Replimune Group, Inc., a clinical-stage biotechnology company, focuses on the development and commercialization of oncolytic immunotherapies to treat cancer in the United States and the United Kingdom. The company's proprietary oncolytic immunotherapy product candidates are designed and intended to activate the immune system against cancer. Its lead product candidate is RP1, a selectively replicating version of HSV-1 that expresses GALV-GP R(-) and human GM-CSF for a range of solid tumors. The company is also developing RP2 that expresses an anti-CTLA-4 antibody-like protein to block the inhibition of the immune response otherwise caused by CTLA-4. The company was founded in 2015 and is headquartered in Woburn, Massachusetts.
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Replimune prices $150 million stock offering
Replimune Group priced an underwritten offering of 9,701,490 shares of common stock at $12.06 per share, expecting gross proceeds of approximately $150 million before underwriting discounts and expenses. The company is also issuing pre-funded warrants with an exercise price of $0.0001 per share. Leerink Partners, J.P. Morgan, and Cantor are acting as joint bookrunning managers, and the offering is scheduled to close on August 11, 2026. The financing follows the recent FDA accelerated approval of Replimune's first commercial product, TUDRIQEV, in combination with Nivolumab for advanced melanoma.
FDA Grants Accelerated Approval to Replimune's TUDRIQEV for Advanced Melanoma
The U.S. FDA has granted accelerated approval to Replimune Group's TUDRIQEV, in combination with Bristol Myers Squibb's Nivolumab, for adults with unresectable advanced cutaneous melanoma who have progressed after anti-PD-1 therapy. The decision was based on the IGNYTE trial, where the combination achieved a 24.2% objective response rate and a median duration of response of 14.1 months among 140 enrolled patients. TUDRIQEV is an oncolytic immunotherapy derived from a modified herpes simplex virus type 1, administered by intratumoral injection every two weeks for eight doses, with Nivolumab given intravenously starting at week three. The approval was granted under the FDA's accelerated pathway, and continued approval may depend on confirmatory trials. Replimune's stock closed Thursday at $12.86, up 8.71%, and was at $12.73 in overnight trading.
Bragar Eagel & Squire Investigates Replimune Group on Behalf of Stockholders
Bragar Eagel & Squire, P.C. is investigating potential claims against Replimune Group Inc. on behalf of Replimune stockholders. The investigation concerns whether Replimune violated federal securities laws or engaged in other unlawful business practices. The inquiry follows a July 28, 2026 FDA release of briefing documents stating that the single-arm mid-stage study for Replimune's skin cancer drug RP1 is not interpretable, which confounds interpretation of efficacy results and limits the FDA's ability to verify reported results. Replimune's stock price dropped $3.27, or 37.89%, in intraday trading that day. Stockholders who purchased or acquired Replimune shares and suffered a loss are encouraged to contact the firm.
Biotech stocks hit 52-week highs on Q2 results and regulatory updates
Several biotech stocks reached 52-week highs on Tuesday, driven by second-quarter earnings reports and regulatory milestones. UFP Technologies surged over 25% to $338.70 after reporting net income of $20.9 million on a 15.1% sales increase to $174 million. InfuSystem Holdings climbed over 33% to $12.49 as second-quarter revenue rose 2.6% to $36.9 million, with Patient Services revenue up 15% offsetting a 16% decline in Device Solutions. SOPHiA Genetics gained over 20% to $6.98 following a 27% revenue jump to $23.3 million, fueled by 64% growth in the U.S. market. Replimune Group touched $13.86 intraday after a favorable advisory committee opinion on its RP1 BLA, though the FDA's August 2 response deadline passed without an update. Parabilis Medicines rose over 5% to $36.69, its highest since its June 11 IPO that raised $770.5 million.
Pomerantz Law Firm Investigates Replimune Group Over Securities Fraud Claims
Pomerantz LLP is investigating claims on behalf of investors of Replimune Group, Inc. concerning whether the company and certain officers or directors engaged in securities fraud or other unlawful business practices. The investigation follows the U.S. Food and Drug Administration's publication of briefing documents on July 28, 2026, which raised concerns about the data package supporting accelerated approval for Replimune's drug RP1 in combination with Bristol Myers Squibb's Opdivo for advanced melanoma. The FDA stated that the response assessment in the Phase 1/2 IGNYTE study confounds interpretation of efficacy results and limits the agency's ability to verify reported results. On that news, Replimune's stock price fell $3.28 per share, or 38.01%, to close at $5.35 per share. Investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, extension 7980.
