Fly News Breaks for March 18, 2019
Mar 18, 2019 | 09:02 EDT
The FDA's acceptance of Aimmune Therapeutics' Biologics License Application for AR101 is "clearly derisking," but the standard 12-month review period is "clearly at odds" with the drug's Breakthrough Therapy and Fast Track Designation, Piper Jaffray analyst Christopher Raymond tells investors in a research note. The analyst, however, says he never modeled commercialization before Q1 of 2020, and as such views timing as in-line with his model. Further, the analyst points out that the indicated advisory committee to review the filing has long been expected and "should surprise no one." Raymond keeps an Overweight rating on Aimmune shares with a $60 price target.
News For AIMT From the Last 2 Days
Jun 17, 2019 | 06:25 EDT
Goldman Sachs analyst Graig Suvannavejh started DBV Technologies (DBVT) with a Buy rating and $14 price target. DBVT is a late-stage specialty biotech company, with a proprietary technology platform that could be used to treat a range of food allergies, Suvannavejh tells investors in a research note. The analyst sees 66% upside from current share levels given the potential catalysts over the next 18 months, which include the Biologics License Applications re-filing in Q3 and FDA acceptance in Q4, a potential panel hearing in mid-2020, and likely final U.S. approval by the end of 2020. Suvannavejh sees an 85% probability of success for DBV's Viaskin Peanut and views the treatment as a more compelling option versus Aimmune's (AIMT) AR101 on overall safety and product presentation profiles.