Source: Streetwise Reports   04/27/2020

Avadel Pharmaceuticals Plc (AVDL:NASDAQ) today announced "positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy." The firm pointed out that it met all three of the co-primary efficacy endpoints in the study for each of three dosage levels which it claims demonstrates "highly significant, clinically meaningful improvements on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks."

The company's Chief Medical Officer Jordan Dubow, M.D., commented, "We are excited to see these positive topline data from the REST-ON study, where all three dose levels of once-nightly FT218 demonstrated a statistically significant and clinically meaningful improvement on the measures of the two prominent symptoms of narcolepsy, as well as an improvement in overall functioning compared to placebo...Once-nightly FT218 delivered a clinically meaningful response within three weeks of treatment initiation, which was sustained through each treatment period...We think once-nightly FT218, if approved, has the potential to be a meaningful contributor to patient care."

Avadel Pharma's CEO Greg Divis remarked, "The successful outcome of the REST-ON study strengthens our belief that, if approved, once-nightly FT218 has the potential to be a significant advancement for patients in the estimated $1.7 billion twice-nightly sodium oxybate market. Our proprietary market research with physicians and patients informs us that there is a strong interest in a once-nightly sodium oxybate formulation. We look forward to sharing the results from the REST-ON study with the FDA and progressing toward a potential approval that would allow us to bring this important treatment to the patients who need it most. If approved, FT218 would be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy."

The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of once-nightly FT218, a formulation of sodium oxybate using Avadel's proprietary Micropump technology for extended-release oral suspension in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The company stated that 212 patients were enrolled in the study and result "showed that the 9 g dose of once-nightly FT218 demonstrated a highly significant and clinically meaningful improvement compared to placebo across all three co-primary endpoints."

The company advised that FT218 has been granted Orphan Drug Designation from the U.S. FDA for the treatment of narcolepsy. The firm added that the designation was granted on basis that FT218 may be clinically superior to a formulation of sodium oxybate that is already approved by the FDA for the same indication.

Avadel Pharmaceuticals is biopharmaceutical company headquartered in Dublin, Ireland. The company's primary focus is on the development and potential FDA approval for FT218, which just completed its Phase 3 REST-ON clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. The firm also develops and markets sterile injectable drugs for use in hospital settings.

Avadel started off the day with a market capitalization of around $456.2 million with approximately 46.4 million shares outstanding and a short interest of about 14.00%. AVDL shares opened more than 34% higher today at $13.30 (+$3.37, +34.28%) over Friday's $9.83 closing price and reached a new 52-week high price this morning of $13.49. The stock has traded today between $11.90 and $13.49 per share and is currently trading at $12.27 (+$2.44 +24.82%).

Disclosure:
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4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
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( Companies Mentioned: AVDL:NASDAQ, )

Source: Streetwise Reports   05/06/2020

In a May 4 research note, H.C. Wainwright & Co. analyst Ed Arce reported that Arcturus Therapeutics Holdings Inc. (ARCT:NASDAQ) formed a partnership with Catalent Inc. (CTLT:NYSE), which "raises the profile of LUNAR-COV19 as a leading vaccine candidate."

Arce reviewed Catalent's contribution to the partnership. The global contract development and manufacturing organization is to manufacture Arcturus' messenger RNA (mRNA) LUNAR-COV19 for protection against SARS-CoV-2 to be used first for human clinical trials and potentially, eventually commercially.

As for timing, Arce noted, San Diego, Calif.-based Arcturus intends to transfer its vaccine technology to Catalent this month and expects Catalent to manufacture the first batches of LUNAR-COV19 by June 2020. "Critically, Arcturus continues to anticipate initiation of Phase 1 testing of LUNAR-COV19 in the summer of 2020," Arce highlighted.

Catalent is to produce the vaccine at its biomanufacturing facility in Madison, Wisc. "This facility utilizes Catalent's flex-suite, a current good manufacturing practice manufacturing suite, that can produce batches at multiple scales and support Arcturus' proprietary mRNA manufacturing process," explained Arce.

Obtaining the vaccine from one facility domestically versus multiple entities worldwide should result in several benefits, Arce continued. They include easy development and production, accelerated delivery and improved costs. Arcturus believes Catalent can produce millions of doses of LUNAR-COV19 mRNA in 2020 and, if need be, hundreds of millions of doses each year subsequently for use globally.

Arce pointed out that LUNAR-COV19 differentiates itself from other similar vaccine candidates in that the technology and delivery platform behind it deliver an "extraordinarily low dose (perhaps 2 micrograms)" in "a potential single shot."

H.C. Wainwright has a Buy rating and a $62 per share price target on Arcturus, the stock of which is currently trading at about $42.12 per share.

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures from H.C. Wainwright & Co., Arcturus Therapeutics Holdings Inc., First Take, May 4, 2020

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Ed Arce, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst's household has a financial interest in the securities of Arcturus Therapeutics Holdings Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of April 30, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Arcturus Therapeutics Holdings Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Arcturus Therapeutics Holdings Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did receive compensation from Arcturus Therapeutics Holdings Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Arcturus Therapeutics Holdings Inc. during the past 12 months.

The Firm does not make a market in Arcturus Therapeutics Holdings Inc. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

( Companies Mentioned: ARCT:NASDAQ, )

American Express has

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