Replimune (REPL): The Panel Voted 10-3, the Stock Doubled Through a Full-Day Halt, and the Cash Runs Out Nine Months Before the Confirmatory Data

Replimune was halted for the entire July 30 trading session. It went into the halt at $5.41. It came out of it at $12.70.

That is the cleanest picture of what an FDA advisory committee vote is worth that the market has produced this year. No tape, no price discovery, no partial fills. One number went in, a different number came out, and the difference is the market's estimate of what thirteen people in a Silver Spring conference room decided.

They voted 10 to 3.

What the panel actually voted on

The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee met on July 30 to discuss Replimune's Biologics License Application resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab, in advanced melanoma patients who have progressed on prior anti-PD-1 therapy.

The committee took one vote, on one question, and the wording matters: "Are the efficacy results from IGNYTE evaluable and clinically meaningful?"

Ten yes, three no. The company filed the outcome on an 8-K this morning.

Read that question again, because it tells you exactly how narrow the fight had become. The panel was not asked whether RP1 should be approved. It was asked whether the data from a single-arm Phase 2 trial can be interpreted at all, and if so, whether what it shows matters to patients. That is an unusually low bar to be arguing about three years into a regulatory process, and it is where this application had ended up after two rejections.

The underlying dataset is IGNYTE, and it is not a large one. Of the 140 patients enrolled, the confirmed objective response rate by independent central review was 32.9%, with a 15.0% complete response rate. Median duration of response was 33.7 months. Overall survival was 75.3% at one year and 63.3% at two. The population was genuinely refractory: 65.7% had primary anti-PD-1 resistance, 56.4% were PD-L1 negative, and 46.4% had already failed both anti-PD-1 and anti-CTLA-4 therapy. The results were published in the Journal of Clinical Oncology.

The FDA's own reviewers were not persuaded. In briefing documents released ahead of the meeting, agency staff argued that the single-arm design made it difficult to separate what RP1 did from what nivolumab did, and that survival comparisons between responders and non-responders were unreliable. Those documents hit the tape on July 28. The stock fell from $8.63 to $5.34 that session on 24 million shares, its heaviest volume in months, after already sliding from $11.00 on July 21.

So the sequence over eight trading days was: $11.00, then a 51% decline into the briefing documents, then a full-session halt, then a reopening at more than double the halt price. Pre-market on July 31, REPL traded at $12.68, up 134.38% against the $5.41 last close, on 4.4 million shares before the opening bell. The 52-week high before this week was $12.50.

The part the vote did not settle

The advisory committee is non-binding. The FDA is not required to follow it, and this particular agency has already told Replimune no twice: a complete response letter in July 2025, and a second one on April 10, 2026, which the company said in its annual report "reverses on points the FDA made in the September 2025 Type A meeting."

The current review is a Class 1 resubmission accepted on June 26 with a target action date of August 2, 2026. August 2 is a Sunday. Which means the answer arrives either in the next few hours or on Monday.

That is the event the tape is pricing. It is not the only clock running.

Five weeks ago, on June 29, Replimune filed an annual report in which its auditors attached a going-concern paragraph, and in which the company itself wrote that its cash "will be sufficient to fund its operating expenses and capital expenditure requirements only into the first calendar quarter of 2027."

Separately, if the FDA says no again, the company's next shot at approval depends on data from the IGNYTE-3 confirmatory trial, and that data is not expected until late 2027.

Those two dates do not overlap. The gap between them is the entire investment question, and almost nobody buying this stock in the pre-market has done the arithmetic on it.

The rest of this briefing is for paid members: the real economic share count versus the one in the market cap headline, the quarter-by-quarter cash burn schedule and exactly where the runway ends, the authorized-share ceiling that limits how much Replimune can raise without a shareholder vote, the debt maturity nobody is discussing, the commercial precedent that should temper the approval case, and three scenario price zones built off the August 2 decision.

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