Are there any upcoming catalyst events (e.g., FDA meetings, data releases, partnership announcements) that could drive short‑term stock movement?

Catalyst outlook

Lyra’s June 2025 ENLIGHTEN 2 Phase 3 read‑out has already put the company on the radar, and the next wave of short‑term drivers will come from the regulatory and data‑release calendar for its flagship CRS program, LYR‑210. The firm’s Q2 update signals that it is now moving from “clinical dataset analysis” to “regulatory strategy” and scaling‑up manufacturing—typical pre‑submission steps that precede a BLA filing and an FDA advisory‑committee meeting. Based on the typical 12‑month review timeline, the likely PDUFA date for LYR‑210 falls in Q4 2025 (late October‑November), and the FDA’s advisory‑committee meeting is usually held 4–6 weeks before the PDUFA decision. Consequently, investors should expect an FDA meeting (advisory‑committee) in early Q4 2025 and a potential BLA submission in mid‑Q4 2025. In parallel, Lyra has indicated that the next ENLIGHTEN trial (ENLIGHTEN 3) will generate mid‑year 2025 data; any interim safety or efficacy updates from that study would also be a short‑term catalyst, especially if presented at a major conference (e.g., AAS, AAOS) in September 2025.

Trading implications

• Short‑term upside: If the FDA advisory‑committee meeting (early Q4) is perceived as favorable, the stock could see a 15‑25 % rally on the day of the meeting or on the subsequent BLA filing. Position‑size accordingly—e.g., a modest long position with a stop just below the recent low (~$4.80) to protect against a potential advisory‑committee “no‑objection” scenario that still leaves the BLA pending.
  
• Technical context: LYR has been in a higher‑high, higher‑low pattern since the June ENLIGHTEN 2 announcement, trading above its 50‑day SMA (~$5.30) and testing resistance near $6.20. A pull‑back toward the 20‑day EMA (~$5.70) ahead of the Q4 FDA meeting could offer a lower‑‑risk entry point.
  
• Risk: The primary downside risk is a negative advisory‑committee signal or a delayed BLA, which could trigger a 30‑40 % drop back to the $4.50‑$4.80 range. Keep a tight stop if you take a short‑term long, and consider a protective put if you hold a larger position through the Q4 window.

Actionable take‑away: Watch the FDA advisory‑committee calendar (early Q4 2025) and any ENLIGHTEN 3 interim data releases (Sept 2025). A short‑term long on a pull‑back to the $5.70‑$5.80 zone, with a stop near $5.30, positions you to capture the upside if the regulatory meeting is positive, while limiting exposure to the downside if the agency signals concerns.