Avadel Pharmaceuticals stock rocketed Monday after the biotech company said its narcolepsy treatment succeeded in a Phase 3 test. The drug is a once-nightly form of sodium oxybate.
AVDL earnings call for the period ending March 31, 2020.
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Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it is commencing an underwritten public offering of $100 million in ordinary shares, in the form of American Depositary Shares (“ADSs”). All of the ADSs are being offered by Avadel. In connection with the offering, Avadel intends to grant the underwriters a 30-day option to purchase up to an additional $15 million in ADSs at the public offering price less the underwriting discounts and commissions.
In the current session, Avadel Pharmaceuticals Inc. (NASDAQ: AVDL) is trading at $12.95, after a 31.74% increase. Over the past month, the stock increased by 63.60%, and in the past year, by 939.20%. With performance like this, long-term shareholders optimistic but others are more likely to look into the price-to-earnings ratio to see if the stock might be overvalued.Assuming that all other factors are held constant, this could present itself as an opportunity for shareholders trying to capitalize on the higher share price. The stock is currently above from its 52 week high by 20.47%.The P/E ratio measures the current share price to the company's earnings per share. It is used by long-term investors to analyze the company's current performance against its past earnings, historical data and aggregate market data for the industry or the indices, such as S&P 500. A higher P/E indicates that investors expect the company to perform better in the future, and the stock is probably overvalued, but not necessarily. It also shows that investors are willing to pay a higher share price currently, because they expect the company to perform better in the upcoming quarters. This leads investors to also remain optimistic about rising dividends in the future.Depending on the particular phase of a business cycle, some industries will perform better than others.Compared to the aggregate P/E ratio of the 7.57 in the specialty & generic drug manufacturers industry, Avadel Pharmaceuticals has a lower P/E ratio of 0.0. Shareholders might be inclined to think that they might perform worse than its industry peers. It's also possible that the stock is undervalued.P/E ratio is not always a great indicator of the company's performance. Depending on the earnings makeup of a company, investors may be unable to attain key insights from trailing earnings.See more from Benzinga * Morning Market Stats in 5 Minutes * Stocks That Hit 52-Week Highs On Monday(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Shareholders in Avadel Pharmaceuticals plc (NASDAQ:AVDL) had a terrible week, as shares crashed 39% to US$6.01 in the...
Will a small change in a drug's method of delivery be enough to generate over $1 billion in new sales?
On Avadel's (AVDL) Q1 earnings call, investor focus will be on the company's lead candidate, FT218, currently being evaluated to treat excessive daytime sleepiness and cataplexy in narcolepsy patients.
Reported positive topline data from the pivotal Phase 3 REST-ON studyStrengthened balance sheet with $190 million in gross proceeds from a private placement in February 2020 and.
SBBP shares continue to be significantly discounted relative to the opportunity for Recorlev as a treatment for Cushing's Syndrome.Peak revenue estimates for Recorlev range between $300-500 million, if Phase 3 is successful.Commercial product, Keveyis, is gro…
Investors need to pay close attention to Avadel Pharmaceuticals (AVDL) stock based on the movements in the options market lately.
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, May 11, 2020, to provide a corporate update and discuss the Company's financial results for the first quarter ended March 31, 2020. A live audio webcast can be accessed by visiting the investor relations section of the Company’s website, www.avadel.com. Avadel Pharmaceuticals plc (AVDL) is an emerging biopharmaceutical company.
Avadel Pharmaceuticals (AVDL) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.
The primary analysis of investigational, once-nightly FT218 at 9 g demonstrated highly statistically significant (p<0.001), and clinically meaningful improvement across all.
JAZZ earnings call for the period ending March 31, 2020.
Avadel's (AVDL) first quarter 2020 earnings and revenues surpass expectations.
Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week Highs April 27) * AstraZeneca plc (NYSE: AZN) * Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) * Arcturus Therapeutics Ltd (NASDAQ: ARCT) * Avadel Pharmaceuticals PLC (NASDAQ: AVDL) * BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) * Bio-Rad Laboratories, Inc. (NYSE: BIO) * BioSig Technologies Inc (NASDAQ: BSGM) * Black Diamond Therapeutics Inc (NASDAQ: BDTX) * Cytosorbents Corp (NASDAQ: CTSO) * DexCom, Inc. (NASDAQ: DXCM) * Erytech Pharma SA (NASDAQ: ERYP) * Exelixis, Inc. (NASDAQ: EXEL) * Halozyme Therapeutics, Inc. (NASDAQ: HALO) * I-Mab ADR (NASDAQ: IMAB) * Imara Inc (NASDAQ: IMRA) * Incyte Corporation (NASDAQ: INCY) * Kala Pharmaceuticals Inc (NASDAQ: KALA) * Keros Therapeutics Inc (NASDAQ: KROS) * Masimo Corporation (NASDAQ: MASI) * Novo Nordisk A/S (NYSE: NVO) * OraSure Technologies, Inc. (NASDAQ: OSUR) * Quidel Corporation (NASDAQ: QDEL) * REDHILL BIOPHAR/S ADR (NASDAQ: RDHL) * Repligen Corporation (NASDAQ: RGEN) * Seattle Genetics, Inc. (NASDAQ: SGEN) * Translate Bio Inc (NASDAQ: TBIO) * Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) * Vaxart Inc (NASDAQ: VXRT) * Vermillion, Inc. (NASDAQ: VRML) * West Pharmaceutical Services Inc. (NYSE: WST) * Y-mAbs Therapeutics, Inc (NASDAQ: YMAB) * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL) * Zynex Inc. (NASDAQ: ZYXI)None of the Nasdaq- or NYSE-listed biotech/medical device/diagnostics