Eiger BioPharmaceuticals, Inc. (EIGR - Free Report) announced that it has completed rolling submission of a new drug application (“NDA”) to the FDA for its pipeline candidate, lonafarnib. The NDA seeks approval for lonafarnib as a treatment for progeria and progeroid laminopathies, ultra-rare diseases causing accelerated aging in children. The company had initiated the rolling submission of the NDA in December 2019.
The candidate enjoys Breakthrough Therapy designation and Rare Pediatric Disease designation. These designations make the candidate eligible for priority review. Eiger expects the FDA’s acceptance of the NDA to be completed within 60 days.
A regulatory application seeking approval for lonafarnib for same indications has been accepted and granted accelerated assessment by the European Medicines Agency earlier this month.
The company has also started preparations to support commercial launch of the candidate, following a potential approval.
Shares of Eiger were up 5.4% on Mar 23, following the announcement. However, the company’s shares have declined 60.4% so far this year, compared with the industry’s decrease of 16%.
Apart from the aforementioned indications, the company is also developing lonafarnib as a treatment for hepatitis delta virus (“HDV”) in a phase III study. The study is currently enrolling patients and the process is expected to be completed by the end of this year. Top-line data is expected to be announced in 2021.
Please note that Eiger has a license agreement with Merck (MRK - Free Report) , which grants Eiger exclusive right to develop and commercialize lonafarnib.
The company is also developing another candidate, peginterferon lambda (lambda), for treating HDV patients. The company successfully completed an end-of-phase II meeting with the FDA earlier this year and reached an agreement on a single phase III study related to development of lambda as HDV treatment. It has in-licensed the candidate from Bristol-Myers (BMY - Free Report) . The company also has a mid-stage candidate, avexitide, which is being developed for post-bariatric hypoglycemia and congenital hyperinsulinism.
Although EIger’s candidates target rare indications, a few other biotechs are also developing their candidates for similar indications. These include Xeris Pharmaceuticals (XERS - Free Report) and Zealand Pharmaceuticals among others.
Eiger currently holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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