What happened
Shares of DecipheraPharmaceuticals(NASDAQ: DCPH) had risen 13.4% for the week as of late Thursday afternoon, according to data provided by S&P Global Market Intelligence. The company, which focuses on oncology therapies, announced that the Food and Drug Administration (FDA) had given Deciphera's Qinlock a Breakthrough Therapy designation to treat second-line gastrointestinal stromal tumors (GIST) in patients with certain genetic mutations.
Qinlock was approved initially in 2020 to treat adults with advanced GIST who have received prior treatment with three or more kinase inhibitors. The company also announced that the drug is now listed in the National Comprehensive Cancer Network's guidelines as a preferred regimen for second-line GIST patients intolerant to sunitinib.
So what
Deciphera said it plans to begin, in the second half of this year, an Insight phase 3 study of Qinlock in comparison to sunitinib in second-line GIST patients with certain genetic mutations. It's important to note that in another phase 3 study with patients previously treated with imatinib, Qinlock did not stand out against sunitinib.
Now what
Qinlock is the company's only marketed therapy, so the chance to add another indication for the drug is a big deal. Since the drug's launch in 2020, it has boosted revenue from $40 million to $126 million in 2022.
The company's other lead therapy is Vimseltinib, which is in a phase 3 clinical study to treat patients with tenosynovial giant cell tumors (TGCT), which are non-malignant tumors of the joints. The company said if Vimseltinib is approved, there is the potential for $1 billion in annual sales between Qinlock and Vimseltinib.
The company closed 2022 with $125.5 million in sales, up from $96.1 million in 2021. But it is still losing money, including $178.9 million in 2022, or a per-share loss of $2.37.
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Jim Halley has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
