FDA Decision Watch: Summit’s Lung Cancer Drug, Cytokinetics’ Heart Therapy And Teva’s Igalmi In Spotlight This Week

• Summit’s Ivonescimab faces a critical FDA decision after its Phase 3 trial failed to show a statistically significant survival benefit in its primary analysis.
• Cytokinetics seeks to add head-to-head clinical trial results to the label of its already-approved heart disease treatment, Myqorzo.
• Teva recently acquired worldwide rights to IGALMI from BioXcel Therapeutics for $57.5 million.

The U.S. Food and Drug Administration (FDA) is set to decide on three major drug applications this week, covering treatments for lung cancer, heart disease, and acute agitation associated with psychiatric disorders

In what could potentially be a busy month, the regulator will announce its decision on therapies by Summit Therapeutics (SMMT), Cytokinetics (CYTK), and Teva Pharmaceutical Industries (TEVA), after approving Johnson & Johnson’s (JNJ) Rybrevant Faspro to treat adults with recurrent or metastatic head and neck squamous cell carcinoma last week.

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Summit Awaits FDA Decision On Lung Cancer Drug

Summit Therapeutics’ Ivonescimab is a cancer treatment developed in partnership with China-based Akeso, for patients with advanced non-small cell lung cancer (NSCLC) carrying EGFR mutations whose disease has progressed following targeted therapy. Ivonescimab is designed to block two proteins, PD-1 and VEGF, that lead to cancer cell growth.

The Phase 3 Harmoni trial met its primary goal of improving progression-free survival, though the study’s initial analysis failed to show a statistically significant improvement in overall survival.

Last week, Summit said updated results from the trial showed a 24% reduction in the estimated risk of death with Ivonescimab plus chemotherapy compared with chemotherapy alone.

Cytokinetics Seeks Label Update For Myqorzo

Cytokinetics is awaiting an FDA decision on whether it can add results from its Phase 3 Maple-HCM trial to the prescribing information for Myqorzo, an already-approved treatment for a heart condition that restricts blood flow.

The Maple-HCM trial showed that patients receiving the drug achieved significantly greater improvements in exercise capacity after 24 weeks compared with those receiving Metoprolol, a commonly used heart medication. According to the company, Myqorzo improved peak oxygen consumption by an additional 2.3 ml per kilogram per minute compared with metoprolol.

Teva Eyes Igalmi Approval For At-Home Treatment

The FDA is set to decide on the expanded use of Igalmi to treat acute agitation associated with schizophrenia or bipolar disorder for adults at home.

Igalmi is already approved for use under medical supervision, and the proposed expansion would allow patients to administer the treatment outside healthcare facilities.

The application is supported by the Phase 3 Serenity At-Home trial, which met its primary safety objective. Exploratory analyses also showed reductions in agitation symptoms compared with placebo.

Last month, Teva announced that it had acquired worldwide rights to Igalmi from BioXcel Therapeutics following the latter’s bankruptcy proceedings. Under the agreement, Teva paid $57.5 million upfront, while BioXcel’s estate remains eligible for up to $67.5 million in additional payments tied to FDA approval, along with potential commercial milestones.

Retail’s Take On CYTK, SMMT And TEVA

Retail sentiment for CYTK on Stocktwits remained ‘extremely bullish’ over the past 24 hours, ‘bullish’ for TEVA, while sentiment turned ‘neutral’ for SMMT from ‘bullish.’

Teva has been the best-performing stock in the cohort this year, surging 36.7%, while Cytokinetics and Summit Therapeutics have declined 13% and 6.8%, respectively.

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