JAZZ Jazz Pharmaceuticals plc

161.4
+0.46  (+0%)
Previous Close 160.94
Open 161.41
52 Week Low 101.81
52 Week High 178.64
Market Cap $9,090,925,370
Shares 56,325,436
Float 54,914,262
Enterprise Value $9,181,576,669
Volume 328,864
Av. Daily Volume 789,972
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Drug Pipeline

Drug Stage Notes
PF743 (JZP-458)
Acute lymphoblastic leukemia (ALL)
BLA Filing
BLA Filing
BLA filing announced December 21, 2020.
Vyxeos
Acute myeloid leukemia
Approved
Approved
Approval announced August 3, 2017.
JZP-150
Post-traumatic stress disorder (PTSD)
Phase 2
Phase 2
Phase 2 trial to be initiated late-2021.
JZP-385
Essential Tremor
Phase 2b
Phase 2b
Phase 2b trial to be initiated mid-2021.
JZP-258
Idiopathic Hypersomnia
sNDA Filing
sNDA Filing
sNDA filing has been completed - February 16, 2021.
Lurbinectedin
Small cell lung cancer (SCLC)
Phase 3
Phase 3
Phase 3 trial did not meet overall survival endpoint - December 3, 2020.
Defibrotide
acute Graft-versus-Host-Disease (aGvHD)
Phase 2
Phase 2
Phase 2 data showed modest trend toward benefit.
Defibrotide
VOD in high-risk patients following hematopoietic stem cell transplantation
Phase 3
Phase 3
Phase 3 trial stopped early due to lack of efficacy.
Xywav
Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
Approved
Approved
FDA Approval announced July 22, 2020.
Lurbinectedin
Small cell lung cancer (SCLC)
Approved
Approