# CAMZYOS (mavacamten) PDUFA Event: Symptomatic obstructive hypertrophic cardiomyopathy in adolescents

Canonical URL: https://biopharmsignal.com/pdufa-calendar/BMY/camzyos-adolescent-obstructive-hypertrophic-cardiomyopathy

Ticker: BMY

Company: BMYBristol-Myers Squibb Company

Event date: 2026-09-30

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: sNDA

FDA decision expected. FDA assigned a September 30, 2026 PDUFA date to the CAMZYOS sNDA for adolescents with symptomatic obstructive hypertrophic cardiomyopa...

## Event Timeline

### September 30, 2026 — FDA decision expected

FDA assigned a September 30, 2026 PDUFA date to the CAMZYOS sNDA for adolescents with symptomatic obstructive hypertrophic cardiomyopathy.

[Bristol Myers Squibb — sNDA acceptance and PDUFA date](https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Supplemental-New-Drug-Application-for-Camzyos-mavacamten-to-Treat-Adolescents-with-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-oHCM/default.aspx)

### June 1, 2026 — FDA accepted the sNDA with Priority Review

FDA accepted the application based on the Phase 3 SCOUT-HCM trial and granted Priority Review.

[Bristol Myers Squibb — sNDA acceptance and Priority Review](https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Supplemental-New-Drug-Application-for-Camzyos-mavacamten-to-Treat-Adolescents-with-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-oHCM/default.aspx)

### March 29, 2026 — Detailed SCOUT-HCM results were presented and published

CAMZYOS produced a clinically meaningful and statistically significant reduction in Valsalva left-ventricular outflow-tract gradient, with no new safety signals in the 44-patient trial.

[Bristol Myers Squibb — Detailed Phase 3 SCOUT-HCM results](https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Presents-Positive-Results-from-Phase-3-SCOUT-HCM-Trial-Demonstrating-Efficacy-and-Safety-of-Camzyos-mavacamten-in-Adolescents-with-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-oHCM/default.aspx)

### January 12, 2026 — SCOUT-HCM reported positive topline results

The Phase 3 trial met its primary endpoint and multiple secondary endpoints, and the safety findings were consistent with the established adult profile.

[Bristol Myers Squibb — Positive SCOUT-HCM topline results](https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Announces-Positive-Topline-Results-from-Phase-3-SCOUT-HCM-Trial-Evaluating-Camzyos-mavacamten-in-Adolescents-with-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-oHCM/default.aspx)

### April 17, 2024 — Phase 3 SCOUT-HCM study started

The pivotal pediatric study began evaluating mavacamten in adolescents aged 12 to under 18 years with symptomatic obstructive hypertrophic cardiomyopathy.

[ClinicalTrials.gov — SCOUT-HCM study record (NCT06253221)](https://clinicaltrials.gov/study/NCT06253221)

## Regulatory Designations

- Priority Review FDA: [Bristol Myers Squibb — sNDA acceptance and Priority Review](https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Supplemental-New-Drug-Application-for-Camzyos-mavacamten-to-Treat-Adolescents-with-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-oHCM/default.aspx)

## Related Pages

- BMY PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/BMY.md

- BMY company profile: https://biopharmsignal.com/company/BMY.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-08-29 — Bristol Myers Squibb Presents Data Up to Five Years Reinforcing the Long-Term Efficacy and Safety of Camzyos (mavacamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) at the European Society of Cardiology (ESC) Congress 2026: https://biopharmsignal.com/news/BMY/bristol-myers-squibb-presents-data-up-to-five-years-reinforcing-the-long-term-ef-186fbc57.md

- 2026-08-13 — U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse: https://biopharmsignal.com/news/BMY/u-s-fda-grants-accelerated-approval-to-bristol-myers-squibb-s-first-celmod-thera-5a44f400.md

- 2026-08-13 — U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse: https://biopharmsignal.com/news/BMY/u-s-fda-grants-accelerated-approval-to-bristol-myers-squibb-s-first-celmod-thera-6ca324c7.md

- 2026-08-10 — Bristol Myers Squibb Advances U.S. Manufacturing Investment with New $2.3 Billion Campus in Houston, Texas: https://biopharmsignal.com/news/BMY/bristol-myers-squibb-advances-u-s-manufacturing-investment-with-new-2-3-billion--e74338c6.md

- 2026-07-30 — Bristol Myers Squibb Reports Second Quarter Financial Results for 2026: https://biopharmsignal.com/news/BMY/bristol-myers-squibb-reports-second-quarter-financial-results-for-2026-87f265f8.md