Cytori Therapeutics CYTX Stock News

Cytori Therapeutics Inc (NASDAQ: CYTX) is gaining big in the market early on this morning, with gains of more than 30%. The gains come after the company provided a regulatory update with regard to ATI-1123. Here’s what’s happening:

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CYTX Flies ON ATI-1123 Regulatory Update

In a press release issued early this morning, Cytori Therapeutics provided an update with regard to the development of ATI-1123. In the release, the company said that the update was the result of feedback from the FDA.

ATI-1123 is based on the active pharmaceutical ingredient, docetaxel, which has been substantially redesigned and reformulated. It is expected that ATI-1123 will show strong efficacy in the treatment of several difficult-to-treat cancer types.

CYTX said that it reached out to the FDA about ATI-1123 for three reasons:

  1. To learn the suitability of the 505(b)(2) pathway  for approval of the proposed drug product.
  2. To get a view of the adequacy of the clinical, nonclinical and pharmaceutical quality information, alongside the proposed drug development program for the support of a potential new drug application.
  3. To address any concerns that the FDA may have surrounding other filing issues with regard to the product.

According to the release, the FDA feedback suggested that all appears to be in line with a positive regulatory approach with docetaxel injection as a potential acceptable drug. Also, the FDA agreed that the completed nonclinical studies are sufficient to support the initiation of a clinical trial.

The company said that the new clinical trial of ATI-1123 will assess the treatment as an option for patients with platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line therapy.

In a statement, Dr. Marc H. Hedrick, President and CEO at CYTX, had the following to offer:

Small cell lung cancer is an aggressive neuroendocrine malignancy characterized by high metastatic potential and poor relative outcomes.

Due to the propensity of small cell lung cancer to metastasize widely and early in the disease course, it is considered the most lethal lung cancer subtype and new therapies such as ATI-1123, are desperately needed for these patients.

This Is Overwhelmingly Positive News

Essentially, the news that was released today means that the company will be moving into a Phase 2 clinical study of the treatment relatively soon. This is overwhelmingly positive for Cytori and its investors as ATI-1123 represents a significant market opportunity.

In fact, if all goes well, the treatment may be approved as an option for non-small cell lung cancer. This is a massive indication with experts suggesting that the market could grow to be worth more than $7.9 billion annually by as soon as next year. Considering the sub $7 million market cap at CYTX, an entrance into this market and penetration of even a very small percentage of it could prove to be significant for the company and its investors.

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