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Applied Genetic Technologies Corporation (Nasdaq: AGTC) will participate in the 124th Annual American Optometric Association Congress from June 24-26 in Denver. Jill Dolgin, PharmD, Executive Director of Global Patient Advocacy, will discuss gene therapy trial recruitment for inherited retinal diseases (IRDs). Collaborating with Dr. Rachelle Lin, the presentations will cover ethical considerations, current advancements, and future management of IRDs. AGTC aims to educate future optometrists on the vital role of patient registries and clinical trials in developing therapies for IRDs. The company will also exhibit at booth #1316.
AGTC has appointed regulatory expert Janet C. Rae as Senior Vice President of Global Regulatory and Quality, effective June 18, 2021. This strategic move aims to bolster compliance ahead of anticipated late-stage development for the company's X-Linked Retinitis Pigmentosa (XLRP) and Achromatopsia (ACHM) programs. Rae brings nearly 30 years of experience in regulatory affairs, particularly in gene therapy and orphan drugs, and her appointment coincides with AGTC's recent positive data from its XLRP clinical trial and planned expansion of manufacturing capabilities.
Applied Genetic Technologies Corporation (AGTC) reported a 50% response rate in visual sensitivity among high-dose groups in its ongoing Phase 1/2 clinical trial for X-linked Retinitis Pigmentosa (XLRP). The company plans to expand its manufacturing capabilities by leasing a 21,000 square foot cGMP facility in Florida. Financially, AGTC reported a net loss of $14.9 million for the quarter ended March 31, 2021, with no revenue generated. As of this date, the company held $111 million in cash and investments, which it believes is sufficient for its upcoming clinical programs.
Concept Companies has commenced the development of a new 21,000 square foot laboratory facility for Applied Genetic Technologies Corporation (Nasdaq: AGTC) in Alachua, FL, expected for occupancy in 2022. The facility will enhance AGTC's quality control labs and manufacturing suite, supporting its Phase 2/3 clinical trial for the XLRP candidate. This expansion aims to increase control over cGMP manufacturing and meet future demands. The move reflects a trend of larger companies relocating to areas offering more affordable R&D facilities, bolstering the North Florida biotechnology ecosystem.
Applied Genetic Technologies Corporation (Nasdaq: AGTC) plans to lease a 21,000 square foot cGMP manufacturing facility in Florida, enhancing its capabilities for upcoming clinical trials of its X-Linked Retinitis Pigmentosa (XLRP) and Achromatopsia (ACHM) programs. The facility aims to speed up the Biologics Licensing Application process. AGTC also secured an additional $10 million loan from Hercules Capital, extending the maturity date to 2024. Recent clinical data shows a promising 50% response rate for the XLRP candidate, supporting its path towards commercialization.
Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced it will report financial results for the fiscal quarter ending March 31, 2021, on May 17, 2021. A conference call will follow at 4:30 PM ET for management to review the results and provide updates. AGTC focuses on gene therapies for rare retinal diseases and is currently conducting clinical trials for X-linked retinitis pigmentosa and achromatopsia. The call will be accessible via phone and a live webcast on their Investor Relations page.
Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced significant improvements to its manufacturing process for the gene therapy candidate rAAV2tYF-GRK1-RPGRco, aimed at treating X-linked retinitis pigmentosa (XLRP). At the ASGCT Annual Meeting, AGTC presented data showing enhanced production methods that increased the full/empty capsid ratio from 30% to over 80%, which is crucial for efficacy. A novel expression assay was also validated to support the Phase 2/3 Vista trial, aligning with ICH guidelines for quality assurance.
Applied Genetic Technologies Corporation (Nasdaq: AGTC) has reported promising results from its X-linked retinitis pigmentosa (XLRP) Phase 1/2 clinical trial. Groups 5 and 6 revealed a 50% response rate among qualifying patients. After 12 months, significant improvements in Best Corrected Visual Acuity (BCVA) and retinal sensitivity were observed. Furthermore, data from Group 4 at 24 months indicated durable responses and a favorable safety profile, with no significant inflammatory responses noted.
Upcoming milestones include presentations at the American Academy of Ophthalmology Annual Meeting.
Applied Genetic Technologies Corporation (Nasdaq: AGTC) will release significant clinical trial data on May 6, 2021, regarding its Phase 1/2 study targeting X-linked Retinitis Pigmentosa (XLRP). This update includes 12-month data on Groups 5 and 6, focusing on safety and durability of effect, and 24-month data from a subset of Group 4 patients. A conference call will accompany the data release at 8:00 AM ET, providing updates on the ongoing trial. AGTC specializes in gene therapies for rare retinal diseases and is advancing other clinical and preclinical programs.
Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced the presentation of two abstracts at the virtual ASGCT 24th Annual Meeting, scheduled for May 11-14, 2021. The abstracts focus on retinal studies involving novel AAV vectors crucial for the X-linked retinitis pigmentosa (XLRP) clinical Phase 2/3 Vista study. Key presentations include:
- Title: Expression Assay Development for rAAV Vector Encoding RPGRco (Abstract 884)
- Title: Subretinal Rd9 Mouse Study Comparing RPGR Expression (Abstract 806)
AGTC specializes in gene therapies for rare diseases.
