Pfizer Inc. - PFE STOCK NEWS

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.

Astellas Pharma Inc. (TSE: 4503) will present eight abstracts at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, showcasing data from its oncology portfolio and pipeline. Key highlights include:

1. EV-302 study results on enfortumab vedotin with pembrolizumab for first-line treatment of urothelial cancer.

2. Five-year follow-up data from the EV-103 DE/A study on enfortumab vedotin with pembrolizumab in first-line cis-ineligible urothelial cancer.

3. Final pooled overall survival data from SPOTLIGHT and GLOW trials on zolbetuximab plus chemotherapy for gastric/GEJ adenocarcinoma.

4. EMBARK post-hoc analyses on enzalutamide for non-metastatic hormone-sensitive prostate cancer.

5. Phase 1 data on ASP3082, a KRAS G12D protein degrader, and ASP1570, a novel DGKζ inhibitor.

Rocket Pharmaceuticals (NASDAQ: RCKT) has appointed Mikael Dolsten, M.D., Ph.D., as an independent director to its Board of Directors. Dr. Dolsten is currently the Chief Scientific Officer and President of Research & Development at Pfizer Inc. (NYSE: PFE), focusing on advancing gene therapies, small-molecule medicines, biotherapeutics, and vaccines. His extensive experience includes leadership roles at Wyeth, Boehringer Ingelheim, AstraZeneca, Pharmacia, and Upjohn.

Dr. Dolsten is a member of the Board of Overseers for the Scripps Research Institute and a Foreign Member of The Royal Swedish Academy of Engineering Sciences. He has also advised the Obama administration on regulatory and drug development issues and Vice President Biden's Cancer Moonshot Initiative. This appointment aims to strengthen Rocket's scientific capabilities and support its mission to develop transformative treatments for rare disorders.

Pfizer Inc. (NYSE: PFE) has announced a public webcast featuring David Denton, Chief Financial Officer and Executive Vice President, at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 4, 2024, at 8:30 a.m. EDT. Investors and the public can access the webcast through www.pfizer.com/investors.

The transcript and replay will be available on Pfizer's website within 24 hours after the live discussion and will remain accessible for at least 90 days. This event aligns with Pfizer's commitment to transparency and its mission to deliver breakthroughs that change patients' lives. As a leading biopharmaceutical company, Pfizer focuses on developing innovative medicines and vaccines, collaborating globally to improve healthcare access and affordability.

Pfizer Inc. (NYSE: PFE) has launched PfizerForAll, a digital platform aimed at simplifying healthcare access for millions of Americans. The platform focuses on patients with migraine, COVID-19, or flu, and adults seeking vaccines for preventable diseases. PfizerForAll offers:

• Same-day appointments with healthcare professionals
• Home delivery of medicines and diagnostic tests
• Vaccine appointment scheduling
• Help with paying for Pfizer medicines
• Access to patient support services

The platform works within the existing healthcare system and partners with organizations like UpScriptHealth, Alto Pharmacy, and Instacart. This initiative responds to the overwhelming nature of the U.S. healthcare system, with 65% of Americans finding healthcare coordination overwhelming and time-consuming.

Pfizer (NYSE: PFE) announced positive top-line results from substudy B of the Phase 3 MONeT trial, evaluating ABRYSVO vaccine in immunocompromised adults at risk of severe RSV-associated lower respiratory tract disease. The study involved 203 adults across four groups: non-small cell lung cancer patients, hemodialysis patients, autoimmune disorder patients on immunomodulator therapy, and solid organ transplant recipients.

Key findings:

• ABRYSVO was well-tolerated with a safety profile consistent with previous studies
• A single 120 µg dose generated strong neutralizing responses against RSV-A and RSV-B across all cohorts and age groups
• Results support ABRYSVO's potential to address unmet needs in vulnerable populations aged 18-59

Pfizer plans to share these findings at an upcoming scientific conference and submit data to regulatory agencies for review.

Pfizer (NYSE: PFE) reported robust second-quarter 2024 financial results, driving a raise in full-year 2024 revenue guidance to $59.5-$62.5 billion and adjusted diluted EPS to $2.45-$2.65. The company's revenue hit $13.3 billion, growing 3% operationally year-over-year, despite a decline in COVID-related revenues. Excluding Comirnaty and Paxlovid, revenues surged by 14%. Reported diluted EPS was $0.01, impacted by $1.3 billion in one-time manufacturing optimization costs, while adjusted diluted EPS was $0.60. Pfizer anticipates $1.5 billion in cost savings from its Manufacturing Optimization Program by 2027.

Key product highlights include a 71% operational growth for the Vyndaqel family, 8% for Eliquis, and 44% for Nurtec ODT/Vydura. However, Xeljanz and Ibrance saw declines of 34% and 8% operationally, respectively. Pfizer also announced advancements in its R&D pipeline and several product developments.

Pfizer's DURVEQTIX® (fidanacogene elaparvovec), a one-time gene therapy for adults with severe and moderately severe hemophilia B, has received conditional marketing authorization from the European Commission. This innovative treatment is designed to enable patients to produce factor IX themselves, potentially eliminating the need for frequent intravenous infusions. Key highlights:

- Demonstrated a median annualized bleed rate of zero bleeds after up to four years of follow-up
- Approved for adult patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74
- Met primary efficacy endpoint in Phase 3 BENEGENE-2 study
- Generally well-tolerated with a safety profile consistent with Phase 1/2 results
- Builds on Pfizer's 40-year commitment to hemophilia treatment innovation

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.