Bristol Myers (BMY) Gets FDA Nod for Label Expansion of Augtyro

Zacks06-15

Bristol Myers Squibb BMY announced that the FDA has approved a label expansion of its lung cancer drug Augtyro (repotrectinib). The regulatory body granted accelerated approval to Augtyro for the ...

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The FDA approval of repotrectinib has broadened the BMY oncology portfolio, adding a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumors for both TKI-nave and TKI-pretreated patients.The acquisition added Mirati’s lung cancer drug Krazati  to BMY’s strong oncology portfolio. The","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0321505439.SGD":"Schroder ISF Global Dividend Maximiser A Acc SGD","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","LU1261432733.SGD":"Fidelity World A-ACC-SGD","BK4559":"巴菲特持仓","LU0321505868.SGD":"Schroder ISF Global Dividend Maximiser A Dis SGD","LU1670711123.USD":"M&G (LUX) GLOBAL DIVIDEND \"A\" (USD) INC","BK4588":"碎股","LU2125154935.USD":"ALLSPRING (LUX) WF GLOBAL EQUITY ENHANCED INCOME \"I\" (USD) INC","NERV":"Minerva Neurosciences","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","LU1032466523.USD":"高盛全球多资产收益组合Acc","LU0882574055.USD":"富达全球健康医疗A ACC","BK4581":"高盛持仓","LU1670711040.USD":"M&G (LUX) GLOBAL DIVIDEND \"A\" (USD) ACC","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","LU1291159041.SGD":"CPR Invest - Global Silver Age A2 Acc SGD-H","LU0061475181.USD":"THREADNEEDLE (LUX) AMERICAN \"AU\" (USD) ACC","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","LU1718418525.SGD":"JPMorgan Investment Funds - Global Select Equity A (acc) SGD","LU1074936037.SGD":"JPMorgan Funds - US Value A (acc) SGD","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","LU2133065610.SGD":"JPMorgan Investment Funds - Global Dividend A (mth) SGD","LU1585245621.USD":"EASTSPRING INV GLOBAL LOW VOLATILITY EQUITY FUND \"A\" (USD) ACC B","LU2242652126.USD":"FIDELITY FUNDS GLOBAL DIVIDENDS PLUS \"A\" (USD) INC","LU1571399168.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"IP\" (USD) ACC","ALXO":"ALX Oncology Holdings","BK4532":"文艺复兴科技持仓","LU0114720955.EUR":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","LU1989771016.USD":"东方汇理环球老龄化投资基金 A2 Acc","BK4534":"瑞士信贷持仓","BK4585":"ETF&股票定投概念","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","BK4139":"生物科技","LU2360032135.SGD":"ALLSPRING GLOBAL EQUITY ENHANCED INCOME \"A\" (SGDHDG) INC","LU2242646821.SGD":"Fidelity Global Dividend Plus A-MINCOME(G)-SGD","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","BK4007":"制药","LU1670710588.SGD":"M&G (LUX) GLOBAL DIVIDEND \"A\" (SGD) ACC","LU2125154778.USD":"ALLSPRING GLOBAL EQUITY ENHANCED INCOME \"A\" (USD) INC","LU0237698245.USD":"富达环球地产基金A","LU1670710661.SGD":"M&G (LUX) GLOBAL DIVIDEND \"A\" (SGD) INC","BMY":"施贵宝","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","LGND":"Ligand Pharmaceuticals Inc."},"translate_title":"百时美施贵宝(BMY)获得FDA批准扩大Augtyro标签","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NERV":1,"ALXO":1,"BMY":1,"LGND":0.9},"content_text":"Bristol Myers Squibb BMY announced that the FDA has approved a label expansion of its lung cancer drug Augtyro (repotrectinib).\nThe regulatory body granted accelerated approval to Augtyro for the treatment of adult and pediatric patients aged 12 years and above with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.\nThe accelerated approval is based on positive results from the phase I/II TRIDENT-1 study, which evaluated Augtyro in adult patients with NTRK-positive solid tumors. The TRIDENT-1 trial included both TKI-naïve (n=40) and TKI-pretreated (n=48) patients with NTRK-positive locally advanced/metastatic solid tumors collectively representing 15 different types of cancer.\nThe latest approval was granted under accelerated approval based on the overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.\nPer BMY, there was no FDA-approved treatment option for NTRK-positive cancers that were studied in both TKI-naïve and TKI-pretreated patients across solid tumors.  The FDA approval of repotrectinib has broadened the BMY oncology portfolio, adding a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumors for both TKI-naïve and TKI-pretreated patients.\nPlease note that the drug was granted full approval in the United States for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in November 2023.\nThe acquisition of Turning Point Therapeutics in 2022 added repotrectinib to BMY’s portfolio.\nHowever, Augtyro is associated with certain warnings and precautions of the central nervous system effects, interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricemia, skeletal fractures and embryo-fetal toxicity.\nBristol Myers is currently in the transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.\nShares of the company have lost 20.4% year to date compared with the industry's decline of 5.6%.\nImage Source: Zacks Investment Research\nThe approval of additional new drugs should enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as blockbuster oncology drugs Revlimid and Eliquis face generic competition.\nBristol Myers’ immuno-oncology drug Opdivo is already approved for NSCLC.\nIn January 2024, BMY acquired oncology-focused company Mirati Therapeutics for a total equity value of $5.8 billion.\nThe acquisition added Mirati’s lung cancer drug Krazati (adagrasib) to BMY’s strong oncology portfolio. The FDA approved the drug in December 2022 for the treatment of adult patients with KRAS-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.\nZacks Rank and Stocks to Consider\nBMY currently has a Zacks Rank #3 (Hold).\nSome better-ranked stocks in the biotech sector are Ligand Pharmaceuticals LGND, ALX Oncology Holdings ALXO and Minerva Neurosciences, Inc. NERV. While LGND sports a Zacks Rank #1 (Strong Buy) at present, ALXO and NERV carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share (EPS) has increased 16 cents to $4.71. During the same time frame, the consensus estimate for 2025 EPS has increased 70 cents to $5.90. Year to date, shares of LGND have risen 12.5%.\nLigand beat on earnings in each of the trailing four quarters, delivering an average surprise of 56.02%.\nIn the past 60 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73.\nALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.\nIn the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimate for 2025 has narrowed from $4.54 to $3.60 during the same time frame.\nNERV’s earnings beat estimates in one of the trailing four quarters and missed the same in the other three, the average negative surprise being 54.43%. \nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nBristol Myers Squibb Company (BMY) : Free Stock Analysis Report\nLigand Pharmaceuticals Incorporated (LGND) : Free Stock Analysis Report\nMinerva Neurosciences, Inc (NERV) : Free Stock Analysis Report\nALX Oncology Holdings Inc. (ALXO) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":1,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.24.2","shortVersion":"4.24.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2443604999"}