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Scholar Rock (SRRK) Up on Pipeline Advancement, Stock Offering
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Shares of clinical-stage biopharmaceutical company Scholar Rock Holding Corporation (SRRK - Free Report) gained 17.7% after the company announced plans to expand into the cardiometabolic disorders space and pricing of its public offering.
The company will leverage its experience in myostatin inhibition to advance SRK-439, a novel investigational myostatin inhibitor for treating cardiometabolic disorders, with an initial focus on obesity. An investigational new drug application (IND) submission is targeted in 2025.
Preclinical data support advancing SRK-439 for the treatment of obesity. Studies in diet-induced obese mice showed that SRK-439, in combination with GLP-1 receptor agonist (GLP-1 RA), achieved a dose-dependent reversal of lean mass loss during GLP-1 RA-mediated weight loss and an increase in fat mass loss mediated by GLP-1 RA treatment.
Scholar Rock Holding has also announced plans to initiate a phase II proof-of-concept study with apitegromab in combination with a GLP-1 RA in 2024, subject to IND acceptance. Data from the clinical trial are expected in mid-2025 and will be used to advance further clinical development of SRK-439.
The top priority for the company remains the development of apitegromab in spinal muscular atrophy (SMA). Last month, Scholar Rock completed enrollment of the phase III SAPPHIRE study evaluating the safety and efficacy of apitegromab in nonambulatory patients with types 2 and 3 SMA who are receiving SMN therapy (either nusinersen or risdiplam). Data readout from this registrational study is expected in the fourth quarter of 2024.
Per the company, muscle-targeted therapies that are well tolerated have the potential to represent a new class of treatments across a wide range of diseases, as shown by apitegromab in SMA.
Scholar Rock has developed SRK-439 with a proposed mechanism of action that aims to safely maintain muscle mass while enhancing body fat loss, thereby potentially enhancing metabolic health and potentially offering a unique opportunity to address a high unmet need in treating metabolic conditions, including obesity.
Year to date, shares of Scholar Rock have declined 10.9% compared with the industry’s 18.8% fall.
Image Source: Zacks Investment Research
Concurrently, Scholar Rock announced the pricing of an upsized underwritten public offering of 12,408,760 shares of its common stock at a public offering price of $6.85 per share. Gross proceeds from the offering are expected to be approximately $85.0 million before deducting underwriting discounts, commissions and other offering expenses.
Scholar Rock plans to use the net proceeds from the offering to advance apitegromab, develop its pipeline and for other general corporate purposes.
Loss estimates for Acadia for 2023 have narrowed to 37 cents from 41 cents in the past 60 days, while earnings estimates for 2024 are pegged at 67 cents per share. The stock has surged 39.4% so far this year
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.
Loss estimates for Sarepta for 2023 have narrowed to $9.19 from $9.73 in the past 60 days, while loss estimates for 2024 have narrowed to $1 from $1.66.
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Scholar Rock (SRRK) Up on Pipeline Advancement, Stock Offering
Shares of clinical-stage biopharmaceutical company Scholar Rock Holding Corporation (SRRK - Free Report) gained 17.7% after the company announced plans to expand into the cardiometabolic disorders space and pricing of its public offering.
The company will leverage its experience in myostatin inhibition to advance SRK-439, a novel investigational myostatin inhibitor for treating cardiometabolic disorders, with an initial focus on obesity. An investigational new drug application (IND) submission is targeted in 2025.
Preclinical data support advancing SRK-439 for the treatment of obesity. Studies in diet-induced obese mice showed that SRK-439, in combination with GLP-1 receptor agonist (GLP-1 RA), achieved a dose-dependent reversal of lean mass loss during GLP-1 RA-mediated weight loss and an increase in fat mass loss mediated by GLP-1 RA treatment.
Scholar Rock Holding has also announced plans to initiate a phase II proof-of-concept study with apitegromab in combination with a GLP-1 RA in 2024, subject to IND acceptance. Data from the clinical trial are expected in mid-2025 and will be used to advance further clinical development of SRK-439.
The top priority for the company remains the development of apitegromab in spinal muscular atrophy (SMA). Last month, Scholar Rock completed enrollment of the phase III SAPPHIRE study evaluating the safety and efficacy of apitegromab in nonambulatory patients with types 2 and 3 SMA who are receiving SMN therapy (either nusinersen or risdiplam). Data readout from this registrational study is expected in the fourth quarter of 2024.
Per the company, muscle-targeted therapies that are well tolerated have the potential to represent a new class of treatments across a wide range of diseases, as shown by apitegromab in SMA.
Scholar Rock has developed SRK-439 with a proposed mechanism of action that aims to safely maintain muscle mass while enhancing body fat loss, thereby potentially enhancing metabolic health and potentially offering a unique opportunity to address a high unmet need in treating metabolic conditions, including obesity.
Year to date, shares of Scholar Rock have declined 10.9% compared with the industry’s 18.8% fall.
Image Source: Zacks Investment Research
Concurrently, Scholar Rock announced the pricing of an upsized underwritten public offering of 12,408,760 shares of its common stock at a public offering price of $6.85 per share. Gross proceeds from the offering are expected to be approximately $85.0 million before deducting underwriting discounts, commissions and other offering expenses.
Scholar Rock plans to use the net proceeds from the offering to advance apitegromab, develop its pipeline and for other general corporate purposes.
Zacks Rank & Stocks to Consider
Scholar Rock currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the healthcare industry are Acadia Pharmaceuticals (ACAD - Free Report) , Dynavax Technologies (DVAX - Free Report) and Sarepta Therapeutics (SRPT - Free Report) , which currently sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for Acadia for 2023 have narrowed to 37 cents from 41 cents in the past 60 days, while earnings estimates for 2024 are pegged at 67 cents per share. The stock has surged 39.4% so far this year
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.
Loss estimates for Sarepta for 2023 have narrowed to $9.19 from $9.73 in the past 60 days, while loss estimates for 2024 have narrowed to $1 from $1.66.