Today, shareholders of CytRx Corporation (NASDAQ:CYTR) woke up to a nice pop in the value of their shares, after the drug maker announced that the FDA has reached an agreement with CytRx on preparations for a New Drug Application (NDA) submission for aldoxorubicin in soft tissue sarcomas (STS).
“We are very pleased to have achieved clarity from the FDA regarding CytRx’s soft tissue sarcoma program,” said Daniel Levitt, MD, PhD, Chief Operating Officer and Chief Medical Officer. “The FDA agreed that CytRx could use the application pathway for its filing that has been successfully used previously by the oncology drugs Abraxane®, Doxil® and Onivyde®. Our interaction with the FDA was part of a continued collaborative and productive relationship with the Agency. We look forward to providing the study reports and analysis that can lead to the approval of aldoxorubicin for the treatment of patients with soft tissue sarcomas.”
The Company’s goal is to submit a rolling NDA under section 505(b)(2) to the FDA for soft tissue sarcomas in the last quarter of 2017. CytRx also plans to discuss with the European Medicines Agency (EMA) a path to filing a Marketing Authorization Application (MAA). The commercial launch of aldoxorubicin is still projected for 2018 in the United States. Aldoxorubicin has received Orphan Drug Designation by the FDA for the treatment of STS. Orphan designation provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan Medicinal Product Designation for STS which confers ten years of market exclusivity among other benefits.
The proposed product label would include the treatment of soft tissue sarcomas. New data could allow future use of aldoxorubicin in neoadjuvant (pre-surgery) settings, as well as a replacement for doxorubicin in combinations. CytRx is also working on a market expansion strategy which could include other indications for aldoxorubicin including combinations with other chemotherapeutics and immunotherapies.
CytRx is under confidentiality agreements with a number of companies for a commercial partnership for the marketing of aldoxorubicin. The Company believes those active discussions may be further advanced by this latest news.
Shares of Cytrx are rising nearly 11% to $0.49 in early trading Wednesday. CYTR has a 1-year high of $3.66 and a 1-year low of $0.36. The stock’s 50-day moving average is $0.43 and its 200-day moving average is $0.45.
On the ratings front, H.C. Wainwright analyst Andrew Fein reiterated a Buy rating on CYTR, with a price target of $4.00, in a report issued on January 20. The current price target represents a potential upside of 809% from where the stock is currently trading. According to TipRanks.com, Fein has a yearly average return of 8.1%, a 49% success rate, and is ranked #559 out of 4557 analysts.
CytRx Corp. operates as a biopharmaceutical research and development company specializing in oncology. It provides clinical development of aldoxorubicin oncology pipeline for the treatment of cancer.