
Overview
Biopharmaceutical firm's Q4 2025 net loss widened to $91 mln, no revenue recorded
Company secured up to $550 mln in non-dilutive capital for apitegromab commercialization
Apitegromab U.S. and European launches expected in 2026, pending regulatory approvals
Outlook
Scholar Rock expects U.S. launch of apitegromab in 2026 after FDA approval
EMA decision on apitegromab MAA anticipated mid-2026, European launch in H2 2026
Company plans to submit sBLA for second fill-finish facility later in 2026
Result Drivers
FDA MEETING - Constructive meeting with FDA and Catalent Indiana, no additional corrective actions required, supports BLA resubmission plans
DEBT FACILITY - Secured up to $550 mln in non-dilutive capital to support apitegromab commercialization and pipeline advancement
PIPELINE ADVANCEMENT - Ongoing development of apitegromab for SMA with anticipated U.S. and European launches in 2026
Company press release: ID:nBw1ljMFca
Key Details
Metric | Beat/Miss | Actual | Consensus Estimate |
FY EPS |
| -$0.88 |
|
FY Net Income |
| -$377.94 mln |
|
FY Income from Operations |
| -$384.65 mln |
|
FY Operating Expenses |
| $384.65 mln |
|
Analyst Coverage
The current average analyst rating on the shares is "buy" and the breakdown of recommendations is 16 "strong buy" or "buy", no "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 Corp is $50.00, about 15% above its March 2 closing price of $43.48
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