RE:Inflation Reduction Act (IRA) boosts biological drugs
ONCY's pelareorep is a "platform drug therapy" that can be used in multiple cancers, most currently in pancreatic, breast, anal, and colon cancer, with the potential of ovarian, glioblastoma and other GI cancers.
With the passing of the IRA into law in 2022. biologics like ONCY's platform drug pelareorep will gain 13 years of FDA market exclusivity in each new indication, startring from the date of regulatory approval. Each BLA will driven by the accelerated approval process - effectively granting marketing approval after Phase 2 studies and shorting the overall final approval process.
Rachel Sachs, a law professor and drug pricing expert at Washinton University, in St Louis, noted that the IRA will exempt certain drugs (Orphan.Rare drugs) from pricing negotiations, and may encourage drug companies to develop more novel products and new combinations of products to benefit from this new opportunity.
Besides ONCY's pelareorep being a "platform drug therapy" for use in multiple cancers, pelareorp has been granted Orphan Drug Status in multiple cancers including pancreatic, ovarian and fallopian tube, peritoneal, gastric, and malignant gliomas, for example.
https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-inc-announces-receipt-of-orphan-drug-designation-from-the-u-s-fda-for-cancer-of-the-fallopian-tube/
https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-inc-announces-receipt-of-orphan-drug-designation-from-the-u-s-fda-for-gastric-cancer/
https://finance.yahoo.com/news/oncolytics-reolysin-gets-one-more-192007897.html