Camzyos (mavacamten) - pediatric oHCM (SCOUT-HCM) was approved by the FDA on September 30, 2026 for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults and pediatric patients weighing 30 kg or more, to improve functional capacity and symptoms.
The FDA approved Camzyos (mavacamten) for pediatric patients weighing 30 kg or more with symptomatic obstructive hypertrophic cardiomyopathy on September 30, 2026, the goal date (NDA 214998, supplement 13). Bristol Myers Squibb announced the approval the same day.
The FDA's approval letter for NDA 214998 supplement 13 is dated September 30, 2026 and describes the supplement as extending the indication to pediatric patients weighing 30 kg or more with obstructive hypertrophic cardiomyopathy, based on the pediatric study CV027010 (SCOUT-HCM) in adolescents aged 12 to 18, with a new 1 mg capsule strength and REMS modifications (FDA approval letter). Bristol Myers Squibb's June 1, 2026 release stated that the FDA had accepted the sNDA for priority review with a PDUFA date of September 30, 2026 (BMS, June 1, 2026); the decision came on that day. Per BMS, SCOUT-HCM (n=44) met its primary endpoint: Valsalva LVOT gradient fell 49.4 mmHg on Camzyos versus 1.8 mmHg on placebo at week 28 (difference 48.0 mmHg, p<0.0001); no patient had LVEF below 50% (BMS release, September 30, 2026). Correction, October 14, 2026: an earlier page on this site dated this approval June 1, 2026; that was the acceptance for review, not the approval.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval letter, NDA 214998 supplement 13, September 30, 2026
FDA record of the action: the FDA approved on September 30, 2026, per NDA 214998 SUPPL-13 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 925,000 | $53.3 million | filed August 14, 2026 |
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Yes. The FDA approved the application for Camzyos (mavacamten) - pediatric oHCM (SCOUT-HCM) on September 30, 2026, per the FDA's own record. The primary source is linked on this page.
Camzyos (mavacamten) - pediatric oHCM (SCOUT-HCM) is a Bristol Myers Squibb (BMY) program. The FDA decision came on September 30, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), BMY moved +5.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.