible for royalties on net sales.

UZEDY's U.S. approval for schizophrenia treatment came in 2023, supported by two Phase 3 studies: the RISE Study and SHINE Study. Currently, UZEDY's safety and efficacy for BP-I are not established and it remains unapproved for this indication by any regulatory authority.

Teva Pharmaceuticals and Sanofi presented new Phase 2b study results for duvakitug, their antibody treatment for ulcerative colitis (UC) and Crohn's disease (CD). In UC patients, duvakitug achieved clinical remission in 36% (450mg) and 48% (900mg) of cases versus 20% for placebo at week 14. For CD patients, endoscopic response was achieved in 26% (450mg) and 48% (900mg) compared to 13% on placebo.

The drug showed positive results in both advanced therapy-experienced and therapy-naïve patients across multiple endpoints. In UC, clinical response rates reached up to 81% (450mg), while CD patients showed endoscopic remission rates up to 26% (900mg). The treatment was generally well tolerated with no emergent safety signals. Phase 3 trials are anticipated to start in H2 2025.