Why Acadia Pharma, Bio-path And Cidara Are Moving Today

ACADIA Pharmaceuticals Inc. ACAD, Bio-Path Holdings, Inc. BPTH and Cidara Therapeutics, Inc. CDTX are among the early movers in the biotech space.

ACADIA Wilts On FDA Rejection: Acadia said the FDA has issued a complete response letter regarding its supplemental new drug application for Nuplazid for the treatment of hallucinations and delusions associated with dementia-related psychosis.

The regulatory agency has deemed the application cannot be approved in its present form. Among the issues raised were a lack of statistical significance in some of the subgroups of dementia, and insufficient numbers of patients with certain less common dementia subtypes.

The FDA did not identify any safety issues. ACADIA said it will immediately request a Type A meeting to work with the FDA to address the CRL and determine an expeditious path forward for the approval.

Acadia shares were sliding 17.06% to $21.23.

Related Link: The Week Ahead In Biotech: Regeneron, Supernus FDA Decisions, Cancer Conference Presentations In The Spotlight

Bio-Path Rallies On Positive Mid-stage Readout For Blood Cancer Drug The Houston-based biotech that is focusing on developing targeted nucleic acid cancer drugs using antisense RNAi nanoparticle technology said it has successfully completed the safety run-in of the stage 2 of the Phase 2 study of its investigational asset BP1001, in combination with frontline medications decitabine and venetoclax, for the treatment of acute myeloid leukemia.

The company noted BP1001 showed clean side effect profile and lack of toxicity and efficacy, with five of the six evaluable relapsed, refractory and newly diagnosed AML patients demonstrating clinical activity.

"These positive signals give us further confidence in the potential for this program in these latestage and compromised patients," said Peter Nielsen, CEO of BioPath.

Bio-Path was surging 25.03% to $8.94.

Cidara Gains On J&J Deal : Cidara, a biotech developing long-acting therapeutics for serious fungal or viral infections, said it has entered into an exclusive worldwide license and collaboration agreement with Johnson & Johnson JNJ Janssen to develop and commercialize Cidara's Cloudbreak antiviral conjugates for the prevention and treatment of seasonal and pandemic influenza.

CD388 will be the first AVC to be developed under the collaboration.

Cidara will receive an upfront payment of $27 million and up to an aggregate of $753 million in budgeted R&D funding and in development, regulatory and commercial milestones, plus tiered royalties on worldwide sales in the mid to high single digits. Cidara also has the option to co-detail CD388 in the U.S.

Cidara was up 8.52% to $2.93.