Soligenix seeks FDA meeting after damaging HyBryte setback

15 February 2023

US rare diseases specialist Soligenix (Nasdaq: SNGX) closed 19% lower after Tuesday’s trading following news of a setback with its lead drug candidate.

Soligenix earlier announced that the US Food and Drug Administration (FDA) had sent the company a Refusal to File letter for its HyBryte (synthetic hypericin) New Drug Application (NDA) in the treatment of early-stage cutaneous T-cell lymphoma (CTCL).

Upon preliminary review, the FDA determined that the NDA, submitted in December, was not sufficiently complete to permit substantive review.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK