Roth Affirms Applied Genetic Tech (AGTC) at 'Neutral' Amid CNGA3 IND Filing; Application Expands Present Pipeline

October 20, 2016 8:20 AM EDT
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Roth Capital affirms Applied Genetic Technologies Corporation (Nasdaq: AGTC) at Neutral with a price target of $12 after the company announced that it has filed an Investigational New Drug application (IND) with the U.S. Food and Drug Administration to conduct a Phase I/II clinical trial of the Company's gene therapy product candidate for the treatment of achromatopsia caused by mutations in the CNGA3 gene.

Analyst Joseph Pantginis commented today, The IND application filing for CNGA3 expands AGTC’s present pipeline and in combination with the present gene therapy program for CNGB3, it broadens the range of ACHM patients it is targeting to include 75% of the afflicted population. To date the company has reported that the Phase I/II trial for ACHM with patients harboring CNGB3 mutations has enrolled two patients who are being monitored in order to evaluate patient safety before further enrollment occurs. As stated in our previous update, trial enrollment has been slower than expected and there is no visibility regarding enrollment completion for the XLRS and ACHM studies or timing of data. The company has stated that it will announce data once it has a substantial body of evidence to inform a potential path forward (stated initially Nov. 2015).

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