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 NASDAQ, hearings 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.