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Cogent (COGT) Up on SUMMIT Study Update Post Positive FDA Meeting
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Cogent Biosciences, Inc. (COGT - Free Report) announced that it has reached alignment with the FDA on the use of patient-reported outcome measure of Mastocytosis Symptom Severity Daily Diary (MS2D2) in part 2 of the ongoing SUMMIT study.
SUMMIT is a randomized, global, multicenter, double-blind, placebo-controlled, multi-part phase II study for patients with nonadvanced systemic mastocytosis (Non-AdvSM). The study is designed to explore the safety and efficacy of COGT’s most advanced candidate, bezuclastinib, in patients with moderate to severe Non-AdvSM, which includes indolent systemic mastocytosis, smoldering systemic mastocytosis and bone marrow mastocytosis.
Bezuclastinib is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17.
The part I portion of the SUMMIT study completed enrollment in the third quarter of 2023. The part 2 portion of the study is a registration-directed study that is currently enrolling and expected to include 159 patients.
Cogent’s questionnaire, MS2D2, interrogates patients about their symptoms at baseline and measures the increase or decrease in those symptoms throughout the trial. A subset, including the 11 most frequent and severe symptoms, will form the basis of the total symptom score, which will be used to measure the primary endpoint of the SUMMIT part 2 study.
Shares of the company rose 4.2% on the positive meeting with the FDA.
Earlier in the month, COGT announced additional data from part 1 of its ongoing SUMMIT clinical trial evaluating bezuclastinib in patients with NonAdvSM.
Patients treated with 100 mg bezuclastinib showed substantial reduction in their most severe symptoms and mast cell reactions. Reductions were shown in all individual MS2D2 symptoms across domains, and objective reduction in skin lesions corresponded with symptomatic improvement.
Cogent remains on track to complete enrollment in part 2 of the SUMMIT study in the second quarter of 2025 and report top-line results by the end of 2025.
The company also remains on track to complete enrollment in the APEX study in patients with advanced systemic mastocytosis by the end of 2024 and report top-line results by mid-2025.
Enrollment is ongoing in the phase III registration-enabling PEAK study, which will include approximately 388 second-line, post-imatinib patients with gastrointestinal stromal tumors (GIST).
PEAK is designed to evaluate the safety, tolerability and efficacy of bezuclastinib, in combination with sunitinib, compared to sunitinib alone in patients with locally advanced, unresectable or metastatic GIST who have received prior treatment with imatinib.
Cogent expects enrollment in the PEAK study to be completed in the third quarter of 2024 due to rapid enrollment. Top-line results from the study are expected by the end of 2025.
Shares of the company have surged 43.7% year to date against the industry’s 5.9% decline.
Image Source: Zacks Investment Research
In addition to bezuclastinib, Cogent is developing a portfolio of novel targeted therapies to help patients fight serious, genetically driven diseases. The therapies will initially target mutations in FGFR2, ErbB2 and PI3Kα.
Cogent has selected its FGFR2 clinical candidate, CGT4859, for further development.
As of Mar 31, 2024, cash, cash equivalents and marketable securities were $435.7 million. Based on its current plans, COGT expects its existing cash, cash equivalents and marketable securities to be sufficient to fund its operating expenses and capital expenditure requirements into 2027 and through clinical readouts from ongoing SUMMIT, PEAK and APEX registration-directed trials.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73.
ALX Oncology’s earnings beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. ANVS beat on earnings in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has increased from 2 to 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.
Image: Bigstock
Cogent (COGT) Up on SUMMIT Study Update Post Positive FDA Meeting
Cogent Biosciences, Inc. (COGT - Free Report) announced that it has reached alignment with the FDA on the use of patient-reported outcome measure of Mastocytosis Symptom Severity Daily Diary (MS2D2) in part 2 of the ongoing SUMMIT study.
SUMMIT is a randomized, global, multicenter, double-blind, placebo-controlled, multi-part phase II study for patients with nonadvanced systemic mastocytosis (Non-AdvSM). The study is designed to explore the safety and efficacy of COGT’s most advanced candidate, bezuclastinib, in patients with moderate to severe Non-AdvSM, which includes indolent systemic mastocytosis, smoldering systemic mastocytosis and bone marrow mastocytosis.
Bezuclastinib is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17.
The part I portion of the SUMMIT study completed enrollment in the third quarter of 2023. The part 2 portion of the study is a registration-directed study that is currently enrolling and expected to include 159 patients.
Cogent’s questionnaire, MS2D2, interrogates patients about their symptoms at baseline and measures the increase or decrease in those symptoms throughout the trial. A subset, including the 11 most frequent and severe symptoms, will form the basis of the total symptom score, which will be used to measure the primary endpoint of the SUMMIT part 2 study.
Shares of the company rose 4.2% on the positive meeting with the FDA.
Earlier in the month, COGT announced additional data from part 1 of its ongoing SUMMIT clinical trial evaluating bezuclastinib in patients with NonAdvSM.
Patients treated with 100 mg bezuclastinib showed substantial reduction in their most severe symptoms and mast cell reactions. Reductions were shown in all individual MS2D2 symptoms across domains, and objective reduction in skin lesions corresponded with symptomatic improvement.
Cogent remains on track to complete enrollment in part 2 of the SUMMIT study in the second quarter of 2025 and report top-line results by the end of 2025.
The company also remains on track to complete enrollment in the APEX study in patients with advanced systemic mastocytosis by the end of 2024 and report top-line results by mid-2025.
Enrollment is ongoing in the phase III registration-enabling PEAK study, which will include approximately 388 second-line, post-imatinib patients with gastrointestinal stromal tumors (GIST).
PEAK is designed to evaluate the safety, tolerability and efficacy of bezuclastinib, in combination with sunitinib, compared to sunitinib alone in patients with locally advanced, unresectable or metastatic GIST who have received prior treatment with imatinib.
Cogent expects enrollment in the PEAK study to be completed in the third quarter of 2024 due to rapid enrollment. Top-line results from the study are expected by the end of 2025.
Shares of the company have surged 43.7% year to date against the industry’s 5.9% decline.
Image Source: Zacks Investment Research
In addition to bezuclastinib, Cogent is developing a portfolio of novel targeted therapies to help patients fight serious, genetically driven diseases. The therapies will initially target mutations in FGFR2, ErbB2 and PI3Kα.
Cogent has selected its FGFR2 clinical candidate, CGT4859, for further development.
As of Mar 31, 2024, cash, cash equivalents and marketable securities were $435.7 million. Based on its current plans, COGT expects its existing cash, cash equivalents and marketable securities to be sufficient to fund its operating expenses and capital expenditure requirements into 2027 and through clinical readouts from ongoing SUMMIT, PEAK and APEX registration-directed trials.
Zacks Rank & Stocks to Consider
COGT currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ALX Oncology Holdings (ALXO - Free Report) , Annovis Bio (ANVS - Free Report) and Compugen (CGEN - Free Report) , each 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 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73.
ALX Oncology’s earnings beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95.
ANVS beat on earnings in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has increased from 2 to 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.