Wednesday, January 21, 2009

GTC partly back in Nasdaq’s good graces

By Mass High Tech staff

Transgenic therapeutics company GTC Biotherapeutics Inc. reports it has heard from the Listing Qualifications Staff of The Nasdaq Stock Market indicating that the Framingham company has regained compliance with the minimum market value requirement for continued listing on The Nasdaq Capital Market.

By exceeding $35 million of market capitalization for 10 consecutive trading days, GTC (Nasdaq: GTCB) has cleared one hurdle in its race to keep from being delisted. GTC also has until at least July 20, 2009, to regain compliance with the minimum $1 bid price requirement for stay listed on the Nasdaq market.

January has been a good month for GTC. Just last week, its drug ATryn, GTC’s recombinant form of human antithrombin, was recommended for approval by the Blood Products Advisory Committee of the U.S. Food and Drug Administration for use in the prevention and treatment of venous thromboembolism in hereditary antithrombin deficient patients undergoing surgery or childbirth procedures.

The FDA also established guidance last week about the review and approval of a New Animal Drug Application for animals that incorporate additional genetic information, which is how GTC makes its drugs — genetically creating animals that produce recombinant human proteins in their milk. Under the priority review process, the FDA is expected to act on the Biologics License Application for ATryn by Feb. 7, 2009.

Last month, GTC announced shareholder approval of three proposals, relating to a $15 million financing agreement with French firm LFB Biotechnologies. This included a proposal for LFB to purchase $15 million in GTC common stock and convertible debt.