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.
Teva Pharmaceutical Industries Limited reports developments across its global pharmaceutical business, including complex generic medicines, biosimilars, pharmacy brands, and innovative medicines in neuroscience and immunology. News commonly covers financial results, investor conference presentations, R&D updates, regulatory milestones, and product or patient-support launches tied to brands and candidates such as UZEDY, PONLIMSI, and proposed biosimilars.
As an Israel-based issuer with ADSs traded under TEVA, company updates also address ADR-relevant investor communications, operating outlook materials, partnerships, and strategy around a generics platform supporting a broader biopharmaceutical portfolio.
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.
Teva Pharmaceuticals has announced a strategic collaboration with Klinge Biopharma and Formycon AG for the semi-exclusive commercialization of FYB203, a biosimilar candidate to Eylea® (aflibercept) in Europe (excluding Italy) and Israel. The product will be marketed under the brand name AHZANTIVE®, pending regulatory approval.
The collaboration leverages Teva's commercial experience in biosimilars and distribution network across Europe, combined with Formycon's expertise in biosimilar development. Under the agreement, Teva will lead commercialization efforts, while Klinge will receive milestone payments and revenue sharing.
The EMA's CHMP issued a positive recommendation for FYB203 in November 2024, with European Commission's decision expected in January 2025. The FDA has already approved the biosimilar in June 2024. Eylea®, used to treat neovascular age-related macular degeneration and other retinal diseases, generated global sales of approximately $9 billion in 2023, including $2.9 billion in the European market.
Samsung Bioepis and Teva have announced a strategic partnership for the commercialization of EPYSQLI® (eculizumab-aagh) in the United States. Under the agreement, Samsung Bioepis will handle development, regulatory registration, manufacturing, and supply, while Teva will manage U.S. commercialization.
EPYSQLI, a biosimilar to Soliris®, is approved for treating rare diseases including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG). The FDA approved EPYSQLI in July 2024 for PNH and aHUS, with gMG indication added in November 2024.
The partnership aligns with Teva's Pivot to Growth strategy and expands its biosimilar portfolio to 18 assets. EPYSQLI is already commercially available in Europe since July 2023 and Korea since April 2024.