Sanofi - American Depositary Shares (SNY)

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity

Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to one year

Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype

Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life

Novo Nordisk has received both good and bad news recently when it comes to weight loss and diabetes drugs. So, where does the firm stand now?

Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved histological remission compared to placebo, consistent with improvements seen in adults and adolescents

Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP

The iShares Biotechnology ETF (IBB) has turned $140 resistance into support, positioning the overall sector for a potential breakout above $150.

Trial met the primary and all key secondary endpoints in adults with moderate-to-severe disease; five times more patients achieved sustained disease remission with Dupixent than placebo

Novavax Inc. (NASDAQNVAX) is a biotechnology company that focuses on developing and commercializing vaccines for serious infectious diseases.

Annovis Bio (NYSEANVS), a late-stage, clinical-drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), is reporting new preclinical data regarding buntanetap, its lead compound. According to the report, the date demonstrates the synergistic effect of buntanetap when combined with the glucagon-like peptide 1 (“GLP-1”) agonist dulaglutide (Trulicity[R]) in a mouse model of Alzheimer’s disease.

EQNX::TICKER_START (NYSEANVS),NYSE:MRKNYSEMRK)(NASDAQ:SNYNASDAQSNY,(NYSE:JNJNYSE),(NYSE:NVSNVS) EQNX::TICKER_END

PALM BEACH, Fla., Aug. 06, 2024 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - According to a report from Mordor Intelligence, the Alzheimer's Disease Diagnostics And Therapeutics Market size is estimated at USD 7.70 billion in 2024, and is expected to reach USD 10.10 billion by 2029, growing at a CAGR of 5.57% during the forecast period (2024-2029). The report said: “The major factors driving the growth of the Alzheimer's disease diagnostics and therapeutics market are the increasing use of biomarkers in Alzheimer's diagnosis and drug development and the rising prevalence of Alzheimer's worldwide. For instance, in September 2023, a report by the WHO stated that about 55 million people around the world are living with dementia, and nearly 10 million cases are reported annually. WHO also said that Alzheimer's is the most common form of dementia and constitutes about 60%-70% of the total cases of dementia. Also, with the growing prevalence of Alzheimer's around the world, government and non-government entities are investing heavily in developing diagnostics and therapeutics for the disease, which may augment the market's growth.” Active biotech, pharma companies in the markets this week include: Annovis Bio Inc. (NYSEANVS) (ANVS Profile), Merck & Co., Inc. NYSE: MRKNYSEMRK)(NASDAQ: SNYNASDAQSNY, Johnson & Johnson (NYSE: JNJNYSE), Novartis AG (NYSE: NVSNVS).

Majority of patients in this age group with eosinophilic esophagitis (EoE) receiving Dupixent achieved histologic remission, with improvements sustained up to one year

Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function

TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQREGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The revised target action date is September 27, 2024. The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.

Digital advertising verification and measurement solutions provider DoubleVerify Holdings Inc. (NYSEDV) shares took a 39% plunge on its Q1 2024 earnings

― Entered into a collaboration and ex-U.S. license agreement with Sanofi for the development and commercialization of losmapimod ―

― Sanofi receives exclusive rights to commercialize losmapimod in all territories outside the U.S.; Fulcrum retains full U.S. commercialization rights ―

If approved, Dupixent would be the first treatment in the U.S. indicated for adolescents aged 12-17 years with inadequately controlled CRSwNP, a condition driven in part by underlying type 2 inflammation that obstructs the sinuses and nasal passages and can lead to a loss of sense of smell

Novo Nordisk has had success with Ozempic and Wegovy for Type 2 diabetes and obesity, seeks to expand indications to include cardio diseases and neuro disorders

Investors seeking a long-term and undervalued pharmaceutical play should take a close look at Teva Pharmaceuticals, and here are six reasons why

Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved histological remission compared to placebo

The new year brings a clean slate heading into the fourth-quarter earnings season. Check out a few companies that have raised revenue guidance.