Today’s Research Reports on Stocks to Watch: Calithera Biosciences and Cerus Corporation


Calithera Biosciences scored a big win on Wednesday after the FDA granted it Fast Track Designation on its cancer treatment CB-839. Cerus Corporation shares also exploded as the company announced that a shortage of a product it relies on is now less severe than feared.

RDI Initiates Coverage on:

Calithera Biosciences, Inc.

Cerus Corporation

Calithera Biosciences, Inc. shares closed up 5.84% on Wednesday and even hit a new high of $17.70 during intra-day trading. The company had some huge news that had the Street roaring. Calithera has been granted a Fast Track Designation by the U.S. Food and Drug Administration (FDA) for CB-839 in combination with everolimus. According to the company’s website, CB-839 has the potential to be an important new therapeutic agent with a novel mechanism of action for the treatment of a broad range of cancers. The Fast Track Designation Approval was for the treatment of patients with metastatic renal cell carcinoma who have received two or more prior lines of therapy. CEO Susan Molineaux, PhD stated, "We are pleased that CB-839 has been granted Fast Track designation, demonstrating the FDA’s commitment to facilitate the development and expedite the review of our glutaminase inhibitor as an important new therapy for patients with relapsed renal cell carcinoma. We look forward to initiating a global randomized trial of CB-839 in combination with everolimus for the treatment of renal cell carcinoma in the second half of 2017." Shares of the company are up 401% year to date and over the last year have seen gains of around 222%.

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Cerus Corporation shares closed up 11.49% on Wednesday but climbed as much as 17.4% during intra-day trading. The big move came after the company announced that an expected supply disruption of its main product could be less severe than what the company previous expected. The fear started just weeks ago when Fresenius Kabi, a global healthcare company, announced that it was experiencing delays in gaining U.S. Food and Drug Administration approval for changes to a medical device that is used to make platelet additive solution (PAS). The delay had caused a shortage across the U.S. of PAS and Cerus was one of the companies to suffer as they rely on a steady supply of it. PAS is used along with one of two approved formulations that contain intercept platelets manufactured at its blood centers across the U.S. Apparently the FDA is now reviewing changes to Fresenius Kabi’s medical device via Changes Being Effected in 30 Days (CBE-30). This method allows sales of the medical device to continue while the application is being reviewed. Traders cheered as this was very optimistic news for Cerus.

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Our Actionable Research on Calithera Biosciences, Inc. (NASDAQ: CALA) and Cerus Corporation (NASDAQ: CERS) can be downloaded free of charge at Research Driven Investing.

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