Bristol Myers Squibb Shares Jump 6.5% Following Positive Phase 3 Trial Results for Two Therapies

Bristol Myers Squibb (NYSE:BMY) shares rose 6.5% on Monday after the pharmaceutical company announced positive results from two Phase 3 clinical trials evaluating treatments for neuroendocrine tumours and idiopathic pulmonary fibrosis.

The results involved RYZ101, an investigational radiopharmaceutical therapy for gastroenteropancreatic neuroendocrine tumours, and admilparant, an experimental treatment for idiopathic pulmonary fibrosis.

Both studies met their primary endpoints, providing potential support for future regulatory submissions as Bristol Myers Squibb advances its late-stage drug development pipeline.

RYZ101 Meets Primary Endpoint in Neuroendocrine Tumour Trial

The company reported that its pivotal Phase 3 ACTION-1 trial of RYZ101 (225Ac-DOTATATE) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with standard treatment options.

The randomised study evaluated RYZ101 in patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) whose disease had progressed following treatment with a lutetium-177-based radiopharmaceutical.

Patients receiving RYZ101 were compared with those receiving an investigator-selected standard-of-care treatment.

Progression-free survival measures the length of time patients remain alive without their disease worsening and is a key measure of treatment effectiveness in oncology studies.

GEP-NETs are relatively rare cancers that develop in the gastrointestinal tract or pancreas. Approximately 18,000 new cases are diagnosed annually in the United States.

Treatment options can become limited after patients experience disease progression following initial radiopharmaceutical therapy, creating a need for additional therapeutic approaches.

RYZ101 received Orphan Drug Designation from the US Food and Drug Administration (FDA) in August 2026 for the treatment of GEP-NETs.

Bristol Myers Squibb said it intends to meet with the FDA to discuss the results and determine the next steps towards a potential regulatory submission.

The company did not disclose detailed progression-free survival figures in the top-line announcement.

Admilparant Achieves Primary Endpoint in Pulmonary Fibrosis Study

Separately, Bristol Myers Squibb announced that its Phase 3 ALOFT-IPF trial evaluating admilparant in adults with idiopathic pulmonary fibrosis (IPF) had achieved its primary endpoint.

The study assessed the treatment’s ability to slow deterioration in lung function, measured by the absolute change in forced vital capacity (FVC) from baseline after 52 weeks.

FVC measures the volume of air a person can forcibly exhale following a full inhalation and is commonly used to assess disease progression in patients with pulmonary fibrosis.

Patients receiving admilparant at a dose of 60 mg twice daily demonstrated a statistically significant improvement compared with placebo in the primary endpoint.

A separate group receiving the higher 120 mg twice-daily dose also experienced a slowing of FVC decline, although the difference compared with placebo did not reach statistical significance.

The company reported that admilparant was generally well tolerated across both treatment groups.

Discontinuations associated with adverse events remained low and were comparable with those recorded in the placebo group.

Idiopathic pulmonary fibrosis is a progressive lung disease characterised by scarring of lung tissue, which gradually reduces respiratory function.

The positive results from the lower-dose treatment group could support further regulatory development, although additional analysis will be required to establish the full clinical profile of admilparant.

Regulatory Submissions and Additional Trial Results Ahead

Bristol Myers Squibb is conducting a comprehensive assessment of the ALOFT-IPF dataset ahead of discussions with global health authorities regarding potential regulatory applications.

The company is also awaiting results from another late-stage study involving admilparant.

Top-line findings from the Phase 3 ALOFT-PPF trial, which is evaluating the therapy in patients with progressive pulmonary fibrosis, are expected in early 2027.

The two positive trial announcements represent developments across separate therapeutic areas within Bristol Myers Squibb’s research portfolio.

However, both RYZ101 and admilparant remain investigational treatments, and commercial availability will depend on regulatory review and approval.

Further clinical data, including detailed efficacy and safety findings, will be important in assessing the potential regulatory and commercial implications of the programmes.

Bristol Myers Squibb stock price