FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Cellectis’s investigational cell therapy.
- RMAT status, granted based on the company’s early-stage trial data, provides early and frequent FDA interaction and potential priority review.
- The designation, however, does not guarantee approval.
- Late last month, Barclays initiated coverage of Cellectis with an ‘Overweight’ rating and $9 price target, which represents a potential upside of about 201% from Tuesday’s close.
Shares of Cellectis (CLLS) surged more than 24% in after-hours trading on Tuesday, after the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational cell therapy.
The FDA granted the designation to lasmecabtagene timgedleucel, the company’s off-the-shelf CAR-T therapy for relapsed/refractory B-cell acute lymphoblastic leukemia.
Perks Of The Designation
RMAT status, granted based on the company’s early-stage trial data, provides early and frequent FDA interaction, potential priority review, and accelerated approval pathways for therapies addressing serious unmet needs. The designation, however, does not guarantee approval.
“The granting of RMAT designation reflects the FDA’s recognition of lasme-cel’s potential,” the company said. CEO André Choulika added that the designation “strengthens our dialogue with the FDA” as the company has begun enrolling patients for its mid-stage trial.
Cellectis views lasme-cel as a ready-to-use option for heavily pretreated patients who cannot wait for autologous therapies. While autologous therapies use a patient’s own cells, making them highly personalized with a low risk of immune rejection, allogeneic therapies like lasme-cel use healthy donor cells, allowing for immediate availability.
How Did CLLS Retail Traders React?
On Stocktwits, retail sentiment around CLLS stock stayed within the ‘neutral’ territory over the past 24 hours, while message volume remained at ‘normal’ levels.
Late last month, Barclays initiated coverage of Cellectis with an ‘Overweight’ rating and $9 price target, which represents a potential upside of about 201% from Tuesday’s close. Barclays then said that Cellectis' allogeneic platform allows for potentially quicker reaction time from diagnosis to treatment than autologous CAR-T therapies, opening up treatment settings that were previously inaccessible.
CLLS stock has fallen 38% this year.
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