Cidara Therapeutics Inc (NASDAQ:CDTX) shares are trading higher after the company announced that Janssen Pharmaceuticals Inc, a unit of Johnson & Johnson (NYSE:JNJ), decided to proceed with CD388 (JNJ-0953), which is being developed for the universal prevention of influenza A and B.
As part of a recent prioritization of its R&D business, in July, Janssen announced its intention to discontinue the internal development of most of its infectious disease pipeline, including JNJ-0953 (CD388).
Under the Janssen agreement, within 90 days after Cidara delivers the complete CD388 Phase 2a data package to Janssen (anticipated later this year), Janssen must notify Cidara whether it will proceed with clinical development.
Responsibility for future development, manufacturing, and commercialization activities of CD388 will be assumed by Janssen, which intends to transfer its rights and obligations under the agreement to another entity.
Cidara is studying CD388 in Phase 1 and Phase 2a trials evaluating safety and pharmacokinetics as well as efficacy as pre-exposure prophylaxis against an influenza virus in healthy volunteers during a human challenge study.
Earlier this year, Cidara announced interim efficacy and safety data from the Phase 2a study.
The interim analysis demonstrated that a single dose of CD388 decreased viral replication in the upper respiratory tract and lowered the influenza incidence rate compared to placebo.
Cidara will receive a $7 million milestone payment and is eligible to potentially receive an additional $685 million in milestone payment, plus tiered royalties on worldwide sales.
Price Action: CDTX shares are up 26.40% at $1.00 on the last check Wednesday.
