Momenta (MNTA) More than Just Copaxone, Maxim Group Says
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Go back to Momenta (MNTA) More than Just Copaxone, Maxim Group Says
December 1, 2014 8:16 AM EST
Momenta Phama (NASDAQ: MNTA) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of necuparanib, the Company's novel oncology drug candidate, as a first-line treatment in combination with Abraxane® and gemcitabine in patients with metastatic pancreatic cancer. Momenta recently announced the successful completion of Part A of the Phase 1/2 study and has initiated the Part B (Phase 2 proof-of-concept) study.
The FDA's Fast Track Drug Development Program is a process designed to facilitate the... More
December 1, 2014 8:03 AM EST
Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) today announced the acceptance by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a Clinical Trial Application (CTA) to initiate a clinical trial for M923, a biosimilar version of Humira® (adalimumab), in its collaboration with Baxter International's biopharmaceutical business. Acceptance of the CTA triggers two milestones under the Baxter collaboration with an aggregate payment of $12 million. Momenta expects to receive the payment in December 2014.
"The European CTA acceptance for M923, our biosimilar version of... More
