# Disc Medicine Phase 3 APOLLO Trial Meets All Endpoints for Bitopertin

- URL: https://stocks.freetheai.org/news/disc-medicine-phase-3-apollo-trial-meets-all-endpoints-for-bitopertin-d16615
- Published: 2026-10-19T11:00:00Z
- Category: company_news; sentiment: bullish; impact: high
- Symbols: [NASDAQ:IRON](https://stocks.freetheai.org/symbols/NASDAQ-IRON)
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Disc Medicine, Inc. (IRON) announced that its pivotal Phase 3 APOLLO trial evaluating bitopertin in patients with erythropoietic protoporphyria and X-linked protoporphyria (EPP/XLP) met all primary and secondary endpoints. Bitopertin is an oral GlyT1 inhibitor being developed for these rare conditions.

The successful late-stage trial validates the company's lead drug candidate following earlier Phase 2 testing. EPP and XLP are rare diseases with limited treatment options, and bitopertin's oral administration offers a convenient dosing option for patients.

Following the trial outcome, Disc Medicine plans to resubmit a New Drug Application to the U.S. Food and Drug Administration by the end of 2026. The company expects an FDA regulatory decision by mid-2027. Shares of Disc Medicine were last trading at $56.84, up 0.34% on the day.

## Key points

- The Phase 3 APOLLO trial of bitopertin met all primary and secondary endpoints in EPP/XLP patients.
- Bitopertin is an oral GlyT1 inhibitor offering convenient dosing for patients with rare diseases.
- Disc Medicine plans to resubmit a New Drug Application to the FDA by the end of 2026.
- An FDA regulatory decision on bitopertin is expected by mid-2027.

## Questions and answers

### What were the results of Disc Medicine's Phase 3 APOLLO trial?

The pivotal Phase 3 APOLLO trial evaluating bitopertin in EPP/XLP patients met all primary and secondary endpoints.

### When does Disc Medicine plan to submit bitopertin to the FDA?

Disc Medicine plans to resubmit its New Drug Application to the FDA by the end of 2026, with a decision expected by mid-2027.

### What is bitopertin and how is it administered?

Bitopertin is an oral GlyT1 inhibitor designed as a convenient treatment for patients with EPP/XLP.