Welcome to our dedicated page for Eiger BioPharmaceuticals news (Ticker: EIGR), a resource for investors and traders seeking the latest updates and insights on Eiger BioPharmaceuticals stock.
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR) is a commercial-stage biopharmaceutical company headquartered at 500 Crescent Ct Ste 300, Dallas, Texas. The company focuses on the development of innovative therapies for rare and ultra-rare diseases.
Recently, Eiger has redirected its efforts towards the development of avexitide for hyperinsulinemic hypoglycemia indications. This includes significant potential in treating post-bariatric hypoglycemia (PBH), where Phase 2 clinical trials have shown promising results, and the FDA has provided alignment on Phase 3 endpoints and study design. Eiger also plans to develop avexitide for congenital hyperinsulinism as a secondary indication.
The company continues to commercialize Zokinvy® (lonafarnib) for the treatment of Hutchinson-Gilford progeria syndrome (HGPS) and processing-deficient progeroid laminopathies (PDPL). Eiger recently received marketing approval for Zokinvy in Japan through a partnership with AnGes, Inc., further expanding its global reach.
In a strategic move, Eiger is exploring partnering opportunities for its virology assets, including lonafarnib-based regimens for hepatitis delta virus (HDV) and peginterferon lambda. Despite recent challenges, such as the discontinuation of the Phase 3 LIMT-2 study of peginterferon lambda due to safety concerns, Eiger remains committed to its primary goals.
Financially, Eiger reported total revenue of $4.6 million for Q2 2023 and $3.2 million for Q3 2023, indicating a stable financial condition supported by strategic cost reductions and workforce optimization. The company’s cash runway is extended into the fourth quarter of 2024, enhancing its capacity to pursue ongoing projects and strategic initiatives.
As of January 2024, Eiger announced a 1-for-30 reverse stock split to comply with Nasdaq's listing requirements and maintain its market position. The company is also navigating a Chapter 11 bankruptcy process to facilitate an orderly wind down of its operations and the sale of its assets, including a “stalking horse” agreement for Zokinvy.
Dr. David Apelian, with extensive experience in clinical development and regulatory affairs, leads Eiger as its CEO, guiding the company through these transformative times.
For further details and updates, visit the company’s website at www.eigerbio.com.
Eiger BioPharmaceuticals (Nasdaq:EIGR) announced the sale of its Priority Review Voucher (PRV) for $95 million. Eiger will receive 50% of the proceeds, totaling $47.5 million, as per its agreement with The Progeria Research Foundation. The PRV was granted following the FDA approval of Zokinvy™ (lonafarnib) for Progeria treatment. This sale provides Eiger with non-dilutive capital, enhancing its balance sheet and allowing better access to Zokinvy for affected children globally. The transaction is subject to standard closing conditions.
Eiger BioPharmaceuticals has received FDA approval for ZokinvyTM (lonafarnib), the first treatment for Hutchinson-Gilford Progeria Syndrome (HGPS) and processing-deficient Progeroid Laminopathies. This groundbreaking therapy demonstrated a 60% reduction in mortality and extended average survival by 2.5 years in treated patients. With an identified patient population of approximately 20 in the U.S., Eiger plans to sell the Rare Pediatric Disease Priority Review Voucher awarded by the FDA. The drug's commercial launch is a significant milestone for both Eiger and the Progeria community.
Eiger BioPharmaceuticals (Nasdaq:EIGR) announced positive results from the Phase 2 LIFT study, evaluating the combination of Peginterferon lambda and Lonafarnib for treating chronic Hepatitis Delta Virus (HDV). The study involved 26 adult patients, with 77% achieving a >2 log decline in HDV RNA at Week 24. At Week 48, 55% showed improvement in the Histology Activity Index. Adverse effects were mostly mild to moderate. Lambda and Lonafarnib are both investigational agents, with ongoing regulatory designations. Upcoming milestones include a PDUFA date for Hutchinson-Gilford Progeria Syndrome on November 20, 2020.
