Pfizer Stock Price, News & Analysis

Pfizer Inc. reported its third-quarter 2022 results, with revenues of $22.6 billion, a 6% decline compared to the previous year. Excluding contributions from Paxlovid and Comirnaty, the revenue showed a 2% operational growth. Reported diluted EPS increased by 6% to $1.51, and adjusted diluted EPS rose 40% to $1.78. The company raised its 2022 revenue guidance to $99.5-$102 billion and narrowed its adjusted diluted EPS guidance to $6.40-$6.50. Pfizer's pipeline includes promising candidates with positive Phase 3 data, and it plans to launch up to 19 new products within 18 months.

Pfizer announced positive Phase 3 trial results for its investigational RSV vaccine, RSVpreF, showing an efficacy of 81.8% against severe lower respiratory illness in infants up to 90 days old. The vaccine was well-tolerated with no safety issues noted in vaccinated individuals or their newborns. Pfizer plans to submit a Biologics License Application to the FDA by the end of 2022. If approved, this could be the first maternal vaccine to help prevent RSV in young infants, filling a critical public health need.

ViiV Healthcare has announced positive results from its phase IIa study of N6LS, a novel broadly neutralizing antibody, for treating HIV. The study demonstrated strong antiviral efficacy and tolerability at both high and low doses. Out of 14 participants, 13 showed a significant reduction in viral load. The results will be presented at the 30th HIV Glasgow Conference. ViiV plans to launch a phase IIb study in 2023 to further explore this treatment's potential.

The CARISEL study revealed that the long-acting regimen of cabotegravir and rilpivirine was successfully implemented across various European healthcare settings. Conducted by ViiV Healthcare, the study showed high acceptability, appropriateness, and feasibility among clinical staff and people living with HIV. At 12 months, 87% of participants maintained viral suppression while 81% felt the regimen was less stigmatizing than daily treatments. Staff identified and overcame initial implementation barriers, further endorsing this innovative treatment approach.

Pfizer Inc. (NYSE: PFE) is set to present diverse data from its infectious disease portfolio at IDWeek 2022, focusing on the efficacy and safety of its bivalent RSVpreF vaccine for older adults, alongside findings on PAXLOVID™ for COVID-19 treatment. A late-breaking presentation will detail results from the Phase 3 clinical trial of RSVpreF on October 20, 2022. The company aims to demonstrate its commitment to addressing critical health challenges posed by infectious diseases. Presentations will span a range of topics, showcasing investigational vaccines and therapies.

Pfizer and BioNTech have announced encouraging early results from a Phase 2/3 clinical trial of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Following a 30-µg booster dose, participants exhibited a significant increase in neutralizing antibodies against the Omicron BA.4/BA.5 variants. Both younger and older adults demonstrated similar responses. Notably, the bivalent vaccine is expected to outperform the original vaccine in providing protection against these variants. The vaccine was well tolerated, with safety profiles resembling that of the original formulation. Additional data is forthcoming.

Pfizer and BioNTech announced that the FDA granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children aged 5 to 11. The CDC's recommendation is pending before shipping. This booster aims to enhance protection as Omicron subvariants dominate U.S. cases. A clinical trial is underway for younger children. The companies have also applied for regulatory approvals in Europe and plan global submissions. Eligible residents will receive vaccines for free under U.S. government provisions.

Pfizer (NYSE: PFE) has successfully completed the acquisition of Global Blood Therapeutics (GBT) for $68.50 per share, totaling approximately $5.4 billion. This strategic move enhances Pfizer's commitment to addressing the needs of the sickle cell disease (SCD) community, with GBT's portfolio including the first-in-class drug Oxbryta® (voxelotor). Pfizer aims to innovate and expedite treatments for SCD, which affects millions globally, particularly among underserved populations. GBT's assets also include promising investigational therapies, with FDA designations in place.

Pfizer (NYSE: PFE) announced positive results from its Phase 3 TALAPRO-2 study of TALZENNA (talazoparib) combined with XTANDI (enzalutamide) for men with metastatic castration-resistant prostate cancer (mCRPC), achieving the primary endpoint of radiographic progression-free survival (rPFS) with a hazard ratio of 0.696. Consistent efficacy was noted irrespective of homologous recombination repair gene mutations. While a trend towards improved overall survival was observed, it needs further analysis. Safety profiles were generally consistent with known data, paving the way for potential regulatory discussions.