Pfizer Stock Price, News & Analysis

ViiV Healthcare announced 48-week results from the DOLCE study showing that the 2-drug HIV regimen Dovato (dolutegravir/lamivudine) demonstrated comparable efficacy to 3-drug therapy in treating advanced HIV patients. The study involved 230 treatment-naïve individuals with low CD4 counts, with 82% of Dovato patients and 80% of 3-drug therapy patients achieving viral suppression. A post-hoc analysis confirmed Dovato's non-inferiority regardless of baseline viral load. The study population included severely immunosuppressed patients, with 43% having CD4 counts below 100 cells/mL and 69% having high viral loads. Safety profiles were comparable between both treatment groups.

ViiV Healthcare will present 42 abstracts at HIV Glasgow 2024, showcasing data from its HIV treatment and prevention portfolio. Key presentations include analyses of Vocabria + Rekambys (cabotegravir + rilpivirine LA) in over 10,000 people, Dovato in more than 50,000 people, and Apretude in over 1,300 people. The data includes real-world evidence, cost-effectiveness studies, and findings from the DOLCE study exploring the efficacy of two-drug regimen versus three-drug regimen in people with advanced HIV. New findings from the BANNER study on VH3810109, a broadly neutralizing antibody, will also be presented.

Pfizer (NYSE: PFE) has announced a public webcast featuring Aamir Malik, Chief U.S. Commercial Officer and Executive Vice President, at the UBS Global Healthcare Conference on November 13, 2024, at 12:30 p.m. PST.

Investors and the public can access the webcast through www.pfizer.com/investors, where registration details are currently available. A transcript and replay will be accessible within 24 hours after the live discussion and remain available for at least 90 days.

Pfizer reported strong Q3 2024 results with revenues of $17.7 billion, representing 32% year-over-year operational growth. Excluding Paxlovid and Comirnaty, revenues grew 14% operationally. The company raised its full-year 2024 guidance, with revenue now expected between $61.0-$64.0 billion and adjusted EPS of $2.75-$2.95. Q3 reported diluted EPS was $0.78, while adjusted diluted EPS reached $1.06. Strong performance was driven by exceptional growth in Oncology products and heightened Paxlovid demand. The company is on track to deliver net cost savings of at least $5.5 billion from cost reduction initiatives.

Pfizer announced that the CDC's Advisory Committee on Immunization Practice (ACIP) voted to expand pneumococcal vaccine recommendations, including PREVNAR 20®, to all adults aged 50 and older. The vaccine protects against 20 serotypes responsible for the majority of invasive pneumococcal disease cases. In the U.S., these serotypes cause over 2,000 deaths and more than 65,000 cases of invasive pneumococcal disease annually in adults aged 50-64. The recommendation includes adults aged 19-49 with certain underlying conditions who haven't received a PCV or have unknown vaccination history.

The U.S. FDA has approved Pfizer's ABRYSVO®, a bivalent RSV prefusion F vaccine, for preventing lower respiratory tract disease (LRTD) caused by RSV in adults aged 18-59 at increased risk. This marks the first and only RSV vaccine indicated for adults under 50. The approval is based on data from the pivotal Phase 3 MONeT trial, which evaluated the vaccine's safety, tolerability, and immunogenicity. ABRYSVO also remains the sole RSV immunization approved for pregnant individuals at 32-36 weeks gestation, protecting infants up to 6 months. Pfizer aims to publish the MONeT trial results in a peer-reviewed journal and present them at an upcoming scientific conference.

Starboard Value LP, an investment adviser, announced that its CEO Jeffrey Smith presented at the 2024 Active-Passive Investor Summit. The presentation highlighted value creation opportunities at three companies: Kenvue Inc. (NYSE: KVUE), Pfizer Inc. (NYSE: PFE), and Salesforce Inc. (NYSE: CRM).

The full presentation and individual company presentations are available on Starboard's website. Starboard Value LP focuses on investing in deeply undervalued companies and actively engages with management teams and boards to unlock shareholder value.

ViiV Healthcare presented new real-world evidence and implementation data for Apretude (cabotegravir long-acting), the only approved long-acting HIV PrEP, at IDWeek 2024. Key findings include:

1. OPERA and Trio Health cohort studies showed >99% effectiveness in preventing HIV acquisition among nearly 1,300 individuals.

2. The PILLAR implementation study demonstrated reduced stigma and anxiety among 200 users compared to daily oral PrEP.

3. Trio Health cohort: Zero HIV diagnoses during follow-up, 83% persistence on CAB LA for PrEP injections.

4. OPERA study: 99.7% effectiveness, high adherence, and timely injections in a diverse U.S. cohort.

5. PILLAR study: Lower rates of PrEP stigma and anxiety, high acceptability, and convenience reported by users.

Pfizer (NYSE: PFE) announced FDA approval of HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis to prevent or reduce bleeding episodes in adults and adolescents 12+ with hemophilia A or B without inhibitors. HYMPAVZI is the first anti-TFPI approved in the U.S. for hemophilia A or B treatment and the first to be administered via a pre-filled, auto-injector pen.

Key points:

• Once-weekly subcutaneous dosing
• 35% and 92% reduction in annualized bleeding rate compared to routine prophylaxis and on-demand treatment, respectively
• Common adverse reactions: injection site reactions, headache, and pruritus
• Approval based on Phase 3 BASIS trial results

This approval marks Pfizer's second hemophilia treatment approved by the FDA this year, following BEQVEZ™ for hemophilia B gene therapy.