Pfizer announces FDA approval of Braftovi combination
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 20 2024
0mins
Should l Buy PFE?
FDA Approval: Pfizer announced the FDA's approval of Braftovi in combination with cetuximab and mFOLFOX6 for treating metastatic colorectal cancer with a BRAF V600E mutation, based on positive results from the Phase 3 BREAKWATER trial.
Project FrontRunner: This accelerated approval is part of the FDA's Project FrontRunner initiative aimed at facilitating the development of new cancer treatments for advanced stages of the disease, with continued approval dependent on further verification of clinical benefits.
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Analyst Views on PFE
Wall Street analysts forecast PFE stock price to rise
16 Analyst Rating
5 Buy
11 Hold
0 Sell
Moderate Buy
Current: 27.370
Low
24.00
Averages
28.56
High
35.00
Current: 27.370
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.
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- New Application Strategy: Moderna's revised regulatory approach seeks full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, addressing FDA criticisms of its trial design and enhancing the vaccine's market competitiveness.
- Changing Regulatory Environment: The FDA's decision highlights significant shifts in U.S. vaccine regulatory policies, particularly under the leadership of the new Secretary of Health and Human Services, with Moderna's application process facing stricter scrutiny, illustrating the complexities and challenges of vaccine regulation.
See More
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- Increased Transparency: Makary emphasized that OTC sales would bypass insurers and pharmacy benefit managers, potentially lowering drug prices and increasing transparency, with cash prices for OTC medications possibly being lower than patients' copays for prescription drugs, thereby alleviating financial burdens on patients.
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See More
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- Increased Disease Awareness: As awareness of juvenile idiopathic arthritis rises, the total cases in the 7MM are expected to increase from 141,800 in 2025 to 173,000 by 2036, with a CAGR of 1.8%, driving demand for new treatment options.
- Emerging Therapies Launch: Emerging therapies such as SOTYKTU from Bristol-Myers Squibb and BIMZELX from UCB Biopharma are in clinical trials and are expected to transform the market landscape by providing more effective treatment options, thereby enhancing patient quality of life.
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