SAN DIEGO, August 22, 2026, 11:16 a.m. PDT
- Capricor closed Friday at $6.29, down 8.0% for the session.
- June cash equaled about $4.09 per share on reported shares outstanding.
- The FDA postponed its August 22 deadline to review new 24-month data.
- Analyst targets span $2 to $28, showing sharply divided approval assumptions.
Capricor Therapeutics, Inc. NASDAQ:CAPR ended Friday with only about $2.20 per share of equity value above its June cash. That preliminary figure frames the wager on deramiocel after regulators delayed their decision.
The shares closed at $6.29, down 8.0% on Friday. They also finished 5.4% below their August 14 close, when news of further FDA review had sparked a 70% intraday surge. The market was closed Saturday.
The U.S. Food and Drug Administration agreed to examine 24-month HOPE-3 data focused on upper-limb function. Capricor said that amendment would replace Saturday’s target action date. A revised deadline has not been disclosed.
| Date | Close | Volume | Change from Aug. 14 |
|---|---|---|---|
| Aug. 14 | $6.65 | 66.33 million | — |
| Aug. 17 | $7.45 | 19.22 million | +12.0% |
| Aug. 18 | $7.08 | 8.54 million | +6.5% |
| Aug. 19 | $7.98 | 8.57 million | +20.0% |
| Aug. 20 | $6.84 | 8.11 million | +2.9% |
| Aug. 21 | $6.29 | 8.26 million | -5.4% |
The delayed decision removes an immediate binary event. It does not resolve the evidence dispute. An FDA advisory committee voted 9-3 against finding substantial evidence of effectiveness for Duchenne cardiomyopathy on July 29.
The committee did not vote on HOPE-3’s upper-limb primary endpoint. Capricor described that discussion as directionally supportive, while stressing that the cardiomyopathy vote was nonbinding.
| Evidence | Reported result | Investor reading |
|---|---|---|
| HOPE-3 upper-limb primary endpoint | PUL 2.0, p=0.029 | Statistically significant |
| Full-trial LVEF after corrected model | 1.8-point difference, p=0.09 | Not conventionally significant |
| Prespecified cardiomyopathy subgroup | p=0.02 | Supportive subgroup result |
| FDA advisory vote | 3 yes, 9 no | Negative and nonbinding |
| New amendment | 24-month upper-limb data | Review accepted; timing undisclosed |
The cash cushion matters now. Capricor held $237.9 million in cash and marketable securities on June 30. It had 58.1 million shares outstanding, equal to about $4.09 per share.
Friday’s close therefore placed a preliminary $127.6 million equity premium above cash on the reported share count. That is the $2.20-per-share deramiocel and platform bet. It is not liquidation value and excludes liabilities, later share changes and cash use.
| Metric | Latest period | Comparison | Change |
|---|---|---|---|
| Cash and securities | $237.9 million at June 30, 2026 | $318.1 million at Dec. 31, 2025 | -25.2% |
| Second-quarter operating expense | $42.9 million in 2026 | $27.7 million in 2025 | +55.0% |
| Second-quarter net loss | $40.7 million in 2026 | $25.9 million in 2025 | +57.2% |
| First-half net loss | $74.7 million in 2026 | $50.3 million in 2025 | +48.5% |
The balance is shrinking. Cash fell $80.2 million during the first half, while operating expense rose. At the first-half net-loss pace, June cash covered about 19 months. That preliminary measure ignores working-capital movements and management’s ability to change spending.
Management says its resources fund at least 12 months. It slowed commercial hiring and paused programs not tied to deramiocel pending regulatory clarity. Chief Executive Linda Marbán said, “we continue to believe there is a path to approval for Deramiocel.” Capricor second-quarter results
Analysts remain unusually divided. The average target is $10.50, yet the median is $6. The difference shows that one bullish target pulls the mean well above Friday’s close.
| Firm | Latest action | Rating | Target | Date |
|---|---|---|---|---|
| Cantor Fitzgerald | Upgrade | Buy | $28 | Aug. 14 |
| Piper Sandler | Maintain | Hold | $2 | Aug. 14 |
| B. Riley | Maintain | Hold | $5 | July 31 |
| Jones Trading | Downgrade | Hold | Not stated | July 30 |
| Oppenheimer | Downgrade | Hold | Not stated | July 30 |
Friday’s price sits 4.6% above the $6 median target. The $2 low target is 68.2% below Friday, while the $28 high target is 345.2% above it. That spread is chiefly a regulatory probability argument.
The week ahead should bring attention to the amendment’s filing status and any revised FDA timetable. Capricor has not given a new action date. A Roth Capital analyst told Reuters that a major amendment could add roughly three months, but that remains an estimate.
Risks: The FDA may reject deramiocel, request more work or narrow any label. A longer review increases cash use. Approval could lift the shares sharply, while another setback could erase much of the premium above cash.
