Kadimastem: Orphan drug status for AstroRx constitutes recognition of the drug's uniqueness and medical potential.
Kadimastem (TASE: KDST) notified investors that the US Food and Drug Administration (FDA) had granted orphan drug status to the company's AstroRx drug for treatment of ALS. Kadimastem's share price is up by over 6% in trading on the Tel Aviv Stock Exchange (TASE).
The FDA grants orphan drug status in order to provide an incentive for the development of drugs and medical treatments. Companies whose drugs have been awarded this status enjoy exclusive marketing rights for the drugs for seven years after marketing approval is obtained. This recognition is also useful in obtaining grants and financial concessions in development and registration of drugs for marketing.
Orphan drug status provides faster testing tracks and responses from the FDA and other regulatory agencies. "The company believes that the granting of orphan drug status for AstroRx constitutes recognition of the drug's uniqueness and medical potential, and will provide a significant boost in entering the market, should it be approved," Kadimastem's notice to the TASE stated.
Published by Globes, Israel business news - en.globes.co.il - on November 4, 2018
© Copyright of Globes Publisher Itonut (1983) Ltd. 2018
Kadimastem CEO Yossi Ben-Yosef, photo: Studio-One