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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) presented significant data at the EASL International Liver Congress 2022 on their hepatitis delta virus (HDV) therapies. The Phase 3 D-LIVR study showcases the largest cohort of HDV patients, revealing alarming cirrhosis rates, with over 40% of affected patients being ≤ 45 years old. The studies on peginterferon lambda demonstrate its superior antiviral activity. Eiger also holds Breakthrough Therapy designations for several of its programs. Topline results from D-LIVR are anticipated by year-end.
Eiger BioPharmaceuticals (Nasdaq: EIGR) announced Phase 2b results for avexitide, presented at ENDO 2022, showing significant reductions in hypoglycemia events in patients with post-bariatric hypoglycemia (PBH) and hyperinsulinemic hypoglycemia (HH). The study met primary and secondary endpoints with reductions of up to 68% in severe hypoglycemic events. Avexitide has been granted Breakthrough Therapy designation by the FDA for both PBH and congenital hyperinsulinism, supporting its potential as a targeted treatment option for affected patients.
Eiger BioPharmaceuticals announced four abstracts to be presented at the EASL International Liver Congress from June 22-26, 2022, in London. Notable presentations include an oral session on the LIFT-1 HDV study examining the effects of Lonafarnib with Peginterferon Lambda on hepatitis delta virus. Additional poster presentations cover correlations in chronic hepatitis delta patients and predictive clinical features of cirrhosis. Eiger is advancing innovative therapies for HDV and other serious diseases, with all five rare disease programs holding FDA Breakthrough Therapy designation.
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR) has secured approximately $11 million after retiring its previous debt facility and entered a $75 million term loan agreement and a $5 million stock purchase agreement with Innovatus Capital Partners. The new funding strengthens Eiger's cash position and provides access to an additional $35 million tied to clinical milestones. This financial boost is expected to extend the company's cash runway through 2024 and support its late-stage drug development efforts.
Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR) announced that President and CEO David Cory will present at the Jefferies Global Healthcare Conference on June 8, 2022, at 9:00 AM ET in New York City. The presentation will provide an overview of the company’s innovative therapies aimed at treating hepatitis delta virus (HDV) and other diseases. Investors will also have the opportunity for one-on-one meetings at the conference. A live webcast of the presentation will be accessible on Eiger's website, with a replay available for 90 days.
Eiger BioPharmaceuticals announced that the CHMP of the European Medicines Agency issued a positive opinion for Zokinvy (lonafarnib) as a treatment for Hutchinson-Gilford progeria syndrome (HGPS). If approved, Zokinvy will be the only treatment available in Europe that significantly extends life in children with HGPS by an average of 4.3 years. The decision is based on clinical trials demonstrating a 72% reduction in mortality risk. Eiger plans to commercialize Zokinvy in Europe following reimbursement discussions, continuing their strategy to provide innovative treatments for rare diseases.
Eiger Biopharmaceuticals and AnGes have formed a partnership for the regulatory approval and commercialization of Zokinvy (lonafarnib) in Japan for treating Hutchinson-Gilford progeria syndrome and progeroid laminopathies. AnGes will handle the regulatory process, while Eiger will receive up to $1.5 million in upfront and milestone payments, along with revenue from Zokinvy sales. Zokinvy is a first-in-class therapy that has significantly improved survival rates in children with progeria. The companies aim for swift regulatory action to benefit patients in Japan.
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR) reported a net loss of $22.6 million, or $0.64 per share, for Q1 2022, compared to a net income of $29.2 million for the same period in 2021, largely due to a one-time gain last year. Cash and equivalents stand at $153.5 million post-a $20.8 million stock sale, expected to fund operations into Q4 2024. Significant milestones anticipated include an EUA application for peginterferon lambda for COVID-19 and topline data from the D-LIVR study for HDV by year-end.
Eiger BioPharmaceuticals (Nasdaq: EIGR) announced that its Compensation Committee has granted stock options totaling 290,000 shares to two newly hired employees. These options are part of the 2021 Inducement Plan, with an exercise price of $6.87, reflecting the closing stock price on April 29, 2022. Vesting occurs over four years, starting with 25% after one year, followed by monthly vesting for the remaining shares. This move aligns with Nasdaq Listing Rule 5635(c)(4) and highlights Eiger's commitment to incentivizing talent in its biopharmaceutical initiatives.
Eiger BioPharmaceuticals published positive results from a Phase 2 study of avexitide, demonstrating a significant reduction in hypoglycemia in children with congenital hyperinsulinism, as seen in Diabetes Care. The study revealed a 76-84% decrease in fasting hypoglycemia likelihood at mid- and high doses. Eiger plans to initiate a Phase 3 registrational program by the end of 2022. The FDA has granted avexitide orphan drug designation, rare pediatric disease designation, and breakthrough therapy designation, underscoring its potential impact on this underserved medical condition.
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