CORT FDA Approval. AMLN CTIC receive CHMP recommendations + CYTR GALE ALXA news

Feb 17, 2012 No Comments by

Corcept Therapeutics Incorporated (NASDAQ: CORT – The FDA said in a press release that it has approved Korlym to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. It noted that about 5,000 patients will be eligible for Korlym treatment.

CytRx Corporation (NASDAQ: CYTR) said that it received notification on February 15, 2012 that because it had not regained compliance with the $1.00 minimum bid price requirement for continued listing, it would be subject to delisting from The NASDAQ Capital Market on or before February 22, 2012, unless the it requests a hearing before a NASDAQ Hearings Panel. The company mentioned that it does intend to request a hearing which will stay any delisting action. It  intends to present a plan to push its bid price above $1 regain compliance. According to NASDAQhearings are typically scheduled 30 to 45 days from the company’s request.The Panel generally issues a written decision approximately 35 days after the hearing, but the company could receive a written decision sooner. 

Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC) announced today that Pixuvri (pixantrone dimaleate) has been granted a positive opinion for conditional approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The Committee recommended conditional approval, because the data supplied show that the medicine’s benefits outweigh its risks but noted that the data are not yet comprehensive, and that more information is needed on the benefits of the medicine in patients who have received rituximab in the past. It concluded that Pixuvri satisfies an unmet medical need, because there are no approved and standard treatments for this stage of the disease. Therefore, the benefits of making this medicine available on the market immediately, according to the committee, outweigh the risks inherent in the fact that additional data are required. The conditional approval will be renewed on a yearly basis until the obligation to provide additional data on rituximab-pretreated patients has been fulfilled. The company said that it will be able to provide the results of the additional study by mid-2015. A final approval decision by the EMA should occur within two to three months.

Galena Biopharm (NASDAQ: GALE) entered into a Controlled Equity Offering where it may sell from time to time up to $10m of common stock.
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) priced its public offering of 44m shares and warrants to purchase 44m shares of common stock at a price of $0.50 for both shares and warrants, with net proceeds of approximately $20.4m.
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that CHMP issued a positive opinion in the European Union (EU) for the expanded use of BYETTA for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents. Final approval by the EMA should occur within two to three months.


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Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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