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Cytori's Chemotherapy Candidate Gets Orphan Drug Status

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Cytori's Chemotherapy Candidate Gets Orphan Drug Status

Cytori Therapeutics' (CYTX) chemotherapy candidate, ATI-1123, gets orphan drug status from the FDA for small cell lung cancer.

Cytori Therapeutics CYTX announced that the FDA has granted Orphan Drug designation to its chemotherapy candidate, ATI-1123, for the treatment of small cell lung cancer (“SCLC”).

We note that orphan drug designation is granted to drugs capable of treating diseases that affect less than 200,000 people in the United States. The status makes ATI-1123 eligible for seven years of marketing exclusivity in the United States, following an approval for SCLC. The designation also makes the company eligible for certain other benefits, including tax credits related to clinical trial expenses, exemption from the FDA-user fee and assistance from the FDA in clinical trial design.

Cytori’s share price has decreased 85.7% so far this year, significantly underperforming the industry’s decline of 4.6% in the same time frame.

Pipeline candidate, ATI-1123, has successfully completed a phase I study demonstrating clinical benefit in patients. The company is planning to advance the candidate in a phase II study. ATI-1123 is a liposomal formulation of docetaxel. Data has shown potential of the candidate in improving safety concern of docetaxel.

There has not been any major progress in SCLC disease treatment in the past three decades. There is significant unmet need for treatment options with better safety profile for patients who are intolerant to adverse effects of first-line chemo-radiotherapy or topotecan treatment in relapsed/refractory patients. In August. The FDA approved Bristol-Myers’ BMY Opdivo as a treatment of SCLC in second-line setting.

Per the press release, chemo-radiotherapy only cures 20% of SCLC patients and topotecan is the most used FDA-approved treatment in second-line setting in the remaining 80% of patients. Successful development of ATI-1123 will be a boost for Cytori, which has no marketed products. However, a potential approval is years away.

Cytori Therapeutics Inc Price


Cytori Therapeutics Inc Price | Cytori Therapeutics Inc Quote

Zacks Rank & Key Picks

Cytori currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks from the pharma space are Illumina, Inc. ILMN and Ligand Pharmaceuticals LGND. Both the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Illumina’s earnings per share estimates have increased from $5.41 to $5.46 for 2018 and from $6.10 to $6.14 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 25.23%. The stock has rallied 58.9% so far this year.

Ligand’s earnings per share estimates have moved up from $5.64 to $6.33 for 2018 and from $5.59 to $5.74 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 59.54%. The stock has rallied 85.3% so far this year.

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