The company received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application seeking approval of Anaphylm, a sublingual film to treat severe Type I allergic reactions.
The company announced that it has decided to cease clinical development of its lead asset dexamethasone sodium phosphate encapsulated in autologous erythrocytes (eDSP).
The U.S. Food and Drug Administration cleared its Investigational New Drug application for SER-252, a therapy to treat patients with Parkinson’s disease.
The company’s subsidiary, Lucid Diagnostics, secured a contract from the U.S. Department of Veterans Affairs to provide its EsoGuard Esophageal DNA Test for the detection of esophageal precancer.
Retail optimism for One Stop Systems comes amid the company’s about $1.2 million pre-production order from a U.S. defense prime contractor announced last week.
The Food and Drug Administration said in a letter to the company that it is unable to approve its EBVALLO application in present form, citing inadequate evidence of effectiveness for accelerated approval.
HL60 leukemia cells were treated with Telomir-1, which produced a clear, dose-dependent reduction in viable leukemia cells, indicating strong activity in this aggressive human model, the company said.
