FDA Says No To Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) Cancer Drug


Dallas, Texas 07/27/2015 (Financialstrend) – Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) was dealt a major blow after the FDA decided against approving its blood cancer drug Qinprezo.  The stock as a result closed on the red having shed more than 70% in market value with its status being lowered to a speculative company.  The drug is designed to treat acute myeloid in patients who have not responded to previous cancer treatment.

Late Stage Test Results Concerns

 The FDA decided against granting the drug the much needed approval citing a lack of solid clinical results to support the drug.  Qinprezo failed to meet its main goal in a late-stage study seen as one of the reasons why the approval was denied. Patients using the drug failed to live longer than patients using cytarabine and a placebo according to filings.

The company has already announced it will forge forward with plans to convince European regulators to approve the drug despite being turned down back at home.  Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) says it is encouraged by European regulators asking it to seek marketing approval for Qinprezo for patients above 60 years as they need the treatment the most.

However, if the drug is approved for elderly patients alone, it will still be a major blow for Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) as its use would be limited because of age barrier translating to reduced returns.

 Class Action Lawsuit

Separately a number of law firms have started investigations on whether Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) mislead shareholders who bought the stock between March 12, 2015, and June 23, 2015. The investigations centers around the FDA stating it will not support the filing of the new drug Qinprezo based on the data collected during the Phase 3 trials.

 The stock is currently trading below the $1 mark as its sentiments on the Street change from bad to worse on the remarks by the FDA.