Lannett Company Inc. ( LCI) shares were up nearly 2%, or 30 cents, in pre-market trading Tuesday, Sept. 5 after the company announced that the Food and Drug Administration has approved its Abbreviated New Drug Application for 20 mg and 40 mg dosages of it equivalent to AstraZeneca PLC's ( AZN) acid reflux and ulcer drug Nexium.
Cellect Biomd Sp ( APOP) was up 14.46%, or $1.32, to $9.13 after announcing that the FDA granted orphan drug status to its ApoGraft as an Orphan Drug for the prevention of acute and chronic graft versus host disease in transplant patients. ApoGraft relies on the company's stem cell selection process to reduce the risk of transplant rejection.
ProQR Therapeutics N.V. ( PRQR) rose almost 4%, or 20 cents, to $5.50 after its investigational drug QRX-421 received orphan drug designation from the FDA and European Medicines Agency for Usher syndrome, a disorder that can lead to hearing loss and an eye disorder called retinitis pigmentosa. Usher Syndrome is the leading cause of combined deafness and blindness.