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Cowen Reiterates Upbeat View Of Celldex Therapeutics As It Wins FDA ‘Breakthrough’ Status


Celldex Therapeutics, Inc. (NASDAQ:CLDX) shares are up 17.5% today following the news that the company’s investigational product rindopepimut (Rintega) has received “breakthrough therapy designation” from the FDA for the treatment of adult patients with EGFRvIII-positive glioblastoma (GBM).

In reaction, Cowen & Co. analyst Boris Peaker came out with a research note, reiterating an Outperform rating and a price target of $26 on the stock, which represents a potential upside of 11% from where the stock is currently trading.

Peaker observed, “This designation now gives CLDX more intensive FDA guidance on the development of rindo, which we believe will become important as CLDX decides whether to file for accelerated approval based on ReACT. Moreover, rindo will now receive expedited review and can file on a rolling basis. All of this further strengthens rindo’s position as the ReACT data matures and CLDX considers filing in 2015.”

Furthermore, “We continue to believe that rindo has a very good chance of approval on the ReACT data. For reference, in 2009 Avastin was approved in 2nd-line GBM based on two open-label studies that demonstrated durable ORRs, but no PFS or OS benefit. In our view the rindo dataset will likely be much stronger, with blinded randomized data, OS, PFS, and a diagnostic biomarker.”

According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Boris Peaker has a total average return of 36.3% and a 66.3% success rate. Peaker has a 11.2% average return when recommending CLDX, and is ranked #27 out of 3480 analysts.