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what it is
Replimune is a biotech betting on virus-based cancer treatments called oncolytic immunotherapies.
how it gets paid
Still pre-commercial — no meaningful product revenue in the earnings summary; operating expenses are almost entirely R&D + SG&A (Q3 FY2026: ~$53.1M R&D, ~$18.7M SG&A).
catalyst
RP1 + nivolumab in anti–PD-1–failed advanced melanoma: BLA resubmission accepted Oct 2025; PDUFA target April 10, 2026. Commercial prep underway per Feb 3, 2026 release.
what just happened
Feb 3, 2026: reported fiscal Q3 FY2026 results; diluted EPS $(0.77) vs $(0.79) in the prior-year quarter (more shares outstanding). Do not treat third-party “consensus” as verified here.
At a glance
B balance sheet — gets the job done, barely
FDA binary + clinical stage — equity risk dominates spreadsheet “predictability”
Nine months FY2026 YTD EPS $(2.62) — Feb 3, 2026 earnings tables
Cash ~$269M · runway late Q1 2027 per company plan
Hercules facility: $35M drawn + milestone tranches
xvary composite: 50/100 — below average
What they do
Replimune is a biotech betting on virus-based cancer treatments called oncolytic immunotherapies.
You are not buying sales yet. You are buying RP1 (BLA path, PDUFA Apr 10, 2026), RP2 (e.g., REVEAL uveal melanoma, HCC cohorts with Roche), and earlier RP3 programs — confirm stages on replimune.com/pipeline and SEC filings. Feb 3, 2026 update also cites IGNYTE-3 confirmatory Phase 3, NMSC cohort data from IGNYTE, and ARTACUS CSCC post-transplant monotherapy data.
How they make money
~$0
product revenue (pre-commercial) · fiscal year ends March 31
RP1 program
$0M
RP2 program
$0M
RP3 program
$0M
R&D (Q3 FY2026)
$53.1M
quarter
SG&A (Q3 FY2026)
$18.7M
quarter
The products that matter
lead program · BLA under review
RP1 + nivolumab
PDUFA target · Apr 10, 2026
RP1 (vusolimogene oderparepvec) with Opdivo® (nivolumab) in anti–PD-1–failed advanced melanoma. Resubmitted BLA accepted; PDUFA April 10, 2026. Company states commercial org and supply are preparing for a rapid launch if approved.
the thesis
earlier-stage oncology pipeline
RP2 & RP3
pre-commercial
RP2: REVEAL registration-directed trial in metastatic uveal melanoma (~280 patients); HCC and biliary cohorts per Feb 3, 2026 update. RP3: separate RPx candidate — see pipeline page / filings for indication mix. No substitute for RP1’s near-term regulatory readthrough.
optionality
Key numbers
$(0.77)
Q3 FY2026 EPS
Quarter ended Dec 31, 2025 — diluted, per Feb 3, 2026 release tables.
$(2.62)
nine months FY2026 EPS
YTD through Dec 31, 2025 vs $(2.25) in the prior-year nine-month period.
$269M
cash + ST investments
Dec 31, 2025 vs ~$483.8M at Mar 31, 2025 — burn funding RP1/RP2 programs and launch prep.
Apr 10
2026 PDUFA
Target action date for RP1 BLA; not a guarantee of approval or timing.
Financial health
B
strength
- balance sheet grade B — adequate — nothing special
- risk rank 3 — safer than 50% of stocks
- price stability 5 / 100
- stockholders’ equity ~$210.5M · Dec 31, 2025 (release table)
- liquidity Working capital ~$230.3M — confirm debt & covenants in 10-Q + Hercules amendment
B — functional but not a standout on the balance sheet.
Total return vs. market
Return history isn't available for REPL right now.
source: n/a — verify total return with your broker or index provider
What just happened
pre-revenue · PDUFA-driven
Fiscal Q3 FY2026 diluted EPS $(0.77); nine-month YTD $(2.62).
Total operating expenses ~$71.9M for the quarter (~$53.1M R&D, ~$18.7M SG&A). Net loss ~$70.9M vs ~$66.3M in the prior-year quarter. Investment income and other items in the release reconciliation net to a small offset vs operating loss. No product revenue — thesis remains regulatory and clinical.
$71.9M
Q3 op. expenses
$246.6M
nine-mo. op. ex.
$269.1M
cash + ST inv.
the number that mattered
April 10, 2026 PDUFA for RP1 — plus whether cash + Hercules capacity cover burn if the review slips or the outcome disappoints.
-
Feb 3, 2026: Fiscal Q3 FY2026 results and corporate update (Globe Newswire / ir. Replimune.com).
-
Hercules Capital loan amendment: $35M funded at close; up to $120M additional at post-approval milestones; repayment timing extended into 2027.
-
Clinical snippets: IGNYTE-3 confirmatory Phase 3; ESMO 2025 acral melanoma ORR data cited; ARTACUS CSCC post-transplant monotherapy data cited.
source: Replimune Group, Inc. press release (Feb 3, 2026) · ir.replimune.com
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What could go wrong
The top risk is an unfavorable or delayed outcome on the April 10, 2026 PDUFA for RP1 in anti–PD-1–failed advanced melanoma. With essentially no product revenue, the lead program is the near-term equity story.
med
RP1 does not clear the PDUFA bar
The BLA was resubmitted after prior regulatory feedback — if approval is denied, delayed, or heavily conditioned on April 10, 2026 (or thereafter), the launch narrative resets.
This risk sits over effectively 100% of the current revenue story, because there is no current revenue story.
med
Cash burn meets calendar risk
Cash ~$269.1M at Dec 31, 2025; company cites runway late into Q1 2027. The Hercules amendment adds liquidity but comes with covenants and milestones — read the credit agreement and 10-Q.
A longer path to revenue or higher spend can pull forward financing questions even with the new facility.
med
Approval would not end the hard part
Even with a green light, REPL still has to turn a clinical asset into a commercial product in a market that already includes competing melanoma therapies. Approval removes one risk. It does not remove execution risk.
The stock could win the headline and still struggle if launch expectations outrun real adoption.
A forced rethink of RP1 would pressure the whole equity story — you are underwriting one near-term PDUFA, ~$270M cash, and Hercules capacity, not a diversified revenue base.
source: institutional data · regulatory filings · risk analysis
Pay attention to
calendar
April 10, 2026
That is RP1's FDA action date. If you remember one thing about REPL, remember the date that could turn $0 revenue into a launch story.
metric
cash vs. burn into 2027
Track quarterly cash spend against the company’s late Q1 2027 runway statement and any change in Hercules utilization.
risk
What the FDA says this time
Read the FDA letter / company 8-K when it drops — label, REMS, or post-marketing requirements can matter as much as a binary “approved.”
trend
Whether RP2 and RP3 start to matter
Those pipeline assets are the backup argument for owning REPL. If RP1 stumbles, you need evidence the earlier-stage programs can carry more of the story.
Analyst rankings
earnings predictability
85 / 100
Composite score on file — not a claim that FDA or launch outcomes are predictable. Biotech losses can swing with legal, stock comp, and milestone timing.
beta
1.0
Beta measures how much a stock tends to move with the market. A 1.0 beta says market-like behavior. A biotech waiting on the FDA can still ignore that script for a day.
price stability
5 / 100
That is extremely low. You are not buying a sleepy healthcare name. You are buying headline sensitivity with a ticker attached.
source: institutional data
Institutional activity
Institutional ownership flows for REPL are not verified on this page.
source: n/a
Price targets
analyst targets not verified here
Illustrative spot on this page: $7.78 — not a forecast.
Want the deeper analysis?
The full deep dive: dcf model, scenario analysis, competitive moat breakdown, and quarterly tracking — everything on this page, taken further.
see plans from $5/moThe deep dive