What milestones (e.g., IND filing, Phase 1/2 trial start) are expected for the OX2R program, and what are the timelines?
Milestones & Timing for the OX2R Program
- IND filing: Centessa expects to submit the IND for its lead OX2R agonist in Q4 2025 (the last quarter of the current year). The filing will clear the regulatory pathway for first‑in‑human studies and is the first major regulatory milestone for the franchise.
- Phase 1/Phase 1‑2 start‑up: The company has indicated that the Phase 1 dose‑range‑finding study and a Phase 1‑2 proof‑of‑concept trial will be initiated shortly after the IND is accepted, targeting Q1–Q2 2026. The Phase 1 trial will generate safety and PK data, while the Phase 1‑2 study will begin to explore efficacy signals in the intended sleep‑disorder indication.
Trading Implications
These near‑term catalysts are likely to drive short‑term volatility in CENTA’s stock. A successful IND filing in Q4 2025 could spark a 10‑15 % rally as investors price in the de‑risking of a first‑in‑human program. Conversely, any regulatory setbacks would pressure the share price. The subsequent Phase 1/1‑2 start‑up in early 2026 provides a second, more substantive catalyst; positive safety data could push the stock toward the $12–$14 range (up ~30 % from current levels), while mixed or negative data may cap upside and trigger a pull‑back.
From a technical standpoint, CENTA is currently holding near its 200‑day moving average (~$8.30) with the price forming a higher‑low pattern on the daily chart, suggesting the upcoming data readouts could break the short‑term resistance at $9.00. Given the limited upside risk and the high‑impact nature of the OX2R milestones, a small‑position, catalyst‑play (e.g., buying on dips to $8.50–$9.00 with a target of $12–$14) is appropriate for traders looking to capitalize on the program’s de‑risking trajectory.