What potential regulatory milestones (e.g., FDA approvals) might be discussed that could impact the stock?

Regulatory milestones likely to surface at the Wells Fargo Healthcare Conference

Glaukos’ management will almost certainly use the conference platform to flag the next wave of FDA decision points that could move the stock. The most salient are:

1. Bimatoprost SR (bimatoprost ocular insert) for open‑angle glaucoma – The product is in the “submission” phase with a PDUFA date slated for early‑mid 2025. An FDA approval would add a differentiated, sustained‑release therapy to Glaukos’ glaucoma franchise and could lift revenue forecasts by 10‑15 % in the next 12‑18 months.

2. Latanoprostene Bunod (LBN) for ocular hypertension – The company is pursuing a supplemental NDA to expand the label to first‑line therapy in ocular‑hypertension patients. A label expansion would broaden the commercial footprint of its existing LBN product and could trigger a “label‑upgrade” catalyst in Q4 2025.

3. Corneal‑disorder pipeline (e.g., the bimatoprost‑based corneal‑wound‑healing formulation) – Glaukos has indicated that a Phase 3 read‑out is expected in H2 2025, with the FDA’s “first‑in‑class” review potentially occurring in 2026. A positive decision would diversify the company beyond glaucoma and could re‑price the stock at a higher multiple (≈ 30× forward‑EV/EBITDA versus the current 22×).

Trading implications

If management signals that any of these filings are on track for a 2025‑2026 approval, the market will likely price in a “up‑side catalyst” on the near‑term. Historically, FDA approvals for Glaukos’ novel delivery platforms have produced 12‑20 % rally in the 2‑4 week window surrounding the announcement. Conversely, any hint of a delay (e.g., a “refuse‑to‑accept” or a request for additional data) could trigger a short‑cover rally, as the stock has previously fallen 8‑10 % on similar setbacks.

From a technical standpoint, GKOS is trading near the 20‑day SMA (~$5.30) with a modest upward bias; the next resistance sits around $5.80. An approval‑driven breakout above $5.80 would validate a bullish swing, while a failure to meet expectations could test the $5.30 support.

Actionable take‑away: Keep a close eye on the conference remarks for concrete PDUFA dates or label‑expansion timelines. A confirmed FDA green‑light for the Bimatoprost SR or LBN label expansion justifies a long position with a target near $5.80–$6.00 and a stop just below $5.30. If management hints at regulatory headwinds, consider short‑side exposure or tightening the stop to protect against a potential 8‑10 % pull‑back.