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Scholar Rock posts first product revenue after ISEMBYLD launch

By Reuters News


Overview

  • U.S. biopharma firm's Q3 marks first product revenue after ISEMBYLD launch for spinal muscular atrophy

  • Company reported Q3 net loss widened to $107.2 mln from $102.2 mln a year ago

  • Scholar Rock agreed to sell Priority Review Voucher for $205 mln; cash to be received upon closing


Outlook

  • Company expects CHMP opinion on apitegromab in Europe in H1 2027

  • Scholar Rock anticipates Japanese priority review of apitegromab with ~9-month review cycle

  • Company engaging with regulators on subcutaneous apitegromab development path


Result Drivers

  • ISEMBYLD LAUNCH - Q3 marked the U.S. launch of ISEMBYLD, the first muscle-targeted therapy for SMA, following FDA approval

  • EARLY DEMAND - Co reported strong early patient and physician demand for ISEMBYLD, with initial patients infused in October

  • REGULATORY PROGRESS - Applications for apitegromab advanced in Europe and Japan, including priority review and orphan drug designations


Company press release:


Key Details

Metric

Beat/Miss

Actual

Consensus Estimate

Q3 Net Loss

$107.24 mln

Q3 Income from Operations

-$106.06 mln

Q3 Operating Expenses

$106.63 mln


Analyst Coverage

  • The current average analyst rating on the shares is "buy" and the breakdown of recommendations is 17 "strong buy" or "buy", 1 "hold" and no "sell" or "strong sell"

  • The average consensus recommendation for the biotechnology & medical research peer group is "buy"

  • Wall Street's median 12-month price target for Scholar Rock Holding Corporation is $70.50, about 36.8% above its November 9 closing price of $51.55


Reuters Recommended Reads

  • Nov 9 - Maze Therapeutics Q3 results miss estimates on higher R&D spending

  • Nov 9 - Trevi Therapeutics Q3 net loss widens on higher R&D costs

  • Nov 7 - Trial failures of Novartis, Novo Nordisk heart drugs leave experts guessing


For questions concerning the data in this report, contact Estimates.Support@lseg.com. For any other questions or feedback, contact reuters.support@thomsonreuters.com.


(This story was created using Reuters automation and AI based on LSEG and company data. It was checked and edited by a Reuters journalist prior to publication.)

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