Pfizer Inc. - PFE STOCK NEWS

Pfizer (NYSE: PFE) announced positive topline results from the Phase 3 AFFINE study evaluating giroctocogene fitelparvovec, a gene therapy for hemophilia A. The study met its primary objective of non-inferiority and superiority in total annualized bleeding rate (ABR) compared to routine Factor VIII replacement prophylaxis. Key findings include:

- Significant reduction in mean total ABR (1.24 vs 4.73)
- 84% of participants maintained FVIII activity >5% at 15 months post-infusion
- 98.3% reduction in mean treated ABR (4.08 to 0.07)
- Generally well-tolerated safety profile

Pfizer plans to discuss these data with regulatory authorities and advance the therapy to address the treatment burden for hemophilia A patients.

ViiV Healthcare announced positive 48-week results from the PASO DOBLE study, comparing the 2-drug regimen Dovato (dolutegravir/lamivudine) to the 3-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate) for HIV-1 treatment. The study showed that:

1. Dovato demonstrated non-inferior efficacy in maintaining viral suppression compared to Biktarvy.

2. Participants taking Dovato experienced significantly less weight gain compared to those on Biktarvy.

3. Safety profiles were comparable between both regimens.

These findings support Dovato as an effective treatment option for virologically-suppressed adults living with HIV, addressing concerns about treatment-related weight gain.

CytoReason, a leader in computational disease modeling, has secured $80 million in funding from OurCrowd, NVIDIA, Pfizer, and Thermo Fisher Scientific. The investment will be used to expand disease models, grow proprietary data, and establish a US hub in Cambridge, Massachusetts. CytoReason's technology provides molecular-level insights and AI tools to help pharma companies make data-driven R&D decisions, improving the probability of phase 2 success.

The company has partnerships with six of the world's top ten pharma companies and has published numerous scientific articles in prestigious journals. This funding round highlights the growing importance of AI and data modeling in pharmaceutical R&D, with investors recognizing CytoReason's potential to revolutionize drug development processes.

ViiV Healthcare, majority owned by GSK, will present 25 abstracts at the 25th International AIDS Conference in Munich, including the largest head-to-head randomized clinical trial comparing their 2-drug regimen Dovato against the 3-drug regimen Biktarvy. Key presentations include:

1. PASO-DOBLE study: 48-week findings on treatment efficacy, safety, and weight changes for Dovato vs Biktarvy

2. Pregnancy data for Apretude (cabotegravir long-acting injectable) for PrEP

3. Phase I findings of VH184, a third-generation integrase inhibitor with potential for ultra long-acting applications

4. Real-world evidence for long-acting treatment regimen Cabenuva

These presentations underscore ViiV Healthcare's leadership in developing long-acting and 2-drug regimens for HIV treatment and prevention, addressing patient needs beyond viral suppression.

Pfizer announced progress in developing a once-daily formulation of the oral GLP-1 receptor agonist danuglipron, showing promising pharmacokinetic data for several candidates. Based on the ongoing pharmacokinetic study NCT06153758, Pfizer selected its preferred formulation and will conduct dose optimization studies in the second half of 2024. Danuglipron, which has shown good efficacy in its twice-daily form, is pivotal in Pfizer's obesity treatment pipeline. The ongoing study has confirmed a supportive pharmacokinetic profile for once-daily dosing and a consistent safety profile with no liver enzyme elevations in over 1,400 participants. The company aims to advance danuglipron into registration-enabling studies to address the medical needs of people living with obesity.

Pfizer (NYSE: PFE) has announced the commencement of a search for a successor to Dr. Mikael Dolsten, their Chief Scientific Officer and President of Research & Development. Dr. Dolsten, who has been with Pfizer for over 15 years, will assist in the transition and stay on until a successor is appointed. During his tenure, over 35 drugs and vaccines were approved, including significant accomplishments like the COVID-19 vaccine. The search process is expected to take several months, extending into early next year. Pfizer’s CEO, Albert Bourla, praised Dr. Dolsten for his contributions to the company and the scientific community.

Pfizer announced the election of Cyrus Taraporevala to its Board of Directors, effective immediately. At 57, Mr. Taraporevala will join Pfizer’s Audit and Compensation Committees. He brings extensive experience from his tenure as President and CEO at State Street Global Advisors (2017-2022) and prior roles at Fidelity, BNY Mellon, Legg Mason, Citigroup, and McKinsey & Company. He currently serves on the boards of Shell and Bridgepoint Group. Pfizer CEO Albert Bourla praised Mr. Taraporevala's investment management and global operations expertise, stating it will benefit Pfizer and its shareholders. Mr. Taraporevala holds a Bachelor of Commerce from the University of Bombay and an MBA from Cornell University.

Pfizer has announced a third-quarter 2024 cash dividend of $0.42 per share, marking the company's 343rd consecutive quarterly dividend. The dividend is payable on September 3, 2024, to shareholders of record as of July 26, 2024. This announcement underscores Pfizer's commitment to returning value to its shareholders.

Pfizer (NYSE: PFE) invites investors and the general public to join a webcast conference call on July 30, 2024, at 10:30 a.m. EDT. The call will discuss the company's Second Quarter 2024 Performance Report. Interested parties can access the webcast and the performance report via Pfizer's investor website. Registration is recommended prior to the event. The call can also be accessed by dialing specific numbers for the United States/Canada and international participants. A transcript and replay will be available on Pfizer's website for 90 days post-event.