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Innate Pharma (IPHA) Gains as FDA Lifts Hold on Lymphoma Study
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Innate Pharma SA (IPHA - Free Report) announced that the FDA lifted the partial clinical hold placed on the lacutamab investigational new drug (IND) in October 2023.
Innate Pharma’s lead proprietary program, lacutamab, is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently being developed for treating cutaneous T-cell lymphoma (CTCL) and peripheral T cell lymphoma (PTCL).
On Oct 5, the FDA placed a partial clinical hold on the lacutamab IND after a patient died in the phase II TELLOMAK study evaluating lacutamab for the treatment of patients with Sézary syndrome and mycosis fungoides (MF) in the United States and EU.
Sézary syndrome and MF are some of the most common subtypes of CTCL. The death of the patient affected by Sézary Syndrome was initially considered due to hemophagocytic lymphohistiocytosis, a rare blood disorder. Following the unfortunate development, patient enrollment was paused in the clinical-stage company’s ongoing lacutamab studies, the phase II TELLOMAK study and the phase Ib PTCL study.
The FDA’s decision to lift the partial clinical hold was based on the regulatory body’s review of the fatal case, which Innate Pharma and a group of independent experts determined to be related to aggressive disease progression and not due to treatment with lacutamab.
Innate Pharma’s stock gained almost 10% during the pre-market hours on Jan 4, 2024, due to the encouraging regulatory update for the lacutamab program. Over the past year, shares of IPHA have lost 16.5% compared with the industry’s 9.7% fall.
Image Source: Zacks Investment Research
Per the press release, patient enrollment has been completed in the phase II TELLOMAK study evaluating lacutamab for CTCL indications. The primary endpoint of the study is the objective global response rate. Key secondary endpoints of the mid-stage study include progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics and immunogenicity and adverse events.
It is important to note that lacutamab currently enjoys the EU regulatory body’s PRIME designation and the FDA’s Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies.
The candidate also enjoys the orphan drug status in the EU and United States for the treatment of CTCL.
Innate Pharma S.A. Sponsored ADR Price and Consensus
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have lost 4.6%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Over the past year, shares of ADMA have gained 22.8%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 loss per share has remained constant at 33 cents. During the same time frame, the consensus estimate for Acadia’s 2024 EPS is pegged at $1.04. Over the past year, shares of ACAD have rallied 71.7%.
ACAD beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average earnings surprise of 20.69%.
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Innate Pharma (IPHA) Gains as FDA Lifts Hold on Lymphoma Study
Innate Pharma SA (IPHA - Free Report) announced that the FDA lifted the partial clinical hold placed on the lacutamab investigational new drug (IND) in October 2023.
Innate Pharma’s lead proprietary program, lacutamab, is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently being developed for treating cutaneous T-cell lymphoma (CTCL) and peripheral T cell lymphoma (PTCL).
On Oct 5, the FDA placed a partial clinical hold on the lacutamab IND after a patient died in the phase II TELLOMAK study evaluating lacutamab for the treatment of patients with Sézary syndrome and mycosis fungoides (MF) in the United States and EU.
Sézary syndrome and MF are some of the most common subtypes of CTCL. The death of the patient affected by Sézary Syndrome was initially considered due to hemophagocytic lymphohistiocytosis, a rare blood disorder. Following the unfortunate development, patient enrollment was paused in the clinical-stage company’s ongoing lacutamab studies, the phase II TELLOMAK study and the phase Ib PTCL study.
The FDA’s decision to lift the partial clinical hold was based on the regulatory body’s review of the fatal case, which Innate Pharma and a group of independent experts determined to be related to aggressive disease progression and not due to treatment with lacutamab.
Innate Pharma’s stock gained almost 10% during the pre-market hours on Jan 4, 2024, due to the encouraging regulatory update for the lacutamab program. Over the past year, shares of IPHA have lost 16.5% compared with the industry’s 9.7% fall.
Image Source: Zacks Investment Research
Per the press release, patient enrollment has been completed in the phase II TELLOMAK study evaluating lacutamab for CTCL indications. The primary endpoint of the study is the objective global response rate. Key secondary endpoints of the mid-stage study include progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics and immunogenicity and adverse events.
It is important to note that lacutamab currently enjoys the EU regulatory body’s PRIME designation and the FDA’s Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies.
The candidate also enjoys the orphan drug status in the EU and United States for the treatment of CTCL.
Innate Pharma S.A. Sponsored ADR Price and Consensus
Innate Pharma S.A. Sponsored ADR price-consensus-chart | Innate Pharma S.A. Sponsored ADR Quote
Zacks Rank and Stocks to Consider
Innate Pharma currently carries a Zacks Rank #3 (Hold).
Some better-ranked drug/biotech stocks are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Acadia Pharmaceuticals (ACAD - Free Report) . PBYI sports a Zacks Rank #1 (Strong Buy), and ADMA and ACAD carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have lost 4.6%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Over the past year, shares of ADMA have gained 22.8%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 loss per share has remained constant at 33 cents. During the same time frame, the consensus estimate for Acadia’s 2024 EPS is pegged at $1.04. Over the past year, shares of ACAD have rallied 71.7%.
ACAD beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average earnings surprise of 20.69%.