Resubmission of Ocaliz NDA Earlier Than Expected, for PDUFA Date 18 Dec

研报英文原文证据摘录

Resubmission of Ocaliz NDA Earlier Than Expected, for PDUFA Date 18 Dec

Sweden | Specialty Pharmaceuticals

Camurus EquityJulyResearch17, 2026

FLASH NOTEResubmission of Oclaiz NDA Earlier Than

RATING BUYExpected, for PDUFA Date 18 Dec

PRICE SEK639.00^

US FDA has accepted Camurus' NDA resubmission for Oclaiz in acromegaly

and assigned a PDUFA date of 18 Dec 2026. The timing is ahead of our PRICE TARGET | % TO PT SEK700.00 | +10%

initial expectation of 4Q26 resubmission, for 1H27 approval, and suggests 52W HIGH-LOW SEK754.50 - SEK430.80

remediation at the existing manufacturing site is sufficient, reducing the FLOAT (%) | ADV MM (USD) 61.4% | 10.77

need for a second manufacturing source ahead of approval. Management MARKET CAP SEK38.7B | $4.0B

believes it is highly likely that FDA will perform an inspection ahead of the TICKER CAMX SS ^Prior trading day's closing price unless otherwise

PDUFA date. noted.

CAM2029 US back on track for PDUFA date 18 Dec 2026: FDA has accepted the NDA

resubmission for Oclaiz in acromegaly and assigned a PDUFA date of 18 Dec 2026. We view the

timing as modestly ahead of expectations, having previously assumed a 4Q26E resubmission

for 1H27E approval, following the June Complete Response Letter (CRL). Recall, the CRL was

largely related to cGMP observations at a third-party manufacturer. With remediation actions

completed, and manufacturer inspection readiness confirmed, the acceptance removes a key

regulatory overhang and restores a defined path toward potential US approval. On the 2Q26

call, management explicitly stated that it is "highly likely" FDA will perform an inspection ahead

of the PDUFA date, given the current regulatory circumstances. We model c.$160m unrisked

US peak sales, with WW opportunity contributing c.SEK80/share NPV (12%).