MHRA Authorizes Deciphera’s QINLOCK in the U.K.

Deciphera Pharmaceuticals (NASDAQ: DCPH) has received marketing authorization for QINLOCK (ripretinib) in the U.K. from the Medicines and Healthcare products Regulatory Agency (MHRA). Following the news, shares of the commercial-stage biopharmaceutical company rose 5.1% on Tuesday to close at $10.32.

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QINLOCK, a switch-control tyrosine kinase inhibitor, is designed to treat adult patients with advanced gastrointestinal stromal tumors (GIST). These patients include individuals who have received prior treatment with three or more kinase inhibitors, including imatinib.

Supporting Data

The regulator’s decision followed the efficacy results from the primary analysis of the pivotal Phase 3 INVICTUS study in patients with advanced GIST and the combined safety results from INVICTUS and the Phase 1 study of QINLOCK.

Notably, in the Phase 3 INVICTUS study, QINLOCK demonstrated a significant reduction in the risk of disease progression or death by 85% and reflected clinically meaningful overall survival.

Official Comments

Deciphera CEO Steve Hoerter commented, “The approval of QINLOCK in the UK is an important milestone for patients with advanced GIST who have been waiting for a new treatment option. The results from the INVICTUS study underscore the potential for QINLOCK to transform the treatment of advanced GIST and establish a new standard of care in the UK for fourth-line GIST.”

Wall Street’s Take

Recently, JMP Securities analyst Reni Benjamin maintained a Hold rating on the stock.

Overall, the stock has a Hold consensus rating based on 2 Buys, 8 Holds, and 1 Sell. The average Deciphera price target of $12.25 implies 18.7% upside potential from current levels. Shares have lost 83.1% over the past year.

Risk Analysis

According to the new TipRanks Risk Factors tool, Deciphera stock is at risk mainly from three factors: Tech and Innovation, Finance and Corporate, and Legal and Regulatory, which contribute 32%, 28%, and 18%, respectively to the total 78 risks identified for the stock.