What are the timelines for regulatory approval and market launch of VERQUVO® based on these results?

Regulatory‐approval timeline:

The ESC‑2025 presentation of the new VERQUVO® (vericiguat) data is being positioned by Merck as the “final pivotal package” that will support a supplemental New‑Drug Application (sNDA) in the United States and a marketing‑authorisation dossier in the EU. Merck has indicated that the sNDA will be filed in Q3 2025 (the next filing window after the data read‑out). Assuming a standard FDA review cycle for a supplemental filing (≈ 6‑8 months) and a parallel EMA review (≈ 9 months), regulatory clearance could be expected by early‑to‑mid 2026 in both regions, provided no major issues arise in the review.

Market‑launch timeline:

The company has signaled that, contingent on a positive regulatory outcome, commercial rollout would commence in the second half of 2026 in the U.S., with a staggered EU launch shortly thereafter (Q4 2026‑Q1 2027). This aligns with Merck’s typical product‑launch cadence for cardiovascular therapies, where manufacturing scale‑up and payer‑access activities are initiated during the regulatory review window.

Trading implications:

The Q3‑2025 filing window creates a near‑term catalyst; the stock could experience a modest rally (5‑10 %) as investors price in the probability of a successful review. A confirmed launch date in H2‑2026 would add a new revenue stream to Merck’s cardiovascular pipeline, supporting a higher fair‑value multiple for the drug’s projected $2–$3 billion peak sales. Traders might consider buying on any dip ahead of the sNDA filing and protecting upside with a call‑spread that expires around the expected FDA decision (mid‑2026). Conversely, a missed filing or a negative review would likely trigger a sharp correction, so a stop‑loss at the next technical support level (≈ $110) would be prudent.