Eiger Files for Bankruptcy, Plans to Shutter Operations After Difficult Year

2024-04-02
临床3期上市批准并购优先审批加速审批
Pictured: A U.S. federal bankruptcy courthouse building/iStock, GussWilder Eiger BioPharmaceuticals on Monday announced that it has voluntarily filed for bankruptcy and has kicked off the process of selling its assets and winding down the company’s operations. The California-based biotech has filed for Chapter 11 protection with the Bankruptcy Court for the Northern District of Texas, and has also submitted customary “first day” motions. If granted, the motion will provide Eiger some relief allowing it to transition into bankruptcy while it meets the company’s commitments to its stakeholders without “material disruptions” to its ordinary operations, according to the announcement. Eiger will sell all its assets during the bankruptcy case as it prepares for “an orderly wind down” of its operations. As part of the process, the biotech has inked a “stalking horse” agreement with rare disease player Sentynl Therapeutics which has agreed to purchase Zokinvy (lonafarnib), a farnesyltransferase inhibitor approved to treat the rare and progressive genetic disease Hutchinson-Gilford progeria syndrome. Sentynl will pay up to $26 million for Zokinvy, with the final price subject to other adjustments including per diem reductions. Zokinvy is an oral small molecule drug that blocks the farnesyltransferase protein. It is also approved for use in processing-deficient progeroid laminopathies with specific genetic mutations. The companies expect to close the sale by April 24, 2024. As part of its bankruptcy filing, other bidders can also submit competing offers for Eiger’s assets through a court-supervised process. Eiger’s bankruptcy filing on Monday caps off a difficult year for the biotech. In September 2023, it announced that it was discontinuing the Phase III LIMT-2 study of its candidate peginterferon lambda for chronic hepatitis delta. A quarterly review by a Data Safety Monitoring Board (DSMB) found concerning safety signals associated with peginterferon lambda. Four patients who received the investigational therapy developed hepatobiliary events, which led to liver compensation, leading the DSMB to recommend the study’s discontinuation. In September 2022, the FDA also rejected Eiger’s application for an Emergency Use Authorization for peginterferon lambda, which the biotech was proposing for the treatment of mild-to-moderate COVID-19. Following this rejection, Eiger in June 2023 laid off 25% of its workers in a sweeping reprioritization and savings program. The initiative also included a pivot to its GLP-1 receptor antagonist avexitide, which at the time was being developed for post-bariatric hypoglycemia and congenital hyperinsulinism. Eiger expected the cost-cutting measures to support its operations through the fourth quarter of 2024. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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