Bristol Myers Squibb Announces Dual Phase 3 Trial Successes in Lung Fibrosis and Neuroendocrine Cancer

On October 12, Bristol Myers Squibb reported topline results from two Phase 3 studies. The ALOFT-IPF trial showed that the 60 mg twice-daily dose of admilparant significantly improved absolute change in forced vital capacity (FVC) after 52 weeks versus placebo in adults with idiopathic pulmonary fibrosis (IPF). The higher 120 mg dose slowed FVC decline but did not reach statistical significance.

BioSpace

In the ACTION-1 trial, the investigational radiopharmaceutical RYZ101 (225Ac-DOTATATE) met its primary endpoint, delivering a statistically significant improvement in progression-free survival (PFS) versus investigator-selected standard-of-care therapies in patients with somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who had progressed after prior lutetium-177 therapy.

Bristol Myers Squibb Reports Positive Phase 3 Results For RayzeBio’s RYZ101 In GEP-NETs Bristol Myers Squibb RYZ101 Phase 3 Trial Meets Survival Endpoint Bristol Myers Squibb stock surges on dual phase 3 clinical trial successes Bristol-Myers Jumps on Dual Phase 3 Clinical Wins

Idiopathic pulmonary fibrosis is a progressive interstitial lung disease characterized by irreversible scarring that impairs breathing. Approximately 1.4 million people worldwide live with IPF, and median survival after diagnosis is three to five years. Existing antifibrotic agents can slow lung-function decline but offer limited tolerability and efficacy, creating a need for new treatments.

BioSpaceReutersBristol Myers Squibb’s admilparant meets phase 3 IPF trial goal Bristol Myers Squibb stock surges on dual phase 3 clinical trial successes

Gastroenteropancreatic neuroendocrine tumors are rare malignancies, with an estimated 18,000 new diagnoses annually in the United States. Standard therapies include somatostatin analogues, everolimus, and sunitinib, yet most patients eventually experience disease progression after lutetium-177-based radiopharmaceutical therapy, leaving few effective options.

Bristol Myers Squibb Reports Positive Phase 3 Results For RayzeBio’s RYZ101 In GEP-NETs

• ALOFT-IPF enrolled approximately 1,255 adults (>= 40 years) with IPF.

BioSpace

• The 60 mg dose of admilparant produced a statistically significant improvement in absolute change in FVC from baseline to Week 52 versus placebo; discontinuations due to adverse events were low and comparable to placebo.

BioSpace

• The 120 mg dose showed a non-significant trend toward slower FVC decline.

Bristol Myers Squibb’s admilparant meets phase 3 IPF trial goal

• ACTION-1 enrolled patients with SSTR-positive GEP-NETs who had progressed after lutetium-177 therapy.

Bristol Myers Squibb Reports Positive Phase 3 Results For RayzeBio’s RYZ101 In GEP-NETs

• RYZ101 achieved a statistically significant increase in PFS compared with standard-of-care options, as confirmed by blinded independent central review.

Bristol Myers Squibb RYZ101 Phase 3 Trial Meets Survival Endpoint

• GEP-NETs affect fewer than 200,000 patients in the United States, with somatostatin receptor type 2 expressed in roughly 80 %–90 % of tumors.

Bristol Myers Squibb Reports Positive Phase 3 Results For RayzeBio’s RYZ101 In GEP-NETs

He added that the company will complete a comprehensive evaluation of the full dataset and engage global health authorities to support forthcoming regulatory submissions.

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

Fernando Martinez, chair of the ALOFT program clinical steering committee and professor of medicine at UMass Chan Medical School, emphasized the unmet need in IPF.

BioSpace

• “Taken together, these topline data reinforce the profile of admilparant as a promising, clinically meaningful investigational therapy for IPF – one that reflects the innovation of targeting the LPA 1 pathway as a first-in-class approach,” — Cristian Massacesi

BioSpace

• “This is the kind of impact we set out to deliver with actinium-based radiopharmaceuticals, and it is an important milestone supporting the pipeline we are building across our RPT platform,” — Amreen Husain, MD, chief medical officer of RayzeBio

Bristol Myers Squibb RYZ101 Phase 3 Trial Meets Survival Endpoint

Bristol Myers Squibb plans to meet with the U.S. Food and Drug Administration in the coming weeks to outline a regulatory pathway for RYZ101, building on its 2026 orphan-drug designation. The company will also finalize its evaluation of the ALOFT-IPF data and prepare submissions for admilparant. Topline results from the Phase 3 ALOFT-PPF trial in progressive pulmonary fibrosis are anticipated in early 2027.

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

The dual successes are expected to influence the company’s upcoming third-quarter 2026 earnings release, scheduled for October 29, and may prompt upward revisions of analyst price targets.

Bristol-Myers Jumps on Dual Phase 3 Clinical Wins