Teva Pharmaceutical Industries

U.S. Court of Appeals for the Federal Circuit affirmed a lower court order requiring Teva to delist several asthma inhaler patents from the FDA’s Orange Book. The FTC had previously urged the delisting, stating it would prevent harm to competition and allow cheaper generic products to enter the market.

Teva and Sanofi's Phase IIb RELIEVE UCCD study showed positive results for duvakitug (TEV’574/SAR447189), a human IgG1-λ2 monoclonal antibody targeting TL1A, in treating moderate-to-severe IBD. Duvakitug met primary endpoints in UC and CD patients, with 36.2% (low-dose) and 47.8% (high-dose) achieving clinical remission in UC, and 26.1% (low-dose) and 47.8% (high-dose) showing endoscopic response in CD, compared to placebo. The study is ongoing, with a long-term extension and maintenance period.

Teva and Sanofi's Phase 2b study of duvakitug, a TL1A antibody for IBD, showed 47.8% remission in ulcerative colitis and Crohn's disease patients, outperforming Merck and Roche's treatments. The partnership aims for duvakitug to achieve blockbuster status with $1 billion annual sales.

The biosimilars market is projected to grow from USD 36.01B in 2024 to USD 114.02B by 2031, at a CAGR of 17.9%. Factors driving growth include rising demand for cost-effective biologics and patent expirations. Key trends include regulatory approvals and new product launches. North America is expected to dominate due to favorable regulations.

Teva and Sanofi's experimental drug duvakitug showed 'best-in-class potential' in Phase 2 trials for inflammatory bowel disease, with significant symptom improvement in ulcerative colitis and Crohn’s disease patients. The drug targets TL1A protein, a focus for several pharma companies. Teva and Sanofi plan to advance to Phase 3 pending regulatory discussions, with Sanofi set to pay Teva $600 million upon initiation.

Teva and Sanofi stocks rise after promising trial results for their experimental inflammatory bowel disease drug. Teva shares gain over 25% on Tuesday, doubling year-to-date.

Teva Pharmaceutical Industries, with a $19.81B market cap, navigates legal challenges and market dynamics. Recent $750M settlement and strong Q2 2024 performance, driven by Austedo and GX sales, suggest growth. Analysts project 4.6% revenue growth for Q2 2024, with EPS estimates at $2.49 (FY1) and $2.85 (FY2). Teva's focus on biosimilars and complex generics positions it for future growth, despite competitive and legal risks.

Intra-Cellular Therapies submitted an sNDA to the FDA for lumateperone as an adjunctive therapy for MDD, with phase 3 studies showing significant symptom reduction. Supernus Pharmaceuticals presented phase 2a data on SPN-820, showing rapid depressive symptom reduction and decreased suicidal ideation. Teva announced phase 3 SOLARIS study results showing TEV-749 improved social functioning in schizophrenia patients. Intra-Cellular Therapies also reported lumateperone delayed relapse in schizophrenia patients. However, emraclidine did not show significant symptom reduction in phase 2 trials. A study found high-dose antipsychotic use increased mortality risk in schizophrenia patients, while high-dose antidepressants reduced it.

Takeda Pharmaceutical to divest its 49% stake in Teva Takeda Pharma, established in 2016, to Teva, which will then sell the unit to J-Will Partners' subsidiary JKI.