Today’s Daily Dose brings you news about the FDA rejecting Adamis Pharma’s ZIMHI high-dose naloxone injection, proposed for the reversal of opioid overdose; ChemoCentryx’ ANCA-associated vasculitis trial results; CymaBay pulling the plug on Seladelpar trials; Global Blood Therapeutics’s scoring FDA nod for sickle cell disease drug, and Zogenix upcoming catalyst in March, among others.
Shares of Adamis Pharmaceuticals Corporation (ADMP) slumped more than 50% on Monday, following disappointing regulatory news related to ZIMHI high-dose naloxone injection product for the treatment of opioid overdose.
The FDA has said that it cannot approve the ZIMHI New Drug Application in its present form and has raised questions related generally to Chemistry, Manufacturing, and Controls. No other clinical safety or efficacy issues were raised by the regulatory agency.
ADMP closed Monday’s trading at $0.61, down 50.96%.
Shares of ChemoCentryx Inc. (CCXI) skyrocketed in extended trading on Monday, following positive topline data from a phase III trial of Avacopan for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis).
ANCA Associated Vasculitis (AAV) is a rare, severe, and often fatal autoimmune disease characterized by destruction and inflammation of small blood vessels that can affect many different organ systems, and commonly involves the kidneys. The current standard of care for AAV, which involves courses of immuno-suppressants (Cyclophosphamide or Rituximab) combined with high dose steroid administration, is associated with significant safety issues.
The pivotal trial, dubbed ADVOCATE, achieved both primary endpoints of clinical remission at weeks 26 and 52 with statistical superiority of Avacopan over the standard of care at 52 weeks. Avacopan also significantly reduced glucocorticoid toxicity and significantly improved kidney function compared to glucocorticoid-containing standard of care.
The Company and its partner Vifor Fresenius Medical Care Renal Pharma plan to make regulatory submissions seeking approval of Avacopan for ANCA-associated vasculitis in the U.S. and Europe in 2020.
CCXI closed Monday’s trading at $8.06, up 1.51%. In after-hours, the stock was up 325.68% to $34.31.
CymaBay Therapeutics Inc. (CBAY) plunged 76% on Monday, following the termination of the Company’s phase IIb study of Seladelpar in subjects with non-alcoholic steatohepatitis and its recently initiated phase II study of Seladelpar in subjects with primary sclerosing cholangitis.
In addition, the company is putting on hold all studies of Seladelpar in subjects with primary biliary cholangitis (PBC).
The decision to halt the development of Seladelpar was based on initial histological findings observed in the phase 2b study of Seladelpar in NASH, which seems to suggest that Seladelpar might be causing changes in the liver structure.
CBAY closed Monday’s trading at $1.33, down 76.04%.
Global Blood Therapeutics, Inc. (GBT) has received accelerated approval for Oxbryta tablets for the treatment of sickle cell disease in adults and children 12 years of age and older.
Oxbryta, an oral therapy taken once daily, is the first approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of sickle cell disease, according to the Company. The medicine is expected to be available through the Company’s specialty pharmacy partner network within two weeks.
Oxbryta will have a list price of $10,417 per month, or $125,000 per year, according to the Company.
On November 15, 2019, the FDA approved Novartis’ (NVS) Adakveo, administered by intravenous infusion, for the prevention of vaso-occlusive crises (VOCs), also known as pain crises, in patients with sickle cell disease.
There is one more drug for sickle cell disease by the name Endari. It was developed by Emmaus Life Sciences, and it received the FDA nod in 2017, becoming the first new drug for sickle cell disease in nearly 20 years.
GBT closed Monday’s trading at $60.03, up 6.93%.
Intercept Pharmaceuticals Inc.’s (ICPT) New Drug Application for obeticholic acid seeking accelerated approval for the treatment of fibrosis due to nonalcoholic steatohepatitis has been granted priority review by the FDA.
The regulatory agency’s decision is expected by March 26, 2020.
Before the agency makes a final decision, the NDA for obeticholic acid will be reviewed by an FDA panel, the date of which is yet to be finalized.
“If approved, OCA would be the first available therapy for patients with fibrosis due to NASH, a condition that is expected to become the leading cause of liver transplant in the U.S. as soon as 2020,” said Mark Pruzanski, President and Chief Executive Officer of Intercept.
ICPT closed Monday’s trading at $96.34, up 8.38%.
La Jolla Pharmaceutical Company (LJPC) is planning to discontinue a pivotal study of LJPC-401 as a treatment for iron overload in beta-thalassemia (BT) patients who, despite chelation therapy, have cardiac iron levels above normal.
A recent interim analysis of the trial that included approximately one-half of the target-enrolled patients showed no significant differences in the primary endpoint or key secondary endpoints between patients on the treatment arm and patients on the control arm.
LJPC closed Monday’s trading at $2.59, down 53.58%.
Zogenix Inc.’s (ZGNX) New Drug Application for FINTEPLA for the treatment of seizures associated with Dravet syndrome has been granted priority review by the FDA, with a decision expected on March 25, 2020.
FINTEPLA is also under a phase III trial in Lennox-Gastaut syndrome, another rare, severe childhood-onset epileptic syndrome, and top-line data results are anticipated in the first quarter of 2020.
ZGNX closed Monday’s trading at $48.48, up 3.17%.
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