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Biotech Roundup: Duchenne Delay, Forum’s Fate, Califf, Ionis & More

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tripled after the company reported positive results from a mid-stage clinical trial of an experimental drug for schizophrenia.

—Shares of Burlington, MA-based Flexion Therapeutics (NASDAQ: FLXN) climbed 50 percent as the FDA, according to the company, indicated that Flexion’s data for long-acting steroid injection FX006 are good enough to allow it to file an approval application.

—Theranos of Palo Alto, CA, is already in hot water with the DOJ, the SEC, and the folks who oversee Medicare. Now here come the personal injury lawyers after Theranos revealed last week it had to correct two years worth of blood test results. One lawsuit was filed in Northern California on behalf of an Arizona man, as the San Francisco Business Times reported.

—-After struggling for years to convince the world it needs a drug for restless legs syndrome, XenoPort of Santa Clara, CA, has found a buyer. Arbor Pharmaceuticals of Atlanta bought XenoPort for gabapentil enacarbil (Horizant), which brought in $41 million in revenue last year, for $467 million.

—Shares of Carlsbad, CA-based Ionis Pharmaceuticals (NASDAQ: IONS) plunged by nearly 40 percent—eviscerating nearly $1 billion in market value—after partner GlaxoSmithKline decided to delay starting a Phase 3 study of its experimental RNA interference drug IONIS-TTRrx due to safety concerns. The FDA placed a clinical hold on a separate IONIS-TTRrx trial a few weeks ago, and according to a research note from Leerink Partners analyst Michael Schmidt, the company said on a conference call with analysts that cases of severe thrombocytopenia—dangerously low platelet counts—have been seen in the testing of two different Ionis treatments.

—Cambridge-based Alnylam Pharmaceuticals (NASDAQ: ALNY) meanwhile, which has a rival drug to IONIS-TTRx—both are treatments for a rare condition called transthyretin amyloidosis—saw its shares jump 12 percent.

—Qualcomm Life is working with Medtronic to develop new systems to help people with type 2 diabetes monitor their blood sugar levels.

—Arrivo BioVentures of Morrisville, NC, raised $49 million from Jazz Pharmaceuticals and other investors to look for drugs already in development and ripe for licensing.

—There were a couple pharma executive shakeups in the news this week. Gilead Sciences brought back a familiar face, Kevin Young, as its COO, and Sanofi has named a new chief of its diabetes unit, Peter Guenter, as part of a larger reorganization.

—Sanofi is trying to shake up San Francisco biotech Medivation (NASDAQ: MDVN), too. The French pharma is one of a few suitors, so far unwanted, for the co-owner of prostate cancer drug enzalutamide (Xtandi). Sanofi this week took its bid hostile, aiming to oust some Medivation boardmembers. Medivation urged shareholders to reject Sanofi’s efforts.

—Clinical news: Seattle Genetics (NASDAQ: SGEN) began a pivotal Phase 3 trial of vadastuximab tailirine to treat newly diagnosed acute myeloid leukemia. Alkermes (NASDAQ: ALKS), stung by a recent clinical failure of its experimental depression treatment, is trying its hand at immuno-oncology, starting a Phase 1 trial in patients with solid tumors.

—U.K.-based Bicycle Therapeutics opened up an office in Kendall Square in Cambridge, and recruited former GSK executive Rosamond Deegan as its president and chief business officer. Deegan will hire the staff for Bicycle’s U.S. team.

—New York health informatics startup COTA got an unspecified investment from Celgene (NASDAQ: CELG), Novartis (NYSE: NVS), Foundation Medicine (NASDAQ: FMI), and consulting firm HealthScape Advisors. COTA has an analytics platform that helps drugmakers identify patients that might better respond to their treatments.

—Cambridge-based Spero Therapeutics announced a deal to grab rights to a group of experimental antibiotic compounds from Vertex Pharmaceuticals, among them a drug called VXc-486/VXc-100. The deal is the latest in a group of licensing agreements Spero has used to amass different ways of attacking troublesome drug-resistant bacteria, so-called “superbugs” that can resist common antibiotics.

—Avalon Ventures and GSK formed their eighth San Diego biotech—a cancer drug developer called PDI Therapeutics—under a collaboration established three years ago. As with the other startups in the Avalon/GSK partnership, PDI will get up to $10 million in Series A cash and research funding, and GSK has an exclusive option to buy the startup later on.

​—Struggling San Diego-based Sophiris ​Bio ​(NASDAQ: SPHS) has hired an investment banking firm to help evaluate strategic alternatives to advance its experimental prostate drug. Sophiris also cut its workforce ​from 10 to five, and has raised $4.6 million to extend its operations for at least one more year.

—An unexpected $70.5 million investment in Tribune Publishing from biotech billionaire Patrick Soon-Shiong has apparently thwarted Gannett’s hostile buyout bid for the media giant, which owns the The Los Angeles Times and The San Diego Union-Tribune. Soon-Shiong’s Culver City, CA-based firm NantHealth, meanwhile, is expected to go public next week.

—Alex Lash and Bruce Bigelow contributed to this report

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