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Celgene Shares Gain after FDA Approval for POMALYST® (CELG)

Shares of Celgene Corporation (NASDAQ: CELG), a global biopharmaceutical company engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases, have edged higher in pre-market trading today after the company’s POMALYST® was approved by the U.S. Food and Drug Administration (FDA).

POMALYST has been approved for treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have shown disease progression on or within 60 days of completion of the last therapy.

CELG shares are also gaining today after the company provided a regulatory update for REVLIMID®. The company said that REVLIMID received full approval from the China State Food and Drug Administration (SFDA) for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. The approval includes an Import Drug License (IDL).

The company also announced that its application for REVLIMID in patients with relapsed or refractory mantle cell lymphoma (MCL) after prior therapy that included bortezomib has been accepted by the U.S. FDA. The agency is expected to take a decision on REVLIMID on June 5, 2013.

Following these positive developments, CELG shares have edged higher in pre-market trading today. At last check, the stock was trading 1.62% higher at $101.75.

CELG shares have had an excellent run so far this year, gaining more than 27%.