Winter Storm Jonas is headed for the East Coast, and the panicked grocery shopping and traffic nightmares have already begun. It’s impacted biotech too, postponing what would have been one of the most closely watched FDA advisory panels in recent memory. So hurry up and grab your bread and milk before you get snowed in—but check out these East Coast headlines first.
—Dublin, Ireland- and Waltham, MA-based Alkermes (NASDAQ: [[ticker:ALKS]]) said its experimental drug for major depressive disorder, ALKS-5461, failed the first two of three Phase 3 trials. Alkermes claimed to see a silver lining in the data, and a possible path to approval for ALKS-5461 should the third trial succeed. But many investors aren’t waiting around to find out. Alkermes lost over $4 billion in market cap as shares of the company fell more than 44 percent, bringing them down to levels they haven’t traded at since 2013.
—Eleven Biotherapeutics (NASDASQ: [[ticker:EBIO]]) also was bludgeoned by investors. Shares are trading in penny stock territory—a $0.37 per share close on Thursday—after the company’s lead drug, isunakinra, failed its second Phase 3 trial in seven months. Eleven is now putting its cash behind a preclinical drug, EBI-031, for diabetic macular edema, and a spokesperson said this week the company is considering “various business development and financing approaches” going forward.
—Shares of Cambridge, MA-based Zafgen (NASDAQ: [[ticker:ZFGN]]), meanwhile, surged more than 62 percent after the company finally got some good news from the Phase 3 study of its potential Prader-Willi Syndrome drug, beloranib, in which two participants have died. The drug met both of its main goals in the trial, which, as CEO Tom Hughes told me, is the “first crucial step” to getting beloranib approved. There’s a long road ahead, of course. Beloranib is still under a clinical hold from the FDA, and Zafgen has to figure out what, if any correlation exists between the drug and the potential blood clots that were responsible for the deaths of two trial volunteers.
—Today was supposed to be the day that Sarepta Therapeutics (NASDAQ: [[ticker:SRPT]]) went before an FDA advisory panel to argue for approval of its Duchenne muscular dystrophy drug, eteplirsen. But that meeting was postponed this week due to Winter Storm Jonas. It’s unclear how long Sarepta, and the Duchenne community, will now have to wait for another meeting; the FDA was supposed to make a decision on eteplirsen by Feb. 22, though that date may now change. It is clear, however, that many don’t think the drug has much of a chance of approval until the company accrues more data. Shares of Sarepta are down more than 62 percent since the release of briefing documents from FDA scientists last week that slammed Sarepta’s data (here’s more on that at TheStreet.com).
—Ardsley, NY-based Acorda Therapeutics (NASDAQ: [[ticker:ACOR]]) paid $363 million in cash for Finland’s Biotie Therapies, the second deal the company has made for a Parkinson’s disease drug developer in less than two years. Acorda paid $525 million for Civitas Therapeutics in September 2014.
—In case you missed it over the holiday weekend, Alex Lash and I rounded up some thoughts from the vortex that is the annual J.P. Morgan Healthcare Conference in San Francisco. There’s more to come in the weeks and months ahead, but for now here are some nuggets from a few of the interviews we conducted with a variety of executives and investors.
—This week we announced our next East Coast biotech event, “New York’s Life Science Disruptors,” which will take place on March 29 at the Alexandria Center for Life Science in Manhattan. The event centers around a key change in the New York biotech scene of late—the influx of early-stage investors and high profile startups.
—The New York Genome Center is getting a combined $100 million gift from the Simons Foundation and The Carson Family Charitable Trust, foundations run by NYGC boardmembers James Simons and Russell Carson. It’s the second cash infusion the NYGC has gotten in two weeks, following a $40 million grant from the National Institutes of Health.
—The New York Digital Health Accelerator held its third demo day, debuting six healthtech startups that have raised some $3 million since entering the program. The startups are Dorsata, iVEDiX, OffTheScale, Parable, TelaDietitian, and Wellth.
—Cambridge-based Exosome Diagnostics began selling a blood-based diagnostic test—often called a “liquid biopsy”—for lung cancer. The test, known as ExoDx Lung(ALK), is for lung cancer patients whose cancers have the genetic mutation EML4-ALK.
—Shares of The Medicines Co. (NASDAQ: [[ticker:MDCO]]), of Parsippany, NJ, climbed over 14 percent on a report from Bloomberg that the company is considering selling itself and has hired advisers to help explore a deal.
Photo courtesy of the Metropolitan Transportation Authority via a Creative Commons license.
