Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital hyperinsulinism (HI)
Ersodetug continues to advance in clinical development as a potential treatment for hypoglycemia caused by all forms of hyperinsulinism; topline sunRIZE data expected second half of this year
Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced that the FDA has accepted an updated protocol for the pivotal Phase 3 AD study, which is slated to begin in January 2025.
In October 2024, the FDA granted clearance for Annovis to proceed with the pivotal Phase 3 AD studies based on its Phase 2/3 data demonstrating cognitive improvement in early-stage AD patients. The original protocol design proposed two separate trials: a 6-month symptomatic study and an 18-month disease-modifying study. Under the revised protocol, these studies are now integrated into a single 6/18-month trial, which will include a 6-month data readout focused on symptomatic effects, followed by an additional 12-month assessment to evaluate the disease-modifying potential of buntanetap.
Johnson & Johnson said its combination therapy for lung cancer outperformed AstraZeneca Plc’s blockbuster Tagrisso in a head-to-head study, a finding that could change the standard of care for one of the most deadly tumor types.
Patients who received J&J’s treatment lived significantly longer than those given Tagrisso, the company said in a statement. The combination is expected to extend patients’ median overall survival by at least a year more than Astra’s medicine, the current standard of care, J&J said.
Shares of J&J rose 2% by midday in New York. Astra was little changed.
The company plans to present the detailed findings from the study of more than 1,000 people with a common form of non-small cell lung cancer at a medical meeting later this year. If the results hold up, it will mark the first time any treatment has proved superior to Astra’s top-selling drug on the critical metric of survival.
The results could upend the market for targeted lung cancer treatments, where Tagrisso, first approved in 2015, has become the dominant product with more than $6 billion a year in revenue. J&J’s therapy, which combines the intravenous Rybrevant with a pill called Lazcluze, won US Food and Drug Administration approval last year based on data showing it delayed the cancer’s progression more than Tagrisso alone.
Both medicines are designed for patients with mutations to a gene called EGFR, which spurs tumor growth and is among the most common drivers of lung cancer.
https://finance.yahoo.com/news/j-j-says-lung-cancer-161434688.html
Company Believes it is Well Positioned for Mid-Term and Long-Term Growth as
Current Capacity Continues to Support up to $300 Million in Annual RevenueTuesday saw bumps in Moderna (NASDAQ:MRNA), Novavax (NASDAQ:NVAX), and other vaccine producers as worries about rising COVID-19 and flu infections in the United States drove demand for immunization-oriented businesses to continue growing.
Moderna rose 11%; Novavax and others, including Inovio Pharmaceuticals (INO), CureVac (NASDAQ:CVAC), and Arcturus Therapeutics (NASDAQ:ARCT), also traded significantly higher. Manufacturers of the COVID-19 vaccination Comirnaty, Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), noted more meager increases.
Based on last week's U.S. Centers for Disease Control and Prevention (CDC) data showing increasing COVID-19 activity in most areas and a concurrent rise in seasonal flu, especially among small children, the rally followed last week's Citing their success in lowering serious disease and hospitalization, the CDC advised Americans to get recommended vaccinations.
The organization also underlined how common respiratory syncytial virus (RSV) is in young children. With its mREVIA medicine, Moderna has joined Pfizer's Abysvo and GSK's Arexvy vaccines on the RSV vaccination market. As health authorities stress preventative actions, the increasing need for vaccinations to treat certain respiratory diseases has attracted investment attention in the sector.
https://finance.yahoo.com/news/vaccine-stocks-surge-moderna-jumps-162633280.html
President-elect Donald Trump on Tuesday announced that Emirati billionaire Hussain Sajwani is pledging "at least" $20 billion to build new data centers across the United States.
"They may go double, or even somewhat more than double, that amount of money," Trump said of Sajwani - a Trump associate and founder of property development company DMAC.
According to Trump, the "first phase" of the plan will take place in Texas, Arizona, Oklahoma, Louisiana, Ohio, Illinois, Michigan and Indiana.
During the same press conference, Trump said that the transition has not been "smooth" - one day after posting to Truth Social that President Biden's team is "doing everything possible" to make the transition difficult.
Trump also said that Biden's new restrictions on offshore drilling "will not stand," and vowed to "reverse it immediately."
"They told me they’re going to do everything possible to make this transition to the new administration very smooth, it’s not smooth because they’re doing that, they’re playing with the courts," Trump said.
https://www.zerohedge.com/political/trump-announces-20-billion-foreign-investment-us-data-centers
