CRL Letter Annoying But Easily Solved With Inspection Assigned Now

研报英文原文证据摘录

CRL Letter Annoying But Easily Solved With Inspection Assigned Now

ndler & Co.

third-party inspection could occur up-to the last few weeks of the June 29th 2026 646 951-0692, dominic.lorenzi@psc.com

PDUFA. Unfortunately, during the last hour, the FDA informed UNCY that the inspection

Changes Previous Current had not occurred, and the only way for the agency to push the date was through a

Rating — Overweight

CRL. Notably, mgmt highlighted the inspection has now been assigned where they Price Tgt — US$90.00

are prepared to resubmit OLC's NDA once the inspection is complete and the third- FY26E Rev (mil) — US$5.7

party vendor is deemed in compliance. Of note, in October 2025 (note here), UNCY FY27E Rev (mil) — US$1,138.4

announced a positive Type A meeting with the FDA where the third-party manufacturing FY26E EPS — US$(1.39)

vendor had made substantial progress to mitigate deficiencies identified in the original FY27E EPS — US$24.06

June 2025 CRL. Hence, we believe the only rate-limiting step to potential approval was 52-Week High / Low US$8.74 / US$3.71

completion of the third-party inspection especially considering the agency approved Shares Out (mil) 26.7

OLC's NDA resubmission in January 2026, which should have accounted for the needed Market Cap. (mil) US$205.6

inspection (in our view). As such, while the second CRL represents a minor set-back Avg Daily Vol (000) 863

we continue to have high PoS OLC will be approved considering the FDA continues to Div Yield 0.00%

not raise concerns regarding OLC's clinical efficacy/safety data (with no additional data Fiscal Year End Dec

requested).

Price Performance - 1 Year

• UNCY can resubmit OLC under a Type I NDA, so the new PDUFA date should occur USD9

much quicker in ~3-4 months (~October 2026, per our math). Importantly,...