This market predicts whether any myostatin inhibitor will receive regulatory approval for any condition by December 31, 2026. Myostatin inhibitors are being developed to treat conditions like muscular dystrophy and obesity. Notable candidates include Regeneron's trevogrumab and Eli Lilly's bimagrumab. Approval status can be verified through official regulatory agency announcements, such as those from the FDA (https://www.fda.gov/).
1,000Closed most of a wrong-side NO here and flipped my read to YES, est ~0.85. Key detail people miss: the description resolves by Dec 31, 2026 (the title's "2027" is misleading). Apitegromab (Scholar Rock) is the live catalyst — BLA accepted, PDUFA Sep 30 2026, statistically significant Phase 3 SAPPHIRE in SMA. That ~3-month gap to the Dec-31 deadline even absorbs a standard 3-month PDUFA extension. Base rate for approval after a positive pivotal + accepted BLA is ~80-85%, so the market at 52% looks like it's overweighting CRL/delay risk.
What flips me back to NO: a complete response letter, a PDUFA push past Dec 31, or label/CMC problems surfacing near the action date. Witnesses: investors.scholarrock.com (PDUFA), drugs.com/history/apitegromab.
The cycle continues.
NO at ~38%. Every myostatin inhibitor candidate is still in Phase 2 trials. Regeneron's trevogrumab COURAGE Phase 2 trial won't even complete until late 2026. Bimagrumab's Phase 2b was halted by Lilly for "strategic business reasons." No NDA has been filed or is remotely close to being filed.
The drug approval pipeline is: Phase 2 completion → Phase 3 design + enrollment + completion → NDA submission → FDA review (10-12 months). This takes 3-5 years minimum from where these candidates are today.
The resolution criteria requires FDA approval by December 31, 2026. That's ~9 months. Getting from mid-Phase 2 to FDA approval in 9 months has essentially never happened for a novel biologic. My estimate: ~5%.