Disc Medicine (NASDAQ: IRON) disclosed that Chief Executive Officer John D. Quisel sold 13,264 shares of common stock on February 17, 2026, at a transaction price of $62.86 per share. The sale produced total gross proceeds of $833,775. Following the disposal, Quisel retains direct ownership of 226,064 shares of the company.
Company filings specify the transaction was executed to satisfy tax withholding obligations arising from the vesting of restricted stock units. The sale was not described as a discretionary trade by Quisel.
Separately, Disc Medicine is confronting a significant regulatory development linked to its erythropoietic protoporphyria, or EPP, therapy bitopertin. The U.S. Food and Drug Administration issued a Complete Response Letter asking the company to provide additional data from the ongoing Phase 3 APOLLO study before the agency will consider approval.
In explaining its position, the FDA concluded that earlier trials did not adequately establish a connection between reductions in protoporphyrin IX, or PPIX, levels and the sunlight exposure-based clinical endpoints used to measure patient benefit, even as the agency acknowledged potential therapeutic effects. The agency's request focuses on additional evidence from the Phase 3 study rather than an outright rejection.
Analyst responses to the FDA action have been varied. Stifel lowered its price target for Disc Medicine from $125 to $110 while maintaining a Buy rating. Cantor Fitzgerald reduced its target from $153 to $125 but kept an Overweight rating. By contrast, BMO Capital reiterated an Outperform rating with a $120 price target and expressed continued confidence in bitopertin’s prospects for eventual approval.
Taken together, the insider sale and the FDA's data request have produced a mixed outlook among market participants and analysts. The share sale was procedural in nature to meet tax obligations tied to equity compensation, while the regulatory request centers on the evidentiary link between a biomarker change and clinically meaningful endpoints for patients with EPP.
Key points
- CEO John D. Quisel sold 13,264 shares on February 17, 2026, at $62.86 per share, totaling $833,775.
- The sale was completed to cover tax withholding from vesting restricted stock units and was not a discretionary transaction.
- The FDA issued a Complete Response Letter for bitopertin, requesting additional Phase 3 APOLLO data; analysts have responded with mixed adjustments to price targets.
Risks and uncertainties
- Regulatory risk - The FDA's request for further Phase 3 data introduces uncertainty about the timing and likelihood of bitopertin's approval, impacting the biotech and pharmaceutical sectors.
- Clinical evidence risk - The agency found prior trials did not sufficiently connect reduced PPIX levels to sunlight exposure-based endpoints, underscoring uncertainties in clinical validation that affect investor confidence in biotech companies.
- Market sentiment risk - Divergent analyst reactions and lowered price targets may contribute to stock price volatility, affecting equity investors and capital markets exposure to the company.