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Pharma Stock Roundup: FDA Nod to PFE Cibinqo for Adolescents, Updates From NVO, RHHBY
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This week, the FDA approved Pfizer’s (PFE - Free Report) eczema drug Cibinqo for adolescent patients. Roche (RHHBY - Free Report) announced new phase III data, which showed that the eye drug Vabysmo improved vision in people with retinal vein occlusion (RVO). Novo Nordisk’s (NVO - Free Report) partner Heartseed dosed the first patient in a phase I/II study on an investigational cell therapy for heart failure.
Recap of the Week’s Most Important Stories
FDA Approves Pfizer’s Cibinqo to Treat Eczema in Adolescents: The FDA granted approval to Pfizer’s oral, once-daily, JAK1 inhibitor, Cibinqo (abrocitinib), to treat refractory moderate-to-severe atopic dermatitis (AD) or eczema in adolescents. Cibinqo was approved for treating eczema in adults 18 years and older in January 2022. The FDA approval for Cibinqo for adolescents was based on data from the phase III study, JADE TEEN.
Pfizer also announced that the FDA has granted priority review for its supplemental new drug application (sNDA) seeking approval for a combination of its cancer drugs, Talzenna plus Xtandi for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC). The FDA is expected to give its decision on the sNDA later this year.
Roche’s Vabysmo Meets Goal in Phase III Studies for New Indication: Roche’s eye drug, Vabysmo, met its primary endpoint in two phase III studies evaluating it for vision loss associated with retinal vein occlusion. The phase III studies, BALATON and COMINO, evaluated Vabysmo (faricimab) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). In the studies, treatment with Vabysmo led to an early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to another eye medicine, aflibercept. The data from the studies also showed that patients treated with Vabysmo experienced an absence of blood vessel leakage in the retina compared to aflibercept in a pre-specified exploratory endpoint. Vabysmo is already approved to treat neovascular or wet age-related macular degeneration and diabetic macular edema. If approved, RVO would be the third indication for Vabysmo.
Novo Nordisk’s Partner Begins Phase I Study on Heart Failure Candidate: Novo Nordisk’s partner, Heartseed announced that it has successfully dosed the first patient in a phase I/II study on pipeline candidate, HS-001 – an investigational cell therapy for heart failure. HS-001 consists of clusters of purified heart muscle cells derived from induced pluripotent stem cells (iPSCs) and is a cell therapy designed to restore heart function in people with advanced heart failure. The study will enroll 10 patients with advanced heart failure caused by ischaemic heart disease.
The NYSE ARCA Pharmaceutical Index declined 1.04% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, AstraZeneca rose the most (0.8%), while Lilly declined the most (4.8%).
In the past six months, Merck has risen the most (17.0%), while Pfizer declined the most (12.8%).
Image: Bigstock
Pharma Stock Roundup: FDA Nod to PFE Cibinqo for Adolescents, Updates From NVO, RHHBY
This week, the FDA approved Pfizer’s (PFE - Free Report) eczema drug Cibinqo for adolescent patients. Roche (RHHBY - Free Report) announced new phase III data, which showed that the eye drug Vabysmo improved vision in people with retinal vein occlusion (RVO). Novo Nordisk’s (NVO - Free Report) partner Heartseed dosed the first patient in a phase I/II study on an investigational cell therapy for heart failure.
Recap of the Week’s Most Important Stories
FDA Approves Pfizer’s Cibinqo to Treat Eczema in Adolescents: The FDA granted approval to Pfizer’s oral, once-daily, JAK1 inhibitor, Cibinqo (abrocitinib), to treat refractory moderate-to-severe atopic dermatitis (AD) or eczema in adolescents. Cibinqo was approved for treating eczema in adults 18 years and older in January 2022. The FDA approval for Cibinqo for adolescents was based on data from the phase III study, JADE TEEN.
Pfizer also announced that the FDA has granted priority review for its supplemental new drug application (sNDA) seeking approval for a combination of its cancer drugs, Talzenna plus Xtandi for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC). The FDA is expected to give its decision on the sNDA later this year.
Roche’s Vabysmo Meets Goal in Phase III Studies for New Indication: Roche’s eye drug, Vabysmo, met its primary endpoint in two phase III studies evaluating it for vision loss associated with retinal vein occlusion. The phase III studies, BALATON and COMINO, evaluated Vabysmo (faricimab) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). In the studies, treatment with Vabysmo led to an early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to another eye medicine, aflibercept. The data from the studies also showed that patients treated with Vabysmo experienced an absence of blood vessel leakage in the retina compared to aflibercept in a pre-specified exploratory endpoint. Vabysmo is already approved to treat neovascular or wet age-related macular degeneration and diabetic macular edema. If approved, RVO would be the third indication for Vabysmo.
Novo Nordisk’s Partner Begins Phase I Study on Heart Failure Candidate: Novo Nordisk’s partner, Heartseed announced that it has successfully dosed the first patient in a phase I/II study on pipeline candidate, HS-001 – an investigational cell therapy for heart failure. HS-001 consists of clusters of purified heart muscle cells derived from induced pluripotent stem cells (iPSCs) and is a cell therapy designed to restore heart function in people with advanced heart failure. The study will enroll 10 patients with advanced heart failure caused by ischaemic heart disease.
The NYSE ARCA Pharmaceutical Index declined 1.04% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, AstraZeneca rose the most (0.8%), while Lilly declined the most (4.8%).
In the past six months, Merck has risen the most (17.0%), while Pfizer declined the most (12.8%).
(See the last pharma stock roundup here: AZN, ABBV Mixed Q4 Results, BAYRY’s New CEO)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.