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Get filing alertsFennec settles Cipla litigation, extends exclusivity to 2033; revenue up 6.1% but loss widens
Filed March 27, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 26, 2025 · ~1 min read
Key Changes
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Cipla generic settlement delays market entry until September 2033 (or earlier under certain conditions), extending PEDMARK exclusivity ~4 years beyond orphan drug expiration in 2029.
Legal Proceedings verify on EDGAR → -
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Net product sales grew 51% to $44.6M in 2025 from $29.6M in 2024, driven by AYA market expansion; net loss widened to $9.7M from $0.4M due to $2M debt extinguishment loss and $5.2M higher G&A.
MD&A: Financial Results verify on EDGAR → -
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Japan trial (STS-J01) showed 50% reduction in hearing loss and 95% clinical response rate; company pursuing regulatory registration and partnering opportunities similar to Norgine model.
Business: Japan Strategy verify on EDGAR →
2 more material changes behind this preview — plus the full narrative summary, section-by-section diffs against the prior filing, and verbatim quotes with EDGAR citations.
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Source-verified from EDGAR · Narrative written by AI · Jun 3, 2026 · How we verify