FDA Approves Priority Review for HYMPAVZI® (Marstacimab) SBLA to Address Significant Medical Needs in Hemophilia A and B Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2d ago
0mins
Should l Buy PFE?
Source: moomoo
FDA Grants Priority Review: The FDA has granted priority review for the treatment of two patient populations with significant medical needs using HYM-PAVZ® (MARS-TACIMAB).
Focus on Hemophilia A: The review specifically targets patients with Hemophilia A, indicating a critical advancement in treatment options for this condition.
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Analyst Views on PFE
Wall Street analysts forecast PFE stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for PFE is 28.56 USD with a low forecast of 24.00 USD and a high forecast of 35.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
16 Analyst Rating
5 Buy
11 Hold
0 Sell
Moderate Buy
Current: 26.490
Low
24.00
Averages
28.56
High
35.00
Current: 26.490
Low
24.00
Averages
28.56
High
35.00
About PFE
Pfizer Inc. is a research-based, global biopharmaceutical company. The Company is engaged in the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide. Its Biopharma segment includes the Pfizer U.S. Commercial Division, and the Pfizer International Commercial Division. Its product categories include oncology, primary care and specialty care. Its oncology products include Ibrance, Xtandi, Padcev, Adcetris, Inlyta, Lorbrena, Bosulif, Tukysa, Braftovi, Mektovi, Orgovyx, Elrexfio, Tivdak and Talzenna. Its primary care products include Eliquis, Nurtec ODT/Vydura, Zavzpret, the Prevnar family, Comirnaty, Abrysvo, FSME/IMMUN-TicoVac, Nimenrix, Trumenba, and Paxlovid. Its specialty care products include Xeljanz, Enbrel (outside the United States and Canada), Inflectra, Abrilada, Cibinqo, Litfulo, Eucrisa, Velsipity, the Vyndaqel family, Genotropin, BeneFIX, Xyntha, Somavert, Ngenla, Hympavzi, Sulperazon, Zavicefta, Octagam and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
PFIZER - FDA SCHEDULES PDUFA DECISION DATE FOR HYMPAVZI IN SECOND QUARTER OF 2026
FDA Action Date: The FDA has set an action date for the approval of HYMPAZIV, which is scheduled for the second quarter of 2026.
HYMPAZIV Overview: HYMPAZIV is a medication developed by Pfizer, indicating ongoing advancements in pharmaceutical treatments.
See More
FDA Approves Priority Review for HYMPAVZI® (Marstacimab) SBLA to Address Significant Medical Needs in Hemophilia A and B Patients
FDA Grants Priority Review: The FDA has granted priority review for the treatment of two patient populations with significant medical needs using HYM-PAVZ® (MARS-TACIMAB).
Focus on Hemophilia A: The review specifically targets patients with Hemophilia A, indicating a critical advancement in treatment options for this condition.
See More
Pfizer Launches TrumpRx Program to Reduce Drug Costs
- Significant Drug Price Reductions: Pfizer's launch of the TrumpRx program offers substantial discounts on over 30 medications, with savings up to 85% and an average of 50%, aimed at alleviating the financial burden on American patients and enhancing their access to healthcare.
- Historic Agreement Support: This initiative is part of Pfizer's landmark Most Favored Nation agreement with the Trump administration, designed to lower prescription drug prices for U.S. patients while reinforcing America's leadership in global pharmaceutical innovation.
- Broad Patient Benefits: More than 100 million patients will benefit from discounted access to these medications, which treat a variety of conditions including migraines, rheumatoid arthritis, and menopause, significantly improving their quality of life and healthcare options.
- Enhanced Partnerships: Pfizer's collaboration with GoodRx allows patients to use coupons at nearly any U.S. pharmacy or opt for home delivery services, further increasing flexibility and convenience in accessing medications.
See More
Healthcare Sector Earnings Overview
- Earnings Progress: As of February 6, 23 healthcare companies reported earnings, bringing the sector's overall reporting progress to 38%, indicating stability in industry performance and heightened investor interest.
- Pfizer Earnings Highlight: Pfizer (PFE) posted a strong Q4 with revenue of $17.6 billion, exceeding expectations; however, its shares fell due to projected revenue contraction in 2026, reflecting market concerns about future growth.
- AbbVie Outperformance: AbbVie (ABBV) reported revenue of $16.62 billion and earnings per share of $2.71, surpassing Wall Street forecasts, driven by strong performance from its flagship product Humira, with a projected total sales growth of 9.5% for the year, boosting market confidence.
- Merck's Dismal Outlook: Merck (MERK) reported a solid Q4 with revenue of $16.4 billion and EPS of $2.04, both beating expectations; however, its 2026 outlook fell short of Wall Street estimates, leading to a decline in share price and reflecting cautious market sentiment regarding future growth.
See More
Pfizer CEO Discusses Progress on Weight-Loss Drugs
- Weight-Loss Drug Development: Pfizer's GLP-1 weight-loss drug is targeted for market entry in 2028, with CEO Albert Bourla stating that the 9.6 mg high dose will be tested in phase three trials, predicting that weight loss at week 28 will surpass competitors.
- Market Demand Analysis: Despite the popularity of GLP-1 medications, 40% to 50% of patients discontinue use within a year, particularly among those over 65, indicating a significant unmet medical need in the market.
- Diverse Product Portfolio: Pfizer's portfolio includes monthly and quarterly injectable medications that combine GLP-1 and Amylin, aiming to enhance patient tolerability and convenience, thereby strengthening its competitive position.
- Strategic Positioning: Pfizer plans to leverage its diverse injectable and oral drug combinations, utilizing the company's robust R&D capabilities to aim for a leading role in the rapidly growing weight-loss drug market.
See More
TrumpRx Launches, But Few Will Reap Its Benefits.
Limited Initial Benefits: Only a small segment of consumers is expected to benefit from the TrumpRx initiative aimed at reducing drug costs.
Expert Opinions: Experts suggest that the initiative may not provide widespread relief for all Americans regarding prescription drug prices.
See More
PFIZER - FDA SCHEDULES PDUFA DECISION DATE FOR HYMPAVZI IN SECOND QUARTER OF 2026
FDA Action Date: The FDA has set an action date for the approval of HYMPAZIV, which is scheduled for the second quarter of 2026.
HYMPAZIV Overview: HYMPAZIV is a medication developed by Pfizer, indicating ongoing advancements in pharmaceutical treatments.
See More
FDA Approves Priority Review for HYMPAVZI® (Marstacimab) SBLA to Address Significant Medical Needs in Hemophilia A and B Patients
FDA Grants Priority Review: The FDA has granted priority review for the treatment of two patient populations with significant medical needs using HYM-PAVZ® (MARS-TACIMAB).
Focus on Hemophilia A: The review specifically targets patients with Hemophilia A, indicating a critical advancement in treatment options for this condition.
See More
Pfizer Launches TrumpRx Program to Reduce Drug Costs
- Significant Drug Price Reductions: Pfizer's launch of the TrumpRx program offers substantial discounts on over 30 medications, with savings up to 85% and an average of 50%, aimed at alleviating the financial burden on American patients and enhancing their access to healthcare.
- Historic Agreement Support: This initiative is part of Pfizer's landmark Most Favored Nation agreement with the Trump administration, designed to lower prescription drug prices for U.S. patients while reinforcing America's leadership in global pharmaceutical innovation.
- Broad Patient Benefits: More than 100 million patients will benefit from discounted access to these medications, which treat a variety of conditions including migraines, rheumatoid arthritis, and menopause, significantly improving their quality of life and healthcare options.
- Enhanced Partnerships: Pfizer's collaboration with GoodRx allows patients to use coupons at nearly any U.S. pharmacy or opt for home delivery services, further increasing flexibility and convenience in accessing medications.
See More
Healthcare Sector Earnings Overview
- Earnings Progress: As of February 6, 23 healthcare companies reported earnings, bringing the sector's overall reporting progress to 38%, indicating stability in industry performance and heightened investor interest.
- Pfizer Earnings Highlight: Pfizer (PFE) posted a strong Q4 with revenue of $17.6 billion, exceeding expectations; however, its shares fell due to projected revenue contraction in 2026, reflecting market concerns about future growth.
- AbbVie Outperformance: AbbVie (ABBV) reported revenue of $16.62 billion and earnings per share of $2.71, surpassing Wall Street forecasts, driven by strong performance from its flagship product Humira, with a projected total sales growth of 9.5% for the year, boosting market confidence.
- Merck's Dismal Outlook: Merck (MERK) reported a solid Q4 with revenue of $16.4 billion and EPS of $2.04, both beating expectations; however, its 2026 outlook fell short of Wall Street estimates, leading to a decline in share price and reflecting cautious market sentiment regarding future growth.
See More
Pfizer CEO Discusses Progress on Weight-Loss Drugs
- Weight-Loss Drug Development: Pfizer's GLP-1 weight-loss drug is targeted for market entry in 2028, with CEO Albert Bourla stating that the 9.6 mg high dose will be tested in phase three trials, predicting that weight loss at week 28 will surpass competitors.
- Market Demand Analysis: Despite the popularity of GLP-1 medications, 40% to 50% of patients discontinue use within a year, particularly among those over 65, indicating a significant unmet medical need in the market.
- Diverse Product Portfolio: Pfizer's portfolio includes monthly and quarterly injectable medications that combine GLP-1 and Amylin, aiming to enhance patient tolerability and convenience, thereby strengthening its competitive position.
- Strategic Positioning: Pfizer plans to leverage its diverse injectable and oral drug combinations, utilizing the company's robust R&D capabilities to aim for a leading role in the rapidly growing weight-loss drug market.
See More
TrumpRx Launches, But Few Will Reap Its Benefits.
Limited Initial Benefits: Only a small segment of consumers is expected to benefit from the TrumpRx initiative aimed at reducing drug costs.
Expert Opinions: Experts suggest that the initiative may not provide widespread relief for all Americans regarding prescription drug prices.
See More
