Sign up today for an exclusive discount along with our 30-day GUARANTEE — Love us or leave, with your money back! Click here to become a part of our growing community and learn how to stop gambling with your investments. We will teach you to BE THE HOUSE — Not the Gambler!

Click here to see some testimonials from our members!

Deciphera Soars On Positive Readouts For Gastrointestinal Tumor Drug

Courtesy of Benzinga

Deciphera Soars On Positive Readouts For Gastrointestinal Tumor Drug

Shares of thinly traded small-cap biotech Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) are skyrocketing Tuesday morning following a couple of clinical readouts from the company.

What Happened

Deciphera released updated data from a Phase 1 study of ripretinib, which continued to support the pipeline asset’s potential across the broad range of KIT and PDGR-alpha mutations that occur in patients with second-line through fourth-line gastrointestinal stromal tumors.

The updated included additional six months of maturity from the company’s last Phase 1 data cut-off.

“In the updated data from the second-line cohort, we believe ripretinib has demonstrated encouraging clinical benefit based on the objective response rate, disease control rate and median progression free survival rates observed,” said Steve Hoerter, CEO of Deciphera.

Separately, the biotech announced positive top-line data from the INVICTUS pivotal Phase 3 study of ripretinib in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors.

The study achieved the primary endpoint of improved progression free survival as determined by blinded independent central radiologic review using modified Response Evaluation Criteria in Solid Tumors version 1:1.

However, the pipeline compound did not meet the key secondary endpoint, as statistical significance was not achieved, with the objective response rate of 9.4% compared to 0% for the placebo. The overall survival, another secondary point, came in at 15.1 months for ripretinib versus 6.6% for placebo. It was also found to be generally well tolerated.

Why It’s Important

There is an unmet need for therapies that can effectively control gastrointestinal stromal tumors who have failed currently approved treatment options, Deciphera said.

Deciphera expects to submit an NDA to the FDA in the first quarter of 2020 for the treatment of patients with advanced gastrointestinal stromal tumors who have receive prior treatment with Imatinib, Sunitinib and Regorafenib.

The company also said it will submit in its NDA INVICTUS data and also the supportive data from the ongoing Phase 1 clinical study, which includes updated data from patients at doses of over 100mg of ripretinib.

“These results strengthen our confidence in the INTRIGUE pivotal Phase 3 clinical study comparing ripretinib to sunitinib, the standard of care for patients receiving second-line treatment for GIST,” the company said of the updated Phase 1 data.

Deciphera shares were soaring 121% to $44.12 at time of publication.

Related Links:

The Week Ahead In Biotech: Vanda Awaits FDA Decision, BioVie Plans IPO

Axovant Analyst Turns Bullish Ahead Of Q4 Gene Therapy Data Readouts

Posted-In: Biotech News Small Cap Analysis FDA Top Stories Movers Trading Ideas General Best of Benzinga


Do you know someone who would benefit from this information? We can send your friend a strictly confidential, one-time email telling them about this information. Your privacy and your friend's privacy is your business... no spam! Click here and tell a friend!





You must be logged in to make a comment.
You can sign up for a membership or get a FREE Daily News membership or log in

Sign up today for an exclusive discount along with our 30-day GUARANTEE — Love us or leave, with your money back! Click here to become a part of our growing community and learn how to stop gambling with your investments. We will teach you to BE THE HOUSE — Not the Gambler!

Click here to see some testimonials from our members!