普通外文研报
IP Layering Increases Our Confidence in Miplyffa Exclusivity; Increase PT to $27
研报英文原文证据摘录
IP Layering Increases Our Confidence in Miplyffa Exclusivity; Increase PT to $27
June 9, 2026 Zevra Therapeutics, Inc.
(ZVRA, Buy, $27 PT)
Kambiz Yazdi
IP Layering Increases Our Confidence in Miplyffa Exclusivity; Increase PT (212) 588-6580 kyazdi@btig.com
to $27 Company Data
Closing Price $12.09
WHAT YOU SHOULD KNOW: Zevra announced submission of U.S. Patent No. Price Target $27.00BIOTECHNOLOGY 11,707,456 to FDA for Orange Book listing for Miplyffa, with nominal expiry in 2041.
Market Cap (M) $709.83 U.S. Patent No. 11,707,456 appears to cover a defined arimoclomol citrate composition
with specified purity and impurity parameters. If listed, the patent would add another Shares Out (M) 58.71
layer to Miplyffa’s IP estate, which already includes Orange Book-listed patents, orphan Avg Daily Vol-3 Months (M) 1.49EQUITY drug exclusivity to 2031, and a pending patent term extension on U.S. Patent No. Revisions
11,045,460 that could extend the term of that patent to ~2034. We increase our price Previous Current
target to $27 on improved IP defensibility and reiterate our BUY rating.
Rating Buy Buy
■ New Orange Book submission could extend the patent estate to 2041. Zevra Price Target $23.00 $27.00
has submitted U.S. Patent No. 11,707,456 for Orange Book listing. FDA’s role in FY26E EPS 1.19 1.19
reviewing Orange Book submissions is largely ministerial and focused on whetherRESEARCH FY27E EPS 1.65 1.51 the patent falls within the relevant statutory listing categories; FDA does not
adjudicate validity. If listed, the patent would become part of the Hatch-Waxman FY26E REV 158.63 158.63
framework for any future generic challenge. Separately, the company’s patent FY27E REV 239.34 228.18
term extension application on U.S. Patent No. 11,045,460 remains pending at the EPS (GAAP)
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