Momenta Pharmaceuticals, (MNTA) announced on Thursday that its novel oncology candidate, necuparanib (formerly M402), has received Orphan Drug Designation from the US Food and Drug Administration for the treatment of pancreatic cancer.
Shares in the biotechnology company lifted 1.03% in the pre-market to $12.73. This remains at the lower end of the company’s 52-week share price range, which has seen a high of $19.90 and a low of $9.85.
The US Food and Drug Administration’s Orphan Drug Designation program provides orphan status to drugs and biologics intended to treat, diagnose or prevent rare diseases or disorders, defined as affecting fewer than 200,000 people in the US.
Jim Roach MD, Chief Medical Officer of Momenta Pharmaceuticals, commented: “We are pleased to receive Orphan Drug Designation for necuparanib, which highlights the great need for new medications for patients suffering from pancreatic cancer”.
Momenta Pharmaceuticals Inc is a biotechnology company that analyzes, characterizes and designs complex pharmaceutical products. It has complex systems analysis platform to resolve the complexity of molecular structures and related biologic systems.
He added: “We are encouraged by the progress of the program to date, and in the next several months, we anticipate completing Part A of our ongoing Phase 1/2 study of necuparanib in combination with Abraxane® and gemcitabine. We look forward to sharing the results from Part A and advancing the product into the Phase 2 part of the study in the second half of 2014.”