Exhausted by the nonstop drama in Washington, DC? Immerse yourself instead in this week’s biotech headlines. Let’s start with a tribute to a life sciences icon, then we’ll head around the Xconomy network with early news from the nation’s big yearly cancer meeting. There was also momentum onthe IPO front and new gigs for high-profile folks (with just one stop on Capitol Hill along the way, we promise). Let’s get right to it.
BIO LEADERS: SO LONG, HENRI
—Henri Termeer, the former Genzyme executive widely credited as a pioneer of the orphan drug business, passed away suddenly at the age of 71. Xconomy rounded up thoughts about Termeer’s impact from a wide group of Boston biotech leaders. “I miss him already,” said Third Rock Ventures co-founder Mark Levin.
GOTTLIEB’S MOVES, FDA REVIEWS
—New FDA commissioner Scott Gottlieb greeted FDA staff with a speech aimed at boosting morale, highlighting science-based decision making, and cheering the agency’s role protecting American lives: “This isn’t like any other job. People need us.” Bloomberg Businessweek reported that one of Gottlieb’s first big moves will be a restructuring—reportedly with no job cuts—so that FDA inspectors are arranged by product specialty instead of geography. The reorg stems from a bill signed in 2011 by President Obama, according to Bloomberg.
—Ionis Pharmaceuticals (NASDAQ: IONS) touted Phase 3 results for its rare nerve disease drug, inotersen, and said it plans to file for FDA approval. But investors noted safety concerns and sent Ionis shares down while boosting rival Alnylam Pharmaceuticals (NASDAQ: ALNY).
—Amgen (NASDAQ: AMGN) filed for FDA approval of erenumab, the first of a new crop of drugs meant to help prevent migraines. Close behind is Eli Lilly (NYSE: LLY), which reported positive Phase 3 data this week and plans to file for FDA approval of its drug galcanezumab later this year.
—Shire’s $6.5 billion bet on Dyax in 2015 may soon pay off. The company posted positive Phase 3 results for landelumab, a hereditary angioedema drug acquired in the Dyax deal, and plans to file for FDA approval by early 2018.
—The FDA suspended a mid-stage study of an experimental alopecia areata treatment from Lexington, MA-based Concert Pharmaceuticals (NASDAQ: CNCE). The agency wants to review more data from preclinical studies before patients start taking the drug.
BACK IN THE HEADLINES
—Scott Gottlieb’s predecessor at FDA, Rob Califf, has resurfaced to become an Advisor—with a capital A—at Verily, the Silicon Valley health R&D group formerly known as Google Life Sciences. From his pre-FDA days at Duke University, Califf has ties to Verily’s long-term Baseline health study and to other multiyear studies. But Verily would not say if he now would work specifically on Baseline, which launched last month and faces recruitment questions.
—Two years after abruptly resigning from Cambridge-based Sarepta Therapeutics (NASDAQ: SRPT), former CEO Chris Garabedian has surfaced as the top executive of Xontogeny, a Boston biotech accelerator that has secured $15 million in a Series A financing round that could reach $25 million.
NEW NIH CUTS COMING?
—Just weeks after Congress appeared to fend off the Trump administration’s planned cuts for biomedical research, the Atlantic reported that a new budget proposal, to be released next week, could offer a different strategy to chop National Institutes of Health funding.
HERE COME THE DATA
—Abstracts, or snippets of data from a variety of studies, were released ahead of the American Society of Clinical Oncology’s annual meeting in Chicago, which starts on June 2 in Chicago. TheStreet.com highlighted some of the most noteworthy releases in these posts.
NOW PUBLIC OR SOON TO BE
—Cambridge-based Synlogic merged into the shell of a dying biotech company to go public instead of taking the traditional IPO route. Synlogic is developing live re-engineered bacteria that enter a patient, seek out a disease-causing situation, and produce therapeutic proteins on the spot.
—Continuing a recent run of biotech IPOs, two companies went public this week: Research Triangle Park, N.C.-based G1 Therapeutics (NASDAQ: GTHX), which raised $105 million; and Dutch drug maker Argenx, which secured $100 million.
—Athenex, a Buffalo, NY, company developing oral versions of chemotherapy drugs like paclitaxel and irinotecan, outlined plans for an IPO.
OTHER DEALS & FUNDINGS
—In the second boost for New York biotech in two weeks, Biogen (NASDAQ: BIIB) bought an experimental stroke drug from New York-based Remedy Pharmaceuticals for $120 million in cash, plus potential future payments. River Vision Development was acquired by Horizon Pharma for $145 million a week ago.
—Seattle’s Genoa Pharmaceuticals has raised a $62 million Series A round and hired local biotech veteran Bruce Montgomery to take the CEO seat and lead the firm through Phase 2 studies of its inhaled version of pirfenidone, a treatment for deadly lung scarring. Genoa is aiming for fewer side effects than the pill version, approved in 2014 and now marketed by Roche.
—Vifor Pharma made a $50 million equity investment in Akebia Therapeutics (NASDAQ: AKBA) at $14 per share. The deal gives Akebia license to sell its anemia pill vadadustat, upon FDA approval, at Fresenius Medical Care dialysis clinics in the U.S. Vadadustat and rival roxadustat from Fibrogen are both in Phase 3 testing.
—Xconomy held its annual “What’s Hot in Boston Biotech” event last week, and this week we circled back with photos and takeaways from the event, including thoughts on immigration, diversity, cancer research, and patient advocacy.
—Alex Lash and Frank Vinluan contributed to this report.