Pfizer Inc NYSE:PFE Price, Chart, News & Insight

NYSE:PFE

Pfizer and BioNTech Win FDA Approval for Updated XFG COVID-19 Vaccine

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) received U.S. FDA approval for their updated 2026–2027 COMIRNATY COVID-19 vaccine targeting the XFG variant.

The updated vaccine is approved for adults aged 65 and older and for people aged 5 to 64 who have at least one underlying condition that increases their risk of severe COVID-19. The XFG formulation follows FDA guidance aimed at more closely matching currently circulating variants.

According to the companies, supporting data showed strong immune responses against several circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1. Pfizer and BioNTech said shipments will begin immediately, with the vaccine expected to reach U.S. pharmacies, hospitals and clinics within days.

The approval is commercially positive for both companies because it keeps their COVID-19 vaccine franchise positioned for the upcoming U.S. vaccination season. However, the financial impact will ultimately depend on vaccination rates and demand for updated COVID-19 shots.

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European Investor 08-28-26

Pfizer and Valneva Lyme Disease Vaccine Application Accepted for EMA Review

Pfizer (NYSE: PFE) and Valneva (NASDAQ: VALN) announced Friday that the European Medicines Agency has validated the Marketing Authorization Application for their experimental Lyme disease vaccine, marking a significant regulatory milestone for the program.

The EMA validation means the agency will now begin formally assessing PF-07307405, a six-valent vaccine designed to prevent Lyme disease in people aged five years and older. The application is supported by results from the Phase 3 VALOR trial.

## Phase 3 Trial Shows More Than 70% Efficacy

In the VALOR trial, the vaccine demonstrated efficacy of more than 70% in preventing Lyme disease and was generally well tolerated, with no safety concerns identified. The randomized study included 9,437 participants aged five and older across the U.S., Canada and Europe.

PF-07307405 targets six variants of outer surface protein A, or OspA, found on the Borrelia bacteria responsible for Lyme disease. The approach is designed to generate antibodies that prevent the bacteria from being transmitted from an infected tick to a vaccinated person.

Potential First Lyme Disease Vaccine Currently Available to Humans

The regulatory milestone could be commercially significant because there are currently no approved human vaccines against Lyme disease. Pfizer and Valneva's candidate is the most advanced Lyme disease vaccine currently in clinical development, with two pivotal Phase 3 studies completed. ([Pfizer][1])

The potential market is substantial. Pfizer said more than 200 million people live in Lyme disease risk areas in Europe, while approximately 132,000 cases are reported annually across European countries with surveillance systems.

Pfizer and Valneva have jointly developed the vaccine under a collaboration established in 2020. If regulatory approval is ultimately secured, Pfizer will be responsible for manufacturing and commercializing the product.

EMA validation does not constitute approval, but it confirms that the application is sufficiently complete to enter the formal regulatory review process. The next major catalyst for the program will therefore be the outcome of the EMA assessment.

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Global Finance News 08-14-26

Pfizer Stock Slips 0.54% Despite Higher Revenue Guidance and Strong Product Growth

Pfizer (NYSE: PFE) shares slipped 0.54% on Tuesday despite reporting solid second-quarter results, raising the midpoint of its full-year revenue guidance and highlighting continued momentum from its newer product portfolio and late-stage pipeline.

Second-quarter revenue increased 3% year over year to $15.0 billion, while operational revenue growth reached 1%. Excluding COVID-19 products Comirnaty and Paxlovid, operational revenue grew 5%, supported by strong performance from recently launched and acquired products, which posted 18% operational growth. Pfizer reported a GAAP loss per share of $0.04 and adjusted EPS of $0.77, with reported results impacted by $4.3 billion in non-cash intangible asset impairment charges.

Growth Portfolio Continues to Offset COVID Declines

Pfizer's underlying business continued to strengthen as growth from key products more than offset declining COVID-related sales.

Eliquis revenue benefited from strong global demand and favorable pricing, while Padcev, the Vyndaqel family and Lorbrena all delivered strong growth. Meanwhile, Paxlovid revenue declined 95% and Comirnaty sales fell 34% as pandemic-related demand continued to normalize.

The company also emphasized continued progress in its obesity and oncology businesses, alongside several expected pivotal clinical readouts over the next 12 months.

