Sorrento Therapeutics (NASDAQ: SRNE), a clinical-stage, antibody-centric biopharmaceutical company, received the go-ahead to commence the Phase 1 clinical trial for allogeneic anti-CD38 Dimeric Antigen Receptor (DAR)-T cell therapy. The U.S. Food and Drug Administration (FDA) has authorized Sorrento’s Investigational New Drug (IND) application for its proprietary DAR-T cell therapy for the treatment of relapsed or refractory multiple myeloma.
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Following the FDA approval, shares of Sorrento closed 1.6% higher on Monday.
Sorrento has designed DAR-T technology to provide a significant advancement to the timeliness and potency of myeloma treatments. The treatment targets patient populations who have already undergone multiple rounds of chemotherapy, and are suffering from persistent disease, the company said.
Driven by the regulatory approval for DAR-T Phase 1 trial, the company now plans to file additional IND applications.
In response to the FDA news, Sorrento CEO Henry Ji said, “This FDA clearance of our first allogeneic DAR-T cell therapy is a seminal event for our cutting-edge KOKI and DAR-T technologies. We foresee the first ‘Off-the-Shelf’ DAR-T trial will open the door to numerous other DAR-T cell therapies for other indications to follow.” (See Sorrento stock charts on TipRanks)
The stock has picked up a rating from one analyst in the past three months. H.C. Wainwright analyst Ram Selvaraju maintained a Buy rating and a price target of $30 (259.7% upside potential), last month.
Selvaraju’s bullish stance was based on the company’s “plethora of pipeline progressions.”
Investors should always be aware of the risks involved in any stock. According to the new TipRanks’ Risk Factors tool, the Sorrento stock is at risk mainly from three factors: Finance and Corporate, Tech and Innovation, and Legal and Regulatory, which contribute 28%, 27%, and 23%, respectively, to the total risk for the stock. Within the Finance and Corporate risk category, SRNE has 26 risks, details of which can be found on the TipRanks website.
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