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2seventy (TSVT) Down 9% on Patient Death in Leukemia Study
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Shares of 2seventy bio (TSVT - Free Report) fell 9.0% on Jun 14 after management announced the halting of the phase I PLAT-08 study, evaluating its investigational CAR T cell therapy SC-DARIC33 in pediatric patients with relapsed/refractory acute myeloid leukemia (“AML”).
The decision to pause the PLAT-08 study was taken by 2seventy bio’s partner and regulatory sponsor of the study, Seattle Children's Therapeutics, in accordance with the clinical study protocol stopping rules for a Grade 5 (fatal) serious adverse event (“SAE”). Per an article by the National Library of Medicine, a grade 5 SAE indicates the worst outcome, i.e., death.
This SAE occurred in the first patient who was treated at the second dose level in the PLAT-08 study.
The PLAT-08 study is the first time SC-DARIC33 was administered to humans. 2seventy bio and Seattle Children's Therapeutics are now investigating the root cause of this SAE and whether there is a potential relationship of the SAE with SC-DARIC33.
The FDA has also been notified of this development. Both 2seventy bio and Seattle Children's Therapeutics are in active communication with the agency to assess the cause of the SAE and determine the next steps to be taken.
Last month, 2seventy bio reported positive preliminary results from the PLAT-08 study at the American Society of Gene & Cell Therapy Annual Meeting. Per management, treatment with SC-DARIC33 was well tolerated and did not show dose-limiting toxicities in AML patients.
So far this year, shares of 2seventy bio have risen 14.7% against the industry‘s 6.3% fall.
Image Source: Zacks Investment Research
Currently, 2seventy bio has only one marketed drug in its portfolio, Abecma, which has been developed in partnership with Bristol Myers (BMY - Free Report) and is currently approved in patients with relapsed/refractory multiple myeloma who have received four or more lines of therapy. Per the terms of the agreement, both 2seventy bio and Bristol Myers are responsible for the development and commercialization of Abecma in the United States. However, Bristol Myers is solely responsible for Abecma manufacturing and commercialization outside of the country.
In April, the FDA accepted Bristol Myers/2seventy bio’s FDA filing seeking label expansion for treating earlier lines of relapsed/refractory multiple myeloma. A final decision is expected in December 2023.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2023 earnings per share have increased from $2.42 to $3.31. During the same period, the earnings estimates per share for 2024 have risen from $3.76 to $4.32. Shares of ANI Pharmaceuticals are up 23.5% in the year-to-date period.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average earnings surprise of 68.64%.
In the past 60 days, the estimate for Ligand Pharmaceuticals’ 2023 earnings per share has increased from $4.16 to $5.25. During the same period, the earnings per share estimate for 2024 has increased from $4.58 to $4.69. So far this year, shares of Ligand Pharmaceuticals have risen 16.8%.
Ligand Pharmaceuticals beat earnings estimates in two of the last four quarters and missed the mark on the other two occasions. On average, the company’s earnings witnessed an earnings surprise of 21.50%.
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2seventy (TSVT) Down 9% on Patient Death in Leukemia Study
Shares of 2seventy bio (TSVT - Free Report) fell 9.0% on Jun 14 after management announced the halting of the phase I PLAT-08 study, evaluating its investigational CAR T cell therapy SC-DARIC33 in pediatric patients with relapsed/refractory acute myeloid leukemia (“AML”).
The decision to pause the PLAT-08 study was taken by 2seventy bio’s partner and regulatory sponsor of the study, Seattle Children's Therapeutics, in accordance with the clinical study protocol stopping rules for a Grade 5 (fatal) serious adverse event (“SAE”). Per an article by the National Library of Medicine, a grade 5 SAE indicates the worst outcome, i.e., death.
This SAE occurred in the first patient who was treated at the second dose level in the PLAT-08 study.
The PLAT-08 study is the first time SC-DARIC33 was administered to humans. 2seventy bio and Seattle Children's Therapeutics are now investigating the root cause of this SAE and whether there is a potential relationship of the SAE with SC-DARIC33.
The FDA has also been notified of this development. Both 2seventy bio and Seattle Children's Therapeutics are in active communication with the agency to assess the cause of the SAE and determine the next steps to be taken.
Last month, 2seventy bio reported positive preliminary results from the PLAT-08 study at the American Society of Gene & Cell Therapy Annual Meeting. Per management, treatment with SC-DARIC33 was well tolerated and did not show dose-limiting toxicities in AML patients.
So far this year, shares of 2seventy bio have risen 14.7% against the industry‘s 6.3% fall.
Image Source: Zacks Investment Research
Currently, 2seventy bio has only one marketed drug in its portfolio, Abecma, which has been developed in partnership with Bristol Myers (BMY - Free Report) and is currently approved in patients with relapsed/refractory multiple myeloma who have received four or more lines of therapy. Per the terms of the agreement, both 2seventy bio and Bristol Myers are responsible for the development and commercialization of Abecma in the United States. However, Bristol Myers is solely responsible for Abecma manufacturing and commercialization outside of the country.
In April, the FDA accepted Bristol Myers/2seventy bio’s FDA filing seeking label expansion for treating earlier lines of relapsed/refractory multiple myeloma. A final decision is expected in December 2023.
2seventy bio, Inc. Price
2seventy bio, Inc. price | 2seventy bio, Inc. Quote
Zacks Rank & Stocks to Consider
2seventy bio currently carries a Zacks Rank #3 (Hold).Some better-ranked stock in the overall healthcare sector are ANI Pharmaceuticals (ANIP - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2023 earnings per share have increased from $2.42 to $3.31. During the same period, the earnings estimates per share for 2024 have risen from $3.76 to $4.32. Shares of ANI Pharmaceuticals are up 23.5% in the year-to-date period.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average earnings surprise of 68.64%.
In the past 60 days, the estimate for Ligand Pharmaceuticals’ 2023 earnings per share has increased from $4.16 to $5.25. During the same period, the earnings per share estimate for 2024 has increased from $4.58 to $4.69. So far this year, shares of Ligand Pharmaceuticals have risen 16.8%.
Ligand Pharmaceuticals beat earnings estimates in two of the last four quarters and missed the mark on the other two occasions. On average, the company’s earnings witnessed an earnings surprise of 21.50%.