PolyPid heads into FDA verdict on D-PLEX100 with European rights back in hand

PolyPid is about two weeks from a US regulatory decision on D-PLEX100, its candidate for preventing infections at the operative site after colon and rectal surgery. The company gave the update with its third-quarter 2026 results on 11 November.

The FDA is reviewing the new drug application on an expedited timetable, with an action date of 28 November 2026 under the Prescription Drug User Fee Act. Once the agency accepted the filing, PolyPid received $15 million from Azurity. The update does not say what other terms the Azurity arrangement contains.

In Europe, the EMA has validated PolyPid's marketing authorisation application, which means the formal assessment has begun. The company expects an outcome in the second half of 2027. Its licence deal with ADVANZ for the region has been terminated, so European rights have returned to PolyPid. The company has not said in this update how it plans to commercialise the product there, leaving the option of a new partner or another route open.

PolyPid also has a pending request with the US Centers for Medicare & Medicaid Services for New Technology Add-on Payment status, with a decision expected in August 2027. As general context, this Medicare mechanism can provide extra payment for certain new technologies used in inpatient care, which makes it relevant to how hospitals weigh the cost of adopting a new product.