CytRx Corporation (NASDAQ: CYTR) is having an incredibly strong morning in the pre-market this morning, and for good reason. The company announced that it has reached a key agreement with the United States Food and Drug Administration. As a result, investor excitement ensued, and the stock is up. Of course, our partners at Trade Ideas were the first to inform us of the gains. At the moment (8:36), CYTR is trading at $0.51 per share after a gain of $0.07 per share (15.91%) thus far today.
CYTR Reaches Agreement With FDA
As mentioned above, CytRx is having a strong morning in the market this morning after announcing that it has reached an agreement with the United States Food and Drug Administration. The agreement surrounds the company's preparations for a New Drug Application submission. Under the agreement, the company now has a pathway toward approval for aldoxorubicin as a treatment for soft tissue sarcomas. In a statement, Daniel Levitt, MD, PhD, CEO and CMO at CYTR, had the following to offer:
“We are very pleased to have achieved clarity from the FDA regarding CytRx's soft tissue sarcoma program... The FDA agreed that CytRx could use the application pathway for its filing that has been successfully used previously by the oncology drugs Abraxane(R), Doxil(R), and Onivyde(R). 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.”
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What We'll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping an incredibly close eye on CYTR. In particular, we'll be watching for any news associated with aldoxorubicin. Considering the pathway toward approval, we're likely to see quite a bit. We'll continue to follow the story closely and bring the news to you as it breaks!
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