Daily Biotech Pulse: GSK's Kidney Disease Drug Approved For Children, Tonix Pharma To Launch Monkeypox Vaccine Study In Kenya, Positive Effect Of Cyclerion's Schizophrenia Candidate

Zinger Key Points
  • GSK's Benlysta is now the first and only biologic approved for adults and children who have lupus or lupus nephritis.
  • Tonix Pharma Says TNX-801 is closer to the smallpox vaccines used before than the modern smallpox vaccines.
Daily Biotech Pulse: GSK's Kidney Disease Drug Approved For Children, Tonix Pharma To Launch Monkeypox Vaccine Study In Kenya, Positive Effect Of Cyclerion's Schizophrenia Candidate

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

FDA Approves GSK's Kidney Disease Drug For Children

The FDA has approved GSK plc's 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.

Allergan To End Around 3,000 Opioid Lawsuits With Over $2B In Settlement: Report

AbbVie Inc's 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 JNJ.

Astria To Launch Hereditary Angioedema Trial In Coming Weeks

The FDA has signed off Astria Therapeutics Inc's 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 Pharma Seeks To Start Monkeypox Vaccine Study In Kenya

Tonix Pharmaceuticals Holding Corp 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.

Acer Therapeutics' Urea Cycle Disorders Candidate Under FDA Review

The FDA has accepted Acer Therapeutics Inc ACER and its collaboration partner Relief Therapeutics Holding SA 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's Schizophrenia Candidate Shows Positive Effect On Cognition, Inflammation

Cyclerion Therapeutics Inc 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. 

Offerings

Lexicon Pharmaceuticals Inc 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.

IPOs

MAIA Biotechnology Inc priced its initial public offering of 2 million shares at $5 per share, raising gross proceeds of $10 million.

On The Radar

Earnings

Pfizer Inc PFE: Before the market open.

Merck & Co Inc PFE: Before the market open.

Novocure Ltd NVCR: Before the market open.

Sanofi SA SNY: Before the market open.

Argenx SE ARGX: Before the market open.

Alnylam Pharmaceuticals Inc ALNY: Before the market open.

Ultragenyx Pharmaceutical Inc RARE: After market close.

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