|Over a week ago|
Applied Genetic to hold research and development day » 09:5507/2107/21/21
Virtual Research &…
Applied Genetic to hold research and development day » 04:5507/2107/21/21
Virtual Research &…
Piper Sandler biotech analysts hold an analyst/industry conference call » 09:5107/1507/15/21
RGNX, ROG, ADVM, SNY, JNJ, BIIB, AGTC, ISEE, GSGTF
Biotechnology Analysts Rahimi & Raymond, along with Roger A. Goldberg, MD, MBA, Ophthalmologist at Bay Area Retina Associates discuss gene therapy for ocular disease on an Analyst/Industry conference call to be held on July 15 at 10 am. Webcast Link
Applied Genetic to hold research and development day » 16:2907/1407/14/21
Virtual Research &…
Applied Genetic coverage transferred at Chardan » 16:3107/0907/09/21
Chardan transferred coverage of Applied Genetic to analyst Geulah Livshits, who maintained a Buy rating and $8 price target on the stock.
Applied Genetic to host R&D Day on July 22 » 07:0707/0807/08/21
Applied Genetic Technologies Corporation announced that it will host a virtual R&D Day from 10:00 am to 1:00 pm ET on Thursday, July 22, 2021. AGTC's R&D Day will include a review of 12-month data from the highest dose groups in the ongoing Phase 1/2 clinical trials in X-linked retinitis pigmentosa, which the Company announced in May, and expanded analysis of the recently reported data from the Company's ongoing Phase 1/2 clinical trial in achromatopsia. The event also will include a discussion on light sensitivity and achromatopsia genetics, and an overview of the Company's manufacturing capabilities, including the 21,000 square foot current Good Manufacturing Practices manufacturing and quality control facility being built in Florida.
|Over a month ago|
Applied Genetic reports 12-month data from ongoing Phase 1/2 trial of ACHM A3 » 07:1506/2406/24/21
Applied Genetic Technologies reported 12-month data from its ongoing achromatopsia Phase 1/2 clinical trials. The path forward for ACHM A3 will be determined after additional pediatric patient data and pre-clinical studies are available and can be evaluated. 12-month data for ACHM A3 are available for 20 patients, including 16 adults and 4 pediatric patients. The results at this time point do not show consistent evidence of ACHM A3 candidate biologic activity, although we believe that the patient-reported anecdotes continue to be encouraging. In contrast with patients in the B3 trial, the majority of whom have mutations that results in the complete absence of B3 protein, the majority of A3 patients have mutations that result in the production of non-functional protein. The results observed to date in the Phase 1/2 ACHM trials suggest that the presence of these non-functional proteins may interfere with the activity of the vector expressed ACHM A3 protein.
Applied Genetic reports 12-month data from ongoing Phase 1/2 trial of ACHM B3 » 07:1506/2406/24/21
Applied Genetic reported…
Applied Genetic reported 12-month data from its ongoing achromatopsia Phase 1/2 clinical trial. For its ACHM B3 candidate, results demonstrate biologic activity based on improvements in visual sensitivity in the treated area measured by static perimetry and light discomfort measured by the Ocular Photosensitivity Analyzer and are supported by anecdotal patient reports. Based on these data, AGTC intends to advance the ACHM B3 trial to the next stage of clinical development. 12-month data, which are available for 25 patients, consisting of 21 adult and 4 pediatric patients, show continued improvements on perimetry for higher dose and younger patients and include positive patient anecdotes. Improvements in retinal sensitivity as measured by static perimetry were seen in the treated eye compared with the untreated eye in four of 11 patients from the high-dose and pediatric cohorts. Improvements in light discomfort as measured by OPA, were also observed in six of these 11 patients. Improvements in light discomfort also were observed in the untreated eye of these patients, which we believe may suggest possible cortical adaptation within the brain. There is no evidence that this observation is due to the presence of the ACHM B3 vector in the untreated eye. Based on these data, AGTC plans to advance its ACHM B3 program to the next stage of clinical development. Toward this end, the Company is drafting an End-of-Phase 2 briefing packet to submit to the U.S. Food and Drug Administration, developing assays for pivotal ready testing, and planning production of clinical trial material. AGTC believes it has a best-in-class ACHM B3 product candidate that may provide significant benefit to patients. The Company expects to report 3-month data from younger pediatric patients in both the ACHM B3 and ACHM A3 trials in the fourth quarter of 2021.
Applied Genetic initiated with a Buy at BTIG » 16:3206/1406/14/21
BTIG analyst Yun Zhong…
BTIG analyst Yun Zhong initiated coverage of Applied Genetic with a Buy rating and $11 price target as part of a broader research note urging biotech investors to "start with gene therapy". The analyst likes the company's strong focus on inherited retinal disorders, which are an "ideal target" for AAV gene therapy. Zhong adds that Applied Genetic offers highly favorable risk-reward with the stock trading slightly above 52-week low.
Editas Medicine announces new Chief Regulatory Officer, Chief Scientific Officer » 09:2406/1406/14/21
Editas Medicine (EDIT)…
Editas Medicine (EDIT) announced that it named Chi Li, Ph.D., MBA, RAC, as the company's Senior Vice President and Chief Regulatory Officer, effective immediately. Li will lead regulatory affairs strategy and activities related to Editas Medicine's drug development programs. Additionally, as previously announced, Dr. Mark Shearman, Ph.D., joined the company as Executive Vice President and Chief Scientific Officer. Shearman joins Editas Medicine from Applied Genetic Technologies Corporation (AGTC), where he served as Chief Scientific Officer and was responsible for leading the company's product candidate selection process, pre-clinical and translational research, and long-term research and development planning. Li joins Editas Medicine from Celularity where he served as Chief Regulatory Officer.