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Applied Genetic Stock Price, News & Analysis

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Welcome to our dedicated page for Applied Genetic news (Ticker: AGTC), a resource for investors and traders seeking the latest updates and insights on Applied Genetic stock.

The AGTC (Applied Genetic Technologies Corporation) news archive on Stock Titan covers the company’s history as a clinical-stage biotechnology developer of adeno-associated virus (AAV)-based gene therapies for rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. News releases repeatedly describe AGTC’s focus on inherited retinal diseases, with its most advanced clinical programs in X-linked retinitis pigmentosa (XLRP) and achromatopsia due to CNGB3 variants (ACHM CNGB3).

Readers will find detailed coverage of the strategic transaction in which a portfolio company of Syncona Limited agreed to acquire AGTC through a tender offer and subsequent merger. Multiple releases from October through December 2022 outline the tender offer terms, the board’s unanimous recommendation, reminders to shareholders about tender deadlines, and the final confirmation that the acquisition closed and AGTC became an indirect, wholly owned subsidiary of Syncona Limited, with its common stock delisted from the Nasdaq Global Stock Market.

The archive also includes earlier corporate updates, such as announcements about AGTC’s participation in investor conferences and reiterations of its development strategy in AAV-based gene therapy, inherited retinal disease programs, and preclinical work in optogenetics, otology and CNS disorders. In addition, later news from Beacon Therapeutics references laru-zova (laruparetigene zovaparvovec), described in a presentation title as “AGTC-501,” providing continuity for those tracking the historical XLRP program originally developed at AGTC.

Investors, researchers and industry observers can use this news page to review AGTC’s public communications, understand the rationale and structure of the Syncona acquisition, and follow how AGTC’s legacy XLRP asset is referenced in subsequent clinical trial updates from Beacon Therapeutics.

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Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced positive interim results from its Phase 1/2 study of AGTC-401, a gene therapy for achromatopsia (ACHMB3). Data from pediatric patients showed a favorable safety profile and over 50% response rate in visual sensitivity improvements at the highest dose (1.1E+12 vg/mL). The totality of results supports its advancement, with no new serious adverse reactions observed. AGTC plans to consult with the FDA later this year for the next steps in clinical development.

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Applied Genetic Technologies Corporation (Nasdaq: AGTC) will announce its financial results for Q2 ended December 31, 2021, on February 14, 2022, before market opening. Management will host a conference call at 8:00 AM ET to discuss the results and provide updates on corporate activities.

AGTC focuses on developing gene therapies for rare diseases, notably inherited retinal diseases (IRDs), using adeno-associated virus (AAV) technology. Its ongoing clinical trials target X-linked retinitis pigmentosa and achromatopsia, aiming to meet significant patient needs.

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Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced it exceeded enrollment targets in the SKYLINE trial for its gene therapy AGTC-501, focused on treating X-linked retinitis pigmentosa (XLRP). A total of 14 patients were enrolled, surpassing the goal of 12. The company expects to release interim results by Q2 2022, highlighting visual acuity and mobility data. Key prior findings showed 50% of high-dose patients responded positively after 12 months. The SKYLINE and VISTA trials aim to support registration, pending continued safety data.

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Applied Genetic Technologies Corporation (AGTC), a clinical-stage biotechnology firm, announced participation in the H.C. Wainwright Virtual BioConnect Conference from January 10-13, 2022. Sue Washer, President & CEO, and Dr. Susan Schneider, CMO, will hold a fireside chat available on-demand starting January 10, 2022, at 7:00 AM ET. AGTC focuses on AAV-based gene therapies for rare diseases, particularly inherited retinal diseases. The company has active clinical trials targeting conditions like X-linked retinitis pigmentosa and achromatopsia, and is advancing multiple pipeline candidates.

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Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced the appointment of James Robinson to its Board of Directors, enhancing its management team with his extensive experience in biotechnology. Robinson, previously CEO of Urovant Sciences, is expected to contribute significantly to AGTC’s goals in developing gene therapies, particularly for inherited retinal diseases (IRDs). His expertise in commercial operations and organizational leadership is anticipated to bolster AGTC’s pipeline, including late-stage programs for X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM).

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Applied Genetic Technologies Corporation (Nasdaq: AGTC) has announced the appointment of Abraham Scaria, Ph.D., as the new Chief Science Officer. With over 25 years of experience in gene therapy and a focus on retinal diseases, Dr. Scaria is expected to enhance AGTC’s clinical and preclinical programs, particularly aimed at treating conditions like X-linked retinitis pigmentosa (XLRP) and achromatopsia. His previous roles include leadership positions at IVERIC Bio and Casebia Therapeutics, where he oversaw significant R&D initiatives.

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AGTC presented significant findings regarding AGTC-501, a gene therapy for X-linked retinitis pigmentosa (XLRP) at the AAO 2021 Annual Meeting. The Phase 1/2 trial showed a 50% responder rate after 12 months, with a statistically significant improvement in best-corrected visual acuity (BCVA). No serious adverse events were reported, indicating strong safety and tolerability. The therapy effectively restored the macular ellipsoid zone, supporting its potential as a treatment option for XLRP, a condition with currently no available treatments.

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Applied Genetic Technologies Corporation (Nasdaq: AGTC) has appointed Hope D'Oyley-Gay as General Counsel, enhancing its leadership team with her extensive experience in legal and business operations within biotech and pharmaceutical sectors. D'Oyley-Gay's past roles include General Counsel at Spirovant Sciences and Vice President at GlaxoSmithKline, where she contributed to strategic collaborations. AGTC is pioneering gene therapies for rare inherited retinal diseases, with ongoing clinical trials and partnerships aimed at advancing its innovative treatment pipeline.

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Applied Genetic Technologies Corporation (Nasdaq: AGTC) will have its President and CEO, Sue Washer, participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on November 17, 2021, at 10:40 a.m. ET. This event will focus on the company's advancements in gene therapies for rare inherited retinal diseases. An audio webcast of the presentation will be available here, with a replay accessible on AGTC’s website afterward.

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Applied Genetic Technologies Corporation (AGTC) reported a net loss of $17.1 million for Q3 2021, up from $15.4 million in Q3 2020. R&D expenses rose to $12.3 million due to increased spending on XLRP clinical trials. AGTC is optimistic about upcoming milestones, including multiple data readouts for XLRP and ACHM programs in 2022. The company has $90.5 million in cash, expected to support operations into 2023. AGTC has strengthened its leadership team to enhance clinical and regulatory capabilities.

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Biological Product (except Diagnostic) Manufacturing
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