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Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced favorable FDA feedback on its manufacturing facility's cGMP design, crucial for its pipeline, particularly X-Linked Retinitis Pigmentosa and Achromatopsia B3 programs. This feedback supports the next construction phase, with initial operations expected in Q4 2022 and GMP capabilities by Q1 2023. The facility is pivotal for upcoming clinical development and commercialization efforts. Positive interim data from AGTC-501 trial also reinforces the potential success in addressing inherited retinal diseases.
Applied Genetic Technologies Corporation (AGTC) announced the pricing of its public offering of 16,666,667 shares of common stock and accompanying warrants at $0.60 per share. The offering is expected to raise approximately $10 million, net of underwriting discounts. The proceeds will fund ongoing clinical trials for X-linked retinitis pigmentosa and Achromatopsia, as well as for preclinical developments and working capital. The offering's close is anticipated around July 15, 2022, pending customary closing conditions.
Applied Genetic Technologies Corporation (AGTC) announced plans for an underwritten public offering of common stock and warrants, subject to market conditions. The offering includes a 30-day option for the underwriter to purchase additional shares. Proceeds will support ongoing clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM), preclinical development, and general corporate needs. The Company continues to leverage its AAV-based gene therapies aimed at treating rare diseases.
Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced interim safety results from three studies at the American Society of Retina Specialists Annual Meeting, taking place from July 13-16, 2022, in New York City. The presentations focus on Phase 1/2 trials of AGTC-401 and AGTC-402 for achromatopsia and the Phase 2 Skyline trial of AGTC-501 for X-linked retinitis pigmentosa. Key presenters include Dr. Lejla Vajzovic and Dr. Rajiv Anand. AGTC aims to develop gene therapies for rare retinal diseases.
Aurion Biotech has appointed Michael Goldstein, M.D., M.B.A., as president and chief medical officer to advance its corneal endothelial cell therapy development. Dr. Goldstein brings extensive experience as a renowned ophthalmologist and biotech executive, previously serving at Ocular Therapeutix (OCUL) and Applied Genetic Technologies Corp (AGTC). His leadership aims to enhance clinical strategy and operations for a treatment addressing corneal edema caused by endothelial dysfunction. This innovative therapy offers significant advantages over traditional corneal transplants, including a more straightforward procedure and a greater supply of cells from donor corneas.
AGTC announces the appointment of Eduardo Jacobo as Sr. Vice President of GMP Manufacturing and Dr. David Jacobs as Sr. Vice President of Clinical Research and Medical Affairs. Jacobo brings over 30 years of healthcare experience, having previously led GMP gene therapy manufacturing at Sangamo Therapeutics. Dr. Jacobs has over 20 years of experience in biopharmaceutical development, previously overseeing clinical programs at Biogen and Daiichi Sankyo. AGTC aims to enhance its manufacturing capabilities and advance its clinical programs in X-linked retinitis pigmentosa and achromatopsia.
Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced an encore presentation of interim data from its ongoing Phase 2 Skyline trial of AGTC-501 at the Macula Society Annual Meeting in Berlin. The trial targets mutations in the RPGR gene in patients with X-linked retinitis pigmentosa (XLRP). Interim results indicate significant improvements in visual sensitivity with a favorable safety profile. AGTC aims to advance AGTC-501 towards a potential Biologics License Application (BLA) submission, with future updates expected as the trial progresses.
Applied Genetic Technologies Corporation (Nasdaq: AGTC) has established a Scientific Advisory Board (SAB) to support the development of its Complement Factor H (CFH) program aimed at treating dry age-related macular degeneration (AMD). The SAB consists of leading experts in ophthalmology who will provide guidance as AGTC advances the program through preclinical testing and clinical development. Approximately 16 million individuals in the U.S. are affected by AMD, with dry AMD being the most common form, impacting around 15 million patients.
Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced that its leadership team, including CEO Sue Washer and CFO Jon Lieber, will present virtually at the H.C. Wainwright Global Investment Conference from May 23 - 26, 2022. The presentation will be available on-demand starting May 24 at 7:00 a.m. ET.
AGTC is focused on developing gene therapies for rare diseases, particularly in ophthalmology. Their clinical trials, including X-linked retinitis pigmentosa and achromatopsia, aim to address significant unmet patient needs.
Applied Genetic Technologies Corporation (Nasdaq: AGTC) reported positive interim results from its Phase 2 Skyline trial of AGTC-501, a gene therapy for X-linked retinitis pigmentosa (XLRP). 62.5% of patients in dose group B showed improvements in visual sensitivity, exceeding the FDA's requirements. The therapy was well-tolerated, with no serious safety concerns reported. A conference call is scheduled for May 17 to discuss the findings further. AGTC aims to leverage these results in upcoming regulatory submissions.
