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DBVT

DBV Technologies

$48.07

0.92 (1.95%)

17:21
10/20/17
10/20
17:21
10/20/17
17:21

DBV Technologies: PEPITES trial does not reach primary endpoint

DBV Technologies announced topline results from the PEPITES, or Peanut EPIT Efficacy and Safety, Phase III trial evaluating the safety and efficacy of Viaskin Peanut in children four to 11 years of age. Topline results show a statistically significant response with a favorable tolerability profile, with 35.3% of patients responding to Viaskin Peanut 250 microg after 12 months of treatment as compared to 13.6% of patients in the placebo arm. However, the primary endpoint, which evaluates the 95% confidence interval in the difference in response rates between the active and placebo arms, did not reach the 15% lower bound of the CI that was proposed in the study's Statistical Analysis Plan submitted to the U.S Food and Drug Administration. 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 BLA preparation process. "We believe that this preliminary analysis shows significant therapeutic promise in the peanut-allergic population, where there is a high unmet medical need and no approved treatments," said Dr. Pierre-Henri Benhamou, Chairman & Chief Executive Officer of DBV Technologies. "Viaskin Peanut has been granted both Breakthrough Therapy and Fast Track designations by the FDA for the treatment of peanut allergy. We are committed to working together with the regulatory agencies to bring forward a safe and effective treatment option for these patients."

DBVT DBV Technologies
$48.07

0.92 (1.95%)

10/02/17
JMPS
10/02/17
NO CHANGE
JMPS
Outperform
Parents excited about peanut allergy immunotherapy, says JMP Securities
After surveying over 60 parents with peanut allergic children, JMP Securities analyst Liisa Bayko said she was "surprised" that 85% of respondents indicated a willingness to adopt an immunotherapy to treat the allergy. While the survey group may represent a more engaged and proactive one than the larger population, Bayko said even 30% adoption would be significant as the peanut allergy market is "enormous". The analyst, who added the survey pointed to a place for both oral and epicutaneous approaches, keeps Outperform ratings on both DBV Technologies (DBVT) and Aimmune (AIMT).
10/06/17
DBAB
10/06/17
NO CHANGE
Target $56
DBAB
Buy
DBV risk/reward favorable into Phase 3 readout, says Deutsche Bank
Deutsche Bank analyst Andrew Peters says the risk/reward for DBV Technologies, despite the stock rallying 31% year-to-date, is favorable into the Phase 3 data readout for Viaskin Peanut expected this month. The analyst continues to see a "strong rationale" for why the study should be successful. The current share value may still underappreciate the potential upside on positive data, Peters tells investors in a research note. He reiterates a Buy rating on DBV with a $56 price target.
10/12/17
SBSH
10/12/17
NO CHANGE
Target $57
SBSH
Buy
DBV news today does not impact timelines for efficacy study, says Citi
Citi analyst Liav Abraham says she confirmed with management of DBV Technologies that today's announcement regarding the Realise study has no bearing on the timelines for readout of the pivotal efficacy study for Viaksin Peanut, the Pepites study, which remains on track for a headline data readout this month. The analyst remains "constructive" on the shares ahead of the Pepites data readout in October. She notes that Realise is DBV's second Phase III study for Viaskin Peanut, and is a safety study, unlike Pepites, which is an efficacy study. Abraham has a Buy rating on DBV with a $57 price target.
10/20/17
PIPR
10/20/17
NO CHANGE
Target $38
PIPR
Overweight
Piper sees ' increasingly favorable' risk/reward for Aimmune Phase III program
After hosting investor meetings with management, Piper Jaffray analyst Charles Duncan sees an "increasingly favorable" risk/reward for Aimmune Therapeutics' (AIMT) AR101 Phase III peanut allergy program heading into the clinical progress results in Q1 of 2018. Aimmune has a "best-in-class" approach to peanut allergy immunotherapy which can address at least 25%-40%) of the moderate to severe peanut allergic market, Duncan tells investors in a research note. The analyst believes some volatility in the shares is possible around the near-term Phase III Pepites results from "mind-share competitor" DBV Technologies (DBVT). Duncan views Aimmune as undervalued and keeps an Overweight rating on the shares with a $38 price target.

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