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Immunome (IMNM) COVID-19 Cocktail Hold Lifted, Shares Gain
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Immunome, Inc. (IMNM - Free Report) announced that the FDA has lifted the clinical hold on its Investigational New Drug (IND) application for its antibody cocktail (IMM-BCP-01) for the treatment of COVID-19. Shares gained on the same.
IMM-BCP-01 is a three-antibody cocktail targeting non-overlapping regions of the Spike protein of SARS-CoV-2, including highly conserved, subdominant epitopes, which elicits both ACE2 and non-ACE2 dependent neutralization and induces natural viral clearance mechanisms, such as antibody-dependent cellular cytotoxicity, complement activation and phagocytosis.
The regulatory body had placed the Immunome’s IND application on clinical hold due to a request for further information related to the preparation and administration of IMM-BCP-01 at clinical sites. Consequently, Immunome provided the FDA with a comprehensive report detailing the necessary information.
Immunome plans to initiate a placebo-controlled dose-escalation study of IMM-BCP-01 in patients infected with SARS-CoV-2.
Immunome’s shares have plunged 69.9% this year so far compared with the industry’s decline of 19.3%.
Image Source: Zacks Investment Research
Last month, Immunome announced in vitro data demonstrating the effectiveness of its antibody cocktail, IMM20253, against live versions of the Omicron variant (B.1.1.529) of COVID-19 when tested at two external laboratories.
The antibody cocktail demonstrated comparable head-to-head potency to Glaxo (GSK - Free Report) /Vir’s (VIR - Free Report) sotrovimab in a live virus neutralization assay against Omicron.
We note that sotrovimab has been granted Emergency Use Authorization in more than 40 countries for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40kg). Vir and GSK plan to submit a biologics license application for sotrovimab to the FDA in the second half of 2022. Vir and Glaxo are also assessing the use of sotrovimab in uninfected immunocompromised patients to determine whether the drug can prevent symptomatic COVID-19 infection.
Vertex Pharmaceuticals’ earnings per share estimates have increased to $14.52 from $13.39 for 2022 over the past 60 days. Shares of Vertex have gained 9.7% in the past year.
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Immunome (IMNM) COVID-19 Cocktail Hold Lifted, Shares Gain
Immunome, Inc. (IMNM - Free Report) announced that the FDA has lifted the clinical hold on its Investigational New Drug (IND) application for its antibody cocktail (IMM-BCP-01) for the treatment of COVID-19. Shares gained on the same.
IMM-BCP-01 is a three-antibody cocktail targeting non-overlapping regions of the Spike protein of SARS-CoV-2, including highly conserved, subdominant epitopes, which elicits both ACE2 and non-ACE2 dependent neutralization and induces natural viral clearance mechanisms, such as antibody-dependent cellular cytotoxicity, complement activation and phagocytosis.
The regulatory body had placed the Immunome’s IND application on clinical hold due to a request for further information related to the preparation and administration of IMM-BCP-01 at clinical sites. Consequently, Immunome provided the FDA with a comprehensive report detailing the necessary information.
Immunome plans to initiate a placebo-controlled dose-escalation study of IMM-BCP-01 in patients infected with SARS-CoV-2.
Immunome’s shares have plunged 69.9% this year so far compared with the industry’s decline of 19.3%.
Image Source: Zacks Investment Research
Last month, Immunome announced in vitro data demonstrating the effectiveness of its antibody cocktail, IMM20253, against live versions of the Omicron variant (B.1.1.529) of COVID-19 when tested at two external laboratories.
The antibody cocktail demonstrated comparable head-to-head potency to Glaxo (GSK - Free Report) /Vir’s (VIR - Free Report) sotrovimab in a live virus neutralization assay against Omicron.
We note that sotrovimab has been granted Emergency Use Authorization in more than 40 countries for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40kg).
Vir and GSK plan to submit a biologics license application for sotrovimab to the FDA in the second half of 2022. Vir and Glaxo are also assessing the use of sotrovimab in uninfected immunocompromised patients to determine whether the drug can prevent symptomatic COVID-19 infection.
Zacks Rank & A Stock to Consider
Immunome currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Vertex Pharmaceuticals (VRTX - Free Report) , which at present carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex Pharmaceuticals’ earnings per share estimates have increased to $14.52 from $13.39 for 2022 over the past 60 days. Shares of Vertex have gained 9.7% in the past year.