In the Study, VAX-24 Demonstrated a Safety and Tolerability Profile Similar to Prevnar 20® (PCV20) at all Doses Studied --
-- All 24 Serotypes of VAX-24 at Conventional 2.2 mcg PCV Dose Met or Exceeded Regulatory Immunogenicity Standards --
-- Results Confirm Potential of Carrier-Sparing, Cell-Free Platform Technology Underlying VAX-24 --
-- Topline Data from the VAX-24 Phase 3 Pivotal Non-Inferiority Study in Adults Expected in 2025 --
Application based on results from the Phase 3 CheckMate -901 trial showing significant survival improvement vs. standard-of-care gemcitabine plus cisplatin in cisplatin-eligible patients with untreated, unresectable or metastatic urothelial carcinoma
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the U.S.
The U.S. Food and Drug Administration assigned a target action date of April 5, 2024
https://finance.yahoo.com/news/u-food-drug-administration-accepts-115900435.html
Johnson & Johnson on Tuesday forecast revenue growth of 5-6% for 2024, its first full year after hiving off its consumer health unit, on strong demand for cancer treatments Darzalex and Carvykti, and blockbuster psoriasis drug Stelara.
The company also forecast 2024 adjusted operating profit of $10.55 to $10.75 per share, including a 15-cent impact from its recent acquisition of private medical device maker Laminar.
"I think they can earn closer to $10.85 vs the $10.55-10.75 guidance," said Jeff Jonas, portfolio manager at Gabelli Funds, adding the company's profit per share target is "always very conservative."
Sales of Stelara in Europe are expected to come under pressure as a key patent on the drug expires next year. Stelara is also expected to face competition in the United States beginning in 2025.
J&J Chief Financial Officer Joseph Wolk said the company, which is now focusing on its drugs and medical devices business, was "very well positioned" even with some Stelara biosimilars launching outside the United States in mid-to-second half of 2024.
The company expects operational revenue, excluding COVID vaccine, to grow at a compounded annual rate of 5-7% between 2025 and 2030.
Jonas said J&J will face challenges in 2025 and beyond - and "might need another acquisition or two" to help fill the sales gap from patent expirations.
J&J, which reiterated its goal of $57 billion in drug sales in 2025, said it plans to seek regulatory approvals for at least 20 new therapies and expanded use of 50 treatments by 2030.
J&J's "lofty" long-term targets for its pharmaceutical unit are "potentially achievable" with new key products, UBS analyst Danielle Antalffy said in a note.
The company said over 10 of its products had the potential to generate more than $5 billion in peak year sales - including newer cancer treatments Talvey and Tecvayli.
https://finance.yahoo.com/news/1-johnson-johnson-forecasts-much-170350186.html
Replimune Group said on Tuesday its experimental drug to treat a common form of skin cancer did not meet the main goals in a mid-stage study.
The therapy, RP1, in combination with cemiplimab failed to significantly remove or reduce cancerous lesions in patients compared to cemiplimab alone.
Still, the company said the combination therapy showed "clinically meaningful" activity.
https://finance.yahoo.com/news/1-replimunes-skin-cancer-drug-123211237.html
Moonlake Immunotherapeutics (MLTX) saw a 5.5% rise as takeover rumors emerged. The identity of the potential buyer remains unknown.
https://seekingalpha.com/news/4043471-moonlake-immunotherapeutics-jumps-amid-takeover-speculation
