Breaking News
Get Actionable Insights with InvestingPro+: Start 7 Day FREE Trial Register here
Investing Pro 0
Ad-Free Version. Upgrade your Investing.com experience. Save up to 40% More details

Minerva Outlines Next Steps For US Application For Schizophrenia Candidate

Stock Markets Apr 07, 2022 18:42
Saved. See Saved Items.
This article has already been saved in your Saved Items
 
© Reuters. Minerva Outlines Next Steps For US Application For Schizophrenia Candidate

Minerva Neurosciences Inc (NASDAQ: NERV) received the official meeting minutes from the Type C meeting with the FDA regarding the development of roluperidone for negative symptoms in schizophrenia.

  • The agency cited concerns related to the applicability of the results of the Phase 2b study (conducted in Europe) to the US population.
  • The agency raised concern regarding the proposed use of post hoc analyses for the primary endpoint results of the Phase 3 study.
  • Even by excluding one trial site that Minerva believes to be subject to potential data integrity issues, the overall study remains negative.
  • For the Phase 3 study to be positive, both roluperidone doses must be statistically significant versus placebo, which was not the case for the 32 mg dose, the agency noted.
  • Related: Minerva Posts Positive Bioequivalence Results For Schizophrenia Candidate Formulations.
  • Excluding the trial site with data integrity issues resulted in a nominal p-value of 0.044 on the primary endpoint for the 64 mg dose. In the Phase 2b study, the 64 mg and the 32 mg doses of roluperidone achieved statistical significance versus placebo.
  • Minerva stated that the relapse rate in these trials was less than 15% of the treated population compared to over 25% in other trials in which patients were treated with antipsychotics.
  • The FDA advised that additional data collection could begin in parallel with Minerva's preparations for a potential marketing application.
  • Price Action: NERV shares are up 3.02% at $0.89 during the market session on the last check Thursday.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Read at Benzinga

Read the original article on Benzinga

Minerva Outlines Next Steps For US Application For Schizophrenia Candidate
 

Related Articles

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind: 

  • Enrich the conversation
  • Stay focused and on track. Only post material that’s relevant to the topic being discussed.
  • Be respectful. Even negative opinions can be framed positively and diplomatically.
  •  Use standard writing style. Include punctuation and upper and lower cases.
  • NOTE: Spam and/or promotional messages and links within a comment will be removed
  • Avoid profanity, slander or personal attacks directed at an author or another user.
  • Don’t Monopolize the Conversation. We appreciate passion and conviction, but we also believe strongly in giving everyone a chance to air their thoughts. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at Investing.com’s discretion.

Write your thoughts here
 
Are you sure you want to delete this chart?
 
Post
Post also to:
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
 
Are you sure you want to delete this chart?
 
Post
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's Investing.com's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Continue with Google
or
Sign up with Email