1Q26: ALXN1840 NDA Filing Still Guided To Mid-'26

研报英文原文证据摘录

1Q26: ALXN1840 NDA Filing Still Guided To Mid-'26

C O M PA N Y N O T E

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Monopar Therapeutics, Inc. (MNPR) Overweight

CONCLUSION PRICE: US$61.44

This afternoon, MNPR reported 1Q26 earnings and a pipeline update. The ALXN1840 NDA TARGET: US$101.00

filing continues to be guided to mid-'26. In parallel, the company is readying for a potential Our $101 PT is based on a DCF through 2036E

commercial launch (we estimate in 2H27) by hiring a CCO. Additionally, MNPR continues (14% discount rate) and assumes approval of

to present new analyses from the Ph3 FoCuS trial to support ALXN1840's clinical benefit in ALXN1840 in Wilson Disease.

Wilson's Disease. At EASL (May 27-30), the presentation will support ALXN1840's ability to

Biren Aminimprove neurological symptoms in addition to QoL. Additionally, the company will present Sr. Research Analyst, Piper Sandler & Co.

at EAN (June 27-30), though these findings were previously presented at AAN this past 732 284-6909, biren.amin@psc.com

April. Cash runway continues to be guided to YE27. Michael Mazzola, Ph.D.

Research Analyst, Piper Sandler & Co.

• NDA Filing Continues To Be on Track for Mid-'26. The ALXN1840 NDA submission to 212 284-9397, michael.mazzola@psc.com

the FDA remains on track for mid-2026. A Chief Commercial and Strategy Officer started Kailie Briza

in March and is leading commercial readiness activities in preparation for the potential Research Analyst, Piper Sandler & Co.

312 281-3437, kailie.briza@psc.com launch. Based on our interactions with mgmt., the FDA has not requested any additional

clinical studies based on communications to date; that said, mgmt. did not disclose the Felicia Berben, PharmD

nature or specifics of the FDA's questions (note here). 212 284-9412, felicia.berben@psc.com