Scholar Rock (NASDAQ: SRRK) Soars on FDA Progress, $200M ATM and Q3 2025 Earnings

Scholar Rock Holding Corporation (NASDAQ: SRRK) is back in the spotlight as its stock jumps more than 25% on the day after a pivotal FDA meeting, fresh Q3 2025 financial results, and the launch of a new $200 million at-the-market (ATM) stock offering.

SRRK stock jumps over 25% after FDA “constructive” meeting

Scholar Rock shares are surging today. As of the latest trade, SRRK is changing hands around $37.98, up roughly 26% on the session, after touching an intraday high above $39. Daily trading volume has climbed to about 2.75 million shares, well above normal levels.

The move is being driven largely by a regulatory update:

On November 12, Scholar Rock held an in‑person Type A meeting with the U.S. Food and Drug Administration (FDA) about its biologics license application (BLA) for apitegromab, its muscle‑targeted therapy for spinal muscular atrophy (SMA).
The company described the discussion as constructive and a key step toward resubmitting the BLA after receiving a Complete Response Letter (CRL) in September due to manufacturing issues at a third‑party fill‑finish site in Indiana, rather than any problem with apitegromab itself. ^[1]
That facility, Catalent Indiana (now part of Novo Nordisk), told the FDA it expects to be ready for reinspection by year‑end 2025, aligning with Scholar Rock’s plan for a U.S. launch in 2026, if approved. ^[2]

Reuters notes that despite today’s rally, the stock had still been down about 30% year‑to‑date before the open, reflecting earlier volatility around the CRL. ^[3]

Q3 2025: Wider loss as launch spending ramps

Alongside the regulatory progress, Scholar Rock today reported third‑quarter 2025 results for the period ended September 30, 2025. ^[4]

Key Q3 2025 figures

From the company’s official press release and related 10‑Q summary:

Revenue: $0 (still pre‑commercial).
Net loss:$102.2 million, versus $64.5 million in Q3 2024.
Net loss per share (basic and diluted):–$0.90, compared with –$0.66 a year ago.
Research & development (R&D) expense:$50.5 million, modestly higher than the $48.7 million in Q3 2024.
General & administrative (G&A) expense:$53.1 million, up sharply from $16.1 million a year ago, reflecting heavy investment in commercial infrastructure, launch readiness, and stock‑based compensation. ^[5]

For the first nine months of 2025, Scholar Rock reported:

Net loss:$286.97 million, up from $179.84 million in the same period of 2024.
Net loss per share:–$2.54 vs –$1.86 a year earlier.
Total operating expenses (nine months):$292.75 million, up about 60% year‑over‑year. ^[6]

These numbers underline a classic late‑stage biotech profile: no product revenue yet, but rapidly escalating spending ahead of a potential first commercial launch.

Cash runway into 2027 – and a new $200M ATM program

Despite the larger loss, Scholar Rock emphasized its liquidity position and runway:

Cash, cash equivalents and marketable securities:$369.6 million as of September 30, 2025.
That balance includes $91.7 million in net proceeds from selling 2.77 million common shares and a $50 million draw from its debt facility earlier this year.
Management expects this cash, together with approximately $60 million of in‑the‑money warrants expiring at the end of 2025, to fund operations into 2027. ^[7]

On top of that, the company added even more financial flexibility today:

Scholar Rock announced a $200 million at‑the‑market (ATM) offering program, allowing it to sell common stock from time to time through Jefferies LLC as sales agent.
The ATM sits under an existing shelf registration (effective since October 2024) and can be tapped opportunistically to bolster cash for commercialization and pipeline programs. ^[8]

According to Investing.com’s summary of the SEC filing, Scholar Rock currently carries moderate debt and maintains strong liquidity, with current assets more than six times current liabilities—though any large ATM usage would come with potential dilution for existing shareholders. ^[9]

Apitegromab: from CRL setback to updated 2026 launch plan

Apitegromab remains the core of the investment story.

What went wrong in September

On September 23, 2025, the FDA issued a Complete Response Letter (CRL) for apitegromab’s BLA in SMA. The letter cited issues identified during a routine inspection of the Catalent Indiana fill‑finish facility. Importantly:

The CRL did not raise concerns about apitegromab’s efficacy, safety, or drug substance manufacturing.
Scholar Rock and patient‑advocacy group Cure SMA stressed that the setback stemmed from site‑specific manufacturing observations, not clinical data. ^[10]

Today’s updated regulatory roadmap

The Q3 2025 press release and earnings materials now sketch a clearer path forward: ^[11]

Type A meeting completed (Nov 12, 2025): Scholar Rock and Catalent met with the FDA in person. Catalent outlined remediation progress and told regulators it expects the Bloomington facility to be ready for reinspection by the end of 2025.
BLA resubmission & U.S. launch: Scholar Rock now anticipates resubmitting the apitegromab BLA after the facility’s status is resolved, with a targeted U.S. launch in 2026, assuming approval.
Second U.S. fill‑finish facility: To reduce reliance on a single CDMO, Scholar Rock has engaged a second U.S.‑based, commercially approved fill‑finish site with a history of successful inspections. Tech transfer is underway, and commercial capacity has been reserved starting Q1 2026.
Europe: The European Medicines Agency (EMA) continues to review apitegromab’s Marketing Authorisation Application (MAA), with a decision still expected by mid‑2026.

For patients with SMA—and for investors—this effectively resets the commercial clock: from an earlier 2025 launch narrative to a 2026 global rollout, with the major gating factor now being the Catalent facility and the resubmitted BLA.

