Disc Medicine Inc. (NASDAQ:IRON) shares closed around 22% lower on Friday as the company navigates a regulatory hiccup with a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its drug bitopertin. On Tuesday, the stock is trading higher.
Bitopertin has been under review for accelerated approval and as part of the Commissioner’s National Priority Voucher (CNPV) pilot program.
In January, FDA reviewers postponed their decision on bitopertin by about two weeks to February 10.
Regulators questioned whether “pain-free time in the sun,” a secondary endpoint in trials, was a statistically reliable measure of effectiveness or whether biomarker data could instead support approval.
FDA Block
The FDA issued a CRL for Disc Medicine’s New Drug Application for bitopertin, which is aimed at treating erythropoietic protoporphyria (EPP), a rare disease that causes extreme sensitivity to sunlight.
The agency concluded that while the clinical trials provided evidence of the drug’s efficacy in lowering whole blood metal-free PPIX, they did not demonstrate a clear association with clinical benefits, which has delayed the approval process.
The company on Friday said that accelerated approval relies on whether there is evidence of an effect on the proposed surrogate endpoint (% change in whole blood metal-free PPIX) and whether the proposed surrogate endpoint, including the magnitude of change, is reasonably likely to predict a clinical benefit.
On the first point, the FDA agreed that AURORA and BEACON provided sufficient evidence that bitopertin significantly lowers whole blood metal-free PPIX.
On the second, based on review of AURORA and BEACON results, the FDA concluded that the trials did not show evidence of association between percent change in PPIX and sunlight exposure-based endpoints, despite the strong mechanistic and biological plausibility supporting the use of the PPIX biomarker in protoporphyria.
The FDA indicated that the results of the APOLLO study could serve as evidence to support traditional approval.
In response to the CRL, Disc Medicine expressed confidence in its ongoing APOLLO trial, which is expected to yield topline data in the fourth quarter of 2026.
The company plans to request a Type A meeting with the FDA to discuss the next steps. Disc maintains a cash position of approximately $791 million as of December 31, 2025, and guidance of providing runway into 2029.
Technical Analysis
Currently, the stock is trading 4.4% above its 20-day simple moving average (SMA) and 2.2% below its 100-day SMA, indicating some short-term strength but potential resistance at longer-term averages. Over the past 12 months, shares have increased by 2.42%, and they are currently positioned closer to their 52-week highs than lows, suggesting a relatively strong performance.
The RSI is at a neutral level, indicating that the stock is neither overbought nor oversold at this time. Meanwhile, MACD is below its signal line, suggesting bearish pressure on the stock.
The combination of neutral RSI and bearish MACD indicates mixed momentum for Disc Medicine at this time.
- Key Resistance: $60.00
- Key Support: $55.00
Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $102.00. Recent analyst moves include:
- Wells Fargo: Overweight (Raises Target to $109)
- Truist Securities: Buy (Raises Target to $114)
- Stifel: Buy (Target $125)
IRON Price Action: Disc Medicine shares were up 4.40% at $58.41 during premarket trading on Tuesday, according to Benzinga Pro data.
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