Replimune Group Inc Dossier - Source-backed chat

Replimune Group Inc

REPLNASDAQ

SectorHealth Care

IndustryBiotechnology

Beta (adjusted)0.94

Intrinsic Value

Insufficient data for a value estimateNot enough reliable inputs to publish a fair value for this company yet.

Market Price $13.45Price as of 1 Oct 2026

Data confidenceNot applicable

Market Cap $1.3B

Enterprise Value $1.2B

Shares Outstanding 98.2M diluted

Next Earnings Date5 Nov 2026

All prices and values are periodic snapshots, not live quotes. Source dates are shown for reference.

Thesis

Street consensus, scenarios, merits, risks, and invalidation triggers

AI-assisted

Thesis Summary

Replimune Group, Inc. is at a critical regulatory and clinical juncture. Following a Complete Response Letter (CRL) in July 2025 and subsequent regulatory setbacks, the company has aligned with the FDA on a path forward for the resubmission of its Biologics License Application (BLA) for its lead asset, RP1 (vusolimogene oderparepvec), in combination with nivolumab for anti-PD-1 failed melanoma. While the FDA has indicated it will treat the resubmission as an urgent matter and prioritize its review, the regulatory path remains highly volatile. The company's cash runway extends late into the first quarter of calendar 2027, supported by a robust cash position of $269.1 million (as of December 31, 2025) and an amended loan agreement with Hercules Capital. However, near-term commercial success is entirely dependent on the prioritized FDA review of RP1, making a Hold recommendation prudent until regulatory clarity is achieved.

This section is the 12-month view: analyst targets and the probability-weighted scenarios built from them. The intrinsic value at the top of this page answers a different question: what the business is worth today.

Street view · analyst 12-month targets6 analysts · as of 18 Aug 2026

Low · most bearish analyst$14.00

Mean target$19.33

High · most bullish analyst$24.00

Our research · scenarios, merits, risks, and invalidation triggersResearch as of 19 Jun 2026

Scenarios · 12-month scenario targetsAnchored at research date

Bear CaseDownside scenario

$1.0020%

The FDA issues another Complete Response Letter or refuses approval for RP1, forcing Replimune to discontinue development of its lead asset. The company is forced to restructure, preserve capital, and raise highly dilutive equity to advance its earlier-stage pipeline (RP2 and RP3) through the clinic, leading to severe downside.

Base CaseCentral scenario

$6.0050%

Replimune successfully resubmits the RP1 BLA, and the FDA conducts a prioritized review. The company continues to advance its confirmatory IGNYTE-3 trial and clinical cohorts for RP2. Valuation remains constrained near current levels as the market awaits the final FDA decision and clinical milestones, with the cash runway sufficient to sustain operations into early 2027.

Bull CaseUpside scenario

$9.0030%

The FDA rapidly reviews and approves the resubmitted RP1 BLA under prioritized review, unlocking a peak sales potential of up to $800 million annually in the high unmet need setting of anti-PD-1 failed melanoma. Positive clinical progress in the confirmatory IGNYTE-3 Phase 3 trial and the expansion of RP2 into a randomized Phase 2/3 trial for metastatic uveal melanoma drive significant valuation upside.

Scenarios are anchored to street consensus at the research date, with our probabilities and rationale.

Key Investment Merits

FDA alignment on a path forward for RP1 BLA resubmission with prioritized review status.
Strong clinical data from the IGNYTE trial showing durable responses in a high unmet need setting.
Robust cash position of $269.1 million (as of Dec 31, 2025) and access to up to $120 million in post-approval milestones under the amended Hercules loan agreement.
Promising pipeline expansion with RP2 showing systemic immune activation and durable responses in advanced solid tumors at ASCO 2026.

Key Investment Risks

High regulatory risk with a history of FDA Complete Response Letters (CRLs) and review team transitions.
Binary dependence on the approval of a single lead asset (RP1) for near-term commercialization.
Substantial cash burn typical of clinical-stage biotechnology companies, with a runway extending only into late Q1 2027 without commercial revenues.
Intense competition in the oncology and immunotherapy space from established pharmaceutical companies.

Thesis Invalidation Triggers

FDA refusal to file or subsequent rejection of the resubmitted RP1 BLA.
Failure to meet primary endpoints (such as overall survival) in the confirmatory IGNYTE-3 Phase 3 trial.
Inability to secure additional capital or draw down milestones under the Hercules loan agreement, leading to a severe cash runway shortage before early 2027.

All scenarios are estimates and subject to change. Past performance is not indicative of future results.

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ValuationIntrinsic value, the six-method breakdown, peer medians, and your assumptions sandbox.Financial SnapshotRevenue, profitability, returns, balance sheet, dividends, and the filing-level detail.Qualitative AnalysisBusiness overview, strategic initiatives, and mergers, acquisitions & partnerships.Outlook & Key DatesForward estimates, reporting calendar, and the monitoring framework.