Pfizer Stock Price, News & Analysis

Pfizer Inc. (NYSE: PFE) announced positive topline results from the final overall survival (OS) analysis of the TALAPRO-2 study. The study evaluated TALZENNA® (talazoparib), an oral PARP inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC).

Results showed a statistically significant and clinically meaningful improvement in OS for all patients and those with homologous recombination repair (HRR) gene-mutated mCRPC, compared to XTANDI alone. This makes TALZENNA plus XTANDI the first and only PARP inhibitor-ARPI combination to significantly improve survival in mCRPC patients, regardless of mutation status.

The safety profile was consistent with known profiles of each medicine. Detailed results will be presented at an upcoming medical congress and shared with global health authorities for potential label updates.

Pfizer Inc. (NYSE: PFE) has announced that its board of directors has declared a $0.42 fourth-quarter 2024 dividend on the company's common stock. The dividend will be payable on December 2, 2024, to shareholders of record at the close of business on November 8, 2024. This marks Pfizer's 344th consecutive quarterly dividend, highlighting the company's commitment to returning value to shareholders.

Pfizer, a global biopharmaceutical company, focuses on developing innovative medicines and vaccines to improve people's lives. With a 175-year history, Pfizer strives to set industry standards in quality, safety, and value in healthcare product development. The company collaborates with various stakeholders to expand access to affordable healthcare worldwide.

Pfizer Inc. (NYSE: PFE) will present 49 abstracts from company- and collaborator-led studies at IDWeek 2024 in Los Angeles from October 16-19, 2024. The presentations will showcase advancements in Pfizer's infectious disease portfolio, covering RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, and serious bacterial and fungal infections.

Key highlights include:

• Pharmacokinetics and safety of nirmatrelvir/ritonavir in pediatric COVID-19 patients
• Real-world effectiveness of Abrysvo vaccine against RSV-related hospitalizations
• Safety and immunogenicity of coadministered COVID-19 and RSV vaccines
• Effectiveness of COVID-19 vaccination against long COVID in older adults
• Updates on Lyme disease vaccine candidate VLA15
• Epidemiology of invasive meningococcal disease in the US
• Impact of pneumococcal conjugate vaccines on vaccine serotypes

ViiV Healthcare, majority owned by GSK with Pfizer and Shionogi as shareholders, has committed to making at least two million doses of long-acting cabotegravir for HIV pre-exposure prophylaxis (CAB LA for PrEP) available for low- and middle-income countries (L&MICs) during 2025-2026. This triples the company's available supply compared to 2024, aiming to accelerate access where HIV burden is highest.

The rollout of CAB LA for PrEP is progressing rapidly in Sub-Saharan Africa and lower income countries, with half of the approvals to date in Sub-Saharan Africa and 79% in L&MICs. ViiV is providing the product at a not-for-profit price for low-income and Sub-Saharan African countries. By the end of 2024, ViiV will have supplied CAB LA for PrEP to partners for rollout in 14 countries.

ViiV is also working with generic manufacturers through a licensing agreement with the Medicines Patent Pool to develop generic formulations, aiming to improve affordability and expand capacity in resource- settings.

Pfizer Inc. (NYSE: PFE) has announced the voluntary withdrawal of OXBRYTA® (voxelotor), a treatment for sickle cell disease (SCD), from all worldwide markets where it is approved. The company is also discontinuing all active voxelotor clinical trials and expanded access programs globally. This decision is based on clinical data indicating that the overall benefit of OXBRYTA no longer outweighs the risks in the approved SCD patient population.

The data suggests an imbalance in vaso-occlusive crises and fatal events, which require further assessment. Pfizer has notified regulatory authorities about these findings and is advising patients to contact their physicians to discuss alternative treatments. The company will continue to investigate the findings and keep stakeholders informed about next steps for OXBRYTA.

Pfizer does not anticipate that this event will impact its full-year 2024 financial guidance.

Pfizer (NYSE: PFE) has announced a conference call with investment analysts scheduled for October 29, 2024, at 10:00 a.m. EDT. The call aims to provide an update on Pfizer's Third Quarter 2024 Performance Report, which will be released that morning. Investors and the public can access the webcast and report at www.pfizer.com/investors.

Participants can join via webcast or by dialing 800-456-4352 (US/Canada) or 785-424-1086 (international) with passcode '72940'. A transcript and replay will be available on Pfizer's website within 24 hours after the call, accessible for at least 90 days.

Pfizer, a leading biopharmaceutical company, focuses on developing innovative medicines and vaccines to improve lives globally. With a 175-year history, Pfizer collaborates with healthcare providers and communities to advance wellness and expand access to affordable healthcare worldwide.

Pfizer (NYSE: PFE) announced positive results from its Phase 2 study of ponsegromab, a monoclonal antibody targeting GDF-15, for cancer cachexia. The study met its primary endpoint, showing significant body weight increases compared to placebo across all doses, with a 5.61% mean increase at the highest dose after 12 weeks. Ponsegromab was generally safe and well-tolerated.

At the highest dose, improvements were observed in appetite, cachexia symptoms, physical activity, and muscle mass. Based on these promising results, Pfizer plans to initiate registration-enabling studies in 2025. The study included 187 participants with non-small cell lung, pancreatic, or colorectal cancer. Ponsegromab is also being investigated for heart failure patients with elevated GDF-15 levels.

Pfizer announced longer-term follow-up results from the Phase 2 PHAROS trial evaluating BRAFTOVI® + MEKTOVI® for patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC). After approximately three years of follow-up:

- In treatment-naïve patients: 75% objective response rate, 40 months median duration of response, and 30.2 months median progression-free survival
- In previously treated patients: 46% objective response rate, 16.7 months median duration of response, and 9.3 months median progression-free survival

These results support BRAFTOVI + MEKTOVI as a potential standard of care option for this patient population. The combination was approved by the FDA in October 2023 and by the European Commission in August 2024 for BRAF V600E-mutant metastatic NSCLC.

Pfizer Inc. (NYSE: PFE) is presenting extensive research at the European Society for Medical Oncology (ESMO) Congress 2024, showcasing its diverse oncology portfolio. Key highlights include:

1. Late-breaking presentations on BRAFTOVI® + MEKTOVI® for BRAF V600E-mutant metastatic NSCLC and ponsegromab for cancer cachexia.

2. Early results for PD-L1 vedotin ADC, disitamab vedotin, and a novel CDK4 + CDK2 inhibitor combination.

3. Data from over 50 abstracts across various tumor areas and scientific modalities.

4. Updated results from the PHAROS study on BRAFTOVI + MEKTOVI in BRAF V600E-mutant mNSCLC.

5. Phase 2 results for ponsegromab in cancer-associated cachexia.

6. Early-stage research on SGN-PDL1V in NSCLC and HNSCC, disitamab vedotin with KEYTRUDA® in HER2-expressing urothelial cancer, and atirmociclib with a CDK2 inhibitor in HR+/HER2-negative metastatic breast cancer.