Apple and Amazon lead midday movers after earnings reports
Several stocks made big midday moves following earnings reports and other developments. IES Holdings surged over 30% after beating quarterly expectations and approving a two-for-one stock split, while GoDaddy tumbled 20% on disappointing guidance and a cash flow miss. Newell Brands rose 11% after lifting its full-year earnings outlook above consensus, and SPX Technologies rallied 14% on strong results and raised guidance. Veracyte fell 24% despite beating estimates and raising revenue guidance, and Replimune Group soared over 94% after an FDA panel backed its skin cancer drug trial. Jersey Mike's gained 6% on its second day of trading after a weak debut. Chevron added 1.6% on better-than-expected earnings, while ExxonMobil slipped 2% on a profit miss. Moderna dipped 1% despite a top- and bottom-line beat. Amazon jumped 15% on strong revenue and cloud growth, but Apple dropped more than 9% even with higher iPhone sales. Coinbase slid over 12% after a wider-than-expected loss, Reddit sank 22% on search traffic concerns, and Novo Nordisk fell 9% after a drug trial failed to meet its main goal.
Glancy Prongay Wolke & Rotter Continues Securities Fraud Investigation Into Replimune Group
Glancy Prongay Wolke & Rotter LLP continues its investigation into Replimune Group Inc. for possible violations of federal securities laws. The investigation follows a July 28, 2026 FDA briefing document release that deemed the single-arm mid-stage study for Replimune's skin cancer drug RP1 as not interpretable, confoundeding interpretation of efficacy results and limiting the FDA's ability to verify reported results. On that news, Replimune's stock price fell $3.27, or 37.89%, in intraday trading, injuring investors. The law firm urges shareholders who lost money to contact them to discuss potential claims.
Amazon fuels AI optimism while Apple sinks premarket on weak outlook
U.S. stock index futures extended gains on Friday as easing concerns over the durability of the artificial intelligence boom boosted technology shares, with Amazon leading gains after strong cloud growth helped offset fresh disappointment from Apple's cautious outlook. Amazon surged more than 12% after reporting its strongest cloud revenue growth in over four years, with its custom AI chip business reaching a $25 billion annual revenue run rate, while Apple dropped 7.3% after issuing fourth-quarter revenue guidance that fell short of Wall Street expectations. Marvell Technology rose 7% and Astera Labs gained 8% as Amazon's AI and cloud update boosted sentiment across AI infrastructure stocks. Replimune soared 125.3% after an FDA advisory committee voted 10-3 in support of the efficacy of its RP1 therapy for advanced melanoma. Roblox tumbled 16.5% on weaker-than-expected bookings growth and disappointing forward guidance, while GoDaddy fell 10.9% after issuing full-year revenue guidance below estimates and Western Union slid 7.7% after missing quarterly estimates and lowering its full-year outlook.
Replimune surges over 130% premarket after FDA panel backs skin cancer drug
Replimune Group shares surged more than 130% in premarket trading after a Food and Drug Administration advisory panel voted in favor of the company's RP1 drug trial results for a type of skin cancer, prompting Wedbush Securities to upgrade the stock to outperform from neutral. Chevron edged higher after reporting second-quarter net income of $12.1 billion, a nearly 400% increase from a year earlier, while ExxonMobil fell 2% on adjusted earnings of $3.52 per share that missed the $3.60 estimate. Amazon jumped over 11% after its cloud revenue grew 37% year over year, the fastest pace in 18 quarters, but Apple dropped more than 7% despite stronger-than-expected fiscal third-quarter revenue driven by a 22% rise in iPhone sales. Moderna lost over 4% even as its second-quarter loss of $1.97 per share on revenue of $145 million beat expectations, and Coinbase slid more than 5% after posting a third straight quarterly loss of $359.5 million, or $1.36 per share, far wider than the anticipated 17-cent loss. Reddit tumbled 12% as CEO Steve Huffman described search-referral traffic as choppy, overshadowing an earnings beat and guidance that sailed past estimates, while Novo Nordisk plunged more than 10% after phase 3 trial results showed its drug ziltivekimab failed to reduce major cardiovascular events compared to placebo.
