BridgeBio Pharma's Acoramidis Shows Competitive Edge Against Pfizer's Tafamidisa In Lucrative But Competitive ATTR-CM Market

Benzinga11-20 03:44

On Monday, BridgeBio Pharma, Inc. (NASDAQ:BBIO) presented initial outcomes from the ATTRibute-CM open-label extension (OLE) study of acoramidis in ATTR-CM at the American Heart Association Scientific ...

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The OLE study involves 330 participants who completed the 30-month ATTRibute-CM Phase 3 study.Key initial results from the OLE study show that continuous treatment with acoramidis led to:. A confirmed sustained improvement relative to placebo in time to the first event  starting at Month 3 in ATTRibute-CM. A significant reduction of composite ACM and CVH by 46% at Month 36 and 48% at Month 42, building upon the previously presented 42% reduction at Month 30 in ATTRibute-CM.The OLE data build on previously reported results fro","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1883839398.USD":"AMUNDI FUNDS INCOME OPPORTUNITIES \"A2\" (USD) ACC","LU0170899867.USD":"EASTSPRING INVESTMENTS WORLD VALUE EQUITY  \"A\" (USD) ACC","BK4516":"特朗普概念","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","BK4592":"伊斯兰概念","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","BK4129":"建筑与工程","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","BBIO":"BridgeBio Pharma, Inc.","BK4585":"ETF&股票定投概念","BK4534":"瑞士信贷持仓","SG9999011175.SGD":"Nikko AM Global Dividend Equity Dis SGD-H","PFE":"辉瑞","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","BK4139":"生物科技","LU0321505439.SGD":"Schroder ISF Global Dividend Maximiser A Acc SGD","BK4533":"AQR资本管理(全球第二大对冲基金)","SG9999002232.USD":"Allianz Global High Payout USD","BK4007":"制药","LU0985481810.HKD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (HKD) INC M","LU0306806265.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" ACC","LU0225771236.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (USD) INC MF","LU1894683264.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) ACC","LU0058720904.USD":"联博国际健康护理基金A","CM":"加拿大帝国商业银行","ACM":"Aecom Technology Corporation","BK4550":"红杉资本持仓","BK4568":"美国抗疫概念","BK4588":"碎股","LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU0122379950.USD":"贝莱德世界健康科学A2","IE000M9KFDE8.USD":"NEUBERGER BERMAN US LARGE CAP VALUE \"A\" (USD) ACC","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","BK4207":"综合性银行","LU0225284248.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" ACC","BK4505":"高瓴资本持仓","BK4581":"高盛持仓","LU1894683348.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) INC","SG9999001176.USD":"United Global Healthcare Acc USD","LU2308191902.HKD":"BNP PARIBAS ECOSYSTEM RESTORATION \"CLASSIC\" (HKD) ACC","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","SG9999003800.SGD":"Nikko AM Global Dividend Equity Acc SGD-H","LU0306807586.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" (USD) INC QF","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H"},"translate_title":"BridgeBio Pharma的Acoramidis在利润丰厚但竞争激烈的ATTR-CM市场中显示出与辉瑞的Tafamidisa的竞争优势","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ACM":1,"PFE":1,"CM":1,"BBIO":0.9},"content_text":"On Monday, BridgeBio Pharma, Inc. (NASDAQ:BBIO) presented initial outcomes from the ATTRibute-CM open-label extension (OLE) study of acoramidis in ATTR-CM at the American Heart Association Scientific Sessions.\nATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis, an investigational small-molecule stabilizer of transthyretin (TTR) gene.\nAlso Read: BridgeBio Pharma’s Lead Candidate Cuts Mortality, Related Hospitalizations In Patients With Certain Type Of Heart Disease\nThe OLE study involves 330 participants who completed the 30-month ATTRibute-CM Phase 3 study.\nKey initial results from the OLE study show that continuous treatment with acoramidis led to:\n\nA confirmed sustained improvement relative to placebo in time to the first event ( cardiovascular-related hospitalizations (CVH) or All-Cause Mortality (ACM)) starting at Month 3 in ATTRibute-CM\nA statistically significant reduction in ACM alone of 36% by Month 36 (p=0.009) and 34% by Month 42 (p=0.006).\nA significant reduction of composite ACM and CVH by 46% at Month 36 and 48% at Month 42, building upon the previously presented 42% reduction at Month 30 in ATTRibute-CM.\nAcoramidis continues to be well tolerated, with no new clinically significant safety signals identified in this long-term evaluation.\n\nThe OLE data build on previously reported results from ATTRibute-CM in which acoramidis demonstrated clinically important treatment effects on mortality, CVH, and quality of life, further supporting that greater transthyretin (TTR) stabilization can improve clinical outcomes for patients.\nThis included a 50% reduction in the cumulative frequency of CVH relative to placebo at Month 30.\nBridgeBio’s marketing application is under FDA review, with a PDUFA action date of November 29, 2024. It also has a marketing application to the European Medicines Agency, with a decision expected in 2025.\nBridgeBio has granted Bayer AG (OTC:BAYRY) exclusive rights to commercialize ceramides for ATTR-CM in Europe.\nWilliam Blair writes that reducing overall mortality is crucial for competing in the ATTR-CM market against Pfizer Inc’s (NYSE:PFE) tafamidis, which already includes proven mortality benefits on its label from the ATTR-ACT trial.\nThe analyst writes, “While Bridge Bio continues to publish analyses of acoramidis demonstrating the TTR stabilizer is safe and efficacious, we deem an on-label claim to all-cause mortality benefit as an important factor for market share in the lucrative, but competitive, ATTR-CM space.”\nPrice Action: BBIO stock is up 0.85% at $22.54 at the last check on Tuesday.\nRead Next:\n\nUnited Airlines Gears Up For Holiday Travel Surge To Europe: Details\n\nLatest Ratings for BBIO\n\n\n\nDate\nFirm\nAction\nFrom\nTo\n\n\n\n\nMar 2022\nJP Morgan\nMaintains\n\nOverweight\n\n\nMar 2022\nSVB Leerink\nMaintains\n\nOutperform\n\n\nMar 2022\nSVB Leerink\nMaintains\n\nOutperform\n\n\n\n View More Analyst Ratings for BBIO \n View the Latest Analyst Ratings \nUNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets.\nGet the latest stock analysis from Benzinga?\n\nThis article BridgeBio Pharma's Acoramidis Shows Competitive Edge Against Pfizer's Tafamidisa In Lucrative But Competitive ATTR-CM Market originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. 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