Pfizer Stock Price, News & Analysis

ViiV Healthcare announced week 240 results from the phase III BRIGHTE study of fostemsavir, demonstrating significant virologic responses in heavily treatment-experienced adults with multidrug-resistant HIV-1. The study involved 371 patients and found that 45% achieved virologic suppression. CD4+ cell counts increased by 296 cells/mm³, with 78% reaching counts of ≥200 cells/mm³. Safety profiles remained consistent, with 95% experiencing adverse events, primarily nausea and diarrhea. Fostemsavir serves as a crucial treatment option for patients facing limited alternatives due to resistance or safety issues.

ViiV Healthcare announced new findings from the HPTN 084 trial at the 24th International AIDS Conference, showing that cabotegravir long-acting (LA) for pre-exposure prophylaxis (PrEP) demonstrated an 89% lower rate of new HIV infections compared to daily oral tablets. No new HIV cases were reported among participants receiving cabotegravir during the unblinded period. Additionally, no birth defects were recorded among women who became pregnant post-injection. Cabotegravir LA is currently approved in the U.S. as Apretude.

ViiV Healthcare, majority owned by GSK and including Pfizer as a shareholder, has signed a new voluntary licensing agreement for cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) to enhance access in low-income regions. This agreement allows selected generic manufacturers to produce cabotegravir LA for PrEP in 90 countries, following regulatory approval. With approximately 1.5 million new HIV cases annually, the long-acting injectable could significantly improve prevention efforts, particularly for women and adolescent girls.

Pfizer (NYSE: PFE) reported second-quarter 2022 revenues of $27.7 billion, a 47% increase, primarily driven by strong sales from Paxlovid and Comirnaty. Reported diluted EPS was $1.73, reflecting a 77% growth compared to Q2 2021. The company raised its full-year guidance for revenues to between $98.0 billion and $102.0 billion, despite foreign exchange headwinds. Pfizer emphasized its commitment to addressing global health needs while ensuring financial performance, with plans to acquire Biohaven and a focus on R&D investments.

AM Best has reaffirmed the Financial Strength Rating of A (Excellent) and Long-Term Issuer Credit Rating of 'a+' (Excellent) for Blue Whale Re Ltd., with a stable outlook. The ratings reflect Blue Whale's strong balance sheet and operating performance, underscoring its crucial role as the captive insurer for Pfizer (PFE). Despite its reliance on Pfizer for capitalization and reinsurance, Blue Whale's operations are expected to maintain strong results. However, any shifts in Pfizer's support could impact Blue Whale's ratings.

Pfizer Inc. (NYSE: PFE) has submitted a New Drug Application (NDA) to the FDA for PAXLOVID™, aimed at treating COVID-19 in high-risk patients. This follows data from the EPIC-HR study, which reported an 86% reduction in the risk of hospitalization or death. Notably, no deaths were recorded in PAXLOVID-treated patients through Week 24. The study highlights that 50-60% of the U.S. population carries risk factors for severe illness, reinforcing the drug's significance in combating COVID-19.

Pfizer and BioNTech have secured a new vaccine supply agreement with the U.S. government for 105 million doses of COVID-19 vaccines. The deal is worth $3.2 billion, with doses to be delivered by Q4 2022, potentially including Omicron-adapted vaccines pending FDA authorization. The agreement allows for an additional 195 million doses if required. This effort aims to ensure access to vaccines as COVID-19 variants evolve and will continue to provide free vaccinations to eligible U.S. residents.

Roivant Sciences and Pfizer have launched Priovant Therapeutics to focus on developing innovative therapies for autoimmune diseases. Priovant is advancing brepocitinib, a dual inhibitor of TYK2 and JAK1, showing statistically significant results in five Phase 2 studies. A Phase 3 trial for dermatomyositis (VALOR) has commenced, and top-line results from an ongoing Phase 2b study in systemic lupus erythematosus (SLE) are expected in the second half of 2023. Pfizer retains a 25% equity stake in Priovant and has licensed rights for both brepocitinib and ropsacitinib.

Pfizer and BioNTech announced positive results from their study of two Omicron-adapted COVID-19 vaccine candidates, a monovalent and a bivalent one. These candidates exhibited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg doses, respectively. The bivalent vaccine demonstrated a 9.1 and 10.9-fold increase against the same variant. Both candidates showed a favorable safety profile, and data will be discussed with regulatory authorities for potential emergency use authorization.