FDA Advisory Committee Votes 10 to 3 That RP1 Efficacy Data Are Evaluable and Clinically Meaningful
Replimune announced a favorable outcome from the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee meeting, which voted 10 to 3 that the efficacy results from the IGNYTE study of RP1 in advanced melanoma are evaluable and clinically meaningful. The committee discussed whether the single-arm IGNYTE study reliably determines response rate and durability, and whether observed responses indicate systemic antitumor activity attributable to RP1. RP1, or vusolimogene oderparepvec, is Replimune's lead oncolytic immunotherapy candidate, used in combination with nivolumab for advanced melanoma patients who have progressed on prior anti-PD-1 therapy. The FDA's target action date for the Biologics License Application resubmission is August 2, 2026. Replimune's CEO Sushil Patel expressed encouragement and gratitude to patients and physicians, calling the vote an important step forward for patients with high unmet need.
Kirby McInerney LLP Investigates Replimune Over Potential Securities Fraud
Kirby McInerney LLP announced an investigation into Replimune Group Inc. concerning potential violations of federal securities laws. The investigation follows the FDA's release of briefing documents on July 28, 2026, which deemed the single-armed mid-stage study for Replimune's skin cancer drug RP1 as non interpretable, with reviewers stating the assessment confounds interpretation of efficacy results and limits the FDA's ability to verify reported results. On that news, Replimune's stock price fell $3.28, or approximately 38%, to close at $5.35. The law firm is examining whether the company or its senior management engaged in unlawful business practices, and no lawsuit has been filed at this stage.
FDA accepts Replimmune's third BLA for RP1 in advanced melanoma, response by August 2026
The FDA has accepted Replimmune Group's third biologics license application for RP1 combined with nivolumab to treat advanced melanoma, with a response expected by August 2, 2026. The company previously received complete response letters in July 2025 and April 2026, the latter due to a disagreement over trial assessment methodologies. RP1 is an attenuated herpes simplex virus designed to target tumor antigens, and it showed positive results in the Phase 3 IGNYTE trial with nivolumab in patients who had prior anti-PD-1 therapy. An advisory committee meeting is planned for July 2026.
Biotech ETFs Rally as FDA Signals More Flexible Drug Approval Pathway
Biotech exchange-traded funds have posted strong gains in the first half of 2026, led by a 17.9% rise in the State Street SPDR S&P Biotech ETF as of June 17, as the FDA signaled a more flexible approach toward approving treatments for serious diseases. The shift fueled a nearly 78% surge in UniQure shares after the agency allowed the company to refile its Huntington's disease gene therapy application using three-year clinical trial data, reversing an earlier position that Phase 1 and Phase 2 data would not support accelerated approval. The FDA also opened new approval pathways for Atara Biotherapeutics and Replimune, and released favorable briefing documents for Moderna's flu vaccine ahead of an advisory committee meeting. Other biotech ETFs have also benefited, with the ARK Genomic Revolution ETF up about 20%, the iShares Genomics Immunology and Healthcare ETF up 14.5%, the Virtus Biotech Clinical Trials ETF up 11.6%, and the Global X Genomics & Biotechnology ETF up 10% year-to-date. The more supportive regulatory environment, which follows leadership changes at the FDA, comes alongside continued M&A activity including Merck's acquisition of Terns Pharmaceuticals and Novartis' purchase of Avidity Biosciences.
QURE Surges 81% on FDA Reversal, Spotlighting Five Biotech Catalysts
UniQure NV shares surged 81% on Wednesday after the FDA reversed course and accepted its Huntington's disease therapy data for an accelerated approval filing, a move flagged days earlier by unusual options activity. The stock jumped from a prior close of $26.99 to an intraday high of $48.88, closing in the high $47s, after the agency indicated AMT-130 data would support a filing, reversing a March decision that had sent shares from $25 to $9. The rally was preceded by weeks of institutional call buying, including a multi-million dollar order on June 9 across October 33 and 43 strikes, which a trader highlighted as a signal of smart-money positioning. The same catalyst-driven approach is now being applied to five other biotech names: Celcuity faces a July 17 FDA decision for gedatolisib in breast cancer, with major funds holding through a prior drawdown; Ionis has two PDUFA dates—June 30 for olezarsen and September for zilganersen—though insider selling of $57.8 million warrants caution; Celldex awaits Phase 3 barzolvolimab data in chronic spontaneous urticaria in Q4 next year, with a Phase 2 readout this summer, but rich options premiums keep it on watch; Travere already won approval for FILSPARI in FSGS in April and is now a commercial execution and takeout story with Overweight ratings from Citi and JPMorgan; and Replimune resubmitted its BLA for RP1 after a second Complete Response Letter, with FDA alignment on May 29, drawing Baker Bros and other funds, though it remains the lowest-conviction name on the board.