Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Clinical Data Psyched For Vilazodone NDA Filing In Second Half

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Clinical Data has kicked off what could prove to be a pivotal year with a flurry of activity, including a new financing, the sale of its Cogenix pharmacogenomics services arm, and the publication of important clinical trial results. But investors are more concerned with what's coming in a couple of months: results from a second pivotal trial for its lead therapeutic candidate vilazodone and the subsequent NDA filing

You may also be interested in...



“Not Approvable” Letter Leaves Vanda’s Schizophrenia Drug With Cloudy Future

FDA requests additional Phase III comparative study and safety data for iloperidone.

Biomarkers for Psychiatric Drugs: Outlier or Opportunity?

A handful of companies are pursuing predictive genetic tests for evaluating psychiatric drugs. The need is apparent, and an early success could trigger a rapid shift in thinking about the sustainability of building a business around biomarkers in a therapeutic area sometimes considered the least likely to benefit near term from their development. That said, firms in this area--and elsewhere--must be wary of leaning too heavily on pharma companies as supportive partners.

Q4 Earnings Preview: Setting The Tone For 2022 (Part 1)

Biopharma will outline its growth goals for 2022 over the coming weeks, with J&J, Novartis, AbbVie, Merck, Roche, Biogen and Lilly among the first to report.

Topics

UsernamePublicRestriction

Register

PS004117

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel