A big drop in biotech stocks set the backdrop for much of the news out of San Diego’s life sciences community this week. The tide rises, and the tide falls. But the surf is forever—at least in San Diego.
—A broad selloff in biotech stocks has prompted widespread concern that the biotech bubble is popping. The Nasdaq Biotech Index slipped after today’s opening, hitting a level that was 21 percent down from the intraday peak set on Feb. 25. For some experts, a 20 percent decline from the most recent peak means the sector is flirting with a bear market. Talk of the biotech bubble bursting has even prompted some gallows humor, exemplified by a video, “Hitler Reacts to Biotech Bubble,” a meme created from the film “Downfall.”
—San Diego’s Celladon Corporation (NASDAQ: CLDN) gained $1.22, or 11.5 percent, closing at $11.87 in regular trading Thursday, after the company said the FDA gave its “breakthrough therapy” designation to Celladon’s gene therapy treatment for patients with advanced heart failure. It is the first time the FDA has given the designation to a gene therapy program, and means the development and review of Celladon’s Mydicar therapy can be expedited, Wiklund said.
—The FDA put Halozyme Therapeutics’ (NASDAQ: HALO) pancreatic cancer drug candidate PEGPH20 on clinical hold. The move came a week after Halozyme said it had voluntarily suspended enrolling patients and dosing of PEGPH20, a pegylated formulation of its human hyaluronidase enzyme (Hylenex). An independent monitoring committee asked the company to suspend the trial as a precautionary measure until scientists can analyze whether PEGPH20 increases the potential blood-clot risks among patients taking the drug.
—Meanwhile, at the American Association for Cancer Research meeting in San Diego this week, Halozyme presented two scientific papers concerning the benefits of PEGPH20. The first showed that treating tumors with PEGPH20 enhances the action of immune-based cancer therapy such as monoclonal antibodies, according to preclinical data. The second presentation, also based on preclinical data, showed that overproduction of hyaluronan in tumor stroma enhances tumor growth, and that PEGPH20 suppresses the growth of hyaluronan-rich tumors.
—San Diego’s Vital Therapies, which is developing an artificial liver for treating acute liver failure, lowered the proposed deal size for its upcoming IPO, according to a regulatory filing. Vital Therapies now plans to raise $63 million by offering 4.5 million shares at a price range of $13 to $15. The company postponed its IPO in November, after disclosing that it planned to offer 4.4 million shares at a range of $16 to $18. At the midpoint of the revised range, Vital Therapies would raise 16 percent less than previously anticipated. The 11-year-old device maker plans to list on the Nasdaq market under the ticker symbol VTL.
—Vertical Venture Partners, a new venture fund based in Palo Alto, CA, has held the first close of what is expected to be about a $40 million fund. The maiden fund, founded by Sierra Ventures managing director David Schwab, includes a mini-fund dubbed the Triton Technology Fund that will serve as an accelerator fund for new technologies and startups coming out of the UC San Diego Jacobs School of Engineering.
—-A new report from CB Insights, the New York market research firm that tracks VC activity, says venture investments were just short of $10 billion for the first quarter that ended March 31. That’s the highest level for VC funding since the second quarter of 2001. One big factor cited by the firm was the 35 venture-backed IPOs during the quarter—the highest quarterly tally for VC-backed offerings since Q3 2000. Of the 35 VC-backed IPOs in the first quarter, 22 came from the healthcare sector.
—Circulating tumor cells and cell-free DNA continue to be a hot area in molecular diagnosis—offering a new way to track how well a cancer patient is responding to therapy. One example presented at the American Association for Cancer Research annual meeting came from clinical study results of an assay developed by San Diego’s Trovagene (NASDAQ: TROV). According to a statement, results presented by Filip Janku of the University of Texas MD Anderson Cancer Center showed that Trovagene’s molecular diagnostic platform could identify the BRAF V600E oncogene mutations in urine samples from 29 of the 33 patients enrolled in the study (88 percent). Mutations in the BRAF gene have been identified in a number of cancers, including non-Hodgkin lymphomas, colorectal cancer, malignant melanoma, and certain lung cancers.
—San Diego-based Zogenix (NASDAQ: [ticker:ZGNX]]) said it has asked a federal court in Boston to stay a ban of Zohydro-ER, the company’s FDA-approved prescription drug for chronic pain, that was issued on March 27 by Massachusetts Governor Deval Patrick as part of a statewide public health emergency to combat the growing abuse of opiates. Zohydro-ER is an extended-relief formulation of pure hydrocodone, and the governor cited the potential for abuse in his statewide ban. The U.S. District Court in Boston scheduled a follow-up hearing on Monday.