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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.

$AZN$BDX$ELV$REPL
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.

$AZN$BDX$REPL
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.(covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www..com/contact-us)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%

$DELL$NTAP$REPL
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%.

$REPL$RVMD$SEER$SYRE
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.

$REPL$RVMD$SEER$SYRE
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.(covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www..com/contact-us)

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Research

JPMorgan Downgrades Replimune Group to Underweight From Neutral, $10 Price Target

Replimune Group (REPL) has an average rating of Hold and mean price target of $4, according to analysts polled by FactSet.(covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www..com/contact-us)

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Research

BMO Capital Downgrades Replimune to Underperform From Market Perform, Adjusts PT to $1 From $11

Replimune Group (REPL) has an average rating of Hold and mean price target of $4, according to analysts polled by FactSet.(covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www..com/contact-us)

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Research

Cantor Fitzgerald Downgrades Replimune Group to Neutral From Overweight

Replimune Group (REPL) has an average rating of Hold and mean price target of $4, according to analysts polled by FactSet.(covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www..com/contact-us)

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Research

Leerink Partners Downgrades Replimune Group to Market Perform From Outperform, Adjusts Price Target

Replimune Group (REPL) has an average rating of Hold and mean price target of $4, according to analysts polled by FactSet.(covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www..com/contact-us)

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Research

HC Wainwright Downgrades Replimune to Sell From Buy

Replimune Group (REPL) has an average rating of Hold and mean price target of $4, according to analysts polled by FactSet.(covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www..com/contact-us)

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Research

Wedbush Downgrades Replimune Group to Neutral From Outperform, Cuts Price Target to $2 From $19

Replimune Group (REPL) has an average rating of hold and mean price target of $7.40, according to analysts polled by FactSet.(covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www..com/contact-us)

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Sectors

Sector Update: Health Care Stocks Fall Late Afternoon

Health care stocks declined late Friday afternoon, with the NYSE Health Care Index falling 1.1% and the State Street Health Care Select Sector SPDR ETF (XLV) dropping 1.4%.The iShares Biotechnology ETF (IBB) shed 1.7%.In corporate news, AbbVie (ABBV) is expected to report Q1 earnings within its guidance range, but that may not be enough to improve sentiment toward the drugmaker, RBC Capital Markets said in a client note. The brokerage expects AbbVie to report per-share earnings of $2.59 for the first quarter, while the current consensus on FactSet is for non-GAAP EPS of $2.83. AbbVie shares were down 2.1%.Replimune (REPL) shares tumbled 19%. The company's biologics license application for vusolimogene oderparepvec to treat unresectable advanced cutaneous melanoma was rejected by the US Food and Drug Administration, the regulator said in a complete response letter.Abbott Laboratories (ABT) has been ordered by a jury in Chicago to pay $53 million in compensatory damages to a group of families related to four cases over its infant formula, the Chicago Tribune reported. The families accused the company of allegedly failing to inform them that its infant formula could develop a dangerous intestinal disease in premature infants, the report said. Abbott shares fell 2.7%.Organon (OGN) is closing in on a deal to be acquired by Sun Pharmaceutical Industries for $12 billion, The Economic Times reported. Organon shares surged 27%.

$ABBV$ABT$OGN$REPL
Sectors

Sector Update: Health Care Stocks Lower Friday Afternoon

Health care stocks declined Friday afternoon, with the NYSE Health Care Index decreasing 0.7% and the State Street Health Care Select Sector SPDR ETF (XLV) falling 1.2%.The iShares Biotechnology ETF (IBB) dropped 1.8%.In corporate news, Replimune (REPL) shares tumbled 19%. The company's biologics license application for vusolimogene oderparepvec to treat unresectable advanced cutaneous melanoma was rejected by the US Food and Drug Administration, the regulator said in a complete response letter.Abbott Laboratories (ABT) has been ordered by a jury in Chicago to pay $53 million in compensatory damages to a group of families related to four cases over its infant formula, the Chicago Tribune reported. The families accused the company of allegedly failing to inform them that its infant formula could develop a dangerous intestinal disease in premature infants, the report said. Abbott shares fell 2.9%.Organon (OGN) is closing in on a deal to be acquired by Sun Pharmaceutical Industries for $12 billion, The Economic Times reported. Organon shares surged 23%.

$ABT$OGN$REPL
Sectors

Sector Update: Health Care

Health care stocks declined Friday afternoon, with the NYSE Health Care Index decreasing 0.7% and the State Street Health Care Select Sector SPDR ETF (XLV) falling 1.2%.The iShares Biotechnology ETF (IBB) dropped 1.8%.In corporate news, Replimune's (REPL) shares tumbled 19%. The company's biologics license application for vusolimogene oderparepvec to treat unresectable advanced cutaneous melanoma was rejected by the US Food and Drug Administration, the regulator said in a complete response letter.

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