Eiger BioPharmaceuticals (Nasdaq: EIGR) announced the presentation of two case studies from its Phase 2 LIMT trial at The Liver Meeting Digital Experience™ 2020. This study involved 33 patients treated with Peginterferon lambda for chronic hepatitis delta virus (HDV) infection. Results showed a 36% durable virologic response at 24 weeks post-treatment and significant liver fibrosis regression in two patients. The most common side effects were mild to moderate flu-like symptoms. Eiger continues to develop Lambda, moving towards Phase 3 trials.
Eiger BioPharmaceuticals (Nasdaq:EIGR) announced its participation in two investor conferences in November 2020. The first event is the Stifel Virtual Healthcare Conference on November 18, where Eiger will present from 2:00-2:30 PM ET. The second is the Jefferies Virtual London Healthcare Conference on November 19, with Eiger's presentation scheduled from 6:10-6:40 PM GMT. Live webcasts will be available on the Eiger website. Eiger focuses on treatments for serious rare diseases, including Hepatitis Delta Virus.
Eiger BioPharmaceuticals (Nasdaq:EIGR) reported its Q3 2020 financial results, revealing a net loss of $15.7 million, or $0.52 per share, an improvement from a $18.6 million loss, or $0.76 per share in Q3 2019. Cash reserves totaled $125.3 million. R&D expenses decreased to $9.8 million, down from $14.1 million in the previous year, while G&A expenses rose to $5.0 million from $4.2 million. Upcoming milestones include a PDUFA target date of November 20, 2020 for Zokinvy and full enrollment of the Phase 3 D-LIVR study in 2021.
Eiger BioPharmaceuticals (Nasdaq:EIGR) announced data from its Hepatitis Delta Virus (HDV) programs, featured in three abstracts for The Liver Meeting Digital Experience™ (November 13-16, 2020). The presentations include a Phase 2 study of Peginterferon Lambda, results highlighting noninvasive tests for liver cirrhosis, and regression of liver fibrosis after therapy. Peginterferon Lambda is positioned for Phase 3 development, receiving FDA Orphan Designation and Breakthrough Designation. Lonafarnib, also in Phase 3 trials and with similar designations, aims to address unmet needs in HDV treatment.
Eiger BioPharmaceuticals (Nasdaq: EIGR) reported positive results from the ILIAD Study, testing Peginterferon Lambda in outpatients with mild to moderate COVID-19. In a randomized trial involving 60 patients, Lambda demonstrated a significantly greater decline in SARS-CoV-2 viral load compared to placebo, especially in patients with high baseline viral loads. By Day 7, 80% of Lambda-treated patients were negative for the virus, leading to a median clearance time of 7 days. Lambda was well-tolerated with minimal adverse effects. The study is part of ongoing research evaluating Lambda's efficacy against COVID-19.
Eiger BioPharmaceuticals (Nasdaq:EIGR) announced results from an investigator-sponsored study evaluating Peginterferon Lambda-1a (Lambda) for treating mild COVID-19. The study, involving 120 patients, showed no significant difference in viral shedding or symptom resolution compared to placebo, with both groups ceasing viral shedding within a median of 7 days. Lambda was well-tolerated, with minimal adverse events. Eiger is advancing Lambda for Hepatitis Delta Virus, having secured FDA and EMA concurrence on a Phase 3 study.
Eiger BioPharmaceuticals (Nasdaq:EIGR) announced participation in four investor conferences in September 2020. Highlights include:
- Panels at Citi's 15th Annual BioPharma Conference on September 9, discussing COVID-19 Therapeutics and Rare Disease Drug Development.
- A corporate update at the Baird Global Healthcare Conference on September 9.
- Participation in the H.C. Wainwright Annual Global Investment Conference from September 14-16.
- A corporate update at the Cantor Global Virtual Healthcare Conference on September 17.
Live webcasts will be available on Eiger's website.
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