AVDL - Avadel Pharmaceuticals plc
| Previous Close | 7.14 |
| Open | 7.08 |
| Bid | 6.90 x 2200 |
| Ask | 7.03 x 800 |
| Day's Range | 6.91 - 7.29 |
| 52 Week Range | 1.03 - 8.49 |
| Volume | 261,880 |
| Avg. Volume | 690,080 |
| Market Cap | 261.167M |
| Beta (5Y Monthly) | 1.74 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -2.53 |
| Earnings Date | Mar 11, 2020 - Mar 15, 2020 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 14.50 |
- Zacks
Jazz (JAZZ) Submits NDA for Xyrem Follow-On Candidate JZP-258 (Revised)
Jazz (JAZZ) files regulatory application seeking approval for JZP-258, a low sodium formulation of Xyrem, in the United States.
- Zacks
Jazz's (JAZZ) New Sleep Drug Sunosi Gets Approval in Europe
Jazz (JAZZ) receives approval for Sunosi as a treatment for excessive daytime sleepiness in narcolepsy or obstructive sleep apnea patients in Europe.
- Simply Wall St.
Have Insiders Been Buying Avadel Pharmaceuticals plc (NASDAQ:AVDL) Shares?
It is not uncommon to see companies perform well in the years after insiders buy shares. Unfortunately, there are also...
- PR Newswire
LongueVue Capital Adds Experienced Healthcare Operating Partners to Support New & Existing Investments
LongueVue Capital Partners ("LVC"), a partnership-driven, operator-centric private equity firm based in New Orleans with approximately $500 million of assets under management, announced today that Geoff Glass and Pete Allen have joined the firm as healthcare Operating Partners. Geoff, a seasoned pharma services executive, will focus on the life science space. Pete, a healthcare executive with broad reaching experience, will focus on medical devices and related contract services as well as healthcare supply chain services. The additions of both Pete and Geoff reiterate LVC's commitment to the healthcare industry, which is one of the firm's largest investment verticals.
- Zacks
Avadel (AVDL) Is Up 21.13% in One Week: What You Should Know
Does Avadel (AVDL) have what it takes to be a top stock pick for momentum investors? Let's find out.
- Zacks
5 Top-Ranked ADRs That More Than Doubled the S&P 500 in 2019
Though international markets trailed the U.S. market in 2019, there are hidden gems that crushed the S&P 500 this year on stock-specific strength.
- Insider Monkey
Is Avadel Pharmaceuticals plc (AVDL) A Good Stock To Buy?
Is Avadel Pharmaceuticals plc (NASDAQ:AVDL) a good bet right now? We like to analyze hedge fund sentiment before conducting days of in-depth research. We do so because hedge funds and other elite investors have numerous Ivy League graduates, expert network advisers, and supply chain tipsters working or consulting for them. There is not a shortage […]
- Zacks
Avadel (AVDL) is a Great Momentum Stock: Should You Buy?
Does Avadel (AVDL) have what it takes to be a top stock pick for momentum investors? Let's find out.
- GlobeNewswire
Avadel Pharmaceuticals Completes Enrollment in the REST-ON Phase 3 Pivotal Trial of FT218 for Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy
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 has completed patient enrollment in the REST-ON Phase 3 clinical trial for FT218. The REST-ON study has enrolled a total of 212 patients, which includes additional patients who were in the screening process when the study achieved its enrollment target of 205 patients.
- GlobeNewswire
Avadel Pharmaceuticals Receives U.S. FDA Approval for Nouress™ (AV001), a Cysteine Hydrochloride Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today that the U.S. Food and Drug Administration (FDA) has approved NouressTM (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal patients requiring total parenteral nutrition (TPN). In addition, Avadel announced today that the United States Patent and Trademark Office (USPTO) recently issued United States Patent No. 10,493,051 covering cysteine solutions, including the approved Nouress product. Avadel has additional U.S. patent applications pending for Nouress.
- Benzinga
The Week Ahead In Biotech: Avadel, Epizyme In Focus In A Quiet Week
Biotech stocks were seen consolidating last week after advancing in the previous week. The iShares NASDAQ Biotechnology Index (NASDAQ: IBB ) reached a 52-week high of 121.16 Monday, although it has come ...
- GlobeNewswire
Avadel Pharmaceuticals Appoints Dr. Mark McCamish to its Board of Directors
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today the appointment of Mark McCamish, MD, Ph.D. to its board of directors, effective immediately.
- Zacks
Top Ranked Momentum Stocks to Buy for December 9th
Top Ranked Momentum Stocks to Buy for December 9th
- TipRanks
All Eyes on These 3 Biotech Stocks Ahead of FDA Decisions
Searching for the stocks that can treat you to huge rewards overnight? Look no further than the biotech industry. Regardless of trade wars, economic data and market sentiment, a single positive catalyst like favorable data or an important regulatory decision can drive share prices through the roof. Just remember that these stocks carry substantial risk, too, as the opposite holds true.Having said that, the Street’s seasoned pros remind investors that positive data doesn’t necessarily mean that a drug will receive approval from the FDA. So, when biotechs near these important FDA verdicts, it’s a signal to investors to pay close attention as drug approvals can lead to vital revenues for companies.With this in mind, we used TipRanks’ set of investing tools to take a closer look at 3 biotech stocks ahead of their upcoming FDA approval decisions. Here’s what we uncovered.Intra-Cellular Therapies (ITCI)Schizophrenia is a mental illness that causes abnormal behavior, strange speech as well as a decreased ability to understand reality, with the treatment market for the disease estimated to be worth about $14.9 billion. Intra-Cellular Therapies wants to capitalize on this opportunity, and given the limited competition, several analysts argue the biotech is well-positioned to do so.Currently, the company is preparing for the December 27 PDUFA date for its lumateperone drug in schizophrenia. Some red flags were raised when the review, originally slated for September 27, was delayed and the July AdCom meeting was canceled. However, the company stated that the delay came as a result of its submission of additional non-clinical data, which demonstrated that issues with toxicology seen in animals weren’t present when the drug was used to treat humans.On top of this, the drug is currently being evaluated as a treatment for bipolar depression and major depressive disorder (MDD). In a Phase 3 study of its efficacy in bipolar depression patients, the drug produced a statistically significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.Even with the delay, Ladenburg analyst Matthew Kaplan is optimistic about the drug’s approval.“Despite this delay in the approval timeline, we continue to believe that lumateperone has demonstrated a clinically meaningful improvement and improved safety and metabolic profile over risperidone in the treatment for schizophrenia, which should ultimately support FDA approval of lumateperone,” Kaplan explained.With this in mind, the four-star analyst kept his Buy rating and $33 price target. This brings the potential twelve-month gain to a whopping 224%. (To watch Kaplan’s track record, click here)Similarly, the rest of the Street is optimistic about ITCI. Based on 100% Street support over the last three months, the consensus is a unanimous Strong Buy. Additionally, the $24 average price target puts the upside potential at 135%. (See Intra-Cellular stock analysis on TipRanks)Amarin (AMRN)For investors familiar with biotechs, it’s clear that Amarin was one of the most talked about names in the space this year. The company has only one product on the market, but that one is a true humdinger. The medication, Vascepa, is an omega-3 based treatment for hypertriglyceridemia, with a proven record of reducing triglycerides in adult patients. Vascepa has been commercially available since 2013, and is predicted to reach $2.2 billion in annual sales by 2024.Amarin shares were catapulted higher recently as an FDA panel unanimously voted in favor of Vascepa approval for a cardiovascular (CV) risk reduction indication, which reflected a major step forward. That being said, specifics regarding its use in primary prevention of MACE weren’t set in stone.As the expanded label would create a huge opportunity for the biotech, Leerink Partners’ Ami Fadia sees the December 28 PDUFA date as a major catalyst, adding that the AdCom outcome has made her “incrementally more positive.” Part of the optimism is due to her belief that the panel was open minded about expanding the labeling to include use in primary prevention.“By our count, 11 members were open to a primary prevention label of which a majority noted that they would prefer to keep the primary prevention strictly defined per the REDUCE-IT Cohort 2 studied population while a minority preferred a broad primary prevention definition. In contrast, 5 members were against including primary prevention in the label,” the four-star analyst wrote in a note to clients.Fadia also points out that the AdCom members think that risks related to the treatment’s use could be mitigated with labeling and that the impact of mineral oil didn’t appear to dissuade a positive vote. As a result, she left the Outperform rating unchanged while bumping up the price target from $26 to $29. This new target conveys her confidence in AMRN’s ability to surge 29% in the coming twelve months. (To watch Fadia’s track record, click here)What does the rest of the Street think? Looking at the consensus breakdown, opinions from other analysts are more spread out. 6 Buys, 2 Holds and 1 Sell add up to a Moderate Buy consensus. In addition, the $28 average price target indicates 25% upside potential. (See Amarin stock analysis on TipRanks)Avadel Pharmaceuticals (AVDL)Avadel Pharmaceuticals is best known for developing sleep medicines as well as sterile injectable products. Ahead of its December 15 PDUFA date for its fourth hospital product, AV001, one analyst thinks that AVDL could be bound for greatness.The PDUFA date was originally slated for September 15, with the product being granted priority review by the FDA. However, this was pushed back after the FDA requested additional analytical data.Ladenburg's Matthew Kaplan believes that the delay doesn’t change the fact that AV001 stands to fuel massive growth for AVDL.