Eiger BioPharmaceuticals, Inc. - EIGR STOCK NEWS

Eiger BioPharmaceuticals (Nasdaq:EIGR) announced the inclusion of Peginterferon Lambda in the Phase 3 TOGETHER study targeting COVID-19 outpatients. The trial will evaluate Lambda's efficacy against emergency room visits and hospitalizations, with a target enrollment of 800 patients at various sites in Brazil and potential expansion to Toronto, Canada. The study aims to address the urgent need for outpatient treatments amid the COVID-19 pandemic. Lambda, an investigational agent, is recognized for its potential to stimulate immune responses and tackle emerging viral variants.

Eiger BioPharmaceuticals (Nasdaq:EIGR) will host a conference call on May 6, 2021, at 4:30 PM ET, to discuss its Q1 2021 financial results and provide a business update. The conference will focus on Eiger's advancements in treatments for rare diseases, including Hepatitis Delta Virus and Hutchinson-Gilford Progeria Syndrome. Notably, Lonafarnib is in a global Phase 3 trial, while Peginterferon lambda is entering Phase 3. Zokinvy is the first FDA-approved product, with a Marketing Authorization Application under review in Europe.

Eiger BioPharmaceuticals (Nasdaq:EIGR) announced the appointment of Kim Sablich to its Board of Directors. Ms. Sablich brings over 20 years of pharmaceutical experience, including her role as Executive Vice President at Jazz Pharmaceuticals. Her expertise involves building commercial product portfolios in rare disease programs. Eiger is advancing therapies for Hepatitis Delta Virus and has a strong focus on unmet medical needs. This leadership addition aims to enhance Eiger's strategic insights during the pivotal stages of its product development and commercialization.

Eiger BioPharmaceuticals (Nasdaq: EIGR) reported its 2020 financial results, revealing a net loss of $65.1 million, or $2.31 per share, compared to $70.3 million, or $3.08 per share, in 2019. As of December 31, 2020, cash and equivalents totaled $128.8 million, up from $95 million a year prior. The company plans to complete enrollment of the Phase 3 D-LIVR study for Lonafarnib in 2021, aiming to provide foundational therapies for Hepatitis Delta Virus. Eiger also plans to initiate the Phase 3 LIMT-2 study for Lambda and commercialize Zokinvy, launched in January 2021.

Eiger BioPharmaceuticals (Nasdaq: EIGR) announced positive results from the Phase 2 PREVENT study of Avexitide for treating severe Post-Bariatric Hypoglycemia (PBH). The study showed statistical significance in increasing mean plasma glucose levels, reducing hypoglycemia events, and lowering peak insulin levels. Both dosing regimens (30 mg BID and 60 mg QD) were effective, with fewer participants needing rescue medications. Well-tolerated, the treatment demonstrated significant improvements in clinical outcomes. Eiger has received FDA and EMA concurrence for a Phase 3 study to further evaluate Avexitide.

Eiger BioPharmaceuticals (Nasdaq:EIGR) announced final results from the Phase 2 ILIAD study of Peginterferon Lambda for COVID-19, published in Lancet Respiratory Medicine. The trial showed that a single dose of Lambda accelerated SARS-CoV2 clearance in outpatients, potentially improving clinical outcomes and reducing virus spread. Among 60 patients, only one in the Lambda group required emergency care. Eiger is finalizing FDA guidance for a potential Phase 2/3 registration study of Lambda in COVID-19, amid concerns over virus variants.

Eiger BioPharmaceuticals (Nasdaq:EIGR) has announced the U.S. commercial launch of Zokinvy™ (lonafarnib), the first FDA-approved treatment for Hutchinson-Gilford Progeria Syndrome (HGPS) and processing-deficient progeroid laminopathies. Approved in November 2020, Zokinvy is designed to reduce mortality risk in affected patients. To support patients, Eiger has established Eiger OneCare™, offering personalized assistance and reimbursement support. Approximately 180 eligible patients have been identified, with the company also pursuing international approvals, including an application with the European Medicines Agency.

Eiger BioPharmaceuticals (Nasdaq:EIGR) reports significant progress in its product pipeline, focusing on Hepatitis Delta Virus (HDV) therapies. Key highlights include the planned completion of Phase 3 D-LIVR study enrollment in 2021 and the initiation of Phase 3 LIMT-2 study for Peginterferon Lambda in HDV later in 2021. The company also plans to launch Zokinvy following its FDA approval for Progeria in January 2021. Financially, Eiger anticipates $176M in cash and equivalents, expected to fund operations through Q4 2023, while selling a Priority Review Voucher for $95M.

Eiger BioPharmaceuticals has received FDA approval for Zokinvy (lonafarnib) to treat Hutchinson-Gilford Progeria Syndrome (HGPS) and processing-deficient Progeroid Laminopathies. This groundbreaking treatment shows a 60% reduction in mortality for Progeria patients, extending survival by an average of 2.5 years. The approval grants a Rare Pediatric Disease Priority Review Voucher to Eiger, which can be sold, with proceeds shared with the Progeria Research Foundation. Eiger also announces the launch of Eiger OneCare™ for patient support and access.