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Here's a roundup of top developments in the biotech space over the last 24 hours:
The FDA has approved GSK plc's (NYSE:GSK) Benlysta (belimumab) for the treatment of children ages 5-17 with active lupus nephritis (LN) who are receiving standard therapy.
Belimumab has become the first FDA-approved drug for pediatric lupus nephritis.
Lupus nephritis is a serious inflammation of the kidneys caused by lupus, which can lead to end-stage kidney disease.
The approval extends the current indication in the U.S. to include both lupus and active LN for the intravenous formulation in the pediatric patient population.
AbbVie Inc's (NYSE:ABBV) Allergan unit has agreed to pay more than $2 billion to resolve over 3,000 lawsuits filed by state and local governments over marketing its Kadian opioid painkiller, Bloomberg reported, citing people familiar with the matter.
The agreement is part of consolidated litigation before a federal judge in Cleveland that has produced several other national settlements, including a $26-billion pact covering drug distributors and Johnson & Johnson (NYSE:JNJ).
The FDA has signed off Astria Therapeutics Inc's (NASDAQ:ATXS) investigational new drug application for STAR-0215 for hereditary angioedema.
A Phase 1a trial of STAR-0215 in healthy volunteers is expected to initiate in the coming weeks, with preliminary results anticipated by year-end.
Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) has collaborated with the Kenya Medical Research Institute to plan, seek regulatory approval, and conduct a Phase 1 study in Kenya to develop TNX-8011 as a vaccine to protect against monkeypox and smallpox.
The study is expected to start in the first half of 2023.
"TNX-801 is a live virus vaccine that we believe is closer to the smallpox vaccines used in the U.S. and Europe before 1900 than the modern vaccinia smallpox vaccines. TNX-801 has reduced virulence in animals, and we believe it has the potential for widespread use to protect against monkeypox," said Seth Lederman, CEO of Tonix.
The FDA has accepted Acer Therapeutics Inc (NASDAQ:ACER) and its collaboration partner Relief Therapeutics Holding SA (OTC:RLFTF) resubmitted a marketing application for ACER-001 (sodium phenylbutyrate) in urea cycle disorders.
The FDA designated the application as a Class 2 resubmission and set a Prescription Drug User Fee Act target action date of Jan. 15, 2023.
The companies have also submitted an investigational new drug application to the FDA to evaluate the efficacy and safety of ACER-001 for maple syrup urine disease.
Cyclerion Therapeutics Inc (NASDAQ:CYCN) reported topline data from its clinical study of CY6463 for Cognitive Impairment Associated with Schizophrenia in individuals with stable schizophrenia on a stable antipsychotic regimen.
Data demonstrate that once-daily CY6463 was safe and well tolerated.
Data showed a strong effect on cognitive performance after two weeks of 15mg once-daily dosing. A broad positive movement on inflammatory biomarkers was also observed.
Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) priced its previously announced underwritten public offering of 16.8 million at $2.50 per share, with gross proceeds of approximately $42.1 million.
Pfizer Inc (NYSE:PFE): Before the market open.
Merck & Co Inc (NYSE:PFE): Before the market open.
Novocure Ltd (NASDAQ:NVCR): Before the market open.
Sanofi SA (NASDAQ:SNY): Before the market open.
Argenx SE (NASDAQ:ARGX): Before the market open.
Alnylam Pharmaceuticals Inc (NASDAQ:ALNY): Before the market open.
Ultragenyx Pharmaceutical Inc (NASDAQ:RARE): After market close.
Posted In: ABBV ACER ALNY ARGX ATXS CYCN GSK IBB JNJ LXRX NVCR PFE RARE RLFTF SNY TNXP