News
Press Releases
Press Releases
July 9, 2025
Atsena Therapeutics Announces Alignment with FDA on Regulatory Pathway to Approval for ATSN-201 in X-Linked Retinoschisis (XLRS) Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting ...
May 19, 2025
Atsena Therapeutics Announces Positive Clinical Data from Part A of Phase I/II Trial Evaluating ATSN-201 Gene Therapy to Treat X-linked Retinoschisis (XLRS) First XLRS study ...
April 29, 2025
Atsena Therapeutics to Present at May Scientific Conferences DURHAM, NC, April 29, 2025 – Atsena Therapeutics, a clinical-stage gene therapy company focused on using the ...
April 15, 2025
Atsena Therapeutics Granted U.S. FDA Regenerative Medicine Advanced Therapy Designation for ATSN-201 Gene Therapy to Treat X-linked Retinoschisis Marks fourth FDA designation for ATSN-201, which ...
April 2, 2025
Atsena Therapeutics Announces Oversubscribed $150 Million Series C Financing to Further Advance Ocular Gene Therapy Programs Financing led by new investor Bain Capital with participation ...
March 12, 2025
Atsena Therapeutics Granted U.S. FDA Fast Track Designation for ATSN-201 Gene Therapy to Treat X-linked Retinoschisis Marks third FDA designation for ATSN-201, which has also ...
February 6, 2025
Atsena Therapeutics to Present ATSN-201 Safety and Efficacy Data at The Macula Society’s 48th Annual Meeting DURHAM, NC, February 6, 2025 – Atsena Therapeutics, ...
January 8, 2025
Atsena Therapeutics Initiates Part B of Phase I/II Clinical Trial Evaluating Gene Therapy ATSN-201 to Treat X-linked Retinoschisis Part B of the LIGHTHOUSE study will ...
December 16, 2024
Atsena Therapeutics Announces Dosing Completed in Part A of Phase I/II Clinical Trial Evaluating Gene Therapy ATSN-201 to Treat X-linked Retinoschisis DURHAM, NC, December ...
November 13, 2024
Nippon Shinyaku and Atsena Therapeutics Enter into an Exclusive Strategic Collaboration for ATSN-101 in the U.S. and Japan KYOTO, Japan and Durham, North Carolina, ...
October 10, 2024
Atsena Therapeutics to Present ATSN-201 Safety and Efficacy Data at the American Academy of Ophthalmology 2024 Annual Meeting DURHAM, NC, October 10, 2024 – ...
September 24, 2024
Atsena Therapeutics to Present at Chardan’s 8th Annual Genetic Medicines Conference DURHAM, NC, September 24, 2024 – Atsena Therapeutics, a clinical-stage gene therapy company ...
September 17, 2024
Atsena Therapeutics Receives Orphan Drug Designation from the U.S. FDA for ATSN-201 Gene Therapy to Treat X-linked Retinoschisis Marks second FDA designation for ATSN-201, which ...
September 5, 2024
Atsena Therapeutics Announces 12-Month Safety and Efficacy Data from Phase I/II Clinical Trial of ATSN-101 in LCA1 Published in The Lancet First time patients with ...
August 14, 2024
Atsena Therapeutics Receives Rare Pediatric Disease Designation from the U.S. FDA for ATSN-201 Gene Therapy to Treat X-linked Retinoschisis Priority Review Voucher would be issued ...
July 15, 2024
Atsena Therapeutics Appoints Joseph S. Zakrzewski as Board Chair Biotech and pharma veteran brings expertise in therapeutic development and commercialization DURHAM, NC, July 15, ...
May 1, 2024
Atsena Therapeutics Announces Positive Clinical Data from the First Cohort of Phase I/II Trial Evaluating ATSN-201 Gene Therapy for the Treatment of X-linked Retinoschisis (XLRS) ...
March 13, 2024
Atsena Therapeutics Announces Initiation of Dosing in Second Cohort of Phase I/II Clinical Trial Evaluating ATSN-201 Gene Therapy for the Treatment of X-linked Retinoschisis (XLRS) ...
