The company has not filed an annual or quarterly report since its Q3 FY2019 10-Q, filed Nov 7, 2019. Its latest SEC filing is a SC 13G/A from Feb 14, 2020.
10-Q for Q3 FY2019, filed Nov 7, 2019
The sections below describe the company as of the FY2018 annual report.
Sells LUXTURNA, a gene therapy for inherited retinal disease, through treatment centers and develops gene therapies for genetic diseases affecting the eye, liver and nervous system.
10-K for FY2018, filed Feb 28, 2019In December 2017, the U.S. Food and Drug Administration, or FDA, approved LUXTURNATM (voretigene neparvovec-rzyl) for the treatment of…View ↗
We are supporting the appropriate use of LUXTURNA in the United States through small, targeted commercial and medical affairs teams.…View ↗
We have three gene therapy product candidates, to which we retain global commercialization rights, in clinical development: (i) SPK-8011…View ↗
U.S. institutions traditionally buy LUXTURNA and bill payers; under its contracting model, commercial payers or designated specialty pharmacies can buy it. A sale is counted after a scheduled treatment is verified.
10-K for FY2018, filed Feb 28, 2019
$64.7M
10-K for FY2018, filed Mar 1, 2019
$64.7M ↗
U.S. patients receive LUXTURNA from trained retinal surgeons at selected treatment centers. Institutions traditionally buy it and bill payers, while the company's contracting model lets commercial payers or designated specialty pharmacies purchase it.
10-K for FY2018, filed Feb 28, 2019
No. It lost $78.8M in FY2018.
10-K for FY2018, filed Mar 1, 2019
−$193.6MView ↗
10-K for FY2018, filed Mar 1, 2019
−$78.8MView ↗
10-K for FY2018, filed Mar 1, 2019
−$104.4MView ↗
10-Q for Q3 FY2019, filed Nov 8, 2019
−$66.6MView ↗
8-K, filed Dec 17, 2019
As described in the Introductory Note above, on December 17, 2019, Merger Sub irrevocably accepted for payment all Shares validly tendered…View ↗
Grew. Revenue grew 102.1x in 4 years, from $633.9K in FY2014 to $64.7M in FY2018, about 218% a year.
From candidate to marketed treatment
The older report presented its lead retinal gene therapy as a candidate awaiting a planned U.S. application; the latest describes approved LUXTURNA and its use at treatment centers.
10-K for FY2015, filed Mar 14, 2016 10-K for FY2018, filed Feb 28, 2019
Overseas commercialization
The older report planned global commercialization of its lead retinal treatment; the latest says Novartis holds development and commercialization rights outside the United States.
10-K for FY2015, filed Mar 14, 2016 10-K for FY2018, filed Feb 28, 2019We possess global rights to SPK-RPE65. If approved, we intend to commercialize SPK-RPE65 globally, initially in the United States, the…View ↗
In December 2017, the U.S. Food and Drug Administration, or FDA, approved LUXTURNATM (voretigene neparvovec-rzyl) for the treatment of…View ↗
Hemophilia B program moved to Pfizer
The older report described the hemophilia B program as a collaboration with Pfizer and a clinical trial; the latest says the program transitioned to Pfizer for continued development.
10-K for FY2015, filed Mar 14, 2016 10-K for FY2018, filed Feb 28, 2019In December 2014, we entered into a global collaboration agreement with Pfizer for the development and commercialization of SPK-FIX product…View ↗
In December 2014, we entered into a global collaboration agreement with Pfizer for the development and commercialization of SPK-FIX product…View ↗
Competes with 4D Molecular Therapeutics, Abeona Therapeutics, Actus Therapeutics, Adverum Biotechnologies, Amicus Therapeutics, Applied Genetic Technologies, Asklepios BioPharmaceutical, Audentes Therapeutics, Axovant Sciences, BioMarin Pharmaceutical, GenSight Biologics, Homology Medicines, Horama, Lysogene, MeiraGTx, Nightstar Therapeutics, PTC Therapeutics, REGENXBIO, Sangamo Therapeutics, and Sarepta Therapeutics
10-K for FY2018, filed Feb 28, 2019We are aware of companies focused on developing AAV gene therapies in various indications, including 4D Molecular Therapeutics, Abeona…View ↗
Loading...
