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Replimune Group, Inc.

REPL
OvervaluedBiotech · Commercial
FDA catalysts, PDUFA dates & pipeline intelligence
$13.04
▼ -0.16 · -1.21%

Financials

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52W LOW $1.5052W HIGH $16.33
Volume
1.75 M
Value Traded
119.13 M
Short % Float
25.68%
-0.23%Week
-9.76%1 Month
+18.65%3 Month
+173.95%6 Month
-86.5%5 Year
-67.44%All Time

Cash Data

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  • Burn Trend
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  • SEC Filing

Key Stats

Market Cap
1.22 B
EPS (TTM)
-3.15
P/E Ratio
-
Ent. Value
1.11 B
Total Shares
93.80 M
Float Shares
88.61 M
Insiders
5.95%
Institutions
103.01%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 3 data readout
RP1 (vusolimogene oderparepvec)
Advanced melanoma (patients progressed on anti-PD-1 and anti-CTLA-4 therapies or ineligible for anti-CTLA-4)
BreakthroughPriorityAccelerated
Phase 3Oncolytic VirusesOncology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

REPL Catalyst Timeline

Dated clinical, regulatory and corporate events for Replimune Group, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Replimune Group, Inc.

330Total events
12Upcoming
82Tier-1 (high impact)
2018 to 2030Coverage

Upcoming catalysts 2

T2Runway Guidance Update
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T2Product Launch
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TUDRIQEVApproved

Event history 50

▲Product LaunchTUDRIQEVApprovedPost-Market
TUDRIQEV now commercially available in the U.S.
unresectable advanced cutaneous melanomasource ↗
●Management ChangeCorporate
Michelle DiNapoli appointed Chief Commercial Officer
●Quarterly UpdateCorporate
Fiscal Q1 2027 financial results reported
●Enrollment UpdateRP1FiledTrial
IGNYTE-3 confirmatory trial actively enrolling
advanced melanomasource ↗
●Enrollment UpdateRP2Trial
REVEAL study actively enrolling
metastatic uveal melanomasource ↗
▼Equity OfferingCorporate
Completed $150 million financing
▼Equity OfferingCorporate
Pricing of $150 million underwritten offering
▲FDA ApprovalTUDRIQEVApprovedFDA Decision
FDA granted accelerated approval to TUDRIQEV in combination with nivolumab
unresectable advanced cutaneous melanomasource ↗
▲Full ResultsTUDRIQEVApprovedClinical Data
IGNYTE study data published in Journal of Clinical Oncology
advanced melanomasource ↗
▲Product LaunchTUDRIQEVApprovedPost-Market
Replimune focused on delivering TUDRIQEV to patients
advanced melanomasource ↗
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Past FDA Catalysts and PDUFA Decisions

How REPL actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-08-06RP1 (vusolimogene oderparepvec) in combination with nivolumab PDUFA Date ApprovedPDUFA
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

C40 / 100
Pipeline Score
$433M
Pipeline Value
Overvalued
Valuation Signal
3
Drugs Scored
0.4x
rNPV / MCap
Top 40%
Micro Cap
(rank 264 of 658)
Percentile Rank
Replimune Group, Inc. carries a moderate pipeline score (40/100), with $1.6B risk-adjusted pipeline value, led by Vusolimogene oderparepvec in Non-Small Cell Lung Cancer (NSCLC) (Phase 2).
Showing 1 of 3 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Vusolimogene oderparepvec Gene therapyMarketedNCT06264180Advanced MelanomaPhase 3 RECRUITING 400Mar 31, 2031
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Clinical Trial Results

Readouts, endpoints and source filings for every REPL program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
RP2 advanced solid tumorsPhase 12026-05-31monotherapy or: 19.0%; combination or: 19.1%; disease control rate: 48.9%; median duration response monotherapy: not reached; median duration response combination: 22.1 monthsRead MoreReplimune Presents Final First-in-Human Data for RP2 in Advanced Solid Tumors During Oral Presentation at the 2026 American Society of Clinical Oncology Annual MeetingRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Hill Emily LuisaOfficer (Chief Financial Officer)Sell -9,256 215,852 held$14.28 08/17/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
BAKER BROS. ADVISORS 0.6 % (20 %) 122.27 M 11.05 M
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Shares held by hedge funds each quarter, and who bought or sold.

REPL Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-09
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How REPL ranks across every disease it competes in

Competitive Position is a premium feature
See how REPL ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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REPL News

REPL
Oct 1, 2026
REPLFDA Updates

Replimune Announces TUDRIQEV™ Now Available in the U.S. for Advanced Melanoma

Replimune Group, Inc. has announced the commercial availability of TUDRIQEV in the U.S. for patients with unresectable advanced cutaneous melanoma who have progressed after PD-1 therapy. This therapy, administered in combination with nivolumab, received accelerated FDA approval based on clinical trial data. A confirmatory Phase 3 trial is ongoing to verify its clinical benefits.