January 16, 2024
Atsena Therapeutics Receives Rare Pediatric Disease Designation from FDA for ATSN-101 Gene Therapy for GUCY2D-associated Leber Congenital Amaurosis (LCA1) Positive 12-month safety and efficacy data ...
December 4, 2023
Atsena Therapeutics Announces Positive 12-month Safety and Efficacy Data from Ongoing Phase I/II Clinical Trial of ATSN-101 in Patients with Leber Congenital Amaurosis Caused by ...
November 14, 2023
RMAT designation recognizes the potential of ATSN-101 to address unmet medical needs for patients with LCA1 ATSN-101 has demonstrated clinically meaningful improvements in vision at ...
August 28, 2023
The LIGHTHOUSE study evaluating the safety and tolerability of investigational gene therapy ATSN-201 is enrolling male patients ages 6-64 with RS1-associated XLRS ATSN-201 leverages novel ...
May 1, 2023
ATSN-201 leverages AAV capsid that spreads laterally beyond subretinal injection site to facilitate safe delivery of RS1 to photoreceptors in the central retina/fovea Initiation of ...
April 25, 2023
ATSN-101 demonstrated clinically meaningful improvements in vision at the highest dose with no drug-related serious adverse events 6 months post treatment Data presented at ARVO ...
April 11, 2023
DURHAM, NC, April 11, 2023 – Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or ...
February 8, 2023
ATSN-101 has demonstrated clinically meaningful improvements in vision with no drug-related serious adverse events DURHAM, NC, February 8, 2023 – Atsena Therapeutics, a clinical-stage gene ...
December 7, 2022
DURHAM, NC, December 7, 2022 – Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or ...
November 7, 2022
Biotech leader brings extensive experience in finance, business development and corporate strategy DURHAM, NC, November 7, 2022 – Atsena Therapeutics, a clinical-stage gene therapy company ...
October 3, 2022
ATSN-101 demonstrated clinically meaningful improvements in vision with no drug-related serious adverse events Data presented at the American Academy of Ophthalmology 2022 Annual Meeting DURHAM, ...
October 1, 2022
View the AAO presentation.
September 21, 2022
Data from Phase I/II trial of ATSN-101 in patients with GUCY2D-associated Leber congenital amaurosis (LCA1) to be presented DURHAM, NC – Atsena Therapeutics, a clinical-stage gene ...
July 27, 2022
World-class facility supports the company’s growth, and discovery and development of gene therapies for inherited retinal diseases DURHAM, NC – Atsena Therapeutics, a clinical-stage gene ...
May 2, 2022
Presentations to feature laterally spreading capsid for the treatment of X-linked retinoschisis and dual vector technology for the treatment of MYO7A-associated Usher syndrome DURHAM, NC ...
October 18, 2021
Subretinal delivery of RS1 using AAV capsid that spreads laterally beyond the injection site overcomes challenges associated with intravitreal delivery DURHAM, NC – Atsena Therapeutics, a ...
August 16, 2021
Dr. Couto strengthens leadership team with extensive AAV and ocular gene therapy expertise DURHAM, NC – Atsena Therapeutics, a clinical-stage gene therapy company focused on ...
July 12, 2021
DURHAM, NC – Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or prevent blindness, today ...
June 28, 2021
Phase I/II clinical trial is ongoing in patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D DURHAM, NC – Atsena Therapeutics, a clinical-stage ...
June 14, 2021
Dr. Fujita brings extensive clinical development and regulatory strategy experience DURHAM, NC – Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing ...
December 16, 2020
Round was led by Sofinnova Investments with participation from Abingworth, Lightstone Ventures and all existing investors Company expands board of directors and plans to build ...
July 29, 2020
Therapy currently being evaluated in Phase I/II clinical study Company formed with $8.15 million Series 1; led by founding investors Hatteras Venture Partners and the ...
