Hutchinson-Gilford Progeria Syndrome

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19 05, 2020

Eiger BioPharmaceuticals Announces FDA Acceptance of NDA for Filing with Priority Review of Zokinvy™ (lonafarnib) for Treatment of Progeria and Progeroid Laminopathies

2020-05-19T21:14:10+00:00

Eiger BioPharmaceuticals Announces FDA Acceptance of NDA for Filing with Priority Review of Zokinvy™ (lonafarnib) for Treatment of Progeria and Progeroid Laminopathies PALO ALTO, Calif. May 19, 2020 -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and Drug [...]

Eiger BioPharmaceuticals Announces FDA Acceptance of NDA for Filing with Priority Review of Zokinvy™ (lonafarnib) for Treatment of Progeria and Progeroid Laminopathies2020-05-19T21:14:10+00:00
27 04, 2020

Eiger BioPharmaceuticals Announces EMA Validation of Lonafarnib MAA for Treatment of Progeria and Progeroid Laminopathies

2020-04-27T13:57:56+00:00

Eiger BioPharmaceuticals Announces EMA Validation of Lonafarnib MAA for Treatment of Progeria and Progeroid Laminopathies Accelerated Assessment of MAA Previously Granted by EMA in March PALO ALTO, Calif. April 27, 2020 -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that [...]

Eiger BioPharmaceuticals Announces EMA Validation of Lonafarnib MAA for Treatment of Progeria and Progeroid Laminopathies2020-04-27T13:57:56+00:00
23 03, 2020

Eiger BioPharmaceuticals Completes Submission of New Drug Application to FDA for Lonafarnib for Treatment of Progeria and Progeroid Laminopathies

2020-03-23T17:54:46+00:00

Eiger BioPharmaceuticals Completes Submission of New Drug Application to FDA for Lonafarnib for Treatment of Progeria and Progeroid Laminopathies Progeria MAA Submitted to EMA and Granted Accelerated Assessment PALO ALTO,  Calif. March 23, 2020 -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, [...]

Eiger BioPharmaceuticals Completes Submission of New Drug Application to FDA for Lonafarnib for Treatment of Progeria and Progeroid Laminopathies2020-03-23T17:54:46+00:00
17 12, 2019

Eiger Initiates Rolling Submission of New Drug Application (NDA) with FDA for Lonafarnib for Treatment of Progeria and Progeroid Laminopathies

2019-12-17T00:20:58+00:00

Eiger Initiates Rolling Submission of New Drug Application (NDA) with FDA for Lonafarnib for Treatment of Progeria and Progeroid Laminopathies Rolling NDA Submission Planned for Completion in First Quarter 2020 Marketing Authorization Application (MAA) to EMA Planned in First Quarter 2020 PALO ALTO, Calif., December 16, 2019 — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a late [...]

Eiger Initiates Rolling Submission of New Drug Application (NDA) with FDA for Lonafarnib for Treatment of Progeria and Progeroid Laminopathies2019-12-17T00:20:58+00:00
21 10, 2019

Eiger Announces Peginterferon Lambda Combination Therapy for Treatment of Chronic Hepatitis Delta Virus (HDV) Infection to be Featured in a Late-Breaking Oral Presentation at AASLD 2019

2019-10-21T14:08:32+00:00

Eiger Announces Peginterferon Lambda Combination Therapy for Treatment of Chronic Hepatitis Delta Virus (HDV) Infection to be Featured in a Late-Breaking Oral Presentation at AASLD 2019rectors >50% of Patients Achieve Undetectable or BLOQ HDV RNA at Week 24Median Decline of HDV RNA: -3.4 Log at Week 2495% of Patients Achieve >2 Log Decline in HDV [...]

Eiger Announces Peginterferon Lambda Combination Therapy for Treatment of Chronic Hepatitis Delta Virus (HDV) Infection to be Featured in a Late-Breaking Oral Presentation at AASLD 20192019-10-21T14:08:32+00:00
4 03, 2019

Clinigen and Eiger BioPharmaceuticals launch worldwide Managed Access Program for lonafarnib for patients with Progeria and Progeroid Laminopathies

2019-03-04T15:41:48+00:00

Clinigen and Eiger BioPharmaceuticals launch worldwide Managed Access Program for lonafarnib for patients with Progeria and Progeroid Laminopathies Clinigen Group plc (AIM: CLIN, ‘Clinigen’), the global pharmaceutical and services company, has partnered with Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR, ‘Eiger’) to launch a worldwide lonafarnib Managed Access Program for patients with Progeria and Progeroid Laminopathies.Progeria, also [...]

Clinigen and Eiger BioPharmaceuticals launch worldwide Managed Access Program for lonafarnib for patients with Progeria and Progeroid Laminopathies2019-03-04T15:41:48+00:00
19 12, 2018

Eiger Announces Breakthrough Therapy Designation Granted by FDA for Lonafarnib in Progeria and Progeroid Laminopathies

2018-12-19T14:26:30+00:00

Eiger Announces Breakthrough Therapy Designation Granted by FDA for Lonafarnib in Progeria and Progeroid Laminopathies Survival Benefit in Children with Progeria Published in JAMA 2018 NDA Filing Planned in 2019 PALO ALTO, Calif., December 19, 2018 — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare [...]

Eiger Announces Breakthrough Therapy Designation Granted by FDA for Lonafarnib in Progeria and Progeroid Laminopathies2018-12-19T14:26:30+00:00
3 12, 2018

Eiger BioPharmaceuticals Announces FDA Acceptance of IND Application for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies

2018-12-03T15:51:26+00:00

Eiger BioPharmaceuticals Announces FDA Acceptance of IND Application for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies Plans to File NDA in 2019PALO ALTO, Calif., December 3, 2018 — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the U.S. Food and [...]

Eiger BioPharmaceuticals Announces FDA Acceptance of IND Application for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies2018-12-03T15:51:26+00:00
22 10, 2018

Eiger BioPharmaceuticals Receives FDA Rare Pediatric Disease (RPD) Designation for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies and Plans NDA Filing in 2019

2018-10-22T16:25:07+00:00

Eiger BioPharmaceuticals Receives FDA Rare Pediatric Disease (RPD) Designation for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies and Plans NDA Filing in 2019 - Designation Enables Priority Review Voucher Eligibility Upon NDA Approval PALO ALTO, Calif., October 22, 2018 — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies [...]

Eiger BioPharmaceuticals Receives FDA Rare Pediatric Disease (RPD) Designation for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies and Plans NDA Filing in 20192018-10-22T16:25:07+00:00
4 09, 2018

Eiger Announces Positive Meeting with FDA on Progeria

2018-09-04T14:32:10+00:00

Eiger Announces Positive Meeting with FDA on Progeria -  Company advancing plans to file NDA for Lonafarnib in ProgeriaPALO ALTO, Calif., September 4, 2018 – Today, Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR), a company focused on the development and commercialization of targeted therapies for rare diseases, announced it has received minutes from a pre-investigational new drug [...]

Eiger Announces Positive Meeting with FDA on Progeria2018-09-04T14:32:10+00:00
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