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Intra-Cellular Therapies, Inc.

http://www.intracellulartherapies.com

Latest From Intra-Cellular Therapies, Inc.

Keeping Track: Novel Orphan Drugs Amondys 45, Nulibry Clear US FDA; First-Line NSCLC Claim For Libtayo

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals

Intra-Cellular's Lumateperone Poised For New Bipolar Depression Opportunity

The company is on track to file an sNDA for lumateperone after a Phase III clinical trial met the primary endpoint in bipolar I and II disorder.

Clinical Trials Neurology

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

Drug Review Drug Approval Standards

Finance Watch: Expect A Busy First Half For 2020 IPOs

Public Company Edition: At the J.P. Morgan Healthcare Conference and Biotech Showcase it was noted that the US IPO market is likely to be less active in the second half of the year as election risk chills investment. Also, Apellis leads recent follow-on offerings.

Financing Business Strategies
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