SRRK Scholar Rock Holding Corporation

Bristol Myers Squibb and Egetis await FDA decisions on treatments for heart and rare genetic conditions, while Scholar Rock, Biofrontera and Mirum have already secured regulatory wins ahead of schedule.

Scholar Rock (SRRK) is well positioned for a durable, de-risked commercial ramp in the neuromuscular

The latest installment in BioPharma Dive’s new visualization-focused series features a stock sell-off that confused Wall Street analysts and a closer look at an industry-leading partnership streak.

Scholar Rock Holding Corporation (NASDAQ:SRRK) secured FDA approval on September 11 for ISEMBYLD, apitegromab-mstn, to treat spinal muscular atrophy in adults and children aged two and older currently receiving survival motor neuron 2 (SMN2)-targeted therapy. Approval opens a commercial opportunity built around adding muscle-directed treatment to existing care. The investment question now shifts to how […]

Scholar Rock Holding now carries a slightly higher modelled fair value, shifting from US$59.31 to US$62.06. This places it in line with the low to mid US$60s price targets cited in recent research. Street commentary around the Isembyld approval, updated adoption assumptions and the US$63 JPMorgan target helps explain why analysts are comfortable anchoring expectations around this new level. As you read on, you will see how these evolving targets and the surrounding narrative might shape your...

Scholar Rock (SRRK) could face some friction during the early commercialization of Isembyld after th

The U.S. Food and Drug Administration on Friday approved ISEMBYLD (apitegromab-mstn) from Scholar Rock for spinal muscular atrophy (SMA) in adults and pediatric patients aged 2 years and older. The decision makes ISEMBYLD the first muscle-targeted therapy to demonstrate motor...

On a call on Monday, the company set a list price of $11,659 per vial of Isembyld, or about $310,000 a year for a typical patient.

Scholar Rock Holding (SRRK) won early regulatory approval of Isembyld to treat spinal muscular atrop

The broad market exchange-traded fund SPDR S&P 500 ETF Trust (SPY) was down 0.6%, and the actively t

Scholar Rock Holding Corp (NASDAQ:SRRK) shares rose 9. 1% in pre-market trading to $60.

Investing.com - U.S. stock index futures fell sharply on Monday, with technology stocks under pressure after several leading artificial intelligence executives called for a slower pace of AI development amid concerns over potential risks from the technology.

Projected by some analysts as a future blockbuster, Isembyld is the first “muscle-targeted” treatment for the disease and, in clinical testing, helped improve motor function in people on standard therapies.

FDA approved Isembyld for patients age two and older who already take certain spinal muscular atrophy drugs.

Scholar Rock Holding stock has delivered an extremely strong multi year return, yet the latest valuation checks suggest the current share price may already be baking in a lot of optimism. After such a sharp move, the key issue for investors is whether the recent rally leaves much room for error. Over the past 3 years the stock has returned roughly 8.3x, which is a very large gain and puts extra focus on whether the present price still reflects a reasonable long term payoff. Progress with...

Scholar Rock Holding (SRRK) updated investors after shifting apitegromab’s commercial fill finish work away from Catalent Indiana following FDA inspection issues, while confirming that the FDA is continuing its review, a revised European filing is underway, and a Japanese submission is planned without new trials. See our latest analysis for Scholar Rock Holding. Investor attention around Scholar Rock Holding has coincided with strong recent momentum, with a 7 day share price return of 7.58%,...

Earlier this week, Scholar Rock announced it has removed Catalent Indiana from all commercial fill-finish roles for apitegromab, with the FDA continuing to review its U.S. BLA using an alternate, previously inspected facility and the company preparing for launch upon a potential decision by the September 30, 2026 PDUFA date. At the same time, the company reset its global regulatory plan by withdrawing and planning to resubmit its European filing with the new facility, while securing PMDA...

The company said it has, in accordance with FDA guidance, removed Catalent Indiana—a fill-finish plant now owned by Novo Nordisk—from its U.S. biologics license application for apitegromab.

Scholar Rock (SRRK) said Friday that, under guidance from the FDA, it has removed Novo Nordisk's (NV

Scholar Rock (NASDAQ:SRRK) CEO David Hallal said the company is preparing for a September 30 FDA decision date for apitegromab, its investigational treatment for spinal muscular atrophy, or SMA, following a resubmitted biologics license application supported by an alternate fill-finish manufacturing

Two healthcare players, Scholar Rock Holding Corporation (NASDAQ:SRRK) and Novo Nordisk A/S (NYSE:NVO), find their near-term narratives intertwined over manufacturing compliance. One is smoothly navigating a supply chain hurdle ahead of a critical drug approval, while the other just delivered a complicated financial quarter. The contrast reveals how investors weigh proactive execution against noisy financial […]

Apitegromab awaits FDA decision on Sept. 30 for spinal muscular atrophy treatment.

(Updates with day of announcement in first paragraph, Novo Nordisk's affiliation in the second parag

Scholar Rock (NASDAQ:SRRK) said its resubmitted biologics license application for apitegromab remains on track for a U.S. Food and Drug Administration decision by its Sept. 30 PDUFA date, as the company prepares for a potential launch of the muscle-targeted treatment for spinal muscular atrophy, or

Scholar Rock Holding Corp (SRRK) reports strong cash position and progress toward apitegromab approval, with two independent fill-finish facilities providing regulatory optionality.

Scholar Rock Holding (SRRK) stock has drawn fresh attention after recent trading performance, with shares last closing at $49.37 on 28 July 2026. Investors are weighing this price against the company’s longer term return profile. See our latest analysis for Scholar Rock Holding. Over the past month the stock has pulled back, with a 30 day share price return of down 9.84%. However, the year to date share price return of 15.35% and the very large 3 year total shareholder return of more than 6x...

Bristol Myers is the third pharmaceutical company to recently seek Nvidia’s help building a large AI data center. Elsewhere, a Novartis kidney drug gained a leg up on competitors.