Delayed Nyse  -  04:04 2022-08-16 pm EDT
49.86 USD   +0.22%
04:29pPlaintiff in first Zantac lawsuit set for trial drops case
04:22pAmbrx Biopharma Names Kate Hermans Interim CEO
03:54pPFIZER : Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector newsMarketScreener Strategies

Pfizer Announces Submission of New Drug Application to the U.S. FDA for PAXLOVID

07/01/2022 | 11:06am EDT

NEW YORK - Pfizer Inc. (NYSE: PFE) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for patients who are at high risk for progression to severe illness from COVID-19. PAXLOVID is currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The submission provides the longer-term follow-up data necessary for acceptance and potential approval.

According to the U.S. Centers for Disease Control and Prevention (CDC), 50-60% of the U.S. population is estimated to have one or more risk factors for progressing to severe COVID-19 illness.1 These risk factors include any of the following: being aged 65 and older, obesity, diabetes, hypertension, smoking, physical inactivity, chronic kidney or liver disease, and immunocompromised conditions such as cancer, among others.2

'As the COVID-19 pandemic continues to evolve and be highly unpredictable, we must remain vigilant in protecting those who are at greatest risk of getting very sick from COVID-19, as they remain vulnerable to potential hospitalization or even death,' said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. 'Data from our clinical development program, coupled with the more than 1.7 million patients around the world who have been prescribed our oral treatment to date, reinforce PAXLOVID as an important treatment option for mild-to-moderate COVID-19 in patients at greater risk of progression to severe symptoms, regardless of vaccination status. We look forward to working with the FDA toward full regulatory approval for PAXLOVID.'

The NDA submission is supported by non-clinical and clinical data for PAXLOVID. It includes results from the Phase 2/3 EPIC-HR study (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients), which found that, compared to placebo, treatment with PAXLOVID reduced the risk of hospitalization or death from any cause by 88% in non-hospitalized, high-risk adult patients treated within five days of symptom onset; results from the final Clinical Study Report showed an 86% reduction in relative risk. The submission is also comprised of the most recent analyses from the Phase 2/3 EPIC-SR study (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients), which included data from both vaccinated patients with, and unvaccinated patients without, risk factors for severe COVID-19. While the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, the data were supportive of the efficacy and safety data observed in EPIC-HR for use in patients at increased risk of progression to severe COVID-19 illness. The NDA submission also includes:

An integrated analysis of data across the EPIC-HR and EPIC-SR studies, which showed an 84% reduction (p

(C) 2022 Electronic News Publishing, source ENP Newswire

All news about PFIZER, INC.
04:29pPlaintiff in first Zantac lawsuit set for trial drops case
04:22pAmbrx Biopharma Names Kate Hermans Interim CEO
03:54pPFIZER : Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVI..
06:43aPfizer Inc. - Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive ..
04:44aDigital innovations and congress coverage led to an increase in all hub users
08/15Pfizer CEO tests positive for COVID-19, has mild symptoms
08/15Pfizer Announces Positive Top-Line Results from Phase 3 Study of 20-Valent Pneumococcal..
08/12Creighton students' COVID vaccine mandate appeal dismissed
08/12Drugmakers' shares up after Zantac lawsuit slump
08/12Biotech stocks pin bounce back hopes on M&A boost
More news
Analyst Recommendations on PFIZER, INC.
More recommendations
Financials (USD)
Sales 2022 102 B - -
Net income 2022 32 675 M - -
Net cash 2022 11 522 M - -
P/E ratio 2022 8,85x
Yield 2022 3,25%
Capitalization 280 B 280 B -
EV / Sales 2022 2,64x
EV / Sales 2023 3,35x
Nbr of Employees 79 000
Free-Float 59,0%
Duration : Period :
Pfizer, Inc. Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends PFIZER, INC.
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 22
Last Close Price 49,86 $
Average target price 56,53 $
Spread / Average Target 13,4%
EPS Revisions
Managers and Directors
Albert Bourla Chairman, Chief Executive & Operating Officer
David M. Denton Chief Financial Officer & Executive Vice President
Mikael Dolsten Executive VP, President-Research & Development
Lidia L. Fonseca Executive VP, Chief Digital & Technology Officer
Aida Habtezion Chief Medical Officer
Sector and Competitors
1st jan.Capi. (M$)
PFIZER, INC.-15.56%279 215
JOHNSON & JOHNSON-2.91%436 680
ROCHE HOLDING AG-16.14%277 502
ABBVIE INC.5.09%251 582
NOVO NORDISK A/S5.65%241 077