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CytRx Gets Clarity from FDA for Aldoxorubicin NDA, Shares Up

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CytRx Corporation (CYTR - Free Report) announced that the it has reached an agreement with the regarding the path to filing for its new drug application (NDA) for its lead candidate aldoxorubicin  being developed for the treatment of soft tissue sarcomas (STS).

Shares of the company were up more than 18% on Wednesday on the news. CytRx’s share price shows that the company has outperformed the Zacks classified industry year to date. The stock is up 39.7% compared with the Medical - Biomedical and Genetics industry’s gain of 1.9%.

In November 2016, the company announced updated results from the phase III study of aldoxorubicin which showed a statistically significant improvement in progression-free survival between aldoxorubicin and investigator's choice therapy in 246 patients with either leiomyosarcoma or liposarcoma. The hazard ratio (HR) was 0.62, representing a 38% reduction in the risk of tumor progression for patients receiving aldoxorubicin versus investigator's choice. Based on these results, the company requested the FDA for a Type B pre-NDA meeting.

At the latest meeting, 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.

Moving ahead, CytRx plans to submit a rolling NDA under section 505(b)(2) to the FDA for the candidate in the last quarter of this year. In addition, it anticipates providing the study reports and analysis that can lead to the approval of aldoxorubicin. CytRx expects to commercially launch aldoxorubicin in the U.S. in 2018.  

Also, the company looks forward to discuss with the European Medicines Agency (EMA) about a path to file a marketing application in EU.  

In fact, aldoxorubicin has received Orphan Drug Designation by the FDA for the treatment of STS.  Currently, it is being developed for several other indications including the second-line treatment of small cell lung cancer (phase IIb). The company has completed phase II studies of aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and HIV-related Kaposi's Sarcoma.

Moreover, it is being evaluated in a phase Ib study in combination with gemcitabine in patients with metastatic solid tumors, a phase Ib study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a phase Ib pharmacokinetics clinical trial of aldoxorubicin in patients with metastatic solid tumors.

However, in October last year, another pharmaceutical giant- Eli Lilly and Company (LLY - Free Report) announced that the FDA has granted accelerated approval to its pipeline candidate Lartruvo (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adult patients with advanced soft tissue sarcoma (STS), not amenable to curative treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin. This was the first FDA-approved front-line therapy to win the regulatory nod for STS in four decades. It was also first monoclonal antibody to be approved for STS.

Zacks Rank & Stocks to Consider

CytRx currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector are Heska Corporation (HSKA - Free Report) and Galena Biopharma, Inc. sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 60 days. The company posted positive surprises in three of the four trailing quarters with an average beat of 291.54%. Its share price increased 43.7% year to date.

Galena’s loss per share estimates narrowed from $2.27 to 58 cents for 2017 and from 92 cents to 73 cents for 2018, over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 53.83%.

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