SRRK Stock Soars as Muscle Disease Drug Meets Phase III Study Goal

Zacks10-08

Shares of Scholar Rock SRRK skyrocketed 362% on Monday after the company announced positive top-line results from the late-stage study, evaluating the efficacy and safety of its investigational muscle...

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Myostatin is a protein that is primarily produced in skeletal muscle cells and acts as a negative regulator of muscle growth. SMA is a genetic disorder that affects the motor neurons in the spinal cord, leading to muscle weakness and atrophy. Despite progress in developing treatments targeting motor neuron loss, there remains a significant unmet need for therapies that directly address the progressive muscle weakness responsible for the decline in motor function in SMA.Per the data readout, the phase III SAPPHIREstudy met its primary endpoint demonstrating a statistically significant and clinically meaningful improvement in motor function upon tr","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"III":"信息服务","BK4007":"制药","SRRK":"Scholar Rock Holding Corp","CPRX":"Catalyst Pharmaceutical Partners","ANIP":"ANI Pharmaceuticals, Inc.","BK4134":"信息科技咨询与其它服务","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","BHVN":"Biohaven Pharmaceutical Holding Co Ltd.","BK4139":"生物科技"},"translate_title":"肌肉疾病药物达到III期研究目标，SRRK股价飙升","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ANIP":1,"BHVN":1,"CPRX":1,"III":1,"SRRK":1},"content_text":"Shares of Scholar Rock SRRK skyrocketed 362% on Monday after the company announced positive top-line results from the late-stage study, evaluating the efficacy and safety of its investigational muscle-targeted therapy, apitegromab, to treat spinal muscular atrophy (SMA).\nApitegromab is a fully human monoclonal antibody inhibiting myostatin activation. Myostatin is a protein that is primarily produced in skeletal muscle cells and acts as a negative regulator of muscle growth. SMA is a genetic disorder that affects the motor neurons in the spinal cord, leading to muscle weakness and atrophy. Despite progress in developing treatments targeting motor neuron loss, there remains a significant unmet need for therapies that directly address the progressive muscle weakness responsible for the decline in motor function in SMA.\nSRRK’s Late-Stage SMA Study Meets Primary Goal        \nPer the data readout, the phase III SAPPHIRE study met its primary endpoint demonstrating a statistically significant and clinically meaningful improvement in motor function upon treatment of SMA patients with apitegromab compared with placebo at week 52. The metric used for measuring the same was the gold standard Hammersmith Functional Motor Scale Expanded (HFMSE).\nMotor function outcomes showed meaningful and consistent improvements in both the main efficacy group (ages 2-12) and the exploratory group (ages 13-21), with apitegromab outperforming placebo. In the apitegromab group, 30% of SMA patients saw a 3 point or more improvement in HFMSE compared with 12.5% in the placebo group.\nPatients on apitegromab also showed early motor function gains as soon as eight weeks, with further improvement at 52 weeks. Following the study, 98% of the SAPPHIRE study patient population (185 out of 188) joined the ongoing ONYX open-label extension study for the same indication.\nYear to date, shares of Scholar Rock have surged 82.3% against the industry’s 2.8% decline.\nImage Source: Zacks Investment Research\nSRRK further reported that apitegromab was well-tolerated across all age groups, with no clinically significant differences in adverse events between the two evaluated dosage strengths (10 mg/kg and 20 mg/kg). The observed safety profile of the candidate was consistent with that observed in previous clinical studies. Serious adverse events were not attributed to treatment with apitegromab. Additionally, no patients discontinued the study drug due to adverse events.\nBased on such encouraging results, Scholar Rock is currently gearing up to submit regulatory applications, seeking the approval of apitegromab for SMA in the United States and the EU in the first quarter of 2025.\nPlease note that the candidate already enjoys the Fast Track, Orphan Drug and Rare Pediatric Disease designations in the United States and the Priority Medicines and Orphan Medicinal Product designations in the EU for the same indication.\nScholar Rock anticipates presenting detailed data from the phase III SAPPHIRE study of apitegromab for SMA at an upcoming medical conference in early 2025. \nOther Developmental Programs in SRRK’s Clinical Pipeline\nApart from the SMA indication,Scholar Rock is also currently evaluating apitegromab for cardiometabolic disorders. Last month, the company reported completing patient enrollment in its phase II EMBRAZE proof-of-concept study of the candidate to safely preserve lean muscle mass in individuals on GLP-1 receptor agonist therapy for obesity.\nPer SRRK, the EMBRAZE study results, expected in the second quarter of 2025, will guide the development of SRK-439, an investigational selective myostatin inhibitor. The company intends to advance SRK-439 specifically for treating cardiometabolic disorders like obesity.\nScholar Rock has another candidate in its pipeline, SRK-181, an investigational selective inhibitor of latent TGFβ-1 activation, which is currently being evaluated in a phase I DRAGON proof-of-concept study to treat patients with advanced cancer across multiple tumor types. Enrollment in the DRAGON study was completed last December. \n\nScholar Rock Holding Corporation Price and Consensus\n\nScholar Rock Holding Corporation price-consensus-chart | Scholar Rock Holding Corporation Quote\n\nImpact of SRRK News on Biohaven Stock\nInterestingly, following the positive data readout from Scholar Rock’s late-stage SMA study, Biohaven BHVN also gained 10.8% on Monday. This is likely because the investors also anticipate a positive data readout from BHVN’s ongoing late-stage SMA study.\nBiohaven is currently evaluating its investigational candidate, taldefgrobep alfa (BHV-2000), a novel anti-myostatin adnectin, in a phase III study for treating SMA. BHVN expects to report top-line data from the late-stage SMA study by the end of 2024.\nSRRK’s Zacks Rank & Stocks to Consider\nScholar Rock currently carries a Zacks Rank #3 (Hold).\nSome better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP and Catalyst Pharmaceuticals CPRX, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share (EPS) have moved up from $4.69 to $4.81. EPS estimates for 2025 have improved from $5.37 to $5.86. Year to date, shares of ANIP have gained 1.3%.\nANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.\nIn the past 60 days, estimates for Catalyst’s 2024 EPS have increased from $1.84 to $1.92. The consensus estimate for 2025 EPS has improved from $2.14 to $2.27. Year to date, shares of CPRX have soared 17.4%.\nCatalyst’s earnings beat estimates in three of the trailing four quarters while matching on the remaining occasion, the average surprise being 13.88%.\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\nCatalyst Pharmaceuticals, Inc. (CPRX) : Free Stock Analysis Report\nANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report\nBiohaven Ltd. (BHVN) : Free Stock Analysis Report\nScholar Rock Holding Corporation (SRRK) : 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":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"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":"4.29.1","shortVersion":"4.29.1","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/2474403775"}