Brean Capital Maintains Buy On OHR Pharmaceutical Following End Of Phase 2 Meeting With The FDA
In a research report sent to investors today, Brean Capital analyst Jonathan Aschoff maintained a Buy rating on OHR Pharmaceutical (NASDAQ:OHRP) with a $34 price target, following successful end of Phase 2 meeting with the FDA on Squalamine eye drops in wet AMD.
Aschoff wrote, “We view the Phase 3 primary endpoint as a relatively easy hurdle for squalamine. Following a successful end-of-Phase 2 meeting with the FDA, Ohr plans to initiate two identical Phase 3 trials in 1H15 that test squalamine versus placebo in wet AMD patients. More importantly, the FDA agreed that the primary endpoint will be proportion of patients achieving a ≥3 line gain in visual acuity (VA) at 9 months. Recall that in the interim analysis of the Phase 2 IMPACT trial, 48% of squalamine patients had gains of ≥3 lines at 9 months, versus only 21% with placebo (p=0.025) for all patients; in the subset of patients with any classic CNV, 67% of squalamine patients versus 20% of placebo patients gained ≥3 lines in vision (p=0.007). In light of the robust Phase 2 results, we see a high probability of squalamine hitting its Phase 3 primary endpoint at the same 9 month timepoint used in Phase 2. We also note that the 9 month efficacy endpoint is the shortest evaluation period that the FDA has ever allowed (standard efficacy evaluation is 12 months). Ohr intends to file squalamine for approval after the company collects and analyzes the 9 month data. During year 1 of the trial, background Lucentis therapy will be monthly and during year 2 Lucentis background therapy will switch to PRN. Even if squalamine only does the same 48% responder rate as in Phase 2, historical monthly Lucentis rates are only in the low-mid 30% range.”
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Jonathan Aschoff has a total average return of 11.5% and a 50.6% success rate. Aschoff has a -5.6% average return when recommending OHRP, and is ranked #209 out of 3326 analysts.