“Avadel believes that AV001 corrects the safety issues of the current products in the market (one unapproved and one recently approved in May) and will address a market potential of about $30 million. We look forward to the FDA decision from the PDUFA, and we believe after approval, AV001 will start generating revenues in 2020 in addition to the existing hospital franchise (Akovaz, Bloxiverz, and Vazculep),” Kaplan commented.Its FT218 drug also looks promising. The therapy is progressing through Phase 3 development for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy, with the FDA agreeing to a lower sample size needed to show statistical significance.To this end, the four-star analyst reiterated the bullish call and $8 price target, implying 27% upside potential from current levels. (To watch Kaplan’s track record, click here)It has been relatively quiet when it comes to other analyst activity. In the last three months, only 2 analysts have issued ratings. However, as they were both Buys, the word on the Street is that AVDL is a Moderate Buy. Based on the $7 average price target, shares could climb 11% higher in the next twelve months. (See Avadel stock analysis on TipRanks)
- GuruFocus.com
Brandes Investments' Top 5 Buys in the 3rd Quarter
Firm makes real-time sell in Avadel Continue reading...
- GlobeNewswire
Avadel Pharmaceuticals Announces Key Appointments to Leadership Team To Support Continued Transformation and the Advancement of FT218
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today the appointment of Thomas S. McHugh as its new Chief Financial Officer, replacing Michael Kanan, effective immediately. In addition, the Company has appointed Dr. Jason M. Vaughn to the newly formed role of Senior Vice President of Technical Operations, where his responsibilities will include overseeing the analytical, process development, technical transfer and commercial scale up of the company’s lead clinical program, FT218.
- Benzinga
Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates
Biotech stocks had a fairly robust November, with the iShares NASDAQ Biotechnology Index (NASDAQ: IBB ) advancing over 10% for the month. This compares to the 3% gains for the S&P 500 Index. The month ...
- Zacks
Will Avadel Pharmaceuticals Continue to Surge Higher?
As of late, it has definitely been a great time to be an investor in Avadel Pharmaceuticals.
- Benzinga
The Daily Biotech Pulse: ChemoCentryx Triples On Data Readout, Global Blood Given FDA Nod, Positive Safety Review For Genfit's NASH Drug
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks that hit 52-week highs on Nov. 25.) ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD ) Alnylam ...
- GlobeNewswire
Avadel Pharmaceuticals Achieves Enrollment Target in REST-ON Phase 3 Pivotal Trial of FT218 for Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy
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 achieved its patient enrollment target of 205 patients in the REST-ON Phase 3 clinical trial for its once-nightly sodium oxybate, FT218. Currently, this market is valued at an estimated annualized rate of $1.7 billion1.
- GlobeNewswire
Avadel Pharmaceuticals to Present at Two Upcoming Investor Conferences
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today that its Chief Executive Officer, Greg Divis, will present at two upcoming investor conferences. A live audio webcast of the fireside chat can be accessed at the Investor section of the Company’s website, www.avadel.com. A live audio webcast of the presentation can be accessed at the Investor section of the Company’s website, www.avadel.com.
- Zacks
Jazz's (JAZZ) Sleep Drug Sunosi Nears Approval in Europe
Jazz's (JAZZ) sleep drug, Sunosi, which is under review in Europe, receives recommendation for approval from the CHMP.
- Simply Wall St.
The Avadel Pharmaceuticals (NASDAQ:AVDL) Share Price Is Up 41% And Shareholders Are Holding On
Avadel Pharmaceuticals plc (NASDAQ:AVDL) shareholders might be concerned after seeing the share price drop 12% in the...
- GlobeNewswire
Avadel Pharmaceuticals Reports Third Quarter 2019 Financial Results and Raises Revenue Guidance for FY2019
Enrollment currently at 200 patients for the pivotal REST-ON Phase 3 study (97.5% complete); the Company currently expects to complete patient enrollment by end of 2019, with.
- GlobeNewswire
Avadel Pharmaceuticals to Report Third Quarter 2019 Financial Results on November 12th
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, today announced that it will host a conference call and live webcast at 8:30 a.m. EST on Tuesday, November 12, 2019, to provide a corporate update and discuss the Company's financial results for the third quarter ended September 30, 2019. 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.
