ALNY

What are the projected timelines for potential product approvals and commercial launch in major markets?

Created August 11, 2025 at 12:16 PM

Projected timelines for approvals / launch

Data read‑out (2025): Alnylam will unveil new hypertension and ATTR data at the ESC Congress 2025 (late August – early September 2025). Assuming the data are from late‑stage Phase 2 or early Phase 3 studies, the next logical step will be a regulatory filing in 2026 (e.g., a US BLA and an EU MAA).
Regulatory review (2026‑2027): The FDA’s standard review clock for a BLA is ~10 months (plus a possible advisory committee meeting), while the EMA’s “accelerated assessment” pathway can bring the review to 6‑9 months. If Alnylam submits in mid‑2026, a US approval could be expected by mid‑2027 and an EU approval by late 2027.
Commercial launch (2028): After a positive regulatory decision, companies typically need 12‑18 months to scale up manufacturing, finalize pricing & reimbursement, and launch in the United States, Europe and other major markets (Japan, Canada). Consequently, a first commercial launch in the U.S. and EU is likely to occur in 2028, with subsequent roll‑outs to other regions in 2029‑2030.

Trading implications

Short‑term catalyst: The ESC 2025 presentation will be a key catalyst. Positive efficacy or safety data could push the stock up 10‑15 % in the weeks surrounding the conference as investors price in the accelerated regulatory timeline.
Mid‑term positioning: With a probable 2026 filing and 2027 approval window, the stock may experience a “pre‑approval rally” in 2026‑2027. Traders can consider buying on any pull‑back after the ESC data, targeting the upside from the anticipated 2027 approvals.
Risk considerations: The timeline assumes no major safety setbacks and that Alnylam can meet the manufacturing scale‑up requirements. Any delay in Phase 3 read‑outs, a negative advisory committee, or supply‑chain constraints would push the approval and launch dates out, capping upside and increasing downside risk.