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Replimune Group

REPL Lead: Approved ★ Read the deep dive → 13 Biotech Distilled articles ↓ 35 filings & releases ↓ Cash $308M (Sep 30, 2026) ↓ 13 verdicts ↓ 3 timing quotes ↓
Oncology Gene Therapy

Market cap $2.05B 94.8M shares (10-Q/A, Oct 23, 2026) × $21.62 close Nov 6, 2026

Most recent annual filing: 2026-06-29

Catalyst timeline

4 trackedQuarter catalyst calendar →
  1. RP2 readoutend of 2026RP2 readout, end of 2026, notable
  2. RP2 readout4Q 2026RP2 readout, 4Q 2026, notable
  3. RP2 corporate update1Q 2027RP2 corporate update, 1Q 2027, routine
  4. RP1 interim2H 2027RP1 interim, 2H 2027, notable

Bar width shows how precise the guidance is — a pin is a stated date, a wide band a six-month window. Deeper blue means more of the thesis rides on the event; it is not a view on the stock.

Pipeline (5 active programs)

Technology platforms

RPx

Proprietary oncolytic immunotherapy platform based on an engineered HSV-1 backbone with multiple immune-activating payloads (GALV-GP R(-), GM-CSF, anti-CTLA-4, CD40L, 4-1BBL); designed for intratumoral administration to induce local and systemic anti-tumor immunity; focus areas: skin cancers, liver cancers, uveal melanoma, and other solid tumors

Discontinued (2)

Capital (as filed)

Cash
$308M cash and cash equivalents · Sep 30, 2026 (10-Q)
Operating cash flow
−$47.7M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)
As stated in coverage
$308M cash per the update of Oct 28, 2026 — the company's own words as read there, not the filed figure

Offering documents (2)

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (13)

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (13 calls)

Every verdict Biotech Distilled has published on Replimune Group, oldest first — the full history, never a selection. How calls are scored: the track record.

  1. 2026-02-17 Watch Replimune (REPL): Scientific Deep Dive for RP1, RP2, and Pipeline Products The FDA's July 2025 CRL explicitly rejected single-arm data as insufficient, and betting on a reversal without new randomized data is a high-risk proposition best avoided until after the binary PDUFA event.
  2. 2026-04-10 Avoid UPDATE: Replimune (REPL) - The Hammer Drops The FDA issued a second CRL, the company admitted RP1 development is 'not viable' without accelerated approval, mass layoffs and manufacturing scale-back are underway, and the cash runway is now a wind-down runway.
  3. 2026-05-29 Speculative buy speculative UPDATE: Replimune (REPL) - The FDA Blinks The FDA's willingness to prioritize the BLA resubmission materially de-risks the regulatory tail, the 33.6% ORR data paired with an engaged review team could produce approval on a months-not-years timeline, and the platform optionality re-attaches to the equity — but the stock has already moved 82.6% off lows so this warrants only a small, sized-for-volatility re-entry.
  4. 2026-06-02 Speculative buy speculative UPDATE: Replimune (REPL) - ASCO Delivers the Backstop The 32.9-month median OS and 47.8% 3-year survival data directly address the FDA's CRL objections on heterogeneity and durability, and RP2's final first-in-human data re-validates the platform, but the stock has roughly doubled from the April low so the asymmetric setup is gone.
  5. 2026-06-26 Speculative buy speculative UPDATE: Replimune (REPL) - The Clock Is Set The FDA accepted the BLA resubmission with a Class 1 designation and PDUFA date of August 2, 2026, with a late-July AdCom now the dominant catalyst, but the stock has tripled from the April low and the asymmetric setup is largely gone.
  6. 2026-07-24 Speculative buy speculative UPDATE: Replimune (REPL) - Baker Bros Gets Its Exit Ramp Six Days Before the AdCom The clinical package is unchanged and procedural signals remain directionally favorable, but the Baker Bros 25.9% resale shelf going effective six days before the AdCom and the formal going-concern paragraph worsen the downside geometry if the panel votes no.
  7. 2026-07-30 Speculative buy speculative UPDATE: Replimune (REPL) - The Panel Says Yes The AdCom voted favorably on both CRL objections, the FOIA'd FDA clinical review shows the agency's own reviewers recommended approval, and the -44% slide into the panel partially reopened asymmetry, but the FDA can still diverge from its panel and the letter is not yet signed.
  8. 2026-07-31 Speculative buy speculative UPDATE: Replimune (REPL) - 10 to 3 The 10-3 AdCom margin gives the review division external cover to approve and removes ambiguity, but the stock doubled in one session so the asymmetry that briefly reopened at $5.41 has closed again and the letter still isn't signed.
  9. 2026-08-07 Buy core UPDATE: Replimune (REPL) - Approved, With an Asterisk in the Denominator TUDRIQEV received accelerated approval with a broad label covering the full anti-PD-1-failed melanoma TAM, retiring the regulatory tail and changing the equity from a binary-event name to a commercial-execution name, though the label efficacy numbers (24.2% ORR / 14.1-month DOR) are below the deck figures and a going-concern paragraph, resale shelf, and imminent financing remain.
  10. 2026-08-08 Buy core UPDATE: Replimune (REPL) - The Launch Deck Answers the Question I Ended On The launch deck shows 87% IR champion identification, existing procedural codes, ~80% covered lives engaged, and BSL-1 outpatient handling that collectively address the commercial friction flagged in February, but 60 days to shipment and no disclosed price mean revenue inflection is a 2027 story.
  11. 2026-08-11 Buy core UPDATE: Replimune (REPL) - The Raise Lands, and the Stock Goes Up $150M priced flat at $12.06 with no discount removes the balance sheet risk and formally retires the going-concern overhang, changing the equity to a funded launch-execution name, though the Baker Bros resale shelf and ATM imply further supply and first revenue remains a 2027 event.
  12. 2026-08-15 Buy core UPDATE: Replimune (REPL) - The Confirmatory Clock Just Moved to 2030 The going-concern paragraph is formally alleviated, a CCO with a directly analogous launch track record is hired, and the IGNYTE-3 OS readout moving to 2030 extends commercial runway to four years — but also defers resolution of the contribution-of-effect question and the stock has tripled from the July 29 low.
  13. 2026-10-29 Buy core UPDATE: Replimune (REPL) - First Prescriptions, First Receipts TUDRIQEV is in patients at 15+ sites within three weeks of first delivery, NCCN 2A listing and majority commercial coverage confirm access, and $307.8M cash clears near-term funding concerns, though no revenue has been booked yet and RP2 liver data slipped to Q1 2027.

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Timing, in the company's words (3 quotes from 2 filings)

Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.

Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.

Filings & releases (35)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from May 29, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

12 more filings (13G holder notices, S-8, proxy material, SEC correspondence …)