Regulatory News:
GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the journal
BioDrugs has published results from REVEAL, the Phase I/IIa clinical trial that evaluated the safety of LUMEVOQ
® gene therapy in subjects with
ND4 Leber Hereditary Optic Neuropathy (LHON) and determined the dose subsequently used in the Phase III trials RESCUE and REVERSE.
The paper , published in the February issue of
BioDrugs under the title “Safety of intravitreal gene therapy for treatment of subjects with Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial
Prothena Corporation plc: Prothena Reports Fourth Quarter and Full Year 2020 Financial Results, and Provides Financial Guidance and R&D Update
VITAL study 9-month results expected to be presented at medical conference in 2021
Prasinezumab
New pre-specified exploratory subgroup analyses from Part 1 of the Phase 2 PASADENA study to be presented at the 15th International Conference for Alzheimer s and Parkinson s Diseases in March 2021 (ADPD 2021)
$60 million clinical milestone payment to be achieved upon first patient dosed in late-stage Phase 2b study in patients with early Parkinson s disease; further details expected in 2Q 2021
Results from Part 2 of the PASADENA study expected to be presented at an upcoming medical conference
Idorsia Pharmaceuticals Ltd: Idorsia announces financial results for 2020 - a successful year marked by outstanding clinical data
Idorsia Ltd (SIX: IDIA) today announced its financial results for the full year 2020.
Business highlights
Positive results in the Phase 3 program of daridorexant, demonstrating improved overall sleep and daytime functioning of patients with insomnia
Daridorexant new drug application (NDA) submitted to the US FDA on January 8, 2021
Positive results in the Japanese registration program for clazosentan, demonstrating reduction in vasospasm-related morbidity and all-cause mortality
US commercial operations established, with leadership team in place, and Syneos Health selected as commercialization partner to build the salesforce for the launch of daridorexant in the US
131.2
US GAAP revenue of CHF 72 million in 2020 consisted of contract revenue recognized in connection with the collaboration agreements with Neurocrine Biosciences, Inc. (CHF 50 million), Janssen Biotech, Inc. (CHF 11 million), Roche (CHF 6 million), Mochida Pharmaceutical Co., Ltd (CHF 3 million) and Santhera Pharmaceuticals Ltd (CHF 2 million) compared to a revenue of CHF 24 million in 2019.
US GAAP operating expenses in 2020 amounted to CHF 482 million (CHF 506 million in 2019), of which CHF 381 million relates to R&D (CHF 439 million in 2019), which includes a one-off expense of CHF 9 million as explained in the legal update below, and CHF 101 million to SG&A expenses (CHF 68 million in 2019).
Prothena Corporation plc
Prothena Announces Confirmatory Phase 3 AFFIRM-AL Study of Birtamimab in Mayo Stage IV Patients with AL Amyloidosis under SPA Agreement with FDA
Prothena Announces Confirmatory Phase 3 AFFIRM-AL Study of Birtamimab in Mayo Stage IV Patients with AL Amyloidosis under SPA Agreement with FDA
Significant survival benefit observed in VITAL study for birtamimab-treated patients with AL amyloidosis at high risk for early mortality (Mayo Stage IV, HR 0.413, p 0.025, over 9 months)
SPA agreement with FDA to enable registration of birtamimab at unprecedented p
AFFIRM-AL study of birtamimab expected to initiate mid-2021
Investor conference call and webcast scheduled Feb. 2 at 8:00am ET, Prothena management will be joined by Morie Gertz, MD, MACP, Division of Hematology, Mayo Distinguished Clinician, Mayo Clinic