GAINESVILLE, Fla. and CAMBRIDGE, Mass., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced that it will provide a management update on its planned Phase 2/3 X-Linked Retinitis Pigmentosa (XLRP) clinical trial design, a re-analysis of dose Groups 2 and 4 data, and new preliminary visual sensitivity data from Group 5; data from Group 5 is in advance of the full interim data analysis that the Company expects to provide in 4Q 2020 for both Groups 5 and 6. The Company will also report financial results for the fiscal quarter and year ended June 30, 2020 before the market opens on Wednesday, September 9, 2020. AGTC management will host a conference call and webcast with accompanying slides beginning at 8:00am Eastern Time on the same date.
To access the call, dial 877-407-6184 (US) or 201-389-0877 (outside of the US). A live webcast will be available in the Events and Presentations section of the Investor Relations page at http://ir.agtc.com/events-and-presentations. Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events and Presentations section of the company's website.
About AGTC
AGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. The Companys most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa and achromatopsia (ACHM CNGB3 & ACHM CNGA3). Its pre-clinical programs build on the Companys industry leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in larger ophthalmology indications, optogenetics, otology and CNS disorders.
About X-linked Retinitis Pigmentosa (XLRP)
XLRP is an inherited condition that causes progressive vision loss in boys and young men. Characteristics of the disease include night blindness in early childhood and progressive constriction of the visual field. In general, XLRP patients experience a gradual decline in visual acuity over the disease course, which results in legal blindness around the 4th decade of life. AGTC was granted U.S. Food and Drug Administration (FDA) orphan drug designation in 2017, as well as European Commission orphan medicinal product designation in 2016, for its gene therapy product candidate to treat XLRP caused by mutations in the RPGR gene.
Forward-Looking Statements
This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs, including statements regarding the timing for and expected expansion of its XLRP clinical development program, the timing for reporting data in its XLRP and ACHM clinical programs, and its ability to enroll patients, effectively design and successfully complete its ongoing clinical trials. Forward-looking statements include information concerning possible or assumed preclinical and clinical product development and regulatory progress, future results of operations, financial guidance, business strategies and operations, potential growth opportunities, potential market opportunities, the effects of competition and the impact of the COVID-19 pandemic. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: gene therapy is still novel with only a few approved treatments so far; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or receive reasonable reimbursement; uncertainty inherent in clinical trials and the regulatory review process; risks and uncertainties associated with drug development and commercialization; the direct and indirect impacts of the ongoing COVID-19 pandemic on the Companys business, results of operations, and financial condition; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading "Risk Factors" in the Companys most recent annual or quarterly report and in other reports AGTC has filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management's plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, AGTC assumes no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
IR/PR CONTACTS:David Carey (IR) or Glenn Silver (PR)Lazar FINN PartnersT: (212) 867-1768 or (646) 871-8485david.carey@finnpartners.com or glenn.silver@finnpartners.com
Corporate Contact:Bill SullivanChief Financial OfficerApplied Genetic Technologies CorporationT: (617) 843-5728bsullivan@agtc.com
Stephen PotterChief Business OfficerApplied Genetic Technologies CorporationT: (617) 413-2754spotter@agtc.com
Original post:
- About the Gene Therapy Review [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Contribute an Article [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- EBSCO Publishing Deal [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Advertising Opportunities [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Instructions for Authors [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Isis Collaboration With Ortho-McNeil Inc for Metabolic Diseases [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Dystrophin Gene Transfer safe in Duchenne muscular dystrophy [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Researchers Identify Gene for Rare Form of Spinal Muscular Atrophy [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Fatal brain cancer tamed by New gene therapy [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Gene therapy effective in fighting obesity in mice [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Genzyme gene therapy for people with peripheral artery disease failed in a clinical trial to help them regain some mobility [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Gene Therapy May Stall Inherited Emphysema [Last Updated On: December 31st, 2009] [Originally Added On: December 31st, 2009]
