Inovio Pharmaceuticals Inc (NASDAQ: INO) shares were volatile Wednesday after the company announced Orphan Drug Designation for one of its pipeline drugs.
What Happened: The Plymouth, Pennsylvania-based company said the FDA granted ODD for INO-3107, a DNA medicine that's being evaluated in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis, or RRP.
RRP is a rare disease caused by human papillomavirus types 6 and 11 infections that causes non-cancerous tumor growths leading to life-threatening airway obstructions, the company said.
Why It's Important: The ODD from the FDA qualifies INO-3107 for various development incentives, including a tax credit on expenditures incurred in clinical studies; a waiver of the new drug application fee; a research grant awarded by the FDA; and most importantly, seven years of U.S. market exclusivity upon approval for the treatment of RRP, Inovio said.
"Receiving FDA's orphan drug designation for INO-3107 is an important milestone in the development of Inovio's DNA medicine for this rare disease and clearly underscores the importance of addressing the unmet medical need for this debilitating condition," Ami Shah Brown, Inovio's senior vice president fo regulatory affairs, said in a statement.
Inovio is developing a DNA vaccine for SARS-CoV2, the virus that causes COVID-19. The vaccine program is embroiled in litigation with its CDMO partner, as well as a shareholder lawsuit accusing the company of stock pumping.
The company is scheduled to report second-quarter results Monday, Aug. 10.
INO Price Action: At last check, Inovio shares were sliding 4.23% to $19.91.
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