UPDATE!
$Capricor Therapeutics(CAPR.US$ Item 7.01
Regulation FD Disclosure.
On September 29, 2023, the Company announced a positive outcome from a Type-B clinical meeting with the U.S. Food and Drug Administration (the “FDA”) on the design and execution of HOPE-3, the Phase 3 pivotal trial of CAP-1002 in Duchenne Muscular Dystrophy (“DMD”). Feedback from the FDA on the proposed key clinical and regulatory requirements confirms CAP-1002’s path towards Biologics License Application (“BLA”) submission.
A copy of the press release has been filed as Exhibit 99.1 hereto and is incorporated herein by reference.
Item 8.01
Other Events.
As disclosed above under Item 7.01, on September 29, 2023, the Company announced a positive outcome from a Type-B clinical meeting with the FDA on the design and execution of HOPE-3, the Phase 3 pivotal trial of CAP-1002 in DMD. Because the Company plans to submit a BLA for CAP-1002 in 2025 supported by results using product manufactured from the Los Angeles site, and not from the Company’s San Diego manufacturing site, the Company intends to focus significant time and resources on additional work needed at the Los Angeles site (which is leased under a facilities lease previously disclosed by the Company) to support the BLA submission. The Company will also continue work on its San Diego site with a view toward supporting potential increased commercial demand, subject to the! PLUS just raised 23M from RDO 1 share and 1 warrant![]()
Regulation FD Disclosure.
On September 29, 2023, the Company announced a positive outcome from a Type-B clinical meeting with the U.S. Food and Drug Administration (the “FDA”) on the design and execution of HOPE-3, the Phase 3 pivotal trial of CAP-1002 in Duchenne Muscular Dystrophy (“DMD”). Feedback from the FDA on the proposed key clinical and regulatory requirements confirms CAP-1002’s path towards Biologics License Application (“BLA”) submission.
A copy of the press release has been filed as Exhibit 99.1 hereto and is incorporated herein by reference.
Item 8.01
Other Events.
As disclosed above under Item 7.01, on September 29, 2023, the Company announced a positive outcome from a Type-B clinical meeting with the FDA on the design and execution of HOPE-3, the Phase 3 pivotal trial of CAP-1002 in DMD. Because the Company plans to submit a BLA for CAP-1002 in 2025 supported by results using product manufactured from the Los Angeles site, and not from the Company’s San Diego manufacturing site, the Company intends to focus significant time and resources on additional work needed at the Los Angeles site (which is leased under a facilities lease previously disclosed by the Company) to support the BLA submission. The Company will also continue work on its San Diego site with a view toward supporting potential increased commercial demand, subject to the! PLUS just raised 23M from RDO 1 share and 1 warrant
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