Nothing like a little drama to end your summer, right? Market volatility dragged biotech down this week, and then lifted it back up—at least as of Friday morning. But if you’re confused by the tumult and looking for some distractions, we’ve got plenty of them below. Read on for details of some biotech and digital health initiatives in New York, a long-awaited drug approval, a new potential IPO candidate, and much more.
—There are incubators, accelerators, and venture funds. But as Unity Stoakes, the president and co-founder of StartUp Health told me, his company is a “mashup” of all three. I took an in-depth look at StartUp Health, the New York company that’s helped nurture more than 100 healthtech startups across the globe, and spoke with Stoakes about the challenges confronting the sector.
—In other New York news, the city’s biotech scene got a boost this week when Versant Ventures announced the formation of its latest startup incubator, “Highline Therapeutics.” Highline is a few avenues from the actual High Line—an elevated walkway and park in Manhattan—and will work with the city’s institutions to create new companies. Carlo Rizzuto, a Long Island native who is running High Line, says Versant already has collaborations in place with Columbia University professor Brent Stockwell and Weill Cornell Medical College.
—Sometimes buyout options lead to deals, and sometimes they don’t. It was the latter for Cambridge, MA-based Constellation Pharmaceuticals, as Xconomy reported that Genentech decided to pass on an option to buy the company at a pre-negotiated price. Despite the news, Constellation celebrated. CEO Keith Dionne told me the company has long wanted to chart a different course, and now plans to raise a “crossover” round to support a future IPO.
—Speaking of IPOs, the market tumult appears to have chilled the prospects of at least one Boston-area company, Billerica, MA-based RainDance Technologies. As David Holley reports, RainDance cited “market conditions” when it pulled its IPO on Monday. The company had been in the IPO queue for a while; it filed in February.
—As expected, Tarrytown, NY-based Regeneron Pharmaceuticals (NASDAQ: [[ticker:REGN]]) now has some competition for its newly approved cholesterol lowering drug, alirocumab (Praluent). The FDA this week approved Amgen’s (NASDAQ: [[ticker:AMGN]]) evolocumab (Repatha), which, like alirocumab, fights cholesterol by targeting the protein known as PCSK9. A major issue with these drugs going forward is cost: Amgen priced evolocumab at $14,100 for a year of treatment, roughly on par with alirocumab’s $14,600 price tag. But as Alex Lash reports, the net price of evolocumab will be linked to cholesterol reductions and “anticipated appropriate patient utilization”—something to watch as the details become more clear.
—Crossover investors returned to back another biotech this week—this time, Waltham, MA-based Syndax Pharmaceuticals, which pulled in an $80 million Series C round. It’s the first big move for Syndax since former AstraZeneca chief medical officer Briggs Morrison replaced Arlene Morris as CEO. A few days later, Syndax inked a deal with Genentech to test its experimental cancer drug, entinostat, in tandem with the South San Francisco company’s checkpoint inhibitor atezolizumab. Syndax already has a similar deal in place with Merck.
—Cambridge-based Sarepta Therapeutics (NASDAQ: [[ticker:SRPT]]) took another step forward in its race with BioMarin Pharmaceutical (NASDAQ: [[ticker:BMRN]]) to bring a Duchenne muscular dystrophy drug to market. The FDA accepted Sarepta’s new drug application for eteplirsen, meaning the agency will review the drug and make a decision by Feb. 26. An FDA advisory panel is expected later this year, at which time experts would review both eteplirsen and BioMarin’s drug, drisapersen. There’s more at stake, as well. Both companies have gotten a rare pediatric disease designation for these drugs, meaning they could each get a priority review voucher—a hot, sellable commodity in biotech—should they win regulatory approval.
—Shares of Cambridge-based Verastem (NASDAQ: [[ticker:VSTM]]) fell more than 20 percent after news broke of a snippet of Phase 2 data the company will present at a medical conference next month. The data appeared to show that as of a cutoff date, Verastem’s stem cell drug for cancer, VX-6063, led to just one partial response out of 53 lung cancer patients tested, with 11 of them suffering grade 3 to 5—severe—side effects. Verastem quickly responded with statement that claimed that the study had met its goals, with “encouraging outcomes” it’ll explore in future trials. The full data from Verastem’s trial are under embargo until the company presents at the conference on Sept. 9.
—Hedge fund boss Kyle Bass has been threatening the pharma and biotech industry with patent challenges this year, but at least so far, his efforts have come up short. Hawthorne, NY-based Acorda Therapeutics (NASDAQ: [[ticker:ACOR]]) fended off a threat to its flagship drug, dalfampridine (Ampyra). Bass, through Hayman Capital Management, has cases outstanding against other drugs as well, as you can read in this Bloomberg report.
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