StreetInsider.com News Articles

StreetInsider.com News Articles http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Mon, 20 Jul 2026 08:00:24 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif StreetInsider.com News Articles http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday Scholar Rock says apitegromab EU approval delayed by facility review http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html <p>Scholar Rock (NASDAQ: SRRK) said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) opinion on its apitegromab marketing authorisation application (MAA) for spinal muscular atrophy (SMA) is on hold pending resolution of a manufacturing facility issue.</p> <p>The EMA is awaiting an FDA inspection classification for the Catalent Indiana LLC fill-finish facility, which is part of Novo Nordisk and was inspected by the FDA in April 2026. The apitegromab MAA currently lists Catalent Indiana as a fill-finish site.</p> <p>Scholar Rock said that if the FDA reclassifies Catalent Indiana, a CHMP opinion could come later in 2026. If the facility http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html Mon, 20 Jul 2026 08:00:24 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock says apitegromab EU approval delayed by facility review http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html <p>Scholar Rock (NASDAQ: SRRK) said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) opinion on its apitegromab marketing authorisation application (MAA) for spinal muscular atrophy (SMA) is on hold pending resolution of a manufacturing facility issue.</p> <p>The EMA is awaiting an FDA inspection classification for the Catalent Indiana LLC fill-finish facility, which is part of Novo Nordisk and was inspected by the FDA in April 2026. The apitegromab MAA currently lists Catalent Indiana as a fill-finish site.</p> <p>Scholar Rock said that if the FDA reclassifies Catalent Indiana, a CHMP opinion could come later in 2026. If the facility http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html Mon, 20 Jul 2026 08:00:24 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock says apitegromab EU approval delayed by facility review http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html <p>Scholar Rock (NASDAQ: SRRK) said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) opinion on its apitegromab marketing authorisation application (MAA) for spinal muscular atrophy (SMA) is on hold pending resolution of a manufacturing facility issue.</p> <p>The EMA is awaiting an FDA inspection classification for the Catalent Indiana LLC fill-finish facility, which is part of Novo Nordisk and was inspected by the FDA in April 2026. The apitegromab MAA currently lists Catalent Indiana as a fill-finish site.</p> <p>Scholar Rock said that if the FDA reclassifies Catalent Indiana, a CHMP opinion could come later in 2026. If the facility http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html Mon, 20 Jul 2026 08:00:24 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock says apitegromab EU approval delayed by facility review http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html <p>Scholar Rock (NASDAQ: SRRK) said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) opinion on its apitegromab marketing authorisation application (MAA) for spinal muscular atrophy (SMA) is on hold pending resolution of a manufacturing facility issue.</p> <p>The EMA is awaiting an FDA inspection classification for the Catalent Indiana LLC fill-finish facility, which is part of Novo Nordisk and was inspected by the FDA in April 2026. The apitegromab MAA currently lists Catalent Indiana as a fill-finish site.</p> <p>Scholar Rock said that if the FDA reclassifies Catalent Indiana, a CHMP opinion could come later in 2026. If the facility http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html Mon, 20 Jul 2026 08:00:24 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock says apitegromab EU approval delayed by facility review http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html <p>Scholar Rock (NASDAQ: SRRK) said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) opinion on its apitegromab marketing authorisation application (MAA) for spinal muscular atrophy (SMA) is on hold pending resolution of a manufacturing facility issue.</p> <p>The EMA is awaiting an FDA inspection classification for the Catalent Indiana LLC fill-finish facility, which is part of Novo Nordisk and was inspected by the FDA in April 2026. The apitegromab MAA currently lists Catalent Indiana as a fill-finish site.</p> <p>Scholar Rock said that if the FDA reclassifies Catalent Indiana, a CHMP opinion could come later in 2026. If the facility http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html Mon, 20 Jul 2026 08:00:24 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock says apitegromab EU approval delayed by facility review http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html <p>Scholar Rock (NASDAQ: SRRK) said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) opinion on its apitegromab marketing authorisation application (MAA) for spinal muscular atrophy (SMA) is on hold pending resolution of a manufacturing facility issue.</p> <p>The EMA is awaiting an FDA inspection classification for the Catalent Indiana LLC fill-finish facility, which is part of Novo Nordisk and was inspected by the FDA in April 2026. The apitegromab MAA currently lists Catalent Indiana as a fill-finish site.</p> <p>Scholar Rock said that if the FDA reclassifies Catalent Indiana, a CHMP opinion could come later in 2026. If the facility http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html Mon, 20 Jul 2026 08:00:24 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock says apitegromab EU approval delayed by facility review http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html <p>Scholar Rock (NASDAQ: SRRK) said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) opinion on its apitegromab marketing authorisation application (MAA) for spinal muscular atrophy (SMA) is on hold pending resolution of a manufacturing facility issue.</p> <p>The EMA is awaiting an FDA inspection classification for the Catalent Indiana LLC fill-finish facility, which is part of Novo Nordisk and was inspected by the FDA in April 2026. The apitegromab MAA currently lists Catalent Indiana as a fill-finish site.</p> <p>Scholar Rock said that if the FDA reclassifies Catalent Indiana, a CHMP opinion could come later in 2026. If the facility http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html Mon, 20 Jul 2026 08:00:24 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock says apitegromab EU approval delayed by facility review http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html <p>Scholar Rock (NASDAQ: SRRK) said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) opinion on its apitegromab marketing authorisation application (MAA) for spinal muscular atrophy (SMA) is on hold pending resolution of a manufacturing facility issue.</p> <p>The EMA is awaiting an FDA inspection classification for the Catalent Indiana LLC fill-finish facility, which is part of Novo Nordisk and was inspected by the FDA in April 2026. The apitegromab MAA currently lists Catalent Indiana as a fill-finish site.</p> <p>Scholar Rock said that if the FDA reclassifies Catalent Indiana, a CHMP opinion could come later in 2026. If the facility http://www.streetinsider.com/FDA/Scholar+Rock+says+apitegromab+EU+approval+delayed+by+facility+review/26787276.html Mon, 20 Jul 2026 08:00:24 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Press+Releases/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA) http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html <ul class="bwlistdisc"> <li> <i>July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility</i> </li> <li> <i>Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA</i> </li> </ul> <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fscholarrock.com%2F&esheet=54573378&newsitemid=20260719465114&lan=en-US&anchor=Scholar+Rock&index=1&md5=897d3684b1da437c8f1631072ff2cdb6" shape="rect">Scholar Rock</a> (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 provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the http://www.streetinsider.com/Business+Wire/Scholar+Rock+Provides+Update+on+Timing+of+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+Opinion+for+Apitegromab+Marketing+Authorisation+Application+%28MAA%29+for+Spinal+Muscular+Atrophy+%28SMA%29/26787245.html Mon, 20 Jul 2026 08:00:00 -0400 A.06822034 A.31066700 A.37038267 O.01164031 O.20026344 O.22422661 O.38090903 SRRK Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) http://www.streetinsider.com/Press+Releases/Scholar+Rock+Reports+New+Employee+Inducement+Grants+Under+Nasdaq+Listing+Rule+5635%28c%29%284%29/26784489.html <p> CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Scholar Rock (NASDAQ: SRRK; the “Company”) today announced that the company granted inducement equity awards covering an aggregate of 118,586 shares of its common stock to eleven newly hired employees, consisting of inducement stock options to purchase an aggregate of 33,987 shares of common stock and inducement restricted stock units, covering an aggregate of 84,599 shares of its common stock. </p><p> The awards are subject to all terms and conditions and other provisions set forth in the Company’s 2022 Inducement Equity Plan (the “Plan”) and the award agreements thereunder. </p><p> The Plan, initially adopted by the Company’s board http://www.streetinsider.com/Press+Releases/Scholar+Rock+Reports+New+Employee+Inducement+Grants+Under+Nasdaq+Listing+Rule+5635%28c%29%284%29/26784489.html Fri, 17 Jul 2026 16:15:00 -0400 O.38090903 SRRK