Nasdaq-listed shares of DBV Technologies SA (DBVT) fell nearly 48% to $25 ahead of the open on Monday, Oct. 23, after the Montrouge, France-based firm on Friday unveiled top-line results from its Phase 3 study of a peanut allergy treatment. The study, dubbed Pepites, evaluated Viaskin Peanut in children four to 11 years old.
The company said that the primary endpoint, which assesses the 95% confidence interval (CI) 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 (SAP) submitted to the U.S Food and Drug Administration (FDA)."
The study's top-line results "show a statistically significant response with a favorable tolerability profile," DBV said.
DBV said it will continue its ongoing dialogue with the FDA and intends to proceed with the biologics license application preparation process.
Shares of DBV competitor Aimmune Therapeutics Inc. (AIMT) jumped 41.1% to $36.29. Brisbane, Calif.-based Aimmune on Oct. 16 unveiled a clinical collaboration with Regeneron Pharmaceuticals Inc. (REGN) and its strategic alliance collaborator Sanofi SA (SNY) to evaluate AR101 with adjunctive dupilumab in peanut-allergic patients in a Phase 2 study.
Aimmune on Oct. 19 said it will present data on peanut allergy at the American College of Asthma, Allergy and Immunology Annual Scientific Meeting, which will be held Oct. 26 to 30 in Boston, and the European Academy of Allergy and Clinical Immunology's Pediatric Allergy and Asthma Meeting, which is slated for Oct. 26 to 28 in London.
In other news, Global Blood Therapeutics Inc. (GBT) said Oct. 23 it has discontinued its GBT440 program for idiopathic pulmonary fibrosis. GBT said it made the decision based on results from three proof-of-concept studies, including a Phase 1 and two Phase 2a studies.
Shares were down 9.4% to $29.50 ahead of the market open.
GBT president and CEO Ted W. Love said in a statement that while the results re-affirm the company's confidence in the mechanism of action of GBT440, "the data from these proof-of-concept studies did not demonstrate sufficient overall clinical benefit to justify continuing the program."