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Scholar Rock (SRRK) FDA Events

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FDA Events for Scholar Rock (SRRK)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Scholar Rock (SRRK). Over the past two years, Scholar Rock has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Apitegromab, SRK-181, and SRK-439. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Scholar Rock's Drugs in FDA Review

Apitegromab - FDA Regulatory Timeline and Events

Apitegromab is a drug developed by Scholar Rock for the following indication: Type 2 and Type 3 Spinal Muscular Atrophy (SMA). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

SRK-181 - FDA Regulatory Timeline and Events

SRK-181 is a drug developed by Scholar Rock for the following indication: Locally advanced or metastatic solid tumors. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

SRK-439 - FDA Regulatory Timeline and Events

SRK-439 is a drug developed by Scholar Rock for the following indication: Myostatin inhibitor. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Scholar Rock FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Scholar Rock (SRRK) has reported FDA regulatory activity for the following drugs: Apitegromab, SRK-439 and SRK-181.

The most recent FDA-related event for Scholar Rock occurred on June 18, 2025, involving Apitegromab. The update was categorized as "Positive Results," with the company reporting: "Scholar Rock announced positive results from the Phase 2 EMBRAZE proof-of-concept trial assessing apitegromab in combination with tirzepatide to preserve lean mass during tirzepatide-induced weight loss."

Current therapies from Scholar Rock in review with the FDA target conditions such as:

  • Type 2 and Type 3 Spinal Muscular Atrophy (SMA) - Apitegromab
  • Myostatin inhibitor - SRK-439
  • Locally advanced or metastatic solid tumors - SRK-181

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:SRRK) was last updated on 7/10/2025 by MarketBeat.com Staff
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