Allos Therapeutics, Inc. (NASDAQ: ALTH) today received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation for the medicinal product Folotyn, intended for the treatment of peripheral T-cell lymphoma. The Company plans to submit a request for re-examination of the CHMP opinion within two weeks. CHMP made the following comments as to why such a decision was made.
“The CHMP was concerned that the main study was designed in a way that did not allow the Committee to assess the benefit of the medicine, particularly since Folotyn was not compared with any other treatment or placebo. Moreover, there was no clear improvement seen in the condition of the patients, as the study looked at the patients’ response to treatment but did not further allow the Committee to assess the effect on overall survival (how long the patients lived) or progression free survival (how long the patients lived without their disease getting worse). At this point in time, the CHMP was of the opinion that there was insufficient evidence to establish the benefits of Folotyn in the treatment of peripheral T-cell lymphoma. Therefore the Committee concluded that the medicine’s benefits did not outweigh its risks, and recommended that Folotyn be refused marketing authorisation.”
Novartis AG (ADR)(NYSE:NVS) today received a positive opinion from CHMP for the marketing authorisation for the medicinal product Signifor intended for the treatment of Cushing’s disease. However, in a separate decision, CHMP said it is reviewing Gilenya, used to treat adults with highly active multiple sclerosis (MS), following cases of death and serious cardiovascular events in patients who had recently started treatment with the medicine.
Insmed Incorporated (Nasdaq: INSM) announced today the FDA lifted the clinical hold on ARIKACE for non-tuberculous mycobacteria (NTM) lung disease. However the clinical hold remains for placed on ARIKACE in Cystic Fibrosis (CF) patients with Pseudomonas lung infections. INSM will still need to conduct a Phase 2 trial in adult patients with NTM before proceeding with the Phase 3 clinical trial that was initially halted last year. In addition the company will be required to conduct a 9-month dog inhalation toxicity study of ARIKACE, scheduled to commence next quarter.
Capstone Therapeutics (OTCQB:CAPS) announced today it has taken steps to preserve cash and move toward winding down operations.
Sequenom, Inc. (NASDAQ: SQNM) priced its offering of 13m shares of its common stock, offered at a price to the public at $4.15 per share with gross proceeds of $53.95 million with an option to sell a further 1.95m shares.
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) priced its offering of 9.65m shares of its common stock at a public offering price of $5.20 per share with an additional 1,447,500 shares to cover over-allotments.
Galena Biopharma, Inc. (Nasdaq:GALE) today said it had initiated its Phase 3 PRESENT trial under Special Protocol Assessment (SPA) for NeuVax in HER2 1+ and 2+ breast cancer patients.