Calithera Biosciences Inc. (NASDAQ: CALA) shares made a decent gain early on Wednesday after the company announced that it had been granted a Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designation is for CB-839 in combination with everolimus, for the treatment of patients with metastatic renal cell carcinoma who have received two or more prior lines of therapy.
For some quick background: CB-839 is a first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in Phase 1/2 clinical trials for the treatment of solid tumors, including renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer and melanoma.
This designation will help 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 need. Not to mention, it will facilitate more frequent interations between Calithera and the FDA for a quicker approval process.
Excluding Wednesday’s move, Calithera had vastly outperformed the broad markets, with the stock up over 370% year to date. Over the past year the stock is only up about 160%.
Susan Molineaux, PhD, president and CEO of Calithera, commented:
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 Calithera traded at $16.06, up 4.3%, early Wednesday, with a consensus analyst price target of $16.60 and a 52-week range of $2.20 to $17.40.