We saw a flurry of updates from San Diego’s biotech and medical device companies over the past week, running the gamut from the formation of a new startup to funding deals and fresh regulatory concerns. Here’s my wrap-up:
—Shares of San Diego’s Optimer Pharmaceuticals (NASDAQ: OPTR) gained more than 13 percent Wednesday, rising by over $1.40 to close at $12.13 a share in trading that was more than six times Optimer’s recent average volume. Wall Street rushed to buy after Optimer said it is exploring a possible sale of the company. Investors seemed unconcerned that Optimer also said it had replaced its CEO and general counsel and hired a new independent auditor—after ousting its previous chairman and purging several other executives last April. Few people seemed focused on a sentence in Optimer’s disclosure that I found riveting: “The previously disclosed investigations of these issues by the relevant U.S. authorities are ongoing and the Company continues to cooperate with those authorities.”
—San Diego-based MediciNova (NASDAQ: MNOV) said the FDA granted “fast track” status to ibudilast, the company’s proposed treatment for methamphatamine dependence. MediciNova said fast track status can shorten the time that federal regulators typically need to decide whether a proposed drug should be approved.
—San Diego’s Zogenix (NASDAQ: ZGNX) said the FDA had notified the company that its ruling on the company’s application to market extended-release hydrocodone bitartrate would be delayed by at least several weeks past March 1, the agency’s original target date for taking action. In its statement, Zogenix said the FDA did not say why its ruling would be delayed.
—An Xconomy-led discussion billed as San Diego Biotech Leaders of Tomorrow identified genomics, genetic diagnostics, industrial biotechnology, biologics R&D, stem cell therapies, and health IT technologies as emerging clusters of expertise in San Diego. I recapped the conversation—which came pretty close to serving as a summary of the life sciences industry here.
—Three of San Diego’s most-prominent cancer-research leaders deplored across-the-board federal budget cuts set to take effect today. If no action is taken, they say San Diego will lose more than … Next Page »