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Gilead's (GILD) Leukemia Study Progress Put on Clinical Hold
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Gilead Sciences, Inc. (GILD - Free Report) suffers yet another setback in developing its oncology candidate, magrolimab. The FDA has placed a partial clinical hold on new patient starts in studies evaluating magrolimab to treat acute myeloid leukemia (AML) in the United States.
As a result of the hold, screening and enrollment of new study participants under the U.S. investigational new drug application (IND 147229) and U.S. Expanded Access Program will be paused. Nevertheless, patients already enrolled in AML studies may continue to receive treatment and be monitored, according to the current study protocol.
The candidate is a potential first-in-class anti-CD47 immunotherapy and is being evaluated for several potential indications, including ongoing trials in solid tumors. Management stated that studies of magrolimab in solid tumors can continue without any impact from this hold.
Last month, Gilead announced that the late-stage ENHANCE study on magrolimab in higher-risk myelodysplastic syndromes was discontinued.
The decision to discontinue the ENHANCE study was based on a planned analysis that indicated futility in achieving the study's primary endpoints, which were focused on complete response and overall survival. Secondary endpoints included duration of response, transfusion independence, progression-free survival and time to transform to acute myeloid leukemia, among others.
Gilead stated that the safety data seen in this study was consistent with the known magrolimab profile and adverse events that are typical in this patient population.
The FDA had placed a partial clinical hold in 2022 on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected adverse reactions between study arms, but the hold was subsequently removed.
The acquisition of Forty Seven, Inc. added its investigational lead product candidate, magrolimab, to Gilead’s immuno-oncology research and development portfolio.
Shares of Gilead have lost 11.6% in the year so far compared with the industry’s decline of 13.1%.
Image Source: Zacks Investment Research
We remind investors that Gilead is looking to diversify in the lucrative oncology space as the leading HIV business faces competition. The oncology business put up a stellar performance in the first half, boosting its top line.
The Cell Therapy franchise, comprising Yescarta and Tecartus, also continues to witness a steady increase in sales, primarily due to higher demand for Yescarta in relapsed or refractory (R/R) large B-Cell lymphoma and Tecartus in R/R acute lymphoblastic leukemia and mantle cell lymphoma. The uptake of the breast cancer drug Trodelvy has also been strong.
Gilead’s efforts to bolster its oncology pipeline are encouraging, but the recent setbacks weigh. Earlier, Gilead’s partner Arcellx (ACLX - Free Report) faced a setback when the FDA placed a clinical hold on its iMMagine-1 program, designed to evaluate the lead program, CART-ddBCMA, for treating adult patients with relapsed or refractory multiple myeloma.
Both companies have collaborated to co-develop and co-commercialize CART-ddBMCA, a late-stage clinical asset in development for the treatment of multiple myeloma. The hold was placed on Jun 16 after a patient died.
Arcellx believes limitations on bridging therapy are a contributing factor and is working with the FDA to amend the protocol to expand options for patients consistent with current clinical practice.
The loss per share estimate for SPRO for 2023 has narrowed by 49 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 27 cents to 24 cents for 2023 in the past 30 days. Dynavax has risen 38.3% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.
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Gilead's (GILD) Leukemia Study Progress Put on Clinical Hold
Gilead Sciences, Inc. (GILD - Free Report) suffers yet another setback in developing its oncology candidate, magrolimab. The FDA has placed a partial clinical hold on new patient starts in studies evaluating magrolimab to treat acute myeloid leukemia (AML) in the United States.
As a result of the hold, screening and enrollment of new study participants under the U.S. investigational new drug application (IND 147229) and U.S. Expanded Access Program will be paused. Nevertheless, patients already enrolled in AML studies may continue to receive treatment and be monitored, according to the current study protocol.
The candidate is a potential first-in-class anti-CD47 immunotherapy and is being evaluated for several potential indications, including ongoing trials in solid tumors. Management stated that studies of magrolimab in solid tumors can continue without any impact from this hold.
Last month, Gilead announced that the late-stage ENHANCE study on magrolimab in higher-risk myelodysplastic syndromes was discontinued.
The decision to discontinue the ENHANCE study was based on a planned analysis that indicated futility in achieving the study's primary endpoints, which were focused on complete response and overall survival. Secondary endpoints included duration of response, transfusion independence, progression-free survival and time to transform to acute myeloid leukemia, among others.
Gilead stated that the safety data seen in this study was consistent with the known magrolimab profile and adverse events that are typical in this patient population.
The FDA had placed a partial clinical hold in 2022 on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected adverse reactions between study arms, but the hold was subsequently removed.
The acquisition of Forty Seven, Inc. added its investigational lead product candidate, magrolimab, to Gilead’s immuno-oncology research and development portfolio.
Shares of Gilead have lost 11.6% in the year so far compared with the industry’s decline of 13.1%.
Image Source: Zacks Investment Research
We remind investors that Gilead is looking to diversify in the lucrative oncology space as the leading HIV business faces competition. The oncology business put up a stellar performance in the first half, boosting its top line.
The Cell Therapy franchise, comprising Yescarta and Tecartus, also continues to witness a steady increase in sales, primarily due to higher demand for Yescarta in relapsed or refractory (R/R) large B-Cell lymphoma and Tecartus in R/R acute lymphoblastic leukemia and mantle cell lymphoma. The uptake of the breast cancer drug Trodelvy has also been strong.
Gilead’s efforts to bolster its oncology pipeline are encouraging, but the recent setbacks weigh. Earlier, Gilead’s partner Arcellx (ACLX - Free Report) faced a setback when the FDA placed a clinical hold on its iMMagine-1 program, designed to evaluate the lead program, CART-ddBCMA, for treating adult patients with relapsed or refractory multiple myeloma.
Both companies have collaborated to co-develop and co-commercialize CART-ddBMCA, a late-stage clinical asset in development for the treatment of multiple myeloma. The hold was placed on Jun 16 after a patient died.
Arcellx believes limitations on bridging therapy are a contributing factor and is working with the FDA to amend the protocol to expand options for patients consistent with current clinical practice.
Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are Spero Therapeutics (SPRO - Free Report) and Dynavax Technologies (DVAX - 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.
The loss per share estimate for SPRO for 2023 has narrowed by 49 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 27 cents to 24 cents for 2023 in the past 30 days. Dynavax has risen 38.3% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.