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Humanigen (HGEN) Surges on Lenzilumab Study Data for Leukemia
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Humanigen stock was up almost 20% on Apr 14, as it presented the baseline results of its Precision Approach to Chronic Myelomonocytic Leukemia (PREACH-M) study of lenzilumab in chronic myelomonocytic leukemia (CMML). The results were declared at the 2023 annual meeting of the American Association of Cancer Research in Orlando, FL.
PREACH-M is a phase II/III clinical study that evaluates lenzilumab, a granulocyte-macrophage colony-stimulating factor (GM-CSF) neutralizing antibody, and azacitidine as new therapeutic options for CMML. The study is being conducted in collaboration with the South Australian Health and Medical Research Institute and The University of Adelaide.
The abovementioned study has enrolled 11 intermediate and high-risk CMML subjects and treated them with lenzilumab and azacitidine. As of Dec 31, 2022, six subjects were evaluable based on at least three months of follow up, and all of them demonstrated clinical benefits.
Three high-risk patients achieved clinical benefits and the treatment led to rapid clinical response in all evaluable patients. However, 10 grade 3/4 serious adverse events were observed, of which the investigator assessed two as possibly related to lenzilumab.
GM-CSF is a cytokine that helps make white blood cells in the body and promotes myeloid cell development and maturation, which plays a significant role in the development of CMML. The current early-stage data from the study shows promising treatment response rates in CMML through GM-CSF neutralization with lenzilumab.
Humanigen's shares have plunged 92.7% in the past year compared with the industry's 11.3% decline.
Image Source: Zacks Investment Research
CMML is an orphan form of leukemia disease with limited therapeutic options. Currently, there are no new therapeutic agents with a novel mechanism of action for patients with high-risk CMML in the last thirty years. Treatment options for these patients are limited to blood transfusions, hydroxyurea and supportive care.
Results from the abovementioned study have the potential to qualify lenzilumab for expedited regulatory pathways. As an orphan disease, lenzilumab may be eligible for certain regulatory and commercial advantages that could expedite its development and potential approval.
HGEN and the Principal Investigator are assessing regulatory pathways that might enable early results to support a regulatory submission and potential approval in the United States and the United Kingdom.
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.35 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. The company’s shares have plunged 14.4% in the past year.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $18.34 to $16.54 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. KALA's shares have plunged 57.8% in the past year.
The company’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
ALLO’s earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. The company’s shares have plunged 35.9% in the past year.
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Humanigen (HGEN) Surges on Lenzilumab Study Data for Leukemia
Humanigen stock was up almost 20% on Apr 14, as it presented the baseline results of its Precision Approach to Chronic Myelomonocytic Leukemia (PREACH-M) study of lenzilumab in chronic myelomonocytic leukemia (CMML). The results were declared at the 2023 annual meeting of the American Association of Cancer Research in Orlando, FL.
PREACH-M is a phase II/III clinical study that evaluates lenzilumab, a granulocyte-macrophage colony-stimulating factor (GM-CSF) neutralizing antibody, and azacitidine as new therapeutic options for CMML. The study is being conducted in collaboration with the South Australian Health and Medical Research Institute and The University of Adelaide.
The abovementioned study has enrolled 11 intermediate and high-risk CMML subjects and treated them with lenzilumab and azacitidine. As of Dec 31, 2022, six subjects were evaluable based on at least three months of follow up, and all of them demonstrated clinical benefits.
Three high-risk patients achieved clinical benefits and the treatment led to rapid clinical response in all evaluable patients. However, 10 grade 3/4 serious adverse events were observed, of which the investigator assessed two as possibly related to lenzilumab.
GM-CSF is a cytokine that helps make white blood cells in the body and promotes myeloid cell development and maturation, which plays a significant role in the development of CMML. The current early-stage data from the study shows promising treatment response rates in CMML through GM-CSF neutralization with lenzilumab.
Humanigen's shares have plunged 92.7% in the past year compared with the industry's 11.3% decline.
Image Source: Zacks Investment Research
CMML is an orphan form of leukemia disease with limited therapeutic options. Currently, there are no new therapeutic agents with a novel mechanism of action for patients with high-risk CMML in the last thirty years. Treatment options for these patients are limited to blood transfusions, hydroxyurea and supportive care.
Results from the abovementioned study have the potential to qualify lenzilumab for expedited regulatory pathways. As an orphan disease, lenzilumab may be eligible for certain regulatory and commercial advantages that could expedite its development and potential approval.
HGEN and the Principal Investigator are assessing regulatory pathways that might enable early results to support a regulatory submission and potential approval in the United States and the United Kingdom.
Humanigen Inc. Price and Consensus
Humanigen Inc. price-consensus-chart | Humanigen Inc. Quote
Zacks Rank & Other Stocks to Consider
Currently, Humanigen has a Zacks Rank #2 (Buy).
Some other top-ranked stocks for investors interested in the same sector are CRISPR Therapeutics (CRSP - Free Report) , Kala Pharmaceuticals (KALA - Free Report) and Allogene Therapeutics (ALLO - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.35 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. The company’s shares have plunged 14.4% in the past year.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $18.34 to $16.54 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. KALA's shares have plunged 57.8% in the past year.
The company’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
ALLO’s earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. The company’s shares have plunged 35.9% in the past year.