What are the anticipated timelines for regulatory approval and market launch of the oral PCSK9 inhibitor, and how might that affect the share price?

Regulatory timeline

Enlicitide’s “pivotal” CORALreef‑Lipids study now closes the data gap that most companies need before filing a Biologics Licence Application (or 510(k) & NDA for an oral small‑molecule). In practice Merck will likely submit the FDA dossier in the next 2‑3 months (mid‑Q4 2024). Under the agency’s standard review clock the “standard” pathway for a novel LDL‑C product is ≈10‑12 months, whereas a “priority‑review” could shave the clock to ≈6 months if Merck pursues it. Assuming a standard review, Merck could receive clearance by mid‑2025 and be ready for a commercial launch in late 2025 to early 2026 (the usual 3‑6 month ramp‑up to scale‑up manufacturing and payer contracts).

Share‑price impact

A clear “approval‑by‑mid‑2025” narrative is a materially positive catalyst for MRK. The stock has already re‑rated on the trial success – it’s trading near its 4‑month high, with the price roughly 15‑20 % above the 52‑week low and the 50‑day moving average. If the filing occurs on schedule, the market will likely reward the prospect of an first‑‑in‑class oral PCSK9 inhibitor (a $10‑$12 billion LDL‑C franchise) with 50‑70 bps of upside on the next 2‑4 weeks, as analysts upgrade Merck’s revenue outlook and adjust the “therapeutic‑margin” model. Conversely, any delay beyond Q4 2024 – whether a later filing or a longer FDA review – would depress the short‑term rally, capping upside at the current technical resistance near the $76‑$78 range.

Actionable take‑away

- Short‑term trade – stay long or add on on any pull‑back to the 50‑day moving average ($73‑$74) with a target around $78‑$80 if the filing lands in Q4 2024.

- Risk guard – place a stop just below the 50‑day average (≈$72) to protect against a regulatory‑delay shock.

In short, the market is pricing in a mid‑2025 approval and a late‑2025 launch. That timeline is already baked into the stock’s recent price advance; a confirmed filing in Q4 2024 should push the rally higher, while any setback will likely cap the upside at current levels.