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Biotech Roundup: Duchenne Delay, Forum’s Fate, Califf, Ionis & More

Xconomy National — 

Memorial Day weekend may be fast approaching, but don’t fire up those grills yet: there’s plenty of headlines to dig into first in our biotech trip around the Xconomy network.

In New York, the nation’s most prestigious science competition changed sponsors for just the second time in its 74-year history. In Boston, one company’s controversial quest to potentially get the first drug for Duchenne muscular dystrophy approved drags on, while the fate of another seems to hang by a thread.

And on the West Coast, the first implantable device for opioid addiction was approved—just as the FDA’s commissioner made some pointed remarks at a Stanford University chat about the future rate of drug approvals. Those stories and much more below.

—The multi-year saga of eteplirsen, a Duchenne muscular dystrophy drug from Cambridge, MA-based Sarepta Therapeutics—which could be the first ever approved for the deadly disease—will continue to drag on. The FDA said this week that it wouldn’t complete its view of the drug by the May 26 deadline, and didn’t give any timeline for when a decision would come. Shares of Sarepta (NASDAQ: SRPT) surged more than 25 percent as investors took the delay as a positive sign for eteplirsen’s approval chances. Forbes has more on the potential outcomes that might lie ahead.

—Deborah Dunsire, the former head of Millennium Pharmaceuticals and a well known Boston biotech veteran, told Xconomy that she’s no longer the CEO of Waltham, MA-based Forum Pharmaceuticals. Dunsire aims to head up another biotech after some time off. In the meantime, the fate of Forum—whose lead drug, encenicline, failed two Phase 3 trials in March—remains unclear.

—At a Stanford University conference, new FDA commissioner Robert Califf predicted that the high rate of drug approvals in recent years would continue, thanks to better understanding of biology and adoption of “big data” and other sophisticated technology.

—Titan Pharmaceuticals (NASDAQ: TTNP) and partner Braeburn Pharmaceuticals received FDA approval Thursday for an under-the-skin implant that treats opioid addiction. The implant, branded Probuphine, delivers the drug buprenorphine for up to six months, according to Titan.

—The agency rejected, meanwhile, a drug from AstraZeneca (NYSE: AZN) called ZS-9 for the kidney disease hyperkalemia, citing manufacturing issues. That’s positive news for Redwood City, CA-based Relypsa (NASDAQ: RLYP), which has a rival hyperkalemia drug on the market—Relypsa shares soared 37 percent Friday morning—and a setback for the British drugmaker, which acquired ZS-9 when it paid $2.7 billion for Coppell, TX-based ZS Pharma in November.

—The National Institutes of Health has awarded $142 million to the Mayo Clinic to build a repository for more than 30 million biological samples. The so-called biobank will be part of the Obama administration’s Precision Medicine Initiative, a long-term health study that aims to gather comprehensive health information from 1 million Americans.

—Tarrytown, NY-based Regeneron Pharmaceuticals (NASDAQ: REGN) has been named the new sponsor of the nation’s oldest science competition, the “Science Talent Search” (formerly known as the Westinghouse Award), taking over for Intel, which gave up its sponsorship last year. Regeneron has pledged $100 million in a 10-year commitment to the competition. Here’s more from The New York Times.

—Watertown, MA-based Selecta Biosciences filed for an IPO this week and aims to trade on the Nasdaq under the ticker symbol “SELB.” Selecta is using nanotechnology to trick the immune system into calling off an unwanted attack on a particular target; its lead drug is for chronic refractory gout.

—Shares of Waltham-based Minerva Neurosciences (NASDAQ: NERV) more than … Next Page »

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