StreetInsider.com News Articles

H.C. Wainwright Reiterates Buy Rating on Scholar Rock (SRRK)

Tue, 08 Sep 2026 07:53:29 -0400

H.C. Wainwright analyst Andres Maldonado reiterated a Buy rating and $65.00 price target on Scholar Rock (NASDAQ: SRRK).

The analyst commented: "With FORGE now dosing, we believe an important and largely unpriced source of value beyond SMA is beginning to come into focus for Scholar Rock. Yesterday, the company announced Fast Track and Orphan Drug designations for apitegromab in FSHD, but we view the start of Phase 2 dosing as the more important development for investors because it begins testing a thesis that our work has made us increasingly bullish on. Over the past several weeks, we have diligenced the opportunity

Scholar Rock gets FDA fast track for apitegromab in rare muscle disease

Wed, 02 Sep 2026 08:02:06 -0400

Scholar Rock (NASDAQ: SRRK) announced that the FDA has granted Fast Track and Orphan Drug designations to apitegromab for the treatment of facioscapulohumeral muscular dystrophy (FSHD), a progressive hereditary neuromuscular disease characterized by muscle atrophy, weakness, and functional decline.

The Cambridge, Mass.-based biopharmaceutical company also announced that participant dosing has begun in the Phase 2 FORGE clinical trial, which evaluates apitegromab as a monotherapy in adults with genetically confirmed FSHD.

FORGE is a randomized, double-blind, placebo-controlled, multi-center trial designed to enroll approximately 60 participants, who will be randomized one-to-one to receive apitegromab 10 mg/kg or placebo intravenously every four weeks for 52

Scholar Rock gets FDA fast track for apitegromab in rare muscle disease

Wed, 02 Sep 2026 08:02:06 -0400

Scholar Rock to Present at Upcoming Investor Conferences

Thu, 27 Aug 2026 08:00:00 -0400

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today announced that management will participate in the following investor conferences:

Cantor 2026 Global Healthcare Conference: Scholar Rock is scheduled to participate in a fireside chat at 8:00 a.m. ET on Wednesday, September 9, 2026 in New York, NY.
Citi 2026 BioPharma Back to School Conference: Scholar Rock is scheduled to participate in a fireside chat at 9:20 a.m. ET on Thursday, September 10, 2026

Scholar Rock to Present at Upcoming Investor Conferences

Thu, 27 Aug 2026 08:00:00 -0400

Cantor 2026 Global Healthcare Conference: Scholar Rock is scheduled to participate in a fireside chat at 8:00 a.m. ET on Wednesday, September 9, 2026 in New York, NY.
Citi 2026 BioPharma Back to School Conference: Scholar Rock is scheduled to participate in a fireside chat at 9:20 a.m. ET on Thursday, September 10, 2026

Scholar Rock to Present at Upcoming Investor Conferences

Thu, 27 Aug 2026 08:00:00 -0400

Cantor 2026 Global Healthcare Conference: Scholar Rock is scheduled to participate in a fireside chat at 8:00 a.m. ET on Wednesday, September 9, 2026 in New York, NY.
Citi 2026 BioPharma Back to School Conference: Scholar Rock is scheduled to participate in a fireside chat at 9:20 a.m. ET on Thursday, September 10, 2026

Scholar Rock to Present at Upcoming Investor Conferences

Thu, 27 Aug 2026 08:00:00 -0400

Cantor 2026 Global Healthcare Conference: Scholar Rock is scheduled to participate in a fireside chat at 8:00 a.m. ET on Wednesday, September 9, 2026 in New York, NY.
Citi 2026 BioPharma Back to School Conference: Scholar Rock is scheduled to participate in a fireside chat at 9:20 a.m. ET on Thursday, September 10, 2026

BMO Capital Reiterates Outperform Rating on Scholar Rock (SRRK)

Mon, 24 Aug 2026 09:28:56 -0400

BMO Capital analyst Evan David Seigerman reiterated an Outperform rating and $76.00 price target on Scholar Rock (NASDAQ: SRRK).

The analyst commented: "Removal of Catalent Site From BLA Keeps Approval Time in Line; Announced removal of Catalent facility from apitegromab BLA application is unlikely to surprise investors, but maintained FDA approval timelines remain encouraging. We still expect FDA to approve apitegromab on or before September 30 with Scholar Rock's second fill-finish facility included in its BLA providing additional assurances. Removal of Catalent from European MAA is unsurprising and may mildly delay approval ex-US, but delays are not likely to be material

Scholar Rock updates apitegromab regulatory status in U.S., Europe, Japan

Fri, 21 Aug 2026 09:06:44 -0400

Scholar Rock (NASDAQ: SRRK) announced updates on the regulatory progress of apitegromab, its experimental treatment for spinal muscular atrophy (SMA), across three major markets, according to a company press release.

Under FDA guidance, Scholar Rock removed Catalent Indiana LLC, part of Novo Nordisk, as a commercial fill-finish facility from its apitegromab Biologics License Application (BLA). The FDA review is continuing with an alternate fill-finish facility, and the agency's approval decision is expected by the September 30, 2026 Prescription Drug User Fee Act (PDUFA) date.

The Catalent Indiana facility was classified by the FDA as Official Action Indicated (OAI) following an April 2026

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Fri, 21 Aug 2026 09:06:00 -0400

Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility

Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval

Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment