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Bio Roundup: Biotech IPOs, Migraine Progress, Takeda Woos Shire & More

Xconomy National — 

If the recent IPO activity seems to be on overdrive, it’s not your imagination. The number of companies filing to go public in the U.S. in the first quarter was up 44 percent compared to the same period a year ago, according to data compiled by consulting and accounting firm EY. Life science companies accounted for nearly one third of the quarter’s IPOs.

The strength of the IPO market is notable because the first quarter is typically the slowest time of the year for companies to go public, EY told Xconomy. And the consultancy’s report, finished with one week left to go in the quarter, missed out on the latest life science IPOs as two more biotechs entered the public markets this week.

In other news, a drug developer declared success for its migraine pill, reports of patient deaths stunned the hemophilia community, and a major player in rare disease drug development emerged as a takeover target. For those stories and more, read on in this week’s roundup.

DATA & DECISIONS

—Keeping pace with rival Allergan, Biohaven Pharmaceuticals (NYSE: BHVN) said its migraine pill rimegepant succeeded in two Phase 3 trials and should head to an FDA review next year. But it’s unclear whether the drug is any better than Allergan’s rival ubrogepant, which has passed one Phase 3 study and is nearing the end of another.

—Edge Therapeutics (NASDAQ: EDGEstopped a Phase 3 study of its lead drug early because the drug, EG-1962, developed to treat severe head injuries, was deemed likely to fail. Shares plunged 85 percent, and Edge announced plans to restructure.

Surgical robot developer Auris Health received FDA clearance for its Monarch surgical platform developed for the diagnosis and treatment of lung cancers.

—A peanut allergy treatment developed by AnaptysBio (NASDAQ: ANAB) showed encouraging preliminary results from a small Phase 2a study—just 20 patients. The San Diego biotech plans to progress to multi-dose Phase 2b studies.

—Protagonist Therapeutics (NASDAQ: PTGX) stopped a Phase 2 study testing its experimental ulcerative colitis treatment after a planned interim analysis concluded that the Newark, CA, company’s drug would not work.

CASH CONSIDERATIONS

Surface Oncology filed for an initial public stock offering that the Cambridge, MA, cancer immunotherapy developer plans to use to finance early-stage testing of its lead drug.

—Homology Medicines (NASDAQ: FIXX) has no clinical data yet but it does have $144 million in fresh capital raised from its IPO. The Cambridge, MA, company will use the cash for clinical tests of its experimental gene therapy for a rare, inherited metabolic disorder.

Tempest Therapeutics emerged from stealth with a $70 million Series B funding round that the San Francisco company will use to advance its cancer immunotherapies to the clinic.

—Unum Therapeutics’ (NASDAQ: UMRX) IPO raised $69 million that the Cambridge company will apply toward clinical tests of its universal cell therapies for cancer.

—The Singapore biotech firm Aslan Pharmaceuticals filed for a U.S. IPO on Monday, with the hope of raising up to $86 million. The company, already listed on the Taipei Exchange, is currently testing its drug, varlitinib, in Phase 2 and 3 clinical trials for biliary tract, gastric and other cancers.

—Shanghai, China-based Hua Medicine, which is developing a drug for type 2 diabetes, announced a $117.5 million combined Series D and E round. Hua says the financing will fund the completion of two Phase 3 trials and the commercial launch in China of its diabetes drug, dorzagliatin.

DRUG DEVELOPMENTS

—The dispute between Arcturus Therapeutics (NASDAQ: ARCT) and its former CEO Joseph Payne escalated, with the San Diego company suing Payne and alleging a wide pattern of misconduct. Payne declined comment other than to say Arcturus has its own “pattern of disparagement.”

—Takeda Pharmaceutical said it is “considering making an approach” to buy rare disease drug giant Shire (NASDAQ: SHPG). Shire shares spiked more than 17 percent.

—In a statement, the nonprofit Hemophilia Federation of America said it was told by Roche/Genentech that a total of five patients on its hemophilia drug emicizumab (Hemlibra) have died. Roche told Endpoints News none of the deaths were related to the drug, however.

—Bluebird Bio (NASDAQ: BLUE) exercised an option to split U.S. rights with Celgene (NASDAQ: CELG) to bb2121, Bluebird’s experimental cell therapy for multiple myeloma. Bb2121 is part of a Bluebird/Celgene alliance that dates to 2013.

—GlaxoSmithKline (NYSE: GSK) reached a deal to pay $13 billion to buy out Novartis’ (NYSE: NVS) stake in their consumer health products joint venture. The move follow’s GSK’s decision last week to pull out of contention for the acquisition of Pfizer’s (NYSE: PFE) consumer health business, Reuters reported.

—Remember that Nature Methods article last year that sent CRISPR company shares tumbling? It said that CRISPR gene editing can result in many off-target edits. This week, the same researchers issued a mea culpa. In a preprint, they concluded that in some cases, CRISPR-Cas9 gene editing “may not introduce numerous, unintended, off-target mutations.“ Oops.

THIS WEEK IN DRUG PRICING

—The SEC cleared shareholders of five large drugmakers to vote on proposals that could force the companies to develop reports examining how drug prices are tied to executive compensation. Here’s more from STAT.

—The Institute for Clinical and Economic Review (ICER) concluded in a report late last week that the two CAR-T therapies on the market—Kymriah (list price $475,000) for a childhood leukemia and Yescarta ($373,000) for an adult lymphoma—are cost-effective in the long term. But ICER added that the costs of Yescarta “may be difficult for the health care system to absorb over the short term.”

—Aetna announced that it will pass along the rebates it negotiates with drug companies to some customers starting next year. (UnitedHealthcare made a similar announcement earlier this month.) But an Aetna spokesperson told Axios that this might lead to premium increases.

—Stat profiled John and Laura Arnold and their foundation, which has given out nearly $50 million in various pharma-related grants over the last several years. Many of the grantees are focused on drug pricing, including the nonprofit Patients for Affordable Drugs, which we recently wrote about.

Corie Lok and Ben Fidler contributed to this report.

Image by Depositphotos.