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Curis (CRIS) Gets FDA Nod to Partly Resume Leukemia Study
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Curis, Inc. (CRIS - Free Report) announced that it has received a notification from the FDA, wherein the regulatory body allowed the company to resume enrollment of additional patients in the monotherapy phase of the TakeAim Leukemia study.
The open-label, dose-escalation phase I/II study is evaluating Curis’ IRAK4 kinase inhibitor, emavusertib (CA-4948), for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
The company is looking to enroll at least nine additional patients in the given study. Curis is working with clinical sites to resume enrollment of the additional patients. The company expects to release clinical data from the study in 2023.
The FDA reviewed additional data on emavusertib, including data related to the risk of rhabdomyolysis, before allowing Curis to resume enrollment of additional patients in the monotherapy arm of the phase Ia TakeAim Leukemia study.
However, the partial hold remains on the combination therapy phase and the expansion phase of the study. This partial hold will continue to stay until phase Ia of the study is completed and the regulatory body approves proceeding to the next phases of the study.
Shares of Curis were down 9.8% on Tuesday following the announcement of the news as investors were probably expecting a complete lifting of the hold. The stock, however, recovered in pre-market trading on Wednesday.
Curis’ stock has declined 78.8% this year compared with the industry’s decrease of 24.4%.
Image Source: Zacks Investment Research
Investors must note that in April 2022, the FDA placed a partial clinical hold on Curis’ phase I/II TakeAim leukemia study as well as the phase I/II TakeAim lymphoma study.
Earlier this month, the FDA lifted the partial clinical hold on Curis’ phase I/II TakeAim lymphoma study evaluating emavusertib in patients with B-cell malignancies.
The dose-escalating phase I/II study is evaluating emavusertib for treating patients with B-cell malignancies, both as a monotherapy and in combination with Johnson & Johnson (JNJ - Free Report) /AbbVie’s (ABBV - Free Report) BTK inhibitor, Imbruvica (ibrutinib), in patients with relapsed or refractory (R/R) hematologic malignancies, such as non-Hodgkin lymphomas (NHL).
Clinical data from this study is expected in 2023.
AbbVie markets Imbruvica in partnership with J&J. Imbruvica is currently approved for treating various hematologic cancers.
AbbVie and J&J are conducting several studies on Imbruvica to evaluate the drug alone or in combination in different patient segments. The drug has a multi-billion-dollar potential.
Curis currently has no marketed drugs in its portfolio. Therefore, the successful development of emavusertib, along with other pipeline candidates, remains in key focus for the company.
Achilles Therapeutics’ loss per share estimates narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
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Curis (CRIS) Gets FDA Nod to Partly Resume Leukemia Study
Curis, Inc. (CRIS - Free Report) announced that it has received a notification from the FDA, wherein the regulatory body allowed the company to resume enrollment of additional patients in the monotherapy phase of the TakeAim Leukemia study.
The open-label, dose-escalation phase I/II study is evaluating Curis’ IRAK4 kinase inhibitor, emavusertib (CA-4948), for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
The company is looking to enroll at least nine additional patients in the given study. Curis is working with clinical sites to resume enrollment of the additional patients. The company expects to release clinical data from the study in 2023.
The FDA reviewed additional data on emavusertib, including data related to the risk of rhabdomyolysis, before allowing Curis to resume enrollment of additional patients in the monotherapy arm of the phase Ia TakeAim Leukemia study.
However, the partial hold remains on the combination therapy phase and the expansion phase of the study. This partial hold will continue to stay until phase Ia of the study is completed and the regulatory body approves proceeding to the next phases of the study.
Shares of Curis were down 9.8% on Tuesday following the announcement of the news as investors were probably expecting a complete lifting of the hold. The stock, however, recovered in pre-market trading on Wednesday.
Curis’ stock has declined 78.8% this year compared with the industry’s decrease of 24.4%.
Image Source: Zacks Investment Research
Investors must note that in April 2022, the FDA placed a partial clinical hold on Curis’ phase I/II TakeAim leukemia study as well as the phase I/II TakeAim lymphoma study.
Earlier this month, the FDA lifted the partial clinical hold on Curis’ phase I/II TakeAim lymphoma study evaluating emavusertib in patients with B-cell malignancies.
The dose-escalating phase I/II study is evaluating emavusertib for treating patients with B-cell malignancies, both as a monotherapy and in combination with Johnson & Johnson (JNJ - Free Report) /AbbVie’s (ABBV - Free Report) BTK inhibitor, Imbruvica (ibrutinib), in patients with relapsed or refractory (R/R) hematologic malignancies, such as non-Hodgkin lymphomas (NHL).
Clinical data from this study is expected in 2023.
AbbVie markets Imbruvica in partnership with J&J. Imbruvica is currently approved for treating various hematologic cancers.
AbbVie and J&J are conducting several studies on Imbruvica to evaluate the drug alone or in combination in different patient segments. The drug has a multi-billion-dollar potential.
Curis currently has no marketed drugs in its portfolio. Therefore, the successful development of emavusertib, along with other pipeline candidates, remains in key focus for the company.
Zacks Rank & Stock to Consider
Curis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Achilles Therapeutics plc (ACHL - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Achilles Therapeutics’ loss per share estimates narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.