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Zentalis (ZNTL) Tanks After FDA Puts 3 Cancer Studies on Hold
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Zentalis Pharmaceuticals, Inc. (ZNTL - Free Report) announced that the FDA has placed a partial clinical hold on three studies evaluating its lead product candidate, azenosertib, for three different cancer indications. Shares of ZNTL plunged 50.7% on Jun 18 following the announcement of the news.
The phase I ZN-c3-001 dose-escalation study was investigating azenosertib for treating solid tumors, while the phase II ZN-c3-005 DENALI study was evaluating azenosertib in platinum-resistant ovarian cancer (PROC). The phase II ZN-c3-004 TETON study was evaluating azenosertib for the treatment of uterine serous carcinoma.
The FDA placed a partial clinical hold on all these studies after two patients in the DENALI study died due to presumed sepsis. The company remains focused on resolving this clinical hold at the earliest.
Azenosertib, a potentially first-in-class WEE1 inhibitor, is being studied as a monotherapy and in combination with other therapies for treating different types of cancer indications, including solid tumors and ovarian cancer.
ZNTL has already completed enrollment in cohort 1b of the DENALI study. Overall efficacy and safety data from the same is expected to be announced later in 2024. Zentalis also plans to present data from the ZN-c3-001 and the MAMMOTH studies later this year.
Shares of Zentalis have plunged 72.7% year to date compared with the industry’s decline of 7.1%.
Image Source: Zacks Investment Research
The phase I/II MAMMOTH (ZN-c3-006) is evaluating azenosertib in combination with GSK’s (GSK - Free Report) PARP inhibitor Zejula (niraparib) and azenosertib as monotherapy for treating PROC. The study is being conducted in partnership with GSK.
GSK’s Zejula is already approved for ovarian cancer and is currently being studied for additional ovarian cancer stages as well as non-small cell lung cancer and endometrial cancer.
Further updates on the azenosertib clinical development program, as well as the timeline for data readouts from other studies on azenosertib, are expected once the partial clinical hold is resolved.
Zacks Rank & Stocks to Consider
Zentalis currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.30 to $2.47. Loss per share estimates for 2025 have narrowed from $3.13 to $2.55. Year to date, shares of ACRV have surged 34.8%.
ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining one occasion, the average surprise being 3.56%.
In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, shares of ALGS have declined 36.7%.
Aligos Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 7.83%.
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Zentalis (ZNTL) Tanks After FDA Puts 3 Cancer Studies on Hold
Zentalis Pharmaceuticals, Inc. (ZNTL - Free Report) announced that the FDA has placed a partial clinical hold on three studies evaluating its lead product candidate, azenosertib, for three different cancer indications. Shares of ZNTL plunged 50.7% on Jun 18 following the announcement of the news.
The phase I ZN-c3-001 dose-escalation study was investigating azenosertib for treating solid tumors, while the phase II ZN-c3-005 DENALI study was evaluating azenosertib in platinum-resistant ovarian cancer (PROC). The phase II ZN-c3-004 TETON study was evaluating azenosertib for the treatment of uterine serous carcinoma.
The FDA placed a partial clinical hold on all these studies after two patients in the DENALI study died due to presumed sepsis. The company remains focused on resolving this clinical hold at the earliest.
Azenosertib, a potentially first-in-class WEE1 inhibitor, is being studied as a monotherapy and in combination with other therapies for treating different types of cancer indications, including solid tumors and ovarian cancer.
ZNTL has already completed enrollment in cohort 1b of the DENALI study. Overall efficacy and safety data from the same is expected to be announced later in 2024. Zentalis also plans to present data from the ZN-c3-001 and the MAMMOTH studies later this year.
Shares of Zentalis have plunged 72.7% year to date compared with the industry’s decline of 7.1%.
Image Source: Zacks Investment Research
The phase I/II MAMMOTH (ZN-c3-006) is evaluating azenosertib in combination with GSK’s (GSK - Free Report) PARP inhibitor Zejula (niraparib) and azenosertib as monotherapy for treating PROC. The study is being conducted in partnership with GSK.
GSK’s Zejula is already approved for ovarian cancer and is currently being studied for additional ovarian cancer stages as well as non-small cell lung cancer and endometrial cancer.
Further updates on the azenosertib clinical development program, as well as the timeline for data readouts from other studies on azenosertib, are expected once the partial clinical hold is resolved.
Zacks Rank & Stocks to Consider
Zentalis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Acrivon Therapeutics, Inc. (ACRV - Free Report) and Aligos Therapeutics, Inc. (ALGS - 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 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.30 to $2.47. Loss per share estimates for 2025 have narrowed from $3.13 to $2.55. Year to date, shares of ACRV have surged 34.8%.
ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining one occasion, the average surprise being 3.56%.
In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, shares of ALGS have declined 36.7%.
Aligos Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 7.83%.