Tag Archives: Zogenix

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With Phase 2 Data in Hand, Ovid Eyes Multiple Pivotal Trials for Epilepsy Drug

Ovid Therapeutics and Takeda Pharmaceutical joined forces three years ago to develop a small molecule into a potential epilepsy drug. That research is starting to pay off as the companies now look ahead to pivotal studies testing that compound in several inherited forms of the disorder. On Wednesday, New York-based Ovid (NASDAQ: OVID) reported Phase […]

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Bio Roundup: Gilead’s Pionyr Grab, Relay to IPO, Unicorn Sana & More

Uncertainty related to the continued spread of the pandemic continued to consume most of the oxygen in the room this week, but life sciences news outside of that arena continued apace. Once considered all but shuttered, the IPO market again saw an active week between new public debuts and more companies joining the queue. Indeed, […]

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Bio Roundup: COVID-19 Trials, Esperion’s Approvals, NASH News & More

Clinical trials have historically hewn to a rigid format. A trial is designed, conducted according to that design, and then results are analyzed. Making changes in the midst of the study was a no-no. In recent years, regulators have showed openness to clinical trial designs intended to make drug testing more efficient. We’ll get to […]

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Biotech Roundup: Vaping Toll Rises, NASH News, Akcea Shakeup & More

Lung injuries linked to electronic cigarettes have topped 800 cases, including 12 deaths, according to the Centers for Disease Control and Prevention. Public health officials aren’t sure whether the injuries are from legally sold products made by companies such as Juul, or from black-market items such as those that allow users to “vape” the active […]

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Bio Roundup: Cholesterol Check, J&J’s Opioid Hit, AbbVie’s Flop & More

You might be camping, barbecuing, or sleeping on Monday. It’s Labor Day, after all. But in Paris, this cardiologist will be in a conference center, walking an audience through a slide deck packed with Phase 3 data for a new cholesterol-lowering drug, inclisiran. Inclisiran’s owner, the Medicines Co., jumped the presentation by a week, promising […]

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Bio Roundup: Merger Drama, FDA Trauma, Big IPOs, CRISPR Fights & More

It was a busy week. If we had to choose a theme, it was all about getting together. Two huge drug companies, AbbVie and Allergan, said they’d be better as one. Two more huge drug companies, Celgene and Bristol-Myers Squibb, learned they would have to leave a big product behind if they want to merge. […]

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Stoke Therapeutics Preps IPO to Bring Dravet Syndrome Drug to Clinic

After Stoke Therapeutics closed $90 million in financing last fall, CEO Ed Kaye signaled his biotech would seek more cash through an IPO soon. The preclinical-stage biotech is now officially on a path to the public markets. In paperwork filed late Thursday with the SEC, Bedford, MA-based Stoke set a preliminary $86 million target for […]

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FDA Refuses to Review Zogenix Seizure Drug, Says File Not Complete

[Updated 9:11 p.m. ET. See below.] The FDA is refusing to review a Zogenix drug developed to treat seizures caused by a rare form of epilepsy. Zogenix said Monday that the FDA sent the company a “refusal to file” letter regarding its drug, fenfluramine hydrochloride (Fintepla). Such letters don’t amount to a rejection of a […]

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With $90M Round, Stoke Eyes a “Spinraza For Epilepsy” And a 2019 IPO

Ed Kaye stepped aside from Sarepta Therapeutics (NASDAQ: SRPT) last year after leading the company through one of the most noteworthy and controversial drug approvals in recent memory, for the Duchenne muscular dystrophy drug eteplirsen (Exondys 51). But his hiatus from a publicly traded biotech could be short-lived. Kaye’s new startup, Bedford, MA-based Stoke Therapeutics, […]

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Zogenix Epilepsy Data Sets Up Market Battle With GW’s Cannabis Drug

Just weeks ago, the FDA approved the first ever medicine made from a derivative of marijuana, a drug from GW Pharmaceuticals for a rare form of epilepsy. Yet competition already looms from Zogenix, thanks to new data the Emeryville, CA, company reports this morning. Zogenix (NASDAQ: ZGNX) said that its experimental drug ZX008 succeeded in […]

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