CAPR Stock Rallies Into FDA Decision Month: Retail Spots Approval ‘Tea Leaves’ In Capricor’s Launch Team Hiring

• The FDA’s target decision date is Nov.22, following a three-month extension to review additional data.
• The revised application focuses on preserving arm and hand function in patients with Duchenne muscular dystrophy.
• A July advisory panel voted 9-3 against evidence of effectiveness for the heart-related indication.

Shares of Capricor Therapeutics (CAPR) jumped over 4% in overnight trading late Sunday as retail investors pointed to launch-related job listings as possible clues that FDA approval of its Duchenne muscular dystrophy treatment, Deramiocel, could be approaching.

CAPR stock snapped a three-week losing streak with an 8% gain last week, but ended October down 33%.

Read Next

NCLH Rises Overnight: Analysts Turn Bullish On Norwegian Cruise Line As Bookings And Cost Savings Improve

Shivani Kumaresan

Launch Hiring Fuels Approval Hopes

Capricor’s official careers page lists openings for a senior director of commercial operations and analytics, and a senior director of patient services. Both are remote roles with annual salaries of $240,000 to $315,000.

The commercial operations listing says the executive would build capabilities to support the “anticipated U.S. launch of deramiocel,” including sales planning, forecasting, customer-management systems, and performance tracking. Meanwhile, the patient services role would establish support for patients and families navigating insurance coverage, affordability and treatment access.

Capricor had already said in August that its San Diego manufacturing facility could support an initial launch if Deramiocel is approved. It also said commercial preparations were moving more slowly while it awaited regulatory clarity.

Deramiocel Faces November FDA Test

Deramiocel is an experimental cell therapy being developed to preserve muscle function in Duchenne muscular dystrophy, an inherited disease that causes progressive muscle weakness.

In August, Capricor disclosed that the FDA had moved its decision deadline from Aug.22 to Nov.22 after receiving additional trial data and analyses. The revised request focuses on preserving upper-limb function, which is patients’ ability to use their arms and hands. 

This was followed by a July advisory committee vote of 9-3 against whether the evidence established effectiveness for treating Duchenne-related cardiomyopathy, or heart-muscle disease. The vote was advisory, and the committee was not asked to vote on the HOPE-3 trial’s main upper-limb endpoint, according to Capricor.

“The Advisory Committee outcome was not the one we hoped for,” CEO Linda Marbán said in August. Capricor said Hope-3 met its main upper-limb endpoint, with a statistically significant result of p=0.029.

Deramiocel Data Puts Patient Independence In Focus

Capricor’s October update showed that patients’ arm and hand function declined 76% more slowly after switching to Deramiocel, compared with their previous year on placebo. Patients receiving the treatment throughout both years declined at a similar rate each year.

“Their arms are how they feed themselves, control their wheelchairs and use their phones, and how they stay independent,” Hope-3 principal investigator Craig McDonald said. The follow-up results were included in the FDA submission. Patients knew they were receiving treatment, and the extension was not designed to establish definitive statistical comparisons at two years.

Separately, Capricor’s second-quarter filing showed $237.9 million in cash, cash equivalents and investments at June 30. The company said the timing and scale of launch spending would depend partly on the FDA’s decision.

How Do Retail Traders Feel About CAPR?

On Stocktwits, sentiment for CAPR slipped to ‘neutral’ from ‘bullish’ levels a week ago amid ‘normal’ message volumes.

One user said, “more tea leaves. ~20 days to go,” while sharing a third-party page of Capricor job listings.

Another user said, “$CAPR There has been a definitive change in the facts that gives management the comfort to start hiring.   Could approval be in hand waiting for release tomorrow?”

A separate user questioned why Capricor would spend on recruiting without greater certainty about approval.

CAPR stock has declined 78% year-to-date.

For updates and corrections, email newsroom[at]stocktwits[dot]com.

Read Next: Biotech Stocks Beat The S&P500 – Can Pfizer, Novo And Moderna Earnings Keep The Rally Going?