Guidance Raised While Cost Savings Expand

Reflecting stronger-than-expected demand for non-COVID products, Pfizer raised the midpoint of its 2026 revenue guidance by $500 million to a range of $60.5 billion to $62.5 billion.

The company reaffirmed its adjusted EPS guidance of $2.80 to $3.00 despite absorbing an expected $0.10 per-share impact from its Innovent Biologics transaction. Pfizer also announced an additional $2.5 billion in anticipated productivity savings to be realized between 2027 and 2029 as part of its ongoing efficiency initiatives.

What to Watch

Despite the modest decline in the stock, investors were encouraged by Pfizer's improving underlying business performance and higher revenue outlook. Going forward, markets will closely monitor continued growth from its non-COVID portfolio, execution of its productivity initiatives, progress in obesity and oncology programs, and upcoming late-stage clinical trial results that could support the company's next phase of growth.

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European Investor 08-04-26

Pfizer (PFE) Stock Rises After FDA Expands PADCEV Plus Keytruda Approval for Muscle-Invasive Bladder Cancer

Pfizer (NYSE: PFE) shares gained about 1.1% after the U.S. Food and Drug Administration approved PADCEV in combination with Keytruda as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility.

The expanded approval marks the first platinum-free treatment regimen approved for MIBC across all eligible patient groups, potentially establishing a new standard of care in earlier-stage bladder cancer.

The decision was supported by results from the Phase 3 EV-304 (KEYNOTE-B15) trial, in which PADCEV plus Keytruda demonstrated significant improvements over standard chemotherapy. The combination reduced the risk of tumor recurrence, progression, or death by 47%, lowered the risk of death by 35%, and achieved a pathological complete response rate of 55.8%, compared with 32.5% for standard chemotherapy.

The approval further expands the commercial opportunity for PADCEV, which Pfizer co-develops with Astellas, following its success in advanced bladder cancer. Investors also view the label expansion as strengthening Pfizer’s oncology portfolio by extending the therapy into an earlier-stage, potentially curative treatment setting.

Key factors supporting the stock include:

* The FDA approved PADCEV plus Keytruda for muscle-invasive bladder cancer regardless of cisplatin eligibility.
* The regimen became the first platinum-free treatment approved for this patient population.
* Phase 3 data showed a 47% reduction in the risk of recurrence, progression, or death and a 35% reduction in mortality versus standard chemotherapy.
* The expanded indication broadens PADCEV’s commercial potential and reinforces Pfizer’s long-term oncology growth strategy.

The regulatory approval improved investor sentiment, helping Pfizer shares move higher during the trading session.

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WS News 07-13-26

Pfizer Holds Steady: Solid Q1 Beat, Stock Barely Moves

Tuesday, May 5, 2026

In a sea of earnings-day volatility — Shopify down 7%, Eaton down 6.5% — Pfizer's barely-a-blip 0.27% decline today is almost a compliment. The pharmaceutical giant posted a clean Q1 2026 beat and reaffirmed full-year guidance, delivering exactly what a rebuilding Pfizer needed: no surprises.

The Numbers

Q1 revenues came in at $14.5 billion, up 5% year-over-year (2% operationally), clearing analyst expectations. Reported EPS was $0.47, while adjusted EPS of $0.75 comfortably topped the consensus. Pfizer reaffirmed its full-year 2026 guidance of $59.5–$62.5 billion in revenue and adjusted EPS of $2.80–$3.00 — unchanged from prior guidance.

The headline growth rate of 5% looks modest, but the underlying picture is considerably stronger once COVID-era products are stripped out. Excluding Comirnaty and Paxlovid — both in steep structural decline — revenues grew 7% operationally. More tellingly, revenues from Pfizer's launched and acquired products grew 22% operationally, underscoring that the portfolio transition away from COVID dependency is gaining real traction.

What's Working

The non-COVID portfolio is firing on multiple cylinders. Padcev (bladder cancer) rose 39% operationally on expanding market share. Nurtec (migraine) jumped 41%, driven by strong U.S. demand. Lorbrena (lung cancer) gained 32% on growing first-line patient share. Oncology biosimilars surged 52%, partly on one-time tailwinds but also reflecting genuine supply recovery. Eliquis (blood thinner) grew 8% globally despite some international pricing pressure. Abrysvo (RSV vaccine) also posted 31% growth internationally.

