The FDA Strikes Again at Calithera Biosciences

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The U.S. Food and Drug Administration (FDA) has been busy this week, especially Wednesday, issuing multiple approvals to the likes of Rigel Pharmaceuticals and Teligent. Now Calithera Biosciences Inc. (NASDAQ: CALA) is joining the ranks, but in this case the firm is receiving a Fast Track designation for its kidney cancer treatment.

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics to treat serious or life threatening conditions and to fill an unmet medical needs.

Specifically, the FDA granted Fast Track designation to CB-839 in combination with cabozantinib for the treatment of patients with metastatic renal cell carcinoma who have received one or two prior lines of therapy, including at least one vascular endothelial growth factor tyrosine kinase inhibitor or the combination of nivolumab and ipilimumab.

CB-839 is being evaluated in the CANTATA trial, which is a randomized double-blind clinical study of cabozantinib in combination with CB-839 or placebo in 298 patients with clear cell renal cell carcinoma.  The primary endpoint is progression free survival and the global study is open for enrollment.

Susan Molineaux, Ph.D., president and CEO of Calithera, added:

Despite a number of new therapies for the treatment of renal cell carcinoma, there remains a significant unmet need among advanced patients who have received prior treatment. 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 advanced or metastatic renal cell carcinoma who have failed prior systemic therapy.

Excluding Wednesday’s move, Calithera had underperformed the broad markets with its stock down 42.5% in the past year. In just 2018 alone, the stock was down 24%.

Shares of Calithera were last seen up about 4% at $6.59, with a consensus analyst price target of $14.25 and a 52-week range of $5.35 to $20.05.

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