Clinical pipeline: OPAL, SRK‑439 and additional neuromuscular programs

Scholar Rock is positioning itself as a myostatin‑biology specialist with a broader neuromuscular and oncology pipeline. ^[12]

Apitegromab in broader SMA populations

Phase 3 SAPPHIRE previously showed statistically significant and clinically meaningful motor‑function improvements in non‑ambulatory SMA Types 2 and 3 on standard of care, forming the backbone of the BLA. ^[13]
Scholar Rock has now initiated dosing in the Phase 2 OPAL trial for infants and toddlers under 2 years old who have received gene therapy or SMN‑targeted treatments. This extends apitegromab into younger, earlier‑treated SMA populations. ^[14]

The company also plans to start clinical development in a second neuromuscular indication by the end of 2025, with more details promised in early 2026. ^[15]

SRK‑439: next‑generation myostatin inhibitor

SRK‑439 is a subcutaneously administered, highly selective myostatin inhibitor targeting the pro‑ and latent forms of myostatin, with the goal of increasing muscle mass.
The FDA has cleared the IND for SRK‑439, and Scholar Rock expects to begin dosing healthy volunteers in Q4 2025. ^[16]

If SRK‑439 performs as hoped, it could open up additional neuromuscular or even cardiometabolic indications, giving Scholar Rock a pipeline beyond apitegromab.

SRK‑181 and early‑stage programs

The 10‑Q summary also highlights: ^[17]

SRK‑181, an anti‑latent TGFβ1 antibody, has completed its Phase 1 DRAGON trial in checkpoint‑inhibitor‑resistant cancers, with encouraging signals in certain tumor types.
SRK‑373 and SRK‑256 remain in preclinical development for fibrotic disease and iron‑restricted anemia, respectively.

These programs are earlier‑stage but signal Scholar Rock’s intention to leverage its growth‑factor platform across multiple disease areas.

New equity grants and hiring momentum

While not part of today’s slate of announcements, investors watching dilution and talent acquisition will note that on November 12, Scholar Rock reported inducement equity awards covering 30,000 shares for a newly hired employee, with options priced at $29.37, equal to the closing share price on November 10. ^[18]

This suggests the company continues to build out its workforce ahead of apitegromab’s planned launch and broader pipeline execution.

How Wall Street is reacting

Analyst and market commentary around today’s events has been largely constructive, but not without caveats.

Reuters reports that the average analyst rating on SRRK is “buy”, with 13 buy or strong‑buy recommendations and no holds or sells, and a median 12‑month price target of $45, roughly one‑third above yesterday’s close of about $30. ^[19]
A Finimize brief notes that all 13 analysts tracked remain bullish, despite the widening loss and lack of revenue, seeing apitegromab’s 2026 launch as the key value driver and highlighting the extended cash runway into 2027. ^[20]
According to an Investing.com summary of recent analyst activity, Truist cut its price target from $54 to $44 after the CRL but kept a Buy rating, while BofA Securities initiated coverage with a Buy and a $53 target, citing optimism around apitegromab in SMA. ^[21]
GuruFocus and Simply Wall St both flag the high valuation multiples and deep losses, but also point to strong institutional ownership, positive SMA data, and the FDA meeting as reasons sentiment has turned more positive again. ^[22]

In short, the Street appears to be treating Scholar Rock as a high‑risk, high‑reward late‑stage biotech: highly dependent on successful resolution of manufacturing issues and eventual commercialization, but with a potentially meaningful first‑in‑class therapy.

Key risks and what to watch next

For readers tracking SRRK into year‑end, several milestones stand out:

1. Catalent Indiana reinspection and BLA resubmission

The biggest near‑term swing factor is whether Catalent’s Bloomington facility meets FDA expectations and is reclassified in time for Scholar Rock to resubmit the apitegromab BLA promptly.
Any further delays or new observations could push the 2026 launch timeline out. ^[23]

2. Use of the $200M ATM

Management now has significant flexibility to raise capital. How aggressively Scholar Rock taps the ATM program—and at what share prices—will be watched closely in the context of its existing runway into 2027 and its appetite for additional trials and commercial expansion. ^[24]

3. Early data from SRK‑439 and updates on OPAL

Initial Phase 1 data for SRK‑439 in healthy volunteers and any early OPAL trial readouts could start to shape the narrative around Scholar Rock as a multi‑asset myostatin company, not just a single‑product play. ^[25]

4. EMA decision and ex‑U.S. strategy

An EMA opinion by mid‑2026 would confirm how regulators outside the U.S. view the SAPPHIRE data and manufacturing remediation, and could significantly influence the size and speed of apitegromab’s global ramp. ^[26]

Bottom line

On November 14, 2025, Scholar Rock delivered a dense package of news:

Q3 2025 results showing no revenue and a materially wider net loss, driven mainly by launch preparation and higher stock‑based compensation.
A clearer regulatory path for apitegromab, with the FDA Type A meeting, manufacturing remediation underway, and timelines now pointing to a 2026 U.S. and mid‑2026 EU launch, if approvals come through.
A strengthened balance sheet with cash into 2027 and a newly unveiled $200 million ATM facility, paired with robust but dilutive funding options.
Ongoing pipeline progress in younger SMA populations, new neuromuscular indications, and SRK‑439 as a potential follow‑on myostatin program.

SRRK stock is responding in kind, rallying more than 25% intraday as the market recalibrates the odds of a successful apitegromab launch and longer‑term platform value.

As always, this coverage is for informational purposes only and does not constitute investment advice, a recommendation, or a solicitation to buy or sell any security.

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