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Eiger Completes NDA Submission of Progeria Drug Lonafarnib
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Eiger BioPharmaceuticals, Inc. 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.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Eiger Completes NDA Submission of Progeria Drug Lonafarnib
Eiger BioPharmaceuticals, Inc. 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 BioPharmaceuticals, Inc. Price
Eiger BioPharmaceuticals, Inc. price | Eiger BioPharmaceuticals, Inc. Quote
Zacks Rank
Eiger currently holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>