Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Genelabs' Prestara Phase III Does Not Confirm Bone Mineral Density Effect

This article was originally published in The Pink Sheet Daily

Executive Summary

The trial was designed to meet FDA's "approvable" letter request for confirmation of bone mineral density increases in women with lupus receiving glucocorticoids. Genelabs plans to meet with the agency when it completes data analysis.

You may also be interested in...



Prestara Changes Course: Development To Focus on Lupus Signs And Symptoms

Genelabs will no longer pursue a Prestara indication for prevention of loss of bone mineral density in women with lupus.

Prestara Changes Course: Development To Focus on Lupus Signs And Symptoms

Genelabs will no longer pursue a Prestara indication for prevention of loss of bone mineral density in women with lupus.

Genelabs To Meet With FDA Following Positive Open-Label Prestara Study

The study was an extension of a previous Phase III study that failed to meet its primary endpoint of increased bone mineral density at the lumbar spine.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS058013

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