Monday, Piper Sandler reaffirmed its Overweight rating and $35.00 price target for Capricor Therapeutics (NASDAQ:CAPR). Highlighting the potential of Capricor's deramiocel in treating Duchenne muscular dystrophy (DMD) cardiomyopathy, the firm spotlighted the treatment in its recent BioInsights report.
Capricor is slated to present at Piper Sandler's 36th Annual Healthcare Conference and participate in a Muscle Disease panel in New York this week. The company's stock has shown remarkable momentum, with a 542% return over the past year and a market capitalization of $885 million, according to InvestingPro data.
The positive Phase II HOPE-2 data was a significant point of interest, demonstrating that deramiocel could slow the decline of left ventricular ejection fraction (LVEF) by 107% compared to placebo in DMD boys over a 12-month period, with a p-value of 0.002.
This promising result has set the stage for Capricor to potentially complete its rolling Biologics License Application (BLA) submission for deramiocel by the end of 2024, with the possibility of obtaining FDA approval for DMD cardiomyopathy in the following year. Analyst targets range from $25 to $77, reflecting varied expectations for the company's potential.
In addition to the clinical advancements, Capricor has recently broadened its distribution agreement with Nippon Shinyaku, now encompassing Europe. This expansion comes with a $17.5 million equity investment, a $20 million upfront payment upon the agreement's closure, potential sales milestones up to $715 million, and a double-digit percentage of revenue share. This deal is a strategic move to enhance Capricor's position in the global market.
Financially, Capricor appears to be in a robust position, with an estimated pro forma cash balance of approximately $186 million, which includes the upfront payment from Nippon Shinyaku. Piper Sandler's reiteration of the Overweight rating and price target reflects confidence in Capricor's financial health and the commercial prospects of deramiocel.
In other recent news, Capricor Therapeutics, a biotech firm, has made significant strides in the development of deramiocel, its primary product for Duchenne muscular dystrophy (DMD).
The European Medicines Agency (EMA) has granted Orphan Drug and Advanced Therapy Medicinal Product (ATMP) designations to deramiocel. These designations could expedite the development and potential market exclusivity in Europe for deramiocel. The firm has initiated a rolling Biologics License Application (BLA) with the FDA, aiming for full approval of deramiocel for DMD-cardiomyopathy by year-end.
Jones Trading has given Capricor a Buy rating, highlighting the potential of deramiocel. Capricor has also successfully raised funds, amassing a cash balance of approximately $165 million to support the upcoming commercial launch and manufacturing expansion. Despite reporting a net loss of approximately $12.6 million for the third quarter of 2024, the company's San Diego facility is ready for production, and plans for a new manufacturing site are in progress to meet anticipated demand.
Capricor has established a partnership with Nippon Shinyaku for the commercial distribution of deramiocel in the United States, European Union, and Japan. The company is also exploring opportunities to expand the treatment's use to Becker muscular dystrophy and advancing its StealthX exosome technology for future therapeutics.
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