FDA Greenlights MRK's Keytruda and Keytruda SC Combination for Bladder Cancer Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 24 2025
0mins
Should l Buy PFE?
Source: NASDAQ.COM
FDA Approvals: Merck received FDA approval for both intravenous and subcutaneous formulations of Keytruda in combination with Padcev for treating muscle-invasive bladder cancer in patients ineligible for cisplatin-based chemotherapy.
Clinical Trial Results: The approvals were based on the phase III KEYNOTE-905 trial, which demonstrated a 60% reduction in event-free survival events and a 50% improvement in overall survival when using Keytruda plus Padcev compared to surgery alone.
Market Performance: Despite the positive news, Merck's shares have declined by 1.7% year-to-date, contrasting with a 16.1% rise in the industry, while Keytruda continues to be a significant revenue driver for the company.
Competitor Insights: Other biotech stocks like CorMedix and Castle Biosciences have shown strong performance and positive earnings estimates, with Zacks ranking them higher than Merck, which currently holds a Zacks Rank #3 (Hold).
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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: 27.470
Low
24.00
Averages
28.56
High
35.00
Current: 27.470
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.
Eli Lilly Acquires Orna Therapeutics to Enhance Drug Pipeline
- Market Volatility: Pfizer's stock surged from $33 to nearly $60 in 2020 due to rapid COVID-19 vaccine production, but after a significant drop in 2023, it now trades around $28, indicating the volatility in pharmaceutical demand.
- Patent Expiration Risks: Drug companies face challenges from patent expirations, with typical drug patents lasting 20 years; however, due to lengthy development times, effective market exclusivity often shrinks to just 10 to 12 years, necessitating continuous pipeline replenishment.
- Strategic Acquisition: Eli Lilly announced a $2.4 billion acquisition of Orna Therapeutics, which focuses on innovative drugs that manipulate genes and cells within patients, further solidifying its leadership in the lucrative GLP-1 drug category.
- Collaborative Development: Prior to the acquisition, Lilly entered a $350 million collaboration with a Chinese biotech firm to develop treatments for immune disorders and cancer, showcasing its strategic vision for global innovation in drug development.
See More
Investment Risks and Opportunities in the Pharmaceutical Industry
- Pfizer Vaccine Impact: Pfizer's stock price surged from around $33 to nearly $60 in 2020 due to the rapid production and approval of its COVID-19 vaccine, but demand has since waned, leading to a drop to approximately $28, below pre-pandemic levels, highlighting the volatility in pharmaceutical demand.
- Patent Expiration Risks: Pharmaceutical companies face challenges from patent expirations, where the typical 20-year patent often results in only 10 to 12 years of effective market exclusivity due to lengthy development times, impacting long-term investment returns and competitive positioning.
- Eli Lilly Acquisition Moves: Eli Lilly recently announced a $2.4 billion acquisition of Orna Therapeutics, which focuses on developing innovative drugs that treat diseases within the patient's body, demonstrating the company's proactive strategy in filling its drug pipeline and potentially driving future growth.
- New Drug Development Partnerships: Eli Lilly also entered a $350 million collaboration with a Chinese biotech firm to develop treatments for immune disorders and cancer, further enhancing its competitive edge in the global market, although it was not recommended as a top investment by The Motley Fool.
See More
U.S. Medical Groups Sue CDC to Block Vaccine Advisory Meeting
- Lawsuit Initiated: Several medical groups, including the American Academy of Pediatrics and the American Public Health Association, filed a lawsuit on Friday to prevent the CDC from holding its next vaccine advisory meeting, arguing that the CDC's overhaul of immunization guidelines could jeopardize public health.
- Vaccine Policy Changes: Under Secretary of Health and Human Services Robert F. Kennedy Jr., the CDC recommended earlier this year a significant reduction in the number of diseases covered by the childhood immunization schedule from 17 to 11, raising widespread concerns about the implications for public health.
- Committee Restructuring: Kennedy's abrupt dismissal of all 17 members of the CDC’s Advisory Committee on Immunization Practices in June, followed by the appointment of critics of mRNA vaccines, is viewed as a major interference in vaccine policy that could affect medical practices.
- Public Health Risks: Attorney James Oh stated that this policy change poses a “clear and present danger” to public health and could undermine the functions and missions of healthcare organizations, with Judge Murphy acknowledging the need for a timely decision in this case.
See More
Ongoing Shakeup at HHS with Deputy Secretary Departure
- Leadership Departure: HHS Deputy Secretary Jim O'Neill is set to leave his position, and while he also serves as acting director of the CDC, it remains unclear if this change will affect that role, potentially challenging the continuity of health policies.
- New Oversight Role: An email from HHS Secretary Robert F. Kennedy Jr. indicates that Chris Klomp, Director of Medicare and CMS Deputy Administrator, will now oversee all HHS operations, which could significantly alter the strategic direction of the department.
- Official Reassignments: Several CMS and FDA officials will be promoted to senior counselors at their respective agencies, which may impact the efficiency of drug regulation and policy implementation moving forward.
- Policy Implications: The ongoing shakeup in leadership at HHS raises uncertainties regarding policy execution and drug regulation, particularly in drug approvals and public health responses, potentially affecting market confidence.
See More
Pfizer's Dividend Yield Exceeds Market Average
- Dividend Yield Advantage: Pfizer boasts a dividend yield of 6.3%, and despite a payout ratio exceeding 100%, the company plans to maintain this dividend, reflecting its commitment to shareholder returns and potentially attracting more income-focused investors.
- Patent Cliff Risks: Pfizer faces significant patent expiration risks in 2027 and 2028 for blockbuster drugs like Ibrance, Eliquis, and Vyndaqel, which are expected to lose patent protection, leading to dramatic revenue declines and putting pressure on future growth prospects.
- GLP-1 Drug Competition: Pfizer has fallen behind in the GLP-1 weight loss drug market, with competitors Novo Nordisk and Eli Lilly quickly capturing market share, while Pfizer's internally developed drug was abandoned due to underperformance, necessitating an acquisition to re-enter the race.
- Clinical Trial Progress: Pfizer's GLP-1 candidate PF'3944 is advancing through clinical trials, with data expected to be presented at the American Diabetes Association's Scientific Sessions in June; if results are favorable, this could serve as a catalyst for share price gains and help the company regain competitive footing.
See More
Pfizer's Long-Acting GLP-1 Weight Loss Drug Shows Promising Trial Results
- Clinical Trial Progress: Pfizer's long-acting GLP-1 weight loss drug PF'3944 is undergoing clinical trials, with results expected to be reported at the American Diabetes Association's Scientific Sessions in June, and positive outcomes could serve as a catalyst for stock price increases.
- Stable Dividend Policy: Despite a high dividend yield of 6.3% and a payout ratio exceeding 100%, Pfizer plans to maintain its current dividend level, demonstrating a commitment to shareholder returns and stability amidst financial pressures.
- Market Competition Pressure: Pfizer is trailing behind Novo Nordisk and Eli Lilly in the GLP-1 weight loss drug market, with the former introducing an injection and the latter working on an oral version, prompting Pfizer to acquire another company to re-enter the race, highlighting the intense competition in this sector.
- Future Development Potential: If Pfizer's GLP-1 drug can offer the convenience of monthly injections, it may attract more consumers; despite challenges from patent expirations and market competition, Pfizer has other drugs in development, indicating its potential for long-term survival and growth.
See More
Eli Lilly Acquires Orna Therapeutics to Enhance Drug Pipeline
- Market Volatility: Pfizer's stock surged from $33 to nearly $60 in 2020 due to rapid COVID-19 vaccine production, but after a significant drop in 2023, it now trades around $28, indicating the volatility in pharmaceutical demand.
- Patent Expiration Risks: Drug companies face challenges from patent expirations, with typical drug patents lasting 20 years; however, due to lengthy development times, effective market exclusivity often shrinks to just 10 to 12 years, necessitating continuous pipeline replenishment.
- Strategic Acquisition: Eli Lilly announced a $2.4 billion acquisition of Orna Therapeutics, which focuses on innovative drugs that manipulate genes and cells within patients, further solidifying its leadership in the lucrative GLP-1 drug category.
- Collaborative Development: Prior to the acquisition, Lilly entered a $350 million collaboration with a Chinese biotech firm to develop treatments for immune disorders and cancer, showcasing its strategic vision for global innovation in drug development.
See More
Investment Risks and Opportunities in the Pharmaceutical Industry
- Pfizer Vaccine Impact: Pfizer's stock price surged from around $33 to nearly $60 in 2020 due to the rapid production and approval of its COVID-19 vaccine, but demand has since waned, leading to a drop to approximately $28, below pre-pandemic levels, highlighting the volatility in pharmaceutical demand.
- Patent Expiration Risks: Pharmaceutical companies face challenges from patent expirations, where the typical 20-year patent often results in only 10 to 12 years of effective market exclusivity due to lengthy development times, impacting long-term investment returns and competitive positioning.
- Eli Lilly Acquisition Moves: Eli Lilly recently announced a $2.4 billion acquisition of Orna Therapeutics, which focuses on developing innovative drugs that treat diseases within the patient's body, demonstrating the company's proactive strategy in filling its drug pipeline and potentially driving future growth.
- New Drug Development Partnerships: Eli Lilly also entered a $350 million collaboration with a Chinese biotech firm to develop treatments for immune disorders and cancer, further enhancing its competitive edge in the global market, although it was not recommended as a top investment by The Motley Fool.
See More
U.S. Medical Groups Sue CDC to Block Vaccine Advisory Meeting
- Lawsuit Initiated: Several medical groups, including the American Academy of Pediatrics and the American Public Health Association, filed a lawsuit on Friday to prevent the CDC from holding its next vaccine advisory meeting, arguing that the CDC's overhaul of immunization guidelines could jeopardize public health.
- Vaccine Policy Changes: Under Secretary of Health and Human Services Robert F. Kennedy Jr., the CDC recommended earlier this year a significant reduction in the number of diseases covered by the childhood immunization schedule from 17 to 11, raising widespread concerns about the implications for public health.
- Committee Restructuring: Kennedy's abrupt dismissal of all 17 members of the CDC’s Advisory Committee on Immunization Practices in June, followed by the appointment of critics of mRNA vaccines, is viewed as a major interference in vaccine policy that could affect medical practices.
- Public Health Risks: Attorney James Oh stated that this policy change poses a “clear and present danger” to public health and could undermine the functions and missions of healthcare organizations, with Judge Murphy acknowledging the need for a timely decision in this case.
See More
Ongoing Shakeup at HHS with Deputy Secretary Departure
- Leadership Departure: HHS Deputy Secretary Jim O'Neill is set to leave his position, and while he also serves as acting director of the CDC, it remains unclear if this change will affect that role, potentially challenging the continuity of health policies.
- New Oversight Role: An email from HHS Secretary Robert F. Kennedy Jr. indicates that Chris Klomp, Director of Medicare and CMS Deputy Administrator, will now oversee all HHS operations, which could significantly alter the strategic direction of the department.
- Official Reassignments: Several CMS and FDA officials will be promoted to senior counselors at their respective agencies, which may impact the efficiency of drug regulation and policy implementation moving forward.
- Policy Implications: The ongoing shakeup in leadership at HHS raises uncertainties regarding policy execution and drug regulation, particularly in drug approvals and public health responses, potentially affecting market confidence.
See More
Pfizer's Dividend Yield Exceeds Market Average
- Dividend Yield Advantage: Pfizer boasts a dividend yield of 6.3%, and despite a payout ratio exceeding 100%, the company plans to maintain this dividend, reflecting its commitment to shareholder returns and potentially attracting more income-focused investors.
- Patent Cliff Risks: Pfizer faces significant patent expiration risks in 2027 and 2028 for blockbuster drugs like Ibrance, Eliquis, and Vyndaqel, which are expected to lose patent protection, leading to dramatic revenue declines and putting pressure on future growth prospects.
- GLP-1 Drug Competition: Pfizer has fallen behind in the GLP-1 weight loss drug market, with competitors Novo Nordisk and Eli Lilly quickly capturing market share, while Pfizer's internally developed drug was abandoned due to underperformance, necessitating an acquisition to re-enter the race.
- Clinical Trial Progress: Pfizer's GLP-1 candidate PF'3944 is advancing through clinical trials, with data expected to be presented at the American Diabetes Association's Scientific Sessions in June; if results are favorable, this could serve as a catalyst for share price gains and help the company regain competitive footing.
See More
Pfizer's Long-Acting GLP-1 Weight Loss Drug Shows Promising Trial Results
- Clinical Trial Progress: Pfizer's long-acting GLP-1 weight loss drug PF'3944 is undergoing clinical trials, with results expected to be reported at the American Diabetes Association's Scientific Sessions in June, and positive outcomes could serve as a catalyst for stock price increases.
- Stable Dividend Policy: Despite a high dividend yield of 6.3% and a payout ratio exceeding 100%, Pfizer plans to maintain its current dividend level, demonstrating a commitment to shareholder returns and stability amidst financial pressures.
- Market Competition Pressure: Pfizer is trailing behind Novo Nordisk and Eli Lilly in the GLP-1 weight loss drug market, with the former introducing an injection and the latter working on an oral version, prompting Pfizer to acquire another company to re-enter the race, highlighting the intense competition in this sector.
- Future Development Potential: If Pfizer's GLP-1 drug can offer the convenience of monthly injections, it may attract more consumers; despite challenges from patent expirations and market competition, Pfizer has other drugs in development, indicating its potential for long-term survival and growth.
See More
