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29 stories mentioning REPLUpdated 34d ago

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Wire

Replimune Prices $150 Million Offering

Replimune (REPL) said Monday it has priced an underwritten offering of about 9.7 million shares at $12.06 per share and, in lieu of shares to some investors, pre-funded warrants to buy roughly 2.7 million shares at $12.0599 per pre-funded warrant, for gross proceeds of about $150 million.The offering is expected to close Tuesday, the company said.Replimune shares were up past 6% in early trading.Price: $12.89, Change: $+0.83, Percent Change: +6.88%

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Research

Leerink Partners Upgrades Replimune Group to Outperform From Market Perform, Adjusts Price Target to $17 From $11

Replimune Group (REPL) has an average rating of buy and mean price target of $15.20, according to analysts polled by FactSet.

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Sectors

Sector Update: Healthcare Stocks Decline Late Afternoon

Healthcare stocks fell late Friday afternoon with the NYSE Healthcare Index shedding 0.7% and the State Street Health Care Select Sector SPDR ETF (XLV) decreasing 0.4%.The iShares Biotechnology ETF (IBB) dropped 1.7%.In corporate news, Novo Nordisk (NVO) shares fell past 9% after it said a late-stage trial of ziltivekimab was unable to reduce major adverse cardiovascular events, compared with a placebo.AbbVie (ABBV) lowered its full-year earnings guidance on Friday to account for the expected dilution from its planned acquisition of Apogee Therapeutics (APGE), despite reporting stronger-than-expected Q2 results. AbbVie shares were down 2%.CareDx (CDNA) shares jumped past 14% a day after Q2 results beat market expectations and the company lifted its 2026 revenue guidance.Replimune (REPL) shares surged 101% after the company late Thursday reported a favorable outcome of the US Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in advanced melanoma.

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Wire

Top Midday Gainers

Replimune (REPL) stock soared 94% after the company late Thursday reported a favorable outcome of the US Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in advanced melanoma.The committee voted 10 to 3 that the efficacy results from the IGNYTE study are evaluable and clinically meaningful, it said.After the outcome, Cantor Fitzgerald upgraded Replimune to overweight from neutral.More than 23.4 million shares traded intraday, compared with a daily average of about 5.85 million.CareDx (CDNA) reported Q2 non-GAAP earnings and revenue late Thursday that beat market expectations. The company also lifted its 2026 revenue guidance.Shares jumped 13%, with intraday trading volume rising to more than 1.3 million from a daily average of about 905,000.Amazon's (AMZN) web services cloud-computing unit reported overnight the fastest sales growth in 18 quarters, helping the e-commerce giant handily exceed market expectations for Q2 earnings and revenue.Shares advanced 15% amid a rise in intraday trading volume to over 84.7 million from a daily average of roughly 48.2 million.Price: $10.62, Change: $+5.21, Percent Change: +96.30%

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Wire

Replimune's RP1 Likely to Win US FDA Approval for Advanced Melanoma, Wedbush Says

Replimune's (REPL) RP1, in combination with nivolumab, is likely to receive US Food and Drug Administration approval for PD-1-refractory advanced melanoma, Wedbush analysts said in a Friday note, following an FDA advisory committee's 10-3 vote in favor of the treatment.The biologics license application has a Prescription Drug User Fee Act target action date of Aug. 2, though Wedbush said approval could be delayed.Analysts said the FDA's decision to conduct a third review of the BLA and convene an advisory committee meeting signaled a willingness to approve RP1.Wedbush said that the company will target an initial market of 150 clinics, followed by expansion to 350 treatment centers, within six to nine months of launch.Analysts added that Replimune does, however, face potential financing risk, given its current cash runway is only expected to fund operations into Q1 2027.Wedbush retained a neutral rating on the stock, but increased its price target to $12 from $9.Shares were up more than 100% in Friday trading.Price: $10.28, Change: $+4.87, Percent Change: +89.94%

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Research

Cantor Fitzgerald Upgrades Replimune to Overweight From Neutral

Replimune Group (REPL) has an average rating of overweight and mean price target of $12.40, according to analysts polled by FactSet.

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Research

BMO Capital Upgrades Replimune to Outperform From Underperform, Adjusts PT to $16 From $1

Replimune (REPL) has an average rating of hold and mean price target of $10.67, according to analysts polled by FactSet.

