The partial government shutdown, now the longest in U.S. history, began to take a bite out of biotech this week, served with a hot side dish of confusion.
On Tuesday, Aimmune Therapeutics (NASDAQ: AIMT) said the shutdown would delay the review—and potential approval—of its experimental treatment for peanut allergy. Aimmune said it received a letter from the FDA warning of the delay.
The disclosure sparked what seemed to be a rebuke from FDA commissioner Scott Gottlieb in a series of tweets, although he did not name Aimmune directly. He warned of “some parties who are using the excuse of the shutdown to advance misleading narratives.”
What are those narratives? He didn’t elaborate, and neither did the FDA media-relations staff, whom Gottlieb said (again, on Twitter) was “here to answer inquiries from press.” For a fuller explanation of the confusion, you’ll find our coverage below, plus other headlines on drug prices, cancer immunotherapy, IPO delays, and more. It’s the weekly roundup, fully funded with no strings, or walls, attached.
—Roger Perlmutter, Merck’s (NYSE: MRK) executive vice president and the head of its research division, helps shape the company’s immuno-oncology strategy and its sprawling network of clinical trials. In a Q&A, Xconomy asked Perlmutter what’s next for Merck and immunotherapy, and how drug makers might push beyond the field’s current limitations.
—Aimmune Therapeutics of Brisbane, CA, disclosed Tuesday that the FDA notified it of a review delay for its peanut-allergy treatment. FDA Commissioner Scott Gottlieb responded with comments on Twitter that sowed confusion about Aimmune’s status and the way its lead drug is classified. Aimmune said it hasn’t received clarification about its status from the agency. The agency’s press office said it had nothing more to share.
MORE SHUTDOWN FALLOUT
—If the shutdown continues, several drugs that are supposed to be under review for approval could see delays like Aimmune, Stat reported.
—Two more clinical-stage biotechs, Kaleido Biosciences and Cirius Therapeutics, filed for IPOs. But until the shutdown ends, those IPOs and others filed with the SEC can’t be completed.
—Assuming the shutdown doesn’t last “months or years,” which President Trump has threatened, the FDA expects to deal with a surge of approval decisions for gene and cell therapies. There could be up to 20 approved in 2025 and beyond, officials said this week, as they outlined the agency’s long-term plans to accommodate the increase.
—In the political crisis across the pond, the European Union’s drug regulator has updated plans for its move from London to Amsterdam, forced by Brexit. Fierce Biotech reports that the latest report portends a “relatively painless move” to Amsterdam, with about three-quarters of staff making the trek.
POLITICS & REGULATION
—The House Oversight Committee, now run by Democrats, is launching an investigation into the drug-pricing practices of a dozen companies.
—An FDA advisory panel voted to recommend approval of romosozumab (Evenity), an experimental osteoporosis drug from Amgen (NASDAQ: AMGN). Panelists said cardiovascular risks flagged in clinical trials could be addressed with a warning on the drug’s label and post-marketing studies.
—The agency rejected a breast cancer treatment from Immunomedics (NASDAQ: IMMU) due to manufacturing issues. The news extends a multi-decade struggle for Immunomedics to bring its first product to market, Stat reported.
DEALS & FINANCE
—A regulatory filing showed that Eli Lilly (NYSE: LLY) and Loxo Oncology (NASDAQ: LOXO) cut their $8 billion deal in just over two weeks, with Lilly adamant to finish before the J.P. Morgan Healthcare Conference. What’s more, Loxo didn’t seek other bidders after talks began.
—Alnylam Pharmaceuticals (NASDAQ: ALNY) already had more than $1 billion in cash in the bank but raised another $387.5 million in a stock offering. The cash will help roll out its first product, patisiran (Onpattro), and develop other RNA interference medicines.
—Juvenescence raised $46 million, the first tranche of a projected $100 million Series B round. The startup will use the cash to continue work on its pipeline of experimental anti-aging therapies.
CUTBACKS & SETBACKS
—Five Prime Therapeutics (NASDAQ: FPRX) cut 20 percent of its staff to save cash as the South San Francisco, CA, biotech focuses on five clinical-stage cancer drugs expected to report data later this year.
—Alzheon withdrew plans for an IPO that would fund late-stage tests of its Alzheimer’s disease drug. In a letter to the SEC, the Framingham, MA, company says it could raise money through a private offering.
Alex Lash and Frank Vinluan contributed to this report.