Capricor said in early November that it expects to announce results from the HOPE-3 trial in the coming weeks.
- In July, the FDA refused to approve Capricor’s application for Deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy, stating that it does not meet the requirement for substantial evidence of effectiveness.
- The company intends to meet the FDA’s additional clinical data requirement with the HOPE-3 study and expects a review period of up to six months for the resubmitted application.
- ‘Pharma Bro’ Martin Shkreli announced a short position in Capricor last week.
Capricor Therapeutics stock drew heavy retail attention on Monday as retail investors are now awaiting data from the biotechnology company’s HOPE-3 study in the treatment of cardiomyopathy associated with Duchenne muscular dystrophy.
Capricor said in early November that it expects to announce results from the HOPE-3 trial in the coming weeks and within the fourth quarter. The company intends to submit an application to the U.S. Food and Drug Administration based on the study data. According to the firm, 105 DMD patients have been enrolled in the recent trial.
Capricor’s Rigged Road With Deramiocel Approval
In July, the FDA refused to approve Capricor’s application for Deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy, stating that it does not meet the requirement for substantial evidence of effectiveness and expressed the need for additional clinical data. The company intends to meet the FDA’s additional clinical data requirement with the HOPE-3 study and expects a review period of up to six months for the resubmitted application.
Commercial launch preparations are underway to support market introduction in 2026, the company said in November.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around CAPR fell from ‘extremely bullish’ to ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.
A Stocktwits user noted that the company’s data is the best to date despite the small sample size. However, they added that, “betting against the data without seeing it is very dangerous. As a poet once said “A little knowledge is a dangerous thing, drink deep or taset not the perian spring.”
Another bearish user said, “smell bad, look a like ols [old] bad news from several biotech.”
Short Positions And Pessimism On Trial Data
Last week, former biotech executive and businessman Martin Shkreli announced his short position in Capricor and opined that Deramiocel will not yield positive results in the HOPE-3 study.
Shkreli highlighted concerns, including limitations in cell therapies’ ability to reach target tissue and other safety issues, provided they are derived from donor hearts and are not immunoprivileged cells.
He further alleged that data from the company’s previous HOPE-2 trial was not meaningful. “Note the company and the publication reported a successful PE met, but the FDA disagreed,” he said.
CAPR stock is down by 51% this year and by about 66% over the past 12 months.
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