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Bio Roundup: NIH Precision Boost, AHCA to Senate, New Drugs & More

Xconomy National — 

Two dramatic healthcare stories played out this week. First, to the jubilation of the nation’s science community, Congress proposed to boost National Institutes of Health funding, not slash it as the Trump administration had outlined. Then the patchwork revival of the GOP’s healthcare plan, despite being panned by nearly every major medical group in the country, narrowly passed the House and headed to the Senate.

Beyond Capitol Hill, biotech IPOs gained steam, four new drugs were approved, and deals continued apace. Those headlines and more below.

THIS WEEK IN WASHINGTON

—Avoiding a government shutdown, Congress pushed back against the White House with a budget for the rest of this fiscal year that, among many things, adds $2 billion to NIH funding instead of the $1.2 billion cut proposed by the administration. It’s excellent timing for the NIH’s Precision Medicine Initiative, which could receive as much as $230 million for the 2017 fiscal year as it prepares to recruit its first batch of volunteers, up to 35,000 in its “beta” phase.

—By the slimmest of margins, the House approved the revised American Health Care Act, the GOP replacement for Obamacare. It now moves to the Senate, where pundits feel it has little chance to pass in current form.

FDA GREEN LIGHTS, RED LIGHTS

— Takeda Pharmaceutical won FDA approval of the lung cancer drug brigatinib (Alunbrig), one of the reasons the company paid $5.2 billion to buy Ariad Pharmaceuticals in January. The drug costs $14,250 per month, or $171,000 per year.

—Novartis was cleared to begin selling midostaurin (Rydapt), a treatment for the blood cancers acute myeloid leukemia and advanced systemic mastocytosis. The price for each patient depends on dose and treatment duration; Reuters has details here.

—Radius Health (NASDAQ: RDUS) won FDA approval of a new bone-building osteoporosis drug, abaloparatide (Tymlos), for postmenopausal women at high risk of a fracture. The drug, with a list price of $19,500 per year, will compete with Eli Lilly’s (NYSE: LLY) teriparatide (Forteo) and potentially Amgen’s (NASDAQ: AMGN) romosozumab, which faces an FDA approval decision this summer.

—With an FDA green light for durvalumab (Imfinzi), there are now six cancer drugs known as checkpoint inhibitors on the market. Durvalumab, from AstraZeneca (NYSE: AZN), is approved for patients with a form of bladder cancer and has an average $15,000 per month list price.

—Citing data from an animal study, the FDA has asked Intra-Cellular Therapies (NASDAQ: ITCI) for new information about the safety of long-term use of its experimental schizophrenia drug, lumateperone. Executives downplayed the news on a conference call, but the inquiry raises more questions about lumateperone, which Intra-Cellular intends to seek approval of despite mixed results in Phase 3 trials.

IN WITH THE NEW

—When Boston-based Zafgen (NASDAQ: ZFGN) abandoned its lead drug beloranib a year ago due to safety problems, its future was placed exclusively with an experimental weight loss drug for diabetics, ZGN-1061, that hadn’t even started clinical testing. Zafgen finally provided a look at ZGN-1061’s first data this week.

—The California Institute for Regenerative Medicine (CIRM) said its president and CEO Randy Mills would step down at the end of June. Mills oversaw the state agency’s revamped effort to move more research projects into clinical trials with the remainder of the $3 billion taxpayers originally voted to give the agency in 2004.

ON THE IPO TRAIL

—New York-based Ovid Therapeutics (NASDAQ: OVID) raised $75 million in an IPO, continuing a recent flurry of biotech offerings—among them BioHaven Pharmaceuticals and UroGene Pharma—that have all met or exceeded their share price projections.

—Another biotech to go public this week was Zymeworks (NASDAQ: ZYME), which raised $58.5 million in an IPO that will fund trials for two experimental cancer therapies.

FUNDINGS & DEALS

—Magenta Therapeutics of Cambridge, MA, said it has raised a $50 million Series B round led by GV, formerly Google Ventures, about the same amount it nabbed for its Series A last year. The firm is developing drugs that aim to improve three different procedures involved in bone marrow transplants.

—Parion Sciences licensed a dry eye disease drug candidate to Shire (NASDAQ: SHPG), a deal that pays the Durham, NC, biotech $20 million up front, and potentially as much as $20 million more if the compound hits development and regulatory milestones.

—A compound that Newton, MA-based Karyopharm Therapeutics (NASDAQ: KPTI) tested as a potential treatment for cancer and viruses was licensed to Orange, CA, company Anivive Therapeutics, which plans to bring the drug to market to treat dogs diagnosed with lymphoma.

—San Diego-based DrugCendR entered into a partnership with Xiamen Tobefar Technology to develop a peptide that penetrates tumors to help anti-cancer drugs work better.

—Epic Sciences raised $40 million in funding to support a diagnostic test that helps clinicians determine whether to use a hormone-based therapy or chemotherapy to treat patients with late-stage prostate cancer.

—ChromoCode, of Carlsbad, CA, got $12 million to back a technology that boosts the capabilities of polymerase chain reaction machines so they can test for more diseases.

—Wuxi NextCODE—the Shanghai company formed out of Wuxi Pharmatech’s acquisition of Cambridge, MA, and Iceland-based genomic data startup NextCODE Health two years ago—closed a $75 million Series B round led by Temasek and Yunfeng Capital.

—AstraZeneca paid $45 million up front to work with Pieris Pharmaceuticals (NASDAQ: PIRS) to develop a group of protein drugs for lung diseases, starting with an asthma drug that will begin human testing this year.

EVENT NOTES

—The inaugural Xconomy Awards are coming this fall. Give us your nominations for the Boston area biotech community’s most influential people, most noteworthy organizations, and boldest thinkers.

—We posted the agenda this week for “New York Biotech Seizes the Momentum,” on May 31, which will feature a cross section of young entrpreneurs, academics, venture investors and more trying to help build the life sciences scene in New York. (Separately, there are just a few days left to grab tickets to our annual Boston biotech forum, “What’s Hot in Boston Biotech.” Check out the details here.)

Alex Lash and Frank Vinluan contributed to this report