NEW YORK (TheStreet) -- Prima Biomed (PBMD) shares are up 23.36% to $1.47 in morning trading on Tuesday after the biotech company announced that it received positive advice from the European drug regulatory agency concerning the development of its lead metastatic breast cancer candidate IMP321.
The European Medicines Agency (EMA), which is responsible for approving drugs used in the European Union, endorsed the development of IMP321 after meeting with Prima Biomed and discussing its Phase IIb trials of the breast cancer treatment candidate.
The company said that based on the meeting that European regulatory approval of the treatment is very likely if the results Phase IIb studies reach their primary endpoint.
"The EMA's Scientific Advice represents a significant step forward in terms of IMP321 clinical development in Europe. We now have the opportunity to introduce active immunotherapy to metastatic breast cancer patients, a promising novel strategy that we believe has the potential to fulfil an unmet medical need," said Prima's Chief Scientific and Medical Officer, Professor Frédéric Triebel.