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Wire

Wedbush Lifts Price Target on Replimune to $9 From $6, Maintains Neutral Rating

Replimune (REPL) has an average rating of hold and mean price target of $7.67, according to analysts polled by FactSet.Price: $11.04, Change: $-0.60, Percent Change: -5.12%

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Research

JPMorgan Upgrades Replimune Group to Overweight From Neutral, $17 Price Target

Replimune Group (REPL) has an average rating of underweight and mean price target of $2.20, according to analysts polled by FactSet.Price: $10.99, Change: $-0.15, Percent Change: -1.30%

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Wire

Replimune Says Evaluating RP2 for Metastatic Uveal Melanoma in Phase 2/3 Trial; Shares Up Pre-Bell

Replimune (REPL) said Sunday it is now evaluating RP2 in combination with nivolumab for metastatic uveal melanoma in a phase 2/3 trial based on results from the phase 1 trial.The company said in its phase 1 first-in-human trial, RP2 monotherapy achieved an objective response rate of 19% in patients with advanced solid tumors. RP2 in combination with nivolumab had an objective response rate of 19.1%, it said.In uveal melanoma, the pooled objective response rate, which included RP2 in combination with nivolumab and RP2 monotherapy, was 33.3%, it said.The phase 1 first-in-human trial had enrolled 85 heavily pretreated patients with advanced solid tumors, including uveal melanoma, colorectal cancer, head and neck cancers, pancreatic cancer, cutaneous melanoma, and sarcoma, the company said.Shares of the company were up over 13% in Monday's premarket activity.Price: $9.90, Change: $+1.21, Percent Change: +13.92%

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Sectors

Sector Update: Healthcare Stocks Softer Late Afternoon

Healthcare stocks declined late Friday afternoon, with the NYSE Healthcare Index decreasing 0.8% and the State Street Health Care Select Sector SPDR ETF (XLV) shedding 0.9%.The iShares Biotechnology ETF (IBB) eased 0.1%.In corporate news, AstraZeneca's (AZN) Alexion Rare Disease unit said Friday that a phase 3 program evaluating anselamimab in light chain amyloidosis did not meet its primary endpoint in the overall patient population. Its shares were down 0.2%.The Centers for Medicare & Medicaid Services will not impose intermediate sanctions on Elevance Health (ELV) at this time based on the health insurer's attestation to corrective action steps it has taken, the agency said Friday. CMS notified Elevance in February of its determination to impose intermediate sanctions for "substantial and persistent noncompliance with Medicare Advantage risk adjustment data submission requirements." Elevance shares rose 0.3%.Becton, Dickinson (BDX) said it has resumed US shipments of ChloraPrep after completing additional assessments and implementing final release testing. The shares were down 0.9%.Replimune (REPL) shares surged 84% after the firm said Friday it will resubmit its biologics license application for vusolimogene oderparepvec for advanced melanoma in the coming days.

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Sectors

Sector Update: Healthcare Stocks Fall in Afternoon Trading

Healthcare stocks declined Friday afternoon, with the NYSE Healthcare Index decreasing 0.8% and the State Street Health Care Select Sector SPDR ETF (XLV) shedding 0.9%.The iShares Biotechnology ETF (IBB) rose 0.3%.In corporate news, AstraZeneca's (AZN) Alexion Rare Disease unit said Friday that a phase 3 program evaluating anselamimab in light chain amyloidosis did not meet its primary endpoint in the overall patient population. Shares were fractionally lower.Becton, Dickinson (BDX) said it has resumed US shipments of ChloraPrep after completing additional assessments and implementing final release testing. Shares were little changed.Replimune (REPL) shares surged 85% after the firm said Friday it will resubmit its biologics license application for vusolimogene oderparepvec for advanced melanoma in the coming days.

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Wire

Wedbush Adjusts Price Target on Replimune Group to $6 From $2, Maintains Neutral Rating

Replimune Group (REPL) has an average rating of underweight and mean price target of $2.20, according to analysts polled by FactSet.Price: $8.38, Change: $+3.70, Percent Change: +78.95%

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Wire

Top Midday Gainers

NetApp (NTAP) reported fiscal Q4 non-GAAP earnings and revenue late Thursday above market expectations, and its forecast for the full financial year also beat consensus.Shares soared 27% amid a surge in intraday trading volume to over 6.5 million from a daily average of roughly 2.5 million.Dell Technologies (DELL) reported overnight fiscal Q1 financial results that topped analyst estimates and issued higher-than-expected guidance for fiscal Q2 and the full year.Shares surged 29% as intraday trading volume catapulted to over 27.1 million from a daily average of about 7.99 million.Replimune (REPL) said Friday it will, in the coming days, resubmit a biologics license application with the US Food and Drug Administration for vusolimogene oderparepvec, its experimental treatment for advanced melanoma.Shares catapulted 83% following an increase in intraday trading volume to over 39.8 million from a daily average of about 6.19 million.Price: $180.63, Change: $+38.23, Percent Change: +26.85%

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Sectors

Sector Update: Health Care Stocks Advance Late Afternoon

Health care stocks rose late Monday afternoon, with the NYSE Health Care Index up 0.2% and the State Street Health Care Select Sector SPDR ETF (XLV) adding 0.3%.The iShares Biotechnology ETF (IBB) climbed 1.6%.In corporate news, Seer (SEER) shares jumped 12% after it confirmed Monday that it has received a non-binding and unsolicited offer from its shareholder Radoff-JEC Group to acquire all its outstanding Class A shares for $2.25 per share in cash plus a contingent value right.Revolution Medicines (RVMD) shares surged 40% after it said Monday the phase 3 trial of its experimental drug daraxonrasib to treat a type of pancreatic cancer met key goals.Spyre Therapeutics (SYRE) shares jumped 23% after the company said its SPY001 investigational treatment for moderate-to-severely active ulcerative colitis met its primary and key secondary endpoints in a phase 2 trial.Replimune (REPL) is facing "significant risk" related to its ongoing phase 3 trial of RP1 in melanoma after the US Food and Drug Administration rejected the company's biologics license application for the product candidate, Wedbush Securities said in a note. Wedbush downgraded its rating on Replimune to neutral from outperform, with a lower price target of $2 from $19. Replimune shares tumbled 63%.

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Wire

Top Midday Decliners

Replimune (REPL) is facing "significant risk" related to its ongoing phase 3 trial of RP1 in melanoma after the US Food and Drug Administration rejected the company's biologics license application for the product candidate, Wedbush Securities said in a note.Wedbush downgraded its rating on Replimune to neutral from outperform, with a lower price target of $2 from $19.Shares sank 64% following an increase in intraday trading volume to over 53.9 million from a daily average of about 1.84 million.Children's Place (PLCE) reported a fiscal Q4 adjusted loss and a decline in revenue from a year ago late Friday.Shares slumped 26% as intraday trading volume soared to more than 1.39 million from a daily average of about 276,000.Fastenal (FAST) reported Q1 earnings and sales Monday in line with the FactSet consensus.Its shares were down 7%, with intraday trading volume at more than 10.9 million, compared with the stock's daily average of about 8.68 million.Price: $1.69, Change: $-3.08, Percent Change: -64.60%

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Sectors

Sector Update: Health Care Stocks Softer Monday Afternoon

Health care stocks declined Monday afternoon, with the NYSE Health Care Index down 0.2% and the State Street Health Care Select Sector SPDR ETF (XLV) shedding 0.3%.The iShares Biotechnology ETF (IBB) added 0.8%.In corporate news, Replimune (REPL) is facing "significant risk" related to its ongoing phase 3 trial of RP1 in melanoma after the US Food and Drug Administration rejected the company's biologics license application for the product candidate, Wedbush Securities said in a note. Wedbush downgraded its rating on Replimune to neutral from outperform, with a lower price target of $2 from $19. Replimune shares tumbled 64%.Seer (SEER) shares jumped 12%. The company has received a non-binding proposal from the Radoff-JEC Group to acquire the company for $2.25 per share in cash plus a contingent value right, the latter said.Revolution Medicines (RVMD) shares surged 39% after it said Monday the phase 3 trial of its experimental drug daraxonrasib to treat a type of pancreatic cancer met key goals.Spyre Therapeutics (SYRE) shares jumped 28% after the company said its SPY001 investigational treatment for moderate-to-severely active ulcerative colitis met its primary and key secondary endpoints in a phase 2 trial.

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Wire

Sector Update: Health Care

Health care stocks declined Monday afternoon, with the NYSE Health Care Index and the State Street Health Care Select Sector SPDR ETF (XLV) each shedding 0.3%.The iShares Biotechnology ETF (IBB) added 0.7%.In corporate news, Replimune (REPL) is facing "significant risk" related to its ongoing phase 3 trial of RP1 in melanoma after the US Food and Drug Administration rejected the company's biologics license application for the product candidate, Wedbush Securities said in a note. Wedbush downgraded its rating on Replimune to neutral from outperform, with a lower price target of $2 from $19. Replimune shares tumbled 63%.

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Wire

Replimune Group Facing 'Significant Risk' on RP1's Ongoing Phase 3 Study, Wedbush Says

Replimune Group (REPL) is facing "significant risk" related to the ongoing phase 3 study of RP1 in melanoma after the US Food and Drug Administration rejected the company's biologics license application for the product candidate, Wedbush Securities said in a Monday note.The FDA rejected the application, citing response assessment uncertainty, study population heterogeneity, and failure to isolate RP1's contribution when administered in combination with nivolumab as deficiencies in the phase 2 IGNYTE trial of of RP1, the brokerage noted."We see no path forward for RP1 with IGNYTE," Wedbush said.Wedbush downgraded its rating on Replimune Group to neutral from outperform, with a lower price target of $2 from $19.Shares of Replimune Group were down more than 62% around midday Monday.Price: $1.81, Change: $-2.95, Percent Change: -62.02%

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Research

Piper Sandler Downgrades Replimune to Neutral From Overweight, Adjusts Price Target to $4 From $14

Replimune Group (REPL) has an average rating of Hold and mean price target of $4, according to analysts polled by FactSet.

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