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Vaxcyte (PCVX) Up on Pneumococcal Conjugate Vaccine Data
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Vaxcyte, Inc. (PCVX - Free Report) , a clinical-stage vaccine innovation company, saw its shares rise 16% after it released positive data from the phase II study of its 24-Valent pneumococcal conjugate vaccine (PCV) candidate, VAX-24, in adults aged 65 and older.
Concurrently, the company also announced data from the full six-month safety assessment and prespecified pooled immunogenicity analyses from both the phase II study in adults aged 65 and older and the prior phase 1/II study in adults aged 18-64 (phase 1 portion adults aged 18-49, phase II portion adults aged 50-64).
VAX-24, Vaxcyte’s lead broad-spectrum 24-valent PCV candidate, is being studied for the prevention of invasive pneumococcal disease (IPD).
VAX-24 showed robust immune responses across all 24 serotypes (ST) at all doses (1.1mcg, 2.2mcg and 2.2mcg/4.4mcg), confirming prior phase II results in adults aged 50-64.
At the 2.2mcg dose, which Vaxcyte plans to advance to phase III, VAX-24 achieved opsonophagocytic activity (OPA) response non-inferiority criteria for 18 of the 20 STs common with Prevnar 20 (PCV20) and superiority criteria for the four additional VAX-24 STs.
The six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
At this dose, the candidate also showed further improvement in overall immune responses versus PCV20 relative to results from the phase II study in adults in the age group 50-64.
Based on these positive data, Vaxcyte plans to meet with regulators and advance VAX-24 into a pivotal phase III study (top-line data is expected in 2025).
The stock has gained 79.6% in the past year against the industry’s 10.8% decline.
Image Source: Zacks Investment Research
Vaxcyte also plans to announce top-line safety, tolerability and immunogenicity data from the primary three-dose immunization series of the infant phase II study by 2025.
Vaxcyte’s pipeline also includes VAX-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease and VAX-GI, a vaccine program designed to prevent Shigella.
The company also intends to submit an investigational new drug (IND) application to the FDA for VAX-31 in adults in the second half of 2023.
We note that PREVNAR 20 is Pfizer’s (PFE - Free Report) pneumococcal conjugate vaccine. Pfizer generated sales of $6.4 billion in 2022 from the Prevnar family, which includes Prevnar 13/Prevenar 13 (pediatric and adult) and Prevnar 20 (adult,) driven by the adult indications in the U.S. due to strong patient demand following the launch of Prevnar 20 for the eligible adult population.
Zacks Rank and Stocks to Consider
Vaxcyte currently carries a Zacks Rank #4 (Sell).
Some top-ranked stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) .
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.43 to $4.52. Estimates for 2024 have increased 7 cents to $5.26. NVO carries a Zacks Rank #1 (Strong Buy) at present.
Ligand’s earnings per share estimates for 2023 increased to $4.15 from $3.30 in the past 60 days. LGND beat earnings estimates in one of the last four reported quarters. LGND carries a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
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Vaxcyte (PCVX) Up on Pneumococcal Conjugate Vaccine Data
Vaxcyte, Inc. (PCVX - Free Report) , a clinical-stage vaccine innovation company, saw its shares rise 16% after it released positive data from the phase II study of its 24-Valent pneumococcal conjugate vaccine (PCV) candidate, VAX-24, in adults aged 65 and older.
Concurrently, the company also announced data from the full six-month safety assessment and prespecified pooled immunogenicity analyses from both the phase II study in adults aged 65 and older and the prior phase 1/II study in adults aged 18-64 (phase 1 portion adults aged 18-49, phase II portion adults aged 50-64).
VAX-24, Vaxcyte’s lead broad-spectrum 24-valent PCV candidate, is being studied for the prevention of invasive pneumococcal disease (IPD).
VAX-24 showed robust immune responses across all 24 serotypes (ST) at all doses (1.1mcg, 2.2mcg and 2.2mcg/4.4mcg), confirming prior phase II results in adults aged 50-64.
At the 2.2mcg dose, which Vaxcyte plans to advance to phase III, VAX-24 achieved opsonophagocytic activity (OPA) response non-inferiority criteria for 18 of the 20 STs common with Prevnar 20 (PCV20) and superiority criteria for the four additional VAX-24 STs.
The six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
At this dose, the candidate also showed further improvement in overall immune responses versus PCV20 relative to results from the phase II study in adults in the age group 50-64.
Based on these positive data, Vaxcyte plans to meet with regulators and advance VAX-24 into a pivotal phase III study (top-line data is expected in 2025).
The stock has gained 79.6% in the past year against the industry’s 10.8% decline.
Image Source: Zacks Investment Research
Vaxcyte also plans to announce top-line safety, tolerability and immunogenicity data from the primary three-dose immunization series of the infant phase II study by 2025.
Vaxcyte’s pipeline also includes VAX-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease and VAX-GI, a vaccine program designed to prevent Shigella.
The company also intends to submit an investigational new drug (IND) application to the FDA for VAX-31 in adults in the second half of 2023.
We note that PREVNAR 20 is Pfizer’s (PFE - Free Report) pneumococcal conjugate vaccine. Pfizer generated sales of $6.4 billion in 2022 from the Prevnar family, which includes Prevnar 13/Prevenar 13 (pediatric and adult) and Prevnar 20 (adult,) driven by the adult indications in the U.S. due to strong patient demand following the launch of Prevnar 20 for the eligible adult population.
Zacks Rank and Stocks to Consider
Vaxcyte currently carries a Zacks Rank #4 (Sell).
Some top-ranked stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) .
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.43 to $4.52. Estimates for 2024 have increased 7 cents to $5.26. NVO carries a Zacks Rank #1 (Strong Buy) at present.
Ligand’s earnings per share estimates for 2023 increased to $4.15 from $3.30 in the past 60 days. LGND beat earnings estimates in one of the last four reported quarters. LGND carries a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.