To say it has been a volatile two months for CytRx Corp. (NASDAQ:CYTR) would be a great understatement. After printing a low of 42 cents on April 6, shares bolted ahead to a high of 98.9 cents on April 24, only to slip back to 41.5 cents on May 12 before spiking again, this time to 93.5 cents on May 30.
Six trading days later, CYTX stock hit 48 cents again.
The dramatic movement has been underscored by aldoxorubicin, an engineered cytotoxic which combines the widely used chemotherapeutic drug doxorubicin with a novel linker molecule that binds directly and specifically to the protein albumin. CytRx is developing aldoxorubicin for the treatment of soft tissue sarcomas under an FDA Orphan Drug Designation.
Pressures have come both ways on the stock, stoked upward by optimism over a new drug application seeking to get aldoxorubicin to market and beaten downward by criticisms of CytRx management and practices, as well as some high profile critiques of the therapy in general.
On Thursday, the bulls were back in control following the company releasing an update on the regulatory pathway for aldoxorubicin, saying that "current clinical and preclinical data can support approval" of the treatment. CytRx management also reminded the public that the FDA didn't request any additional clinical trials for aldoxorubicin during a recent meeting.
CytRx says it is going to submit a rolling NDA under section 505(b)(2), a regulatory strategy that allows a company to leverage clinical data of an approved drug that has the same active ingredient as the drug in the development. In the case of aldoxorubicin, that active drug is doxorubicin, a drug whose pharmacokinetic, safety and efficacy profiles are well documented as a drug approved in the U.S. 43 years ago.
Investors seem happy about the latest news, sending shares galloping ahead at the opening bell today. After closing Wednesday at 52.8 cents, shares were up 15.5% at 61 cents around 11 a.m. EDT.