- Gene Therapy and Stem Cells Save Limb [Last Updated On: December 31st, 2009] [Originally Added On: December 31st, 2009]
- Faulty Circuits (preview) [Last Updated On: August 17th, 2024] [Originally Added On: April 7th, 2010]
- Rare flowers and common herbal supplements get unmasked with plant DNA barcoding [Last Updated On: August 17th, 2024] [Originally Added On: April 20th, 2010]
- Biomarker Studies Could Realize Goal of More Effective and Personalized Cancer Medicine [Last Updated On: August 17th, 2024] [Originally Added On: April 27th, 2010]
- Schizophrenia shares genetic links with autism, genome study shows [Last Updated On: August 17th, 2024] [Originally Added On: May 12th, 2010]
- Alzheimer's: Forestalling the Darkness with New Approaches (preview) [Last Updated On: August 17th, 2024] [Originally Added On: May 28th, 2010]
- Alzheimer's: Forestalling the Darkness with New Approaches (preview) [Last Updated On: August 17th, 2024] [Originally Added On: May 28th, 2010]
- Large-Scale Autism Study Reveals Disorder's Genetic Complexity [Last Updated On: August 17th, 2024] [Originally Added On: June 12th, 2010]
- Large-Scale Autism Study Reveals Disorder's Genetic Complexity [Last Updated On: August 17th, 2024] [Originally Added On: June 12th, 2010]
- Cancer Therapy Goes Viral: Progress Is Made Tackling Tumors with Viruses [Last Updated On: August 17th, 2024] [Originally Added On: June 24th, 2010]
- Vaccines Derived from Patients' Tumor Cells Are Individualizing Cancer Treatment [Last Updated On: August 17th, 2024] [Originally Added On: June 26th, 2010]
- Vaccines Derived from Patients' Tumor Cells Are Individualizing Cancer Treatment [Last Updated On: August 17th, 2024] [Originally Added On: June 26th, 2010]
- A genome story: 10th anniversary commentary by Francis Collins [Last Updated On: August 17th, 2024] [Originally Added On: June 29th, 2010]
- Hair Trigger: How a Cell's Primary Cilium Functions as a Molecular Antenna [Last Updated On: August 17th, 2024] [Originally Added On: June 30th, 2010]
- Hair Trigger: How a Cell's Primary Cilium Functions as a Molecular Antenna [Last Updated On: August 17th, 2024] [Originally Added On: June 30th, 2010]
- DNA Drugs Come of Age (preview) [Last Updated On: August 17th, 2024] [Originally Added On: July 16th, 2010]
- 2 Genes Linked to Embryonic Brain Impairment in Down's Syndrome [Last Updated On: August 17th, 2024] [Originally Added On: July 22nd, 2010]
- 2 Genes Linked to Embryonic Brain Impairment in Down's Syndrome [Last Updated On: August 17th, 2024] [Originally Added On: July 22nd, 2010]
- Stem Cells from Reprogrammed Adult Cells Found to Bring Along Genetic Defects of Their Donors [Last Updated On: August 17th, 2024] [Originally Added On: October 11th, 2010]
- Was Darwin a Punk? A Q&A with Punker-Paleontologist Greg Graffin [Last Updated On: August 17th, 2024] [Originally Added On: October 11th, 2010]
- Was Darwin a Punk? A Q&A with Punker-Paleontologist Greg Graffin [Last Updated On: August 17th, 2024] [Originally Added On: October 11th, 2010]
- Parkinsonian Power Failure: Neuron Degeneration May Be Caused by a Cellular Energy System Breakdown [Last Updated On: August 17th, 2024] [Originally Added On: October 11th, 2010]
- Desperation Drives Parents to Dubious Autism Treatments (preview) [Last Updated On: August 17th, 2024] [Originally Added On: October 17th, 2010]
- Revolution Postponed: Why the Human Genome Project Has Been Disappointing (preview) [Last Updated On: August 17th, 2024] [Originally Added On: November 7th, 2010]
- Controlling the Brain with Light (preview) [Last Updated On: August 17th, 2024] [Originally Added On: November 7th, 2010]
- Optogenetics: Controlling the Brain with Light [Extended Version] [Last Updated On: August 17th, 2024] [Originally Added On: November 7th, 2010]
- Clear New Insights into the Genetics of Depression [Last Updated On: August 17th, 2024] [Originally Added On: November 7th, 2010]
- TEDMED 2010: Technology and the people [Last Updated On: August 17th, 2024] [Originally Added On: November 7th, 2010]
- Bacteria, the anti-cancer soldier [Last Updated On: August 17th, 2024] [Originally Added On: November 7th, 2010]
- Scientific regress: When science goes backward [Last Updated On: August 17th, 2024] [Originally Added On: February 14th, 2011]
- Can You Live Forever? Maybe Not--But You Can Have Fun Trying [Last Updated On: August 17th, 2024] [Originally Added On: February 14th, 2011]
- How to Fix the Obesity Crisis (preview) [Last Updated On: August 17th, 2024] [Originally Added On: February 14th, 2011]
- Personalizing cancer medicine [Last Updated On: August 17th, 2024] [Originally Added On: February 14th, 2011]
- New Salmonella strain delivers gene-based therapy to fight virus in mice [Last Updated On: August 17th, 2024] [Originally Added On: February 14th, 2011]
- Steps toward a Bionic Eye [Last Updated On: August 17th, 2024] [Originally Added On: February 20th, 2011]
- Giving HIV a Poor Reception: New AIDS Treatment Tinkers with Immune Cell Genes [Last Updated On: August 17th, 2024] [Originally Added On: March 6th, 2011]
- Smaller, cheaper, faster: Does Moore's law apply to solar cells? [Last Updated On: August 17th, 2024] [Originally Added On: March 27th, 2011]
- Smaller, cheaper, faster: Does Moore's law apply to solar cells? [Last Updated On: August 17th, 2024] [Originally Added On: March 27th, 2011]
- New Drugs for Hepatitis C on the Horizon [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2011]
- Can we capture all of the world's carbon emissions? [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2011]
- Can we capture all of the world's carbon emissions? [Last Updated On: August 17th, 2024] [Originally Added On: April 10th, 2011]
- Drug-resistant genes found in cholera and dysentery strains in New Delhi water supply [Last Updated On: August 17th, 2024] [Originally Added On: May 1st, 2011]
- Fast Track to Vaccines: How Systems Biology Speeds Drug Development (preview) [Last Updated On: August 17th, 2024] [Originally Added On: May 1st, 2011]
- TNVitamins.com – $10 Off Of $50 order [Last Updated On: May 7th, 2011] [Originally Added On: May 7th, 2011]
- 15% Off Any PetAlive Order [Last Updated On: May 7th, 2011] [Originally Added On: May 7th, 2011]
- At PetAlive – $10 off order of $50 or more [Last Updated On: May 7th, 2011] [Originally Added On: May 7th, 2011]
- Native Remedies coupon – 5% Off Any Order [Last Updated On: May 7th, 2011] [Originally Added On: May 7th, 2011]
- Native Remedies – Save $5 coupon [Last Updated On: May 7th, 2011] [Originally Added On: May 7th, 2011]
- Welcome to the Gene Therapy Review [Last Updated On: May 15th, 2011] [Originally Added On: May 15th, 2011]
- Editorial Board [Last Updated On: May 15th, 2011] [Originally Added On: May 15th, 2011]
- Gene Therapy Job Board [Last Updated On: May 15th, 2011] [Originally Added On: May 15th, 2011]
- Corporate Membership [Last Updated On: May 22nd, 2011] [Originally Added On: May 22nd, 2011]
- Native Remedies coupon – 25% Off Any Order [Last Updated On: May 29th, 2011] [Originally Added On: May 29th, 2011]
- What is Gene Therapy? [Last Updated On: June 19th, 2011] [Originally Added On: June 19th, 2011]
- Autism's Tangled Genetics Full of Rare and Varied Mutations [Last Updated On: August 17th, 2024] [Originally Added On: June 19th, 2011]
- Autism's Tangled Genetics Full of Rare and Varied Mutations [Last Updated On: August 17th, 2024] [Originally Added On: June 19th, 2011]
- A New Look at Obsessive-Compulsive Disorder (preview) [Last Updated On: August 17th, 2024] [Originally Added On: June 19th, 2011]
- Close Encounters of Science and Medicine [Last Updated On: August 17th, 2024] [Originally Added On: July 3rd, 2011]
- New Report Details Uphill Battle to Solve the U.S.'s Pain Problem [Last Updated On: August 17th, 2024] [Originally Added On: July 24th, 2011]
- New Report Details Uphill Battle to Solve the U.S.'s Pain Problem [Last Updated On: August 17th, 2024] [Originally Added On: July 24th, 2011]
- A Breath of Fresh Air: New Hope for Cystic Fibrosis Treatment (preview) [Last Updated On: August 17th, 2024] [Originally Added On: August 7th, 2011]
- Studying Mental Illness in a Dish [Last Updated On: August 17th, 2024] [Originally Added On: November 13th, 2011]
- The Puzzle of Pancreatic Cancer: How Steve Jobs Did Not Beat the Oddsbut Nobel Winner Ralph Steinman Did [Last Updated On: August 17th, 2024] [Originally Added On: November 13th, 2011]
- The Puzzle of Pancreatic Cancer: How Steve Jobs Did Not Beat the Odds?but Nobel Winner Ralph Steinman Did [Last Updated On: August 17th, 2024] [Originally Added On: November 13th, 2011]
- Did Alternative Medicine Extend or Abbreviate Steve Jobs's Life? [Last Updated On: August 17th, 2024] [Originally Added On: November 13th, 2011]
- Did Alternative Medicine Extend or Abbreviate Steve Jobs's Life? [Last Updated On: August 17th, 2024] [Originally Added On: November 13th, 2011]
- Calendar: MIND Events in November and December [Last Updated On: August 17th, 2024] [Originally Added On: November 13th, 2011]
- He's No Gregory House--Which Is a Good Thing (preview) [Last Updated On: August 17th, 2024] [Originally Added On: November 20th, 2011]