GenSight Biologics (Euronext: SIGHT), announced that the French Competent Authority, the National Agency for Medicines and Health Products Safety (Agence Nationale de Sécurité du Médicament… Read More »GenSight Biologics has received approval for “LUMEVOQ” for LHON (with ND4 mutations) for a Cohort Temporary Authorization for use in France
Genentech (Roche Group [SIX: RO, ROG; OTCQX: RHHBY]), has announced that the U.S. FDA has accepted a Biologics License Application (BLA), under priority review, for… Read More »Genentech (Roche [SIX: RO, ROG; OTCQX: RHHBY]) has submitted a “Port Delivery System” with ranibizumab for the treatment of wet/neovascular age-related macular degeneration (nAMD)
REGENXBIO Inc. (Nasdaq: RGNX), a clinical-stage biotechnology company has reported that 42 patients have been enrolled in the RGX- 314-001 study (NCT03066258) with up to… Read More »Regenxbio Inc. has reported interim results of >40 patients dosing of Phase II for RGX-314 gene therapy treatment for wet AMD
AsciepiX Therapeutics Inc. has announced the dosing of a Phase 1/2a clinical trial for diabetic macular edema (DME) using an intravitreal “self-forming gel depot peptide”.… Read More »AsciepiX Therapeutics Inc., (New Jersey, US) has announced the dosing of a Phase 1/2a trial of AXT107 for diabetic macular edema (DME).
MeiraGTx (Nasdaq: MGTX), has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its AAV-CNGA3 gene therapy for the treatment… Read More »MeiraGTx (NASDAQ: MGTX), a UK gene therapy company, has announced the receipt of Fast Track Designation by the FDA for the treatment of achromatopsia
Gemini Therapeutics (Nasdaq: GMTX), a US-based clinical stage ophthalmic company focused on age-related macular degeneration (AMD), has announced a Phase 2a treatment (“ReGAtta” study) and… Read More »Gemini Therapeutics (Cambridge, MA) expect to announce Phase 2a results in H12021 for dry AMD therapy.
A French surgical-robotics company in Montpellier, “AcuSurgical”, has announced a Series A funding of around €5.75 million for an advanced robotic microsurgical platform for the… Read More »“AcuSurgical”, a robotics company for retinal microsurgery based in Montpellier, France, has raised €5.75M funding.
A US biotechnology company, Advernum Biotechnologies Inc., (NASDAQ:ADVM), has announced the enrolment of a Phase 2 study for the treatment of diabetic macular edema (DME),… Read More »Advernum Biotechnologies Inc., (NASDAQ: ADVM) expects to enrol Phase 2 patients for a treatment for DME using the aflibercept gene.
A Dutch biotechnology company, ProQR Therapeutcis N.V., (NASDAQ:PRQR), Leiden, has announced the enrolment of a phase 2/3 study for the treatment of Leber Congenital Amaurosis… Read More »ProQR Therapeutics N.V. (NASDAQ: PRQR), expects to enrol 36 patients of LCA10 using a novel therapy for “Sepofarsen” (QR-110)
Genentech (a member of the Roche Group [SIX: RO, ROG; OTCQX: RHHBY]) have announced positive top-line results from two identically designed global Phase III studies,… Read More »Genentech (a subsidiary of Roche) has reported a key non-inferior end-point for faricimab for DME, gearing up for a head-to-head anti-VEGF market