company hit 52-week lows Monday.Stocks In Focus Syndax Presents Positive Pre-clinical & Clinical Data For Blood Cancer Drug Syndax Pharmaceuticals Inc (NASDAQ: SNDX) presented positive preclinical and initial clinical data for SNDX-5613, its potent, highly selective oral menin inhibitor, with the data suggesting the investigational asset can induce response in patients with genetically-defined acute leukemias."Notably, clinical activity was achieved rapidly after a single, 28-day cycle, a highly encouraging sign in this population of patients who face a particularly poor prognosis with few effective treatment options," said Briggs Morrison, CEO of Syndax.The company said it will present additional findings from this trial in the fourth quarter.It also said SNDX-5613 was recently granted Orphan Drug Designation for the treatment of adult and pediatric acute myeloid leukemia.In after-hours trading, Syndax shares added 20.33% to $13.85.Moderna Files IND Application For Phase 2 Study of Coronavirus Vaccine Moderna Inc (NASDAQ: MRNA) said it has submitted an IND application to the FDA for its mRNA vaccine candidate mRNA-1273 against the novel coronavirus - SARS-CoV-2 - for evaluating it in a Phase and late-stage studies if supported by the Phase 1 study conducted by the National Institute of Allergy and Infectious Diseases.The company expects the study to begin in the second quarter.The stock gained 7.18% to $51.50 in after-hours trading.Related Link: A Deep Dive On Coronavirus Vaccine Plays Moderna, InovioRoche Reports Positive Results For Pivotal Study of its Spinal Muscular Dystrophy Treatment Roche Holdings AG's Basel (OTC: RHHBY) presented data from FIREFISH Part 2 - a pivotal global study that is evaluating its risdiplam in infants, ages 1-7 months, with symptomatic Type 1 spinal muscular atrophy, which showed the primary endpoint was met. The company noted that 29% of infants could sit without support for five seconds by month 12, as assessed by the Gross Motor Scale of Bayley Scales of Infant and Toddler Development Third Edition.View more earnings on PFEAdditionally, the company noted that 43.9% of infants were able to hold their head upright, 31.7% were able to roll to the side and 4.9% infants were able to stand with support.Risdiplam is an orally administered survival motor neuron-2 splicing modifier for SMA.Roche is leading the development of risdiplam and is working with the SMA Foundation and PTC Therapeutics, Inc. (NASDAQ: PTCT) on this.The regulatory application for the investigational asset was accepted with priority designation by the FDA, with an expected PDUFA date of Aug. 24.Separately, Roche also released new analyses of Phase 3 OPERA I and OPERA II studies as well as open-label extensions, of its Ocrevus, which showed the treatment reduced the risk of disease and disability progression in relapsing multiple sclerosis and primary progressive multiple sclerosis.Avadel to Offer $100M Worth of ADSs Avadel Pharmaceuticals PLC (NASDAQ: AVDL) said it commenced an underwritten public offering of $100 million shares, in the form of ADSs. All the ADSs are being offered by Avadel.The stock slipped 0.90% to $11.05 in after-hours trading.Earnings Novartis AG's (NYSE: NVS) first-quarter net sales from continuing operations rose 11% to $12.28 billion, EPS climbed 19% to 96 cents and core EPS increased 29% to $1.56, ahead of the $1.36 per share consensus estimate. The company expects 2020 sales to grow mid- to high-single digits and core operating income to increase in high-single to low-double digits.The stock added 0.90% to $90.40 in after-hours trading.On The Radar Clinical Readouts Iovance Biotherapeutics Inc (NASDAQ: IOVA) is scheduled to present at the American Association for Cancer Research, or AACR, 2020 Virtual Annual Meeting Phase 1 data for tumor-infiltrating lymphocytes in non-small cell lung cancer.Earnings Merck & Co., Inc. (NYSE: MRK) (Q1 Revenues of $12.1 billion, up 11%, and non-GAAP EPS $1.50 Vs. consensus of $11.46 billion and $1.34; lowered full-year guidance)Pfizer Inc. (NYSE: PFE) (Q1 Revenues of $12 billion, down 7%, and adjusted EPS of 80 cents Vs. consensus of $11.87 billion and 73 cents; reaffirmed 2020 guidance)See more from Benzinga * The Week Ahead In Biotech (April 26-May 2): Cancer Conference, Earnings News Flow In The Spotlight * BioNTech, Immunic Soar On COVID-19 Developmental Updates(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
The smid-cap biotech earnings deluge hit Wall Street in the week ended May 9, positively impacting the stocks in the sector. The iShares NASDAQ Biotechnology Index (NASDAQ: IBB) gained about 6% for the week.Large-cap pharma names AstraZeneca plc (NYSE: AZN) a…
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today the pricing of an underwritten public offering of 11,630,000 ordinary shares, in the form of American Depositary Shares (“ADSs”) at a price to the public of $10.75 per ADS. All of the ADSs are being offered by Avadel. In connection with the public offering, Avadel has granted the underwriters a 30-day option to purchase up to an additional 1,744,500 ADSs at the public offering price less the underwriting discounts and commissions.
Competition is about to ramp up significantly in the $1.7 billion market for treating chronic sleep disorder.
As of late, it has definitely been a great time to be an investor in Avadel Pharmaceuticals.
It is now my pleasure to introduce your host Tom McHugh, Chief Financial Officer. As a reminder before we begin the following presentation includes several matters that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements.
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it has completed the REST-ON Phase 3 clinical trial for FT218. The REST-ON study enrolled a total of 212 patients, and the last patient last visit occurred earlier this week. The Company currently expects to announce topline data from the study in the second quarter of 2020.