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CYTX

Cytori Therapeutics

$0.49

-0.0108 (-2.18%)

09:32
09/17/18
09/17
09:32
09/17/18
09:32

Cytori Therapeutics receives FDA orphan drug designation for ATI-1123

Cytori Therapeutics announced that it received FDA orphan drug designation for its ATI-1123 chemotherapy drug product candidate, an albumin-stabilized pegylated liposomal docetaxel, for the treatment of small cell lung cancer. Small cell lung cancer, or SCLC, which accounts for approximately 15% of bronchogenic carcinomas with 33,375 new cases and 23,380 deaths estimated for 2017, has been identified by Cytori as a compelling target for ATI-1123. While SCLC is responsive to chemotherapy and radiation therapy, cure occurs only in 20% of patients, generally restricted to those with limited stage disease. The remaining 80% of patients, including all patients with extensive disease, relapse within months of completing their initial therapy. Availability of 2nd line therapy options are limited, toxic, and provide little benefit in terms of extending survival. Topotecan is the only FDA-approved agent for 2nd line treatment of SCLC and is associated with an overall response rate of 24%, median response duration or time to progression of 14 weeks, and median overall survival of 25 weeks. Treatment usually involves a consecutive 5 day regimen of either IV or oral administration of drug, both which have black box warnings for severe myelosuppression as their use is associated with substantial morbidity including bone marrow suppression leading to neutropenia, thrombocytopenia and anemia requiring interventions of transfusion and growth factor support. Cytori's ATI-1123 has been designed to fill this need. ATI-1123's combination of improved liposome stability, reduced toxicity, and superior delivery are expected to provide a therapeutic for SCLC that offers comparable or better efficacy to currently-available standards while having a less intensive administration routine and improved side effect profile. Cytori is also exploring the development of ATI-1123 to address the shortcomings of docetaxel, a workhorse chemotherapy drug which generated $2.7B in worldwide sales at its peak. Compared to docetaxel, ATI-1123 may have potential to improve safety by removing the need for unwanted solvents, reduce morbidity by eliminating the requirement for standard pretreatment medications, provide better patient convenience and comfort via less time spent in the treatment center, decrease the cost of therapy, and enhance systemic docetaxel exposure.

CYTX Cytori Therapeutics
$0.49

-0.0108 (-2.18%)

08/15/18
MAXM
08/15/18
DOWNGRADE
MAXM
Hold
Cytori Therapeutics downgraded to Hold at Maxim on capital concerns
As reported earlier, Maxim analyst Jason McCarthy downgraded Cytori Therapeutics to Hold from Buy. The analyst notes that while his positive fundamental views around the company's liposomal doxorubicin and cell therapy programs are unchanged, the capital constraints are an increasing concern. McCarthy adds that Cytory's cash position of about $8M only give it the operating runway into the first quarter of 2019, and the company also has about $14M in debt that needs to be refinanced before initial payments deadline of September 1st.
08/15/18
HCWC
08/15/18
NO CHANGE
Target $5
HCWC
Buy
Cytori Therapeutics price target lowered to $5.00 from $6.00 at H.C. Wainwright
H.C. Wainwright analyst Jason Kolbert lowered his price target on Cytori Therapeutics to $5.00 from $6.00 to account for a recent fundraising, noting that he thinks Cytori may need to raise capital again soon if the company is not able to monetize ATI-0918. However, he noted Cytori highlighted expected data from clinical trials in scleroderma and urinary incontinence and Kolbert believes good data from those trial could set the stage to file for scleroderma in Europe and UI in Japan. He keeps a Buy rating on Cytori shares.
08/15/18
MAXM
08/15/18
DOWNGRADE
MAXM
Hold
Cytori Therapeutics downgraded to Hold from Buy at Maxim
03/09/18
RILY
03/09/18
UPGRADE
Target $0.7
RILY
Buy
Cytori Therapeutics upgraded to Buy from Neutral at B. Riley FBR
B. Riley FBR analyst Andrew D'Silva upgraded Cytori Therapeutics to Buy and raised his price target for the shares to 70c from 50c. The company's pipeline has "too many shots on goal to ignore," D'Silva tells investors in a research note.

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