Genelabs Technologies Inc. shares on Friday gained back some of Wednesday¿s loss, rising 57 percent. Trading was halted on Thursday while the FDA¿s Arthritis Advisory Committee considered Genelabs¿ new drug application for Aslera, a lupus drug candidate.
The panel did not vote on a recommendation to the FDA Thursday. Genelabs said late Thursday that it intends to work with the FDA to facilitate the completion of the Aslera NDA review.
Aslera¿s new drug application was submitted in September. It received priority review status in October, and was scheduled to go under review by the Arthritis Advisory Committee in March, but was rescheduled for Thursday.
The company agreed in March to extend the review period until no later than June 26. Approval or disapproval is now in the hands of the FDA.
Redwood City, Calif.-based Genelabs¿ stock took a 53 percent dive Wednesday after discouraging data appeared on the FDA web site, prompting analysts and investors to question the likelihood of approval for the synthetic DHEA (dehydroepiandrosterone).
Genelabs¿ stock (NASDAQ:GNLB) closed Friday at $2.75, up $1.
Genelabs entered a collaboration with Watson Pharmaceuticals Inc. for Aslera. That agreement gives Corona, Calif.-based Watson an exclusive license for North American rights to Aslera. (See BioWorld Today, Nov. 14, 2000.)
Under the agreement, Watson will pay Genelabs fees and milestone payments up to $55 million, including a $10 million nonrefundable initial license fee with milestones payable upon FDA approval of Aslera. Genelabs would receive royalties on net sales of Aslera and retains future co-marketing rights. ¿ Matthew Willett