Read more →
REPL
Sep 3, 2026
REPLConferences/Events

Replimune to Present at the Cantor Global Healthcare Conference 2026

Replimune Group, Inc. will present at the Cantor Global Healthcare Conference on September 10, 2026. The management team will engage in a fireside chat, which will also be available via webcast. Replimune focuses on developing oncolytic immunotherapies, with its product TUDRIQEV already approved for advanced melanoma treatment.

Read more →
REPL
Aug 19, 2026
REPLGeneral
▼ -5.1%on this news

Replimune Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Replimune Group, Inc. announced the grant of inducement equity awards to Chief Commercial Officer Michelle DiNapoli. The awards include a non-qualified stock option for 150,000 shares and restricted stock units for 100,000 shares, with specific vesting terms. These awards were approved under Nasdaq Listing Rule 5635(c)(4) and are consistent with the company's equity incentive plan.

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REPL
Aug 14, 2026
REPLFDA Updates

Replimune Reports Fiscal First Quarter 2027 Financial Results and Provides Corporate Update

Replimune Group, Inc. reported strong financial results for Q1 2027, highlighted by the FDA's accelerated approval of TUDRIQEV for advanced melanoma. The company is preparing for a commercial launch within 60 days and has secured $150 million in financing to support this effort. Additionally, Michelle DiNapoli has been appointed as Chief Commercial Officer to enhance the company's commercial strategy.

Read more →
REPL
Aug 10, 2026
REPLGeneral
▲ +13.3%on this news· ran to +26% by day 3

Replimune Announces Pricing of $150 Million Underwritten Offering

Replimune Group, Inc. has announced the pricing of an underwritten offering of 9,701,490 shares of its common stock, raising $150 million. This move is expected to enhance the company's financial resources, enabling further development of its innovative oncolytic immunotherapies. The offering reflects investor confidence in Replimune's growth potential.

Read more →
REPL
Aug 6, 2026
REPLFDA Updates
▼ -6.2%on this news· ran to +19% by day 3shared move

Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen

Replimune Group, Inc. announced the FDA's accelerated approval of TUDRIQEV in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who have progressed on anti-PD-1 therapy. The approval is based on a 24.2% objective response rate observed in the IGNYTE trial. The treatment was well tolerated, although continued approval may depend on further clinical trials to verify its benefits.

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REPL
Jul 30, 2026
REPLFDA Updates
▲ +107%on this news· ran to +120% by day 1

Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

Replimune Group, Inc. announced a favorable outcome from the FDA's advisory committee meeting regarding the BLA resubmission for RP1 in advanced melanoma. The committee voted 10 to 3 on the clinical meaningfulness of the efficacy results from the IGNYTE study. The FDA's target action date for the BLA is August 2, 2026.

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REPL
Jun 29, 2026
REPLFDA Updates

Replimune Reports Fiscal Fourth Quarter and Year End 2026 Financial Results and Provides Corporate Update

Replimune Group reported its fiscal fourth quarter and year-end results, highlighting the FDA's acceptance of the BLA resubmission for RP1 in advanced melanoma. The company is actively enrolling patients in its clinical trials for RP1 and RP2, with promising survival data presented at ASCO 2026. However, the company reported a significant net loss and a decrease in cash reserves compared to the previous year.

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REPL
Jun 26, 2026
REPLFDA Updates

Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced Melanoma

Replimune Group, Inc. announced that the FDA has accepted its resubmission of the Biologics License Application for RP1 in combination with nivolumab for advanced melanoma. The FDA's action is classified as a complete, class 1 response, with an advisory committee meeting expected in late July. The resubmission aims for accelerated approval based on the IGNYTE clinical trial data.

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REPL
May 31, 2026
REPLPhases

Replimune Presents Final First-in-Human Data for RP2 in Advanced Solid Tumors During Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting

Replimune Group presented final first-in-human data for RP2 at the 2026 ASCO meeting. The Phase 1 trial involved 85 patients with advanced solid tumors, showing an objective response rate of 19.0% for RP2 monotherapy and 19.1% when combined with nivolumab. The results indicate durable responses and a favorable safety profile, supporting further evaluation in a Phase 2/3 trial.

Read more →
REPL
May 30, 2026
REPLConferences/Events

Replimune Presents 3-Year Landmark Overall Survival Analysis from IGNYTE Clinical Trial During Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting

Replimune Group, Inc. presented promising 3-year overall survival data from the IGNYTE clinical trial at the 2026 ASCO annual meeting. The trial evaluated RP1 plus nivolumab in patients with anti-PD-1 failed melanoma, showing a median overall survival of 32.9 months. Notably, 47.8% of all treated patients survived at three years, with 83.5% survival among responders, highlighting the treatment's durability and effectiveness.

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REPL
May 29, 2026
REPLFDA Updates
▲ +85.7%on this news· ran to +113% by day 3shared move

Replimune Announces Planned RP1 BLA Resubmission Following Productive Discussion with FDA

Replimune Group, Inc. has announced plans to resubmit its Biologics License Application (BLA) for RP1 following productive discussions with the FDA. The agency has committed to treating the resubmission as urgent, recognizing the unmet needs in advanced melanoma treatment. The BLA is supported by clinical trial data, highlighting the need for new therapies as current options often fail.

Read more →
REPL
Apr 27, 2026
REPLConferences/Events
▲ +10.7%on this news

Replimune to Present at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

Replimune Group, Inc. announced its participation in the 2026 ASCO Annual Meeting, where it will present multiple abstracts. Key presentations include a landmark survival analysis from the IGNYTE trial and final results from a Phase 1 study of RP2. The event will showcase advancements in oncolytic immunotherapies for melanoma and other solid tumors.

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REPL
Apr 10, 2026
REPLFDA Updates
▼ -19.5%on this news· ran to -71% by day 1shared move

Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma

Replimune Group received a complete response letter from the FDA for its RP1 biologics license application for advanced melanoma. The company disagrees with the FDA's assessment of the data supporting RP1's efficacy and safety. This decision has led to job cuts and a scaling back of operations, as the company struggles with the regulatory process. The situation highlights concerns over FDA communication and innovation in cancer treatment.

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REPL
Mar 2, 2026
REPLConferences/Events
▼ -6.4%on this news

Replimune to Present at Two Upcoming Investor Conferences

Replimune Group, Inc. announced that its management team will present at two upcoming investor conferences: the Leerink Partners 2026 Global Healthcare Conference and the Jefferies 2026 Biotech on the Beach Summit. The presentations will include a fireside chat and 1x1 meetings. Live webcasts will be available on their website.

Read more →
REPL
Feb 3, 2026
REPLFDA Updates
▲ +5.8%on this news

Replimune Reports Fiscal Third Quarter 2026 Financial Results and Provides Corporate Update

Replimune Group, Inc. reported its fiscal third quarter 2026 financial results, highlighting the acceptance of its BLA resubmission for RP1 by the FDA. The company is preparing for a potential launch, pending FDA approval, with commercial readiness activities in progress. Additionally, Replimune amended its loan agreement to extend its cash runway into early 2027.

Read more →
REPL
Jan 14, 2026
REPLConferences/Events

Replimune Group Inc. JPM 2026 Presentation Click to edit Master title style 1 Click to edit Master text styles Igniting a systemic immune response to cancer with oncolytic immunotherapy

Replimune Group Inc. presented at the 2026 JPM Healthcare Conference, highlighting the progress of their RPx oncolytic immunotherapy. The company is set to pursue a PDUFA date of April 10, 2026, for melanoma treatment, leveraging a launch-ready commercial team. The presentation detailed clinical trial advancements and the platform's ability to deliver significant immune responses, particularly in resilient cancer cases. However, the company acknowledged various risks that could affect projected outcomes as they navigate the complexities of development and regulatory approval.

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REPL
Dec 18, 2025
REPLConferences/Events

Replimune to Present at the 44th Annual J.P. Morgan Healthcare Conference

Replimune Group, Inc., a clinical stage biotechnology company based in Woburn, MA, has announced that its management will present at the 44th Annual J.P. Morgan Healthcare Conference scheduled for January 14, 2026. The company focuses on developing novel oncolytic immunotherapies using its proprietary RPx platform. This platform aims to enhance immunogenic cell death and systemic anti-tumor immune responses, offering potential synergy with existing cancer treatments. A webinar of the presentation will be available on their website for interested investors and stakeholders.

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REPL
Nov 7, 2025
REPLConferences/Events

Replimune Presents Late-Breaking Abstract and Additional Posters on RP1 at 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC 2025)

Replimune Group, Inc. presented late-breaking abstract data from the IGNYTE trial at the SITC 2025, highlighting the potential of RP1 combined with nivolumab in treating melanoma. The data suggest that this combination may help overcome resistance to immune checkpoint blockade. Additionally, two posters on RP1 were also showcased at the conference.

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About Replimune Group, Inc.

Woburn, MA 465 employees replimune.com
Headquarters500 UNICORN PARK, WOBURN, MA, 01801
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