Welcome to our dedicated page for Teva Pharm news (Ticker: TEVA), a resource for investors and traders seeking the latest updates and insights on Teva Pharm stock.
News about Teva Pharmaceutical Industries Limited (TEVA) focuses on its transformation into an innovative biopharmaceutical company, its generics and biosimilars franchise, and developments across neuroscience and immunology. Company announcements highlight progress on its Pivot to Growth strategy, including updates on branded medicines such as AUSTEDO, AJOVY and UZEDY, as well as late-stage pipeline assets.
Recent news includes clinical and regulatory milestones for AJOVY (fremanezumab-vfrm), where Phase 3 SPACE trial results in children and adolescents with episodic migraine were published in the New England Journal of Medicine. These data supported U.S. FDA approval for preventive treatment of episodic migraine in pediatric patients who meet specified criteria, adding to AJOVY’s existing indication in adults. News items provide details on trial design, efficacy outcomes, and safety profile.
Investors and followers of TEVA can also find updates on pipeline programs such as olanzapine extended-release injectable suspension (TEV-'749) for schizophrenia and the anti‑IL‑15 antibody TEV-'408 for vitiligo and celiac disease, including regulatory submissions and funding agreements. Teva’s news flow covers biosimilar approvals and collaborations, such as European Commission approvals for denosumab biosimilars PONLIMSI and DEGEVMA and the U.S. settlement and license agreement for AVT06, a proposed biosimilar to Eylea.
In addition, TEVA news features financial and capital markets events, including rating agency actions, amendments to credit facilities, quarterly earnings release dates, conference call schedules, and participation in major healthcare conferences. This mix of clinical, regulatory, strategic and financial updates makes the TEVA news page a central resource for tracking how Teva’s generics base, innovative pipeline and biosimilars portfolio contribute to its stated Pivot to Growth strategy. Users interested in TEVA stock can monitor this page for ongoing disclosures that may inform their understanding of the company’s operations and strategic direction.
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.
Teva Pharmaceuticals and Alvotech have announced the U.S. availability of SELARSDI™ (ustekinumab-aekn), a biosimilar to Stelara®. The FDA approved SELARSDI in October 2024 for treating moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis in various age groups.
SELARSDI is the second biosimilar launched under the Teva-Alvotech partnership, which includes nine products. The FDA has granted provisional interchangeability determination with Stelara®, effective April 30, 2025. The drug is available in four presentations: 45 mg/0.5 mL and 90 mg/mL in prefilled syringes, 45 mg/0.5 mL in single-dose vials for subcutaneous injection, and 130 mg/26 mL for intravenous infusion.
This launch follows their first biosimilar, SIMLANDI®, approved in February 2024 and launched in May 2024. Under the partnership, Alvotech handles development and manufacturing, while Teva manages U.S. commercialization.
Teva Pharmaceutical Industries (NYSE and TASE: TEVA) has scheduled a conference call and webcast for February 24, 2025, at 8 am E.T. to discuss new data from duvakitug (anti-TL1A) Phase 2b positive results. The presentation will be made at the 20th Annual Congress of the European Crohn's and Colitis Organisation (ECCO).
The discussion will feature Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer, along with external IBD key opinion leaders. Participants must pre-register to obtain call-in details. A webcast replay will be available within 24 hours on Teva's website.
Alvotech and Teva Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to Eylea® (aflibercept). The regulatory approval process is expected to complete in Q4 2025.
AVT06 is designed to treat eye disorders that can lead to vision loss or blindness. In January 2024, the companies reported positive top-line results from a confirmatory clinical study comparing AVT06 with Eylea®, meeting its primary endpoint and demonstrating therapeutic equivalence and comparable safety.
The companies are also developing AVT29, a biosimilar candidate for Eylea® HD (8 mg), with Teva holding U.S. commercialization rights. Eylea® sales in the U.S. reached $4.77 billion in 2024, covering treatments for conditions including wet Age-related Macular Degeneration, macular edema, and diabetic retinopathy.
Teva Pharmaceutical reported strong financial results for Q4 and FY 2024, marking its second consecutive year of growth. The company achieved revenues of $16.5 billion in 2024, representing a 6% increase in local currency terms compared to 2023.
Key highlights include AUSTEDO exceeding $1.6 billion in revenues, AJOVY reaching $507 million (18% growth), and UZEDY achieving $117 million. The generics business showed robust growth across all segments: 15% in the U.S., 6% in Europe, and 15% in International Markets.
For 2025, Teva projects revenues of $16.8-$17.4 billion, with non-GAAP EPS of $2.35-$2.65. The company continues to execute its Pivot to Growth strategy, expanding its biosimilar pipeline to 18 assets and advancing key innovative products. However, the company reported a GAAP loss per share of $1.45 for FY 2024 and $0.19 for Q4 2024.
Alvotech and Teva Pharmaceuticals announced that the FDA has accepted for review Biologics License Applications (BLA) for AVT05, their proposed biosimilar to Simponi® and Simponi Aria® (golimumab). These are the first U.S. BLA filing acceptances for a golimumab biosimilar candidate, with FDA review expected to complete in Q4 2025.
The announcement follows positive top-line results from a confirmatory clinical study in April 2024 comparing AVT05 with Simponi® in rheumatoid arthritis patients, and successful pharmacokinetic study results in November 2023. This development is part of Alvotech and Teva's strategic partnership, which now includes nine biosimilar products. The partnership has already achieved FDA approval for two other biosimilars: SIMLANDI® (adalimumab-ryvk) in February 2024 and SELARSDITM (ustekinumab-aekn) in April 2024.