Teva Pharm Stock Price, News & Analysis

Teva Pharmaceutical Industries (NYSE and TASE: TEVA) announced its participation in the 7th Annual Evercore ISI HealthCONx Conference. Richard Francis, President and CEO, and Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer, will deliver a presentation on Thursday, December 5, 2024, at 8:20 A.M. Eastern Time. The presentation will be accessible via live webcast on Teva's Investor Relations website, with an archived version available within 24 hours after the live session.

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 The presentation will be accessible via live webcast on Teva's Investor Relations website, with an archived version available within 24 hours after the live session concludes.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.