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Deciphera (DCPH) Gets Breakthrough Tag for Qinlock Expanded Use
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Deciphera Pharmaceuticals (DCPH - Free Report) announced that the FDA has granted Breakthrough Therapy Designation for its drug Qinlock for treating second-line gastrointestinal stromal tumor (GIST) patients with mutations in KIT Exon 11 and 17/18. Qinlock was first approved on May 15, 2020 for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including Novartis’ Gleevec (imatinib). Qinlock is approved in 12 countries across the world, including the major markets of the United States, Europe, the United Kingdom and China, for treating fourth-line GIST.
Deciphera’s stock was up 4.7% on Tuesday in response to the positive news. In the past year, the shares of the company have gained 103.3% against the industry’s decline of 13.2%.
Image Source: Zacks Investment Research
The breakthrough therapy designation by the FDA shows Qinlock’s substantial potential to treat second-line GIST patients with mutations in KIT exon 11 and 17/18. The breakthrough therapy designation is based on data from the ctDNA analysis of the INTRIGUE phase III study, which demonstrated Qinlock’s clinical benefit for the abovementioned patient population. Management claims that Qinlock could become the standard of care for second-line GIST patients globally subject to its approval.
Based on the results from the ctDNA analysis of phase III INTRIGUE study data, the company is also planning to initiate the pivotal phase III INSIGHT study to evaluate Qinlock versus sunitinib for the treatment of second-line GIST patients with mutations in KIT exon 11 and 17/18, later in 2023.
In this context, we would like to remind investors that in November 2021, Deciphera announced top-line data from the phase III INTRIGUE study, which failed to meet its primary endpoint of improved progression-free survival (PFS). In the intention-to-treat population comprising 453 patients, Qinlock demonstrated a median PFS of 8.0 months compared with 8.3 months for the patients treated with sunitinib which was not statistically significant.
In the same press release, the company also announced that its sole marketed product Qinlock (ripretinib) has been included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred treatment therapy for second-line GIST patients intolerant to sunitinib.
The inclusion of Qinlock to NCCN guideline was based on the primary analysis of the phase III INTRIGUE study, anopen-label study to evaluate the efficacy and safety of QINLOCK compared with sunitinib in patients with GIST previously treated with imatinib. Per management, the inclusion of Qinlock, as a preferred treatment therapy for second-line GIST, in the latest NCCN clinical practice guidelines in oncology, contributes to the unmet medical need for additional treatment options for GIST patients in the post-imatinib setting. This inclusion also supports the results from the company’s phase III INTRIGUE study, where Qinlock was established as an active and well-tolerated agent.
It is to be noted that there is substantial competition in the market for the treatment of GIST. Deciphera faces stiff competition from other players in this field, one of them being, Blueprint Medicines (BPMC - Free Report) . In January 2020, Blueprint Medicines received FDA approval for Ayvakit as a treatment for unresectable or metastatic GIST, harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations in adults. In September 2020, the European Commission granted conditional marketing authorization to Ayvakyt as a monotherapy for the treatment of adults with unresectable or metastatic GIST, harboring the PDGFRA D842V mutation. However, Blueprint received a complete response letter from the FDA for its new drug application which sought approval for Ayvakit to treat adult patients with unresectable or metastatic fourth-line GIST. In April 2020, Blueprint’s phase III VOYAGER study, evaluating the safety and efficacy of Ayvakit compared with Stivarga (regorafenib) in patients with third- and fourth-line GIST, did not meet the primary endpoint. Following this, the company discontinued further development of Ayvakit for GIST beyond PDGFRA exon 18 mutant GIST.
Deciphera Pharmaceuticals, Inc. Price and Consensus
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Deciphera (DCPH) Gets Breakthrough Tag for Qinlock Expanded Use
Deciphera Pharmaceuticals (DCPH - Free Report) announced that the FDA has granted Breakthrough Therapy Designation for its drug Qinlock for treating second-line gastrointestinal stromal tumor (GIST) patients with mutations in KIT Exon 11 and 17/18. Qinlock was first approved on May 15, 2020 for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including Novartis’ Gleevec (imatinib). Qinlock is approved in 12 countries across the world, including the major markets of the United States, Europe, the United Kingdom and China, for treating fourth-line GIST.
Deciphera’s stock was up 4.7% on Tuesday in response to the positive news. In the past year, the shares of the company have gained 103.3% against the industry’s decline of 13.2%.
Image Source: Zacks Investment Research
The breakthrough therapy designation by the FDA shows Qinlock’s substantial potential to treat second-line GIST patients with mutations in KIT exon 11 and 17/18. The breakthrough therapy designation is based on data from the ctDNA analysis of the INTRIGUE phase III study, which demonstrated Qinlock’s clinical benefit for the abovementioned patient population. Management claims that Qinlock could become the standard of care for second-line GIST patients globally subject to its approval.
Based on the results from the ctDNA analysis of phase III INTRIGUE study data, the company is also planning to initiate the pivotal phase III INSIGHT study to evaluate Qinlock versus sunitinib for the treatment of second-line GIST patients with mutations in KIT exon 11 and 17/18, later in 2023.
In this context, we would like to remind investors that in November 2021, Deciphera announced top-line data from the phase III INTRIGUE study, which failed to meet its primary endpoint of improved progression-free survival (PFS). In the intention-to-treat population comprising 453 patients, Qinlock demonstrated a median PFS of 8.0 months compared with 8.3 months for the patients treated with sunitinib which was not statistically significant.
In the same press release, the company also announced that its sole marketed product Qinlock (ripretinib) has been included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred treatment therapy for second-line GIST patients intolerant to sunitinib.
The inclusion of Qinlock to NCCN guideline was based on the primary analysis of the phase III INTRIGUE study, anopen-label study to evaluate the efficacy and safety of QINLOCK compared with sunitinib in patients with GIST previously treated with imatinib. Per management, the inclusion of Qinlock, as a preferred treatment therapy for second-line GIST, in the latest NCCN clinical practice guidelines in oncology, contributes to the unmet medical need for additional treatment options for GIST patients in the post-imatinib setting. This inclusion also supports the results from the company’s phase III INTRIGUE study, where Qinlock was established as an active and well-tolerated agent.
It is to be noted that there is substantial competition in the market for the treatment of GIST. Deciphera faces stiff competition from other players in this field, one of them being, Blueprint Medicines (BPMC - Free Report) . In January 2020, Blueprint Medicines received FDA approval for Ayvakit as a treatment for unresectable or metastatic GIST, harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations in adults. In September 2020, the European Commission granted conditional marketing authorization to Ayvakyt as a monotherapy for the treatment of adults with unresectable or metastatic GIST, harboring the PDGFRA D842V mutation. However, Blueprint received a complete response letter from the FDA for its new drug application which sought approval for Ayvakit to treat adult patients with unresectable or metastatic fourth-line GIST. In April 2020, Blueprint’s phase III VOYAGER study, evaluating the safety and efficacy of Ayvakit compared with Stivarga (regorafenib) in patients with third- and fourth-line GIST, did not meet the primary endpoint. Following this, the company discontinued further development of Ayvakit for GIST beyond PDGFRA exon 18 mutant GIST.
Deciphera Pharmaceuticals, Inc. Price and Consensus
Deciphera Pharmaceuticals, Inc. price-consensus-chart | Deciphera Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Deciphera currently has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the same industry are Aptinyx and Annovis Bio (ANVS - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 56 cents. In the past year, the shares of Aptinyx have fallen by 95.4%.
APTX’s earnings witnessed an average earnings surprise of 9.53%, beating all four estimates in the trailing four reported quarters.
In the past 90 days, the consensus estimate for Annovis’ 2023 loss per share has widened from $2.94 to $3.87. In the past year, the shares of Annovis have increased by 22.7%.
ANVS incurred a narrower-than-expected loss per share in the last reported quarter, delivering an earnings surprise of 20.51%.