Bristol Myers Squibb stock surges on dual phase 3 clinical trial successes

Investing.com -- Bristol Myers Squibb (NYSE: BMY) shares surged 6.5% on Monday following the announcement of positive top-line results from two separate Phase 3 clinical trials evaluating targeted therapies for neuroendocrine tumors and idiopathic pulmonary fibrosis. [pro_promotion |

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ACTION-1 Trial Demonstrates Significant PFS Improvement in GEP-NETs

The pivotal ACTION-1 trial evaluating RYZ101 (225Ac-DOTATATE) met its primary endpoint, delivering a statistically significant and clinically meaningful improvement in progression-free survival (PFS). The randomized trial compared RYZ101 against investigator’s choice of standard of care in patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who had disease progression following 177Lu-based radiopharmaceutical therapy.

GEP-NETs are rare malignancies, with approximately 18,000 new cases diagnosed annually in the United States. A majority of patients eventually experience disease progression after initial 177Lu-based therapy, leaving few effective subsequent treatment options.

The FDA granted RYZ101 Orphan Drug Designation for GEP-NETs in August 2026. Bristol Myers Squibb plans to meet with the FDA shortly to outline a path toward a formal regulatory submission.

ALOFT-IPF Trial Reaches Primary Endpoint in Idiopathic Pulmonary Fibrosis

Concurrently, the company announced that its Phase 3 ALOFT-IPF trial evaluating admilparant in adults with idiopathic pulmonary fibrosis (IPF) achieved its primary endpoint.

Key trial details include:

• Efficacy: Admilparant at a dose of 60 mg twice daily demonstrated a statistically significant improvement over placebo in absolute change in forced vital capacity (FVC) from baseline at Week 52.

• Secondary Dose: A higher 120 mg twice-daily cohort slowed FVC decline, but the result did not achieve statistical significance.

• Safety Profile: Admilparant was well tolerated across both dose cohorts. Discontinuations driven by adverse events remained low and comparable to placebo.

Outlook and Regulatory Next Steps

Bristol Myers Squibb is currently completing a comprehensive evaluation of the full ALOFT-IPF dataset to present to global health authorities in support of upcoming regulatory applications.

Additionally, the company reported that it expects top-line results from the Phase 3 ALOFT-PPF trial—evaluating admilparant in patients with progressive pulmonary fibrosis—in early 2027.

Original Article

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