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) announced that their President and CEO, Richard Francis, will deliver a presentation at the Jefferies London Healthcare Conference on November 19, 2024, at 8:30 AM GMT (3:30 AM ET). The presentation will be accessible via live webcast on Teva's Investor Relations website, with an archived version available within 24 hours after the live session concludes.
Teva Pharmaceutical reported strong Q3 2024 results with revenues of $4.3 billion, up 13% year-over-year. Key highlights include AUSTEDO U.S. revenues reaching $435 million (+28%), AJOVY global revenues of $137 million (+21%), and UZEDY U.S. revenues of $35 million. The generics business showed significant growth across all regions. Based on strong performance, Teva raised its 2024 outlook, projecting revenues of $16.1-$16.5 billion, Adjusted EBITDA of $4.7-$5.0 billion, and Non-GAAP EPS of $2.40-$2.50.
Teva Pharmaceuticals announced new interim results from the Phase 4 IMPACT-TD Registry study, revealing key differences in tardive dyskinesia (TD) experiences between patients with psychotic and mood disorders. The study, the largest of its kind, showed that fewer patients with psychotic disorders (36%) received TD diagnoses compared to those with mood disorders (50%), despite similar AIMS scores.
The study also presented real-world patient experience data with AUSTEDO XR, showing that 87% reported satisfaction with the medication, and 74% reported improvement in their extra movements. The registry highlighted that TD significantly impacts quality of life regardless of underlying mental health conditions.
Teva Pharmaceuticals announced positive data from the Phase 3 SOLARIS trial of TEV-'749, a subcutaneous long-acting injectable for schizophrenia treatment. The trial demonstrated significant improvements in social functioning and quality of life across multiple measures from baseline to week 8. Key findings showed no Post-Injection Delirium/Sedation Syndrome events and met primary endpoints across all dosing groups. The company also presented real-world analyses of UZEDY®, showing high adherence rates (69%) among patients with various social challenges, including those with housing instability and food insecurity. The systemic safety profile was consistent with other approved oral formulations, with no new safety signals identified.
Teva Pharmaceuticals has announced its intention to appeal a European Commission decision regarding its practices related to COPAXONE®, a multiple sclerosis treatment. The company strongly disagrees with the Commission's decision, which it describes as based on extreme and untested legal theories lacking factual support.
The company has been cooperating with the EC since 2019 and states it will vigorously defend its position. Teva emphasizes its commitment to ethical business practices and continued support for MS patients, while noting it is financially prepared to mount its defense.
Alvotech and Teva announced FDA approval of a new presentation of SELARSDI™ (ustekinumab-aekn), expanding its label to include treatment of adults with Crohn's disease and ulcerative colitis. The approval is for a 130 mg/26 mL single-dose vial for intravenous infusion, complementing the previously approved 45 mg/0.5 mL and 90 mg/mL prefilled syringes for subcutaneous injection.
SELARSDI's U.S. launch for all indications is expected in Q1 2025. This approval aligns SELARSDI's label with the reference product Stelara® (ustekinumab). The companies highlighted successful launches of the first biosimilar ustekinumab in Canada, Japan, and Europe. Alvotech developed SELARSDI using the same cell line and process as the reference product.
This approval is part of a broader strategic partnership between Alvotech and Teva, which now includes nine biosimilar products.
Teva Pharmaceutical Industries announced that the U.S. FDA has accepted and the EU EMA has validated applications for TVB-009P, a biosimilar candidate to Prolia® (denosumab). The applications seek approval for all indications of Prolia, including osteoporosis in postmenopausal women. Decisions from both agencies are expected in the second half of 2025.
TVB-009P is Teva's first internally developed biosimilar submitted to the U.S. FDA. The submissions are supported by comprehensive data, including results from a Phase 3 trial and a pharmacokinetics study. Teva, with over 120 years of experience, is a leader in the biosimilar market with 7 approved biosimilars and 16 in the pipeline.
The company aims to expand access to affordable treatment options, particularly for conditions like osteoporosis, which affects about 25% of older women in the U.S. and EU.
Teva Pharmaceuticals and mAbxience have expanded their strategic partnership to include an additional oncology biosimilar candidate. This new global licensing agreement focuses on the development of an anti PD-1 oncology biosimilar, marking their second collaboration since April 2024. The partnership aligns with Teva's Pivot to Growth strategy and enhances its biosimilar portfolio.
Under the agreement, mAbxience will lead the development and production of the biosimilar using its facilities in Spain and Argentina, while Teva will manage regulatory approvals and commercialization in designated markets, including Europe and the United States. This collaboration aims to provide cost-effective, high-quality biosimilar treatments in oncology care, addressing unmet needs and improving global healthcare accessibility.
Teva Pharmaceuticals has launched the first and only generic version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension) in the United States. This medication is used to treat acromegaly and severe diarrhea associated with carcinoid syndrome. The launch demonstrates Teva's expertise in complex generic formulations and supports its goal of maintaining a strong position in the generics market.
Octreotide acetate for injectable suspension is indicated for long-term maintenance therapy in acromegalic patients and for the long-term treatment of severe diarrhea and flushing episodes related to metastatic carcinoid tumors and VIP-secreting tumors. The annual sales of Sandostatin® LAR Depot were $826 million as of July 2024, according to IQVIA data.
Teva Pharmaceutical Industries (NYSE and TASE: TEVA) has announced its plans to release its third quarter 2024 financial results on Wednesday, November 6, 2024, at 7:00 a.m. ET. Following this release, the company will host a conference call and live webcast at 8:00 a.m. ET on the same day.
Interested participants are required to register in advance to obtain a local or toll-free phone number and personal pin for the call. A live webcast will be available on Teva's investor relations website. After the call's conclusion, a replay of the webcast will be accessible within 24 hours on the company's website.