Biohaven Ltd. Files 8-K Report

TL;DR

Biohaven filed a standard 8-K, no major news.

AI Summary

Biohaven Ltd. filed an 8-K on September 23, 2024, to report on other events and financial statements. The filing does not contain specific financial figures or material events beyond the standard reporting requirements.

Why It Matters

This filing indicates Biohaven Ltd. is meeting its regulatory reporting obligations, but it does not disclose any new material information that would impact investors.

Risk Assessment

Risk Level: low — The filing is a routine 8-K report and does not contain any new material information or events that would pose a risk to investors.

Key Players & Entities

• Biohaven Ltd. (company) — Registrant
• September 23, 2024 (date) — Date of Report
• 215 Church Street New Haven, Connecticut 06510 (address) — Principal executive offices
• 203-404-0410 (phone_number) — Registrant's telephone number

FAQ

Filing Documents

• bhvn-20240923.htm (8-K) — 32KB
• exhibit991.htm (EX-99.1) — 25KB
• bhvn-20240923_g1.jpg (GRAPHIC) — 353KB
• bhvn-20240923_g2.jpg (GRAPHIC) — 358KB
• bhvn-20240923_g3.jpg (GRAPHIC) — 375KB
• biohaven_quote.jpg (GRAPHIC) — 527KB
• image1a.jpg (GRAPHIC) — 431KB
• imagea.jpg (GRAPHIC) — 441KB
• 0001935979-24-000073.txt ( ) — 4653KB
• bhvn-20240923.xsd (EX-101.SCH) — 2KB
• bhvn-20240923_lab.xml (EX-101.LAB) — 21KB
• bhvn-20240923_pre.xml (EX-101.PRE) — 12KB
• bhvn-20240923_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure On September 23, 2024, Biohaven Ltd. (the "Company") issued a press release announcing topline data from the Company's study to assess the effectiveness of troriluzole in Spinocerebellar Ataxia ("SCA"). A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. In addition, on September 23, 2024, members of management of the Company held a conference call to discuss the results of the SCA study. A copy of the presentation that accompanied the conference call is available on the Company's website at www.biohaven.com. The information contained in this Item 7.01, including Exhibit 99.1, is being "furnished" and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"). The information in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.

01 Other Events

Item 8.01 Other Events On September 23, 2024, the Company announced positive topline results from pivotal Study BHV4157-206-RWE (NCT06529146) demonstrating the efficacy of troriluzole on the mean change from baseline in the f-SARA after 3 years of treatment. The study achieved the primary endpoint and showed statistically significant improvements on the f-SARA at years 1 and 2 (Figure 1). SCA is a rare, progressively debilitating neurodegenerative disease that affects approximately 15,000 people in the United States and 24,000 in Europe and the United Kingdom. There are no U.S. Food and Drug Administration (the "FDA") approved treatments for SCA. Collectively, data across multiple analyses demonstrate a robust and clinically meaningful slowing of disease progression in SCA patients. These treatment benefits translate into a 50- 70% slower rate of decline compared to untreated patients, representing 1.5-2.2 years delay in disease progression over the 3-year study period. Additionally, in a responder sensitivity analysis, disease progression when defined by a 2 point or greater worsening on the f-SARA at 3 years showed an odds ratio ("OR") of 4.1 (95% CI: 2.1, 8.1) for the untreated external control arm versus troriluzole treated subjects (p < 0.0001; pooled analysis). Figure 1: f-SARA Change from baseline demonstrating troriluzole reduced SCA disease progression vs US Natural History External Control 2 Study BHV4157-206-RWE was designed, in discussion with the FDA, to assess the effectiveness of troriluzole in SCA after 3 years of treatment as measured by the change from baseline in the f-SARA. The study utilized Phase 3 data and an external control of matched, untreated SCA subjects from the US Clinical Research Consortium for the Study of Cerebellar Ataxia ("CRC-SCA") in accordance with the FDA's Guidance on Real-World Evidence ("RWE") of effectiveness. All endpoints were prespecified, and both the study protocol and statistical analysis plan were submitted

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit Number Exhibit Description 99.1 Press Release, dated September 23, 2024, titled "Biohaven Achieves Positive Topline Results in Pivotal Study of Troriluzole in Spinocerebellar Ataxia (SCA)." 104 The cover page of this Current Report on Form 8-K formatted as Inline XBRL. 4

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: September 23, 2024 Biohaven Ltd. By: /s/ Matthew Buten Matthew Buten Chief Financial Officer 5

View Full Filing

View this 8-K filing on SEC EDGAR