The tale of two biotechs appears to be playing out between Aimmune Therapeutics Inc. (NASDAQ: AIMT) and DBV Technologies S.A. (NASDAQ: DBVT), not just for the companies but between analysts as well. This all transpired following DBV’s Phase 3 peanut allergy results that did not reach the primary endpoint. Aimmune shares rallied in response.
Although DBV shares are taking a beating, Jefferies is still maintaining a very positive view on the stock. Separately, Wedbush took to backing Aimmune, with a massive hike in its price target, implying the stock will more than double.
According to the study, the primary endpoint did not reach the 15% lower bound of the confidence interval that was proposed in the study’s statistical analysis plan submitted to the U.S. Food and Drug Administration (FDA). Following initial conversations with the FDA on these topline efficacy and safety results, DBV will continue ongoing discussions with the agency and plans to proceed with the Biologic License Application (BLA) preparation process.
[nativounit]
Jefferies believes Phase 3 data for Viaskin Peanut (VP) for peanut allergy is statistically significant, but the effect size is small. Notwithstanding higher risks versus prior, the firm views odds of FDA approval as greater than 50/50 given the statistically significant Phase 3 data, likely clinically meaningful tolerance of three peanuts on VP versus one on placebo, and potential improved response over time.
Jefferies maintained its Buy rating for DBV, but lowered its price target to $37 from $51, implying upside of 52% from the current price level. Although, this is implied downside of 23% from Friday’s closing price of $48.07.
On the other hand, Wedbush believes that the FDA will require another Phase 3 trial, which should reduce competition risk in the firm’s view. At the same time, Wedbush believes that Aimmune is likely to achieve higher than 15% superiority over the placebo based on Phase 2 results. The firm detailed in its report:
FDA created a higher bar for Phase 3 success for peanut allergy in that statistically significant requires a minimum of 15% superiority to be clinically meaningful. We also understand that FDA is concerned that patients may become less diligent in their avoidance of all things peanut while being treated and this resulted in their higher bar. We are not concerned about AR101’s clinically meaningful efficacy since in Phase 2 the difference between treatment and placebo for tolerating 600 mg peanut protein was 62% on an ITT basis. Additionally, the Phase 3 PALISADE trial is 90% powered and did not have a higher dropout rate than in Phase 2.
[recirclink id=420528]
Wedbush reiterated its Outperform rating for Aimmune and raised its price target to $70 from $42, implying upside of 173% from the most recent closing price $25.66.
Aimmune shares were last seen up about 30% at $33.21, with a consensus analyst price target of $36.80 and a 52-week trading range of $14.87 to $37.50.
Shares of DBV were down 47% at $25.50. The stock has a 52-week range of $22.23 to $50.57 and a consensus price target of $58.03.
[wallst_email_signup]
Top Gaining Stocks
Top Losing Stocks