CAPRCAPRICOR THERAPEUTICS, INC.
Capricor Therapeutics, Inc. (CAPR) develops and commercializes therapeutic candidates for neurological and neurodevelopmental disorders, with a focus on its lead asset, deramiocel, for treating autism spectrum disorder. The next catalyst is Sep 28, 2026 — Securities Fraud Lawsuit Decision, which will test the company’s legal exposure and investor confidence ahead of its pending FDA approval timeline.
- Capricor is a biotech firm with a narrow therapeutic focus, operating in a highly competitive and capital-intensive sector.
- The company has a history of regulatory delays and legal challenges, including a delayed FDA approval and ongoing securities fraud litigation.
- Its financials are heavily leveraged, with negative net income and free cash flow, and a reliance on equity financing to sustain operations.
The Read
7% on delayed FDA approval and legal disputes, then plummeted 21.
The schedule
- Mon28Sep
Court decision on the securities fraud lawsuit, which could impact the company's reputation and financials.
- Sun20Dec
- Sun20Dec
- Sun20Dec
FDA call to discuss the status of Deramiocel, which could influence regulatory approval timelines.
Past
- Fri14Aug
Actual outcome: Bull · $7.45 at outcome
Capricor reported Q2 2026 earnings in line with expectations, with an EPS actual of -0.7 versus an estimate of -0.7. However, the stock rallied due to positive developments surrounding the FDA briefing document and the upcoming PDUFA date, which signaled potential progress in the regulatory process. The market reacted favorably to the strategic updates and the outlook for the company's future direction, driving the price higher despite the earnings miss.
Capricor reported Q2 2026 earnings in line with expectations, with an EPS actual of -0.7 versus an estimate of -0.7. However, the stock rallied due to positive developments surrounding the FDA briefing document and the upcoming PDUFA date, which signaled potential progress in the regulatory process. The market reacted favorably to the strategic updates and the outlook for the company's future direction, driving the price higher despite the earnings miss.
- Mon10Aug
Actual outcome: Bull · $4.19 at outcome
Capricor reported Q2 2026 EPS of -$0.59, exactly matching consensus estimates. Despite a challenging backdrop of ongoing securities class action lawsuits and an earnings call that notably omitted a management Q&A session, the in-line financial results provided enough near-term stability to drive an 8.8% relief rally in the stock.
Capricor reported Q2 2026 EPS of -$0.59, exactly matching consensus estimates. Despite a challenging backdrop of ongoing securities class action lawsuits and an earnings call that notably omitted a management Q&A session, the in-line financial results provided enough near-term stability to drive an 8.8% relief rally in the stock.
- Wed22Jul
Actual outcome: Bull · $19.70 at outcome
Although the stock initially ticked higher, shares plummeted to $7.00 by July 27, falling well below the $18.50 bear floor. The massive sell-off was triggered by the release of FDA briefing documents in which staff reviewers raised significant concerns regarding the effectiveness of Capricor's cell therapy, deramiocel, ahead of a key advisory committee meeting.
- Wed13May
Actual outcome: Bear · $29.03 at outcome
While Capricor met Q1 EPS estimates of -$0.62 and confirmed its August PDUFA date for Deramiocel, the stock fell below the bear floor due to a major legal dispute with its distribution partner, NS Pharma. The lawsuit forced Capricor to prepare to commercialize the therapy independently, raising significant concerns about an unexpected operating expense ramp and commercial execution risks ahead of the launch.
- Tue12May
Actual outcome: Bull · $29.80 at outcome
Capricor reported in-line EPS of -$0.59 and delivered a highly positive corporate update, confirming that its HOPE-3 Phase 3 trial for deramiocel met all primary and secondary endpoints. The company also noted that the therapy remains under active FDA review with an August 2026 PDUFA date and that labeling discussions are expected to commence soon. These strong clinical and regulatory milestones, alongside a fully operational GMP manufacturing facility to support solo commercialization, kept the stock trading well above the $26.00 bull target.
- Tue17Mar
Actual outcome: Bull · $30.85 at outcome
Capricor reported a Q4 loss of $0.62 per share, but this was completely overshadowed by major regulatory and clinical breakthroughs. The FDA lifted its Complete Response Letter for Deramiocel and set a new PDUFA date of August 22, 2026, without requiring new studies, while late-breaking Phase 3 HOPE-3 data demonstrated significant functional benefits for Duchenne muscular dystrophy. This crucial regulatory clarity and strong clinical data provided a clear path to commercialization, driving the stock well above the bull target.
