EIGER BIOPHARMACEUTICALS, INC. (NASDAQ:EIGR) Files An 8-K Other Events

ME Staff 8-k
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EIGER BIOPHARMACEUTICALS, INC. (NASDAQ:EIGR) Files An 8-K Other Events
Item 8.01.

On March 23, 2020, Eiger BioPharmaceuticals, Inc. (the “Company”) announced that it has completed submission to the U.S. Food and Drug Administration (the “FDA”) of a New Drug Application (an “NDA”) for lonafarnib for the treatment of Progeria and Progeroid Laminopathies. The FDA previously granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation to lonafarnib, which enables eligibility for Priority Review, if relevant criteria are met. The Company expects to hear from the FDA regarding submission acceptance and Priority Review within 60 days of submission of the NDA.

Lonafarnib, an oral farnesyltransferase inhibitor, has demonstrated extended survival in children and young adults with Progeria, an ultra-rare and fatal disease that causes premature aging in children. Without treatment, children with Progeria die of heart disease at an average age of 14.5 years.

Forward-Looking Statements

Statements in this report that are not strictly historical in nature constitute “forward-looking statements.” Such statements include, but are not limited to the Company’s expectations with respect to the timing and content of any communications with the FDA in connection with the NDA submission, including with respect to Priority Review. Such forward-looking statements involve known and unknown risks, uncertainties and other factors. More information about the risks the Company faces is included under the headings “Risk Factors” in the Company’s most recently filed documents with the U.S. Securities and Exchange Commission. The Company is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this report as a result of new information, future events or otherwise.


About EIGER BIOPHARMACEUTICALS, INC. (NASDAQ:EIGR)

Eiger BioPharmaceuticals, Inc., formerly Celladon Corporation, is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of products for the treatment of orphan diseases. Its pipeline includes Sarasar (lonafarnib) for hepatitis delta virus (HDV), exendin (9-39) for severe hypoglycemia, and Bestatin (ubenimex) for pulmonary arterial hypertension (PAH) and lymphedema. Lonafarnib is an orally active inhibitor of farnesyl transferase that inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply. It is conducting over three Phase II clinical trials, which include LOnafarnib With and without Ritonavir (LOWR) HDV-2 (Ankara, Turkey), LOWR HDV-3 (NIH) and LOWR HDV-4 (Hannover, Germany). Exendin is in Phase II clinical studies for the treatment of hypoglycemia associated with bariatric surgery. Ubenimex is in Phase II clinical studies for the treatment of PAH and lymphedema.