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Curis (CRIS) Lymphoma Study's Clinical Hold Lifted, Shares Gain
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Curis (CRIS - Free Report) shares were up 20% during market hours on Aug 18, after the company announced that the FDA has lifted the partial clinical hold on phase I/II TakeAim lymphoma study evaluating emavusertib (CA-4948) in patients with B-cell malignancies.
The open-label, dose-escalating phase I/II study is evaluating emavusertib, an orally available IRAK4 kinase inhibitor, 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).
With the lifting of the clinical hold, Curis is working with clinical sites to resume enrollment of new patients in this study in the third quarter of 2022. Curis expects to release clinical data from the study in 2023.
AbbVie markets Imbruvica in partnership with J&J. Imbruvica is currently approved for treating various hematologic cancers.
The FDA Division of Hematologic Malignancies 2 (DHM2) placed a partial clinical hold on the TakeAim Lymphoma study on Apr 11, 2022. As a result, enrollment of new patients was also stopped in the study.
With the imposition of the partial clinical hold, the FDA had requested additional safety, efficacy and other data on emavusertib, including data related to rhabdomyolysis and the likely recommended phase II dose for emavusertib.
After reviewing the comprehensive data package submitted by Curis on the emavusertib lymphoma study, the FDA’s DHM2 has now lifted the partial hold, which resulted in a surge in the stock’s price.
The lifting of the partial clinical hold follows an agreement of the company with the FDA regarding the former’s strategy for the identification and management of rhabdomyolysis. Per FDA instructions, Curis will also have to enroll at least nine additional patients in the lymphoma study of emavusertib at a 200mg dose level, in combination with Imbruvica (ibrutinib).
Additionally, Curis is also discussing optimal dosage and the development path of emavusertib in the TakeAim Lymphoma study with DHM2.
Curis stock is down 73.6% in the year-to-date period compared to the industry’s decline of 19.5%.
Image Source: Zacks Investment Research
Emavusertib was also being evaluated in a separate open label, single-arm dose escalating and expansion phase I/II TakeAim Leukemia study for the treatment of acute myeloid leukemia (AML), and high-risk myelodysplastic syndromes (MDS).
The study was also put on hold by the FDA Division of Hematologic Malignancies 1 (DHM1) on Apr 4, 2022, following the death of a patient with R/R AML.
Investors must note that though FDA has lifted the partial hold on the TakeAim Lymphoma study, the partial hold on TakeAim Leukemia Study still continues. Concurrently, patient enrollment in the TakeAim leukemia study is also on hold.
Curis currently has no marketed drugs in its portfolio. The development of emavusertib, along with other pipeline candidates, which include CI-8993 (for the treatment of R/R solid tumors), Fimepinostat (for diffuse large B-cell lymphoma), CA-170 (for mesothelioma) and CA-327 (a pre-IND oncology drug candidate) remains a key focus for the company.
Immunovant’s loss per share estimates for 2022 have narrowed from $1.66 to $1.64 in the past 30 days. The same for 2023 has narrowed from $1.94 to $1.75 in the same time frame.
Earnings of Immunovant missed estimates in three of the trailing four quarters and beat the same on the remaining one occasion. The average negative earnings surprise for IMVT is 8.97%.
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Curis (CRIS) Lymphoma Study's Clinical Hold Lifted, Shares Gain
Curis (CRIS - Free Report) shares were up 20% during market hours on Aug 18, after the company announced that the FDA has lifted the partial clinical hold on phase I/II TakeAim lymphoma study evaluating emavusertib (CA-4948) in patients with B-cell malignancies.
The open-label, dose-escalating phase I/II study is evaluating emavusertib, an orally available IRAK4 kinase inhibitor, 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).
With the lifting of the clinical hold, Curis is working with clinical sites to resume enrollment of new patients in this study in the third quarter of 2022. Curis expects to release clinical data from the study in 2023.
AbbVie markets Imbruvica in partnership with J&J. Imbruvica is currently approved for treating various hematologic cancers.
The FDA Division of Hematologic Malignancies 2 (DHM2) placed a partial clinical hold on the TakeAim Lymphoma study on Apr 11, 2022. As a result, enrollment of new patients was also stopped in the study.
With the imposition of the partial clinical hold, the FDA had requested additional safety, efficacy and other data on emavusertib, including data related to rhabdomyolysis and the likely recommended phase II dose for emavusertib.
After reviewing the comprehensive data package submitted by Curis on the emavusertib lymphoma study, the FDA’s DHM2 has now lifted the partial hold, which resulted in a surge in the stock’s price.
The lifting of the partial clinical hold follows an agreement of the company with the FDA regarding the former’s strategy for the identification and management of rhabdomyolysis. Per FDA instructions, Curis will also have to enroll at least nine additional patients in the lymphoma study of emavusertib at a 200mg dose level, in combination with Imbruvica (ibrutinib).
Additionally, Curis is also discussing optimal dosage and the development path of emavusertib in the TakeAim Lymphoma study with DHM2.
Curis stock is down 73.6% in the year-to-date period compared to the industry’s decline of 19.5%.
Image Source: Zacks Investment Research
Emavusertib was also being evaluated in a separate open label, single-arm dose escalating and expansion phase I/II TakeAim Leukemia study for the treatment of acute myeloid leukemia (AML), and high-risk myelodysplastic syndromes (MDS).
The study was also put on hold by the FDA Division of Hematologic Malignancies 1 (DHM1) on Apr 4, 2022, following the death of a patient with R/R AML.
Investors must note that though FDA has lifted the partial hold on the TakeAim Lymphoma study, the partial hold on TakeAim Leukemia Study still continues. Concurrently, patient enrollment in the TakeAim leukemia study is also on hold.
Curis currently has no marketed drugs in its portfolio. The development of emavusertib, along with other pipeline candidates, which include CI-8993 (for the treatment of R/R solid tumors), Fimepinostat (for diffuse large B-cell lymphoma), CA-170 (for mesothelioma) and CA-327 (a pre-IND oncology drug candidate) remains a key focus for the company.
Curis, Inc. Price
Curis, Inc. price | Curis, Inc. Quote
Zacks Rank and a Key Pick
Currently, Curis holds a Zacks Rank #3 (Hold).
A better stock in the same sector is Immunovant (IMVT - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Immunovant’s loss per share estimates for 2022 have narrowed from $1.66 to $1.64 in the past 30 days. The same for 2023 has narrowed from $1.94 to $1.75 in the same time frame.
Earnings of Immunovant missed estimates in three of the trailing four quarters and beat the same on the remaining one occasion. The average negative earnings surprise for IMVT is 8.97%.