Follow Us "https://stocktwits.com/news articles/markets/equity/capricor therapeutics says fda may not hold advisory committee meeting for dmd therapy approval/chm411nRR3K")
The FDA has indicated that an advisory committee meeting is not required at this time, the company said, while adding that its application for Deramiocel approval remains under priority review.
Capricor Therapeutics (CAPR) said on Tuesday that the U.S. Food and Drug Administration is not eyeing an advisory committee meeting regarding approval for its Deramiocel for the treatment of Duchenne Muscular Dystrophy (DMD) associated cardiomyopathy.
Capricor shares were trading 19% higher at the time of writing.
The FDA indicated that an advisory committee meeting is not required at this time, the company said, while adding that its application for Deramiocel approval remains under priority review.
The company said in May that the FDA is considering an advisory committee meeting, dragging down investor optimism for a possible approval.
The agency is expected to decide on the approval of the drug by Aug. 31.
Company CEO Linda Marbán said that all regulatory milestones to date have proceeded as expected, and no major issues were noted at the mid-cycle review of the application.
An in-person late-cycle meeting is now scheduled for mid-July.
Deramiocel is Capricor’s lead cell therapy candidate for Duchenne Muscular Dystrophy, a genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart, and respiratory muscles. The disease affects approximately 15,000 individuals in the United States and primarily impacts boys.
On Stocktwits, retail sentiment around Capricor stayed unchanged within the ‘extremely bullish’ territory over the past 24 hours while message volume remained ‘extremely high.’
A Stocktwits user expressed optimism for the drug getting approved early following the company’s update.
However, Roth Capital analyst Boobalan Pachaiyappan told investors in a research note that the FDA's intention not to require a meeting "at this time" for Deramiocel “may not necessarily be positive news.”
The analyst believes a promissory advisory committee meeting would be positive, as a potential positive panel vote would put pressure on the new FDA leadership to approve deramiocel in its current form.
The firm reiterates a ‘Buy’ rating and $31 price target on Capricor shares.
H.C. Wainright, however, opined that even in bear case scenarios with the FDA, late-stage trial data readouts are "waiting in the wings" to further strengthen Deramiocel's overall clinical and regulatory package. The analyst believes Deramiocel's first-in-class therapeutic profile, in tandem with strong manufacturing support, will get the therapy over the finish line on expected timelines, as per TheFly.
CAPR stock is down by about 34% this year but up by about 91% over the past 12 months.
For updates and corrections, email newsroom[at]stocktwits[dot]com.<