On the cost side, SI&A expenses fell 4% operationally, reflecting tighter, more targeted marketing spend — a sign of the operational discipline CFO David Denton has emphasized. R&D spending rose 12%, directed primarily at oncology and obesity pipelines, two areas CEO Albert Bourla singled out as where Pfizer expects to lead.

What's Dragging

Comirnaty (COVID vaccine) fell 59% operationally and Paxlovid dropped 63%, as COVID infections declined globally and government procurement normalized. Cost of sales as a percentage of revenue climbed to 24.6% from 20.7% a year ago, driven partly by the non-recurrence of a one-time royalty estimate adjustment in 2025 and FX headwinds. Adjusted EPS of $0.75 was also down 18% from $0.92 in Q1 2025, a reminder that the earnings base built during the COVID windfall years is still unwinding.

No share repurchases are planned for 2026, as Pfizer continues to de-lever its balance sheet — a prudent but shareholder-unfriendly near-term posture.

The Takeaway

Pfizer's flat reaction is the right one. This is a company mid-transition: COVID revenues fading, a new growth engine in oncology and obesity building, and pipeline momentum — approximately 20 key pivotal studies on track to start in 2026 — beginning to show up in the numbers. Today's print doesn't resolve Pfizer's long-term story, but it doesn't complicate it either. For now, steady is good enough.

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WS Investor 05-05-26

Pfizer Inc. announced it has reached settlement agreements with generic drugmakers Dexcel Pharma, Hikma Pharmaceuticals, and Cipla regarding patent litigation over its heart disease treatment VYNDAMAX. The agreements extend the drug’s U.S. patent protection to June 2031, delaying expected generic competition.

As a result, Pfizer now anticipates VYNDAMAX revenues to remain relatively stable from 2028 through mid-2031, instead of declining earlier as previously expected. The drug currently holds a strong market position, accounting for around 75% of prescriptions in its category.

The company emphasized that the outcome supports both patient access and the protection of its intellectual property, while ongoing litigation could still impact future developments.

Source: Business Wire

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The Investor 04-28-26

Bristol Myers Squibb and Pfizer announced a collaboration with Mark Cuban Cost Plus Drug Company to offer Eliquis (apixaban) directly to U.S. patients through the online platform, expanding access to the widely prescribed blood thinner.

Starting April 27, 2026, a 30-day supply of Eliquis will be available for $345, providing a lower-cost option for cash-paying patients and increasing pricing transparency. The move builds on earlier direct-to-patient initiatives aimed at improving affordability and access.

The companies said the partnership supports efforts to reduce barriers to essential medications, particularly for patients managing conditions such as atrial fibrillation and blood clots.
Business Wire

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The Investor 04-26-26

Pfizer Inc. (NYSE: PFE) declared a $0.43 second-quarter 2026 dividend on the common stock, payable June 12, 2026, to holders of the Common Stock of record at the close of business on May 8, 2026.

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Global Finance News 04-24-26

Pfizer and Valneva announced positive Phase 3 results for their Lyme disease vaccine candidate, showing efficacy above 70% in preventing the disease in individuals aged five and older.

The investigational vaccine demonstrated strong efficacy of around 73–75% in key analyses and was well tolerated with no major safety concerns, supporting plans for regulatory submissions.

The results mark a significant step toward the first approved human vaccine for Lyme disease, addressing a growing unmet medical need in North America and Europe.

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WS Investor 03-23-26

Pfizer reported positive Phase 3 results showing that the combination of TALZENNA and XTANDI significantly improved radiographic progression-free survival in patients with metastatic hormone-sensitive prostate cancer carrying HRR gene mutations . The study met its primary endpoint with a clinically meaningful reduction in the risk of disease progression or death compared to standard treatment.

The treatment demonstrated consistent benefits across both BRCA and non-BRCA patient groups, while interim data also संकेत a strong trend toward improved overall survival. Additional secondary endpoints, including response rates and time to PSA progression, also showed favorable outcomes.

Pfizer plans to engage with global regulators to potentially expand the indication of TALZENNA to earlier-stage prostate cancer, highlighting the combination’s potential to shift treatment earlier in the disease course and reinforce the company’s precision oncology strategy.
Business Wire

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Global Finance News 03-19-26

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