Avadel Pharmaceuticals doses first patient in OLE/switch study of FT218 » 08:1407/1307/13/20
Avadel Pharmaceuticals announced that the first patient has been dosed at a Florida Research Institute initiating an open-label extension/switch study of FT218 as a potential treatment for excessive daytime sleepiness and cataplexy in patients with narcolepsy. The OLE/switch study will examine the long-term safety and maintenance of efficacy of FT218 in patients with narcolepsy who participated in the REST-ON study, as well as dosing and preference data for patients switching from twice-nightly sodium oxybate to once-nightly FT218 regardless if they participated in REST-ON or not. The study will enroll about 250 patients at most of the North American clinical trial sites that participated in the REST-ON study.
|Over a week ago|
Avadel sale of legacy assets 'not a surprise,' says Piper Sandler » 14:3007/0107/01/20
Piper Sandler analyst…
Piper Sandler analyst David Amsellem said Avadel's sale of its legacy hospital injectables portfolio, which provided a source of modest cash flows, was "not a surprise" as "it was fairly obvious that it was a noncore segment" with the company now prioritizing the development of FT218, its once-nightly form of sodium oxybate. The analyst, who believes that data so far on FT218 as well as receptivity to a once-nightly option should allow the company "to carve out a meaningful slice of the $1.7B+ oxybate market," keeps an Overweight rating and $18 price target on the stock.
Avadel Pharmaceuticals sells hospital sterile injectable drug portfolio for $42M » 08:0507/0107/01/20
Avadel Pharmaceuticals announced the sale of its portfolio of sterile injectable drugs used in the hospital setting, including three commercial products, Bloxiverz, Vazculep, and Akovaz, as well as Nouress, which is approved by the U.S. Food and Drug Administration, to Exela Sterile Medicines LLC for a total of $42M. Under the terms of the agreement, Avadel will receive $14.5M upfront and the remaining $27.5M will be paid out to Avadel over the next 13 months. The transaction closed on June 30, 2020.
Avadel Pharmaceuticals initiated with a Buy at H.C. Wainwright » 06:1106/3006/30/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Oren Livnat initiated coverage of Avadel Pharmaceuticals with a Buy rating and $15 price target. Avadel is a specialty pharmaceuticals company developing FT218, a once-nightly formulation of sodium oxybate, to treat cataplexy and excessive daytime sleepiness in the orphan narcolepsy market, Livnat tells investors in a research note. The analyst believes FT218 REST-ON data look competitive with Xyrem.
|Over a month ago|
Avadel Pharmaceuticals management to meet virtually with Piper Sandler » 07:2405/2105/21/20
Virtual Meeting to be…
Virtual Meeting to be held on May 21 hosted by Piper Sandler.
Avadel Pharmaceuticals reports Q1 EPS (2c), consensus (24c) » 07:0505/1105/11/20
Reports Q1 revenue…
Reports Q1 revenue $12.2M, consensus $10.15M. "During the first quarter of 2020, we made significant progress advancing the development program for once-nightly FT218 with the completion of the pivotal Phase 3 REST-ON study. In April, we delivered positive topline data from the study, which showed that all three dose levels of once-nightly FT218 demonstrated statistically significant (pless than0.001) and clinically meaningful improvement for all three co-primary endpoints compared to placebo," said Greg Divis, Chief Executive Officer of Avadel. "Looking ahead, we have a multi-pronged strategy to continue advancing towards achieving our objective of bringing once-nightly FT218, if approved, to patients. Our strategic priorities include finalizing the New Drug Application (NDA), compiling additional supporting scientific data to position FT218 in the market and expanding our capabilities to prepare for product launch. We look forward to keeping patients, healthcare providers, and shareholders updated on our progress. If approved, FT218 could be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy. As such, we believe once-nightly FT218 could offer a meaningful alternative for patients in the approximate $1.7 billion twice-nightly sodium oxybate market.1"
Avadel Pharmaceuticals price target raised to $18 from $14 at Piper Sandler » 06:0305/0405/04/20
Piper Sandler analyst…
Piper Sandler analyst David Amsellem raised the firm's price target on Avadel Pharmaceuticals to $18 from $14 and reiterates an Overweight rating on the shares following the company's recently completed equity offering. The analyst now sees reduced clinical and regulatory risk associated with FT218, Avadel's once-nightly form of sodium oxybate, for excessive daytime sleepiness and cataplexy in narcolepsy patients.
Avadel Pharmaceuticals files to sell 9.17M American Depositary Shares for holder 16:5205/0105/01/20
Avadel Pharmaceuticals 11.63M share Spot Secondary priced at $10.75 » 20:3504/2804/28/20
The deal priced below the…
The deal priced below the last closing price of $11.75. Jefferies is acting as lead book running manager for the offering.
Avadel Pharmaceuticals files to sell $100M of American Depositary Shares » 18:0804/2704/27/20
Avadel Pharmaceuticals announced that it is commencing an underwritten public offering of $100M in ordinary shares, in the form of American Depositary Shares. Each ADS represents the right to receive one ordinary share. Jefferies, Piper Sandler & Co. and Stifel, Nicolaus & Company, Incorporated are acting as the joint book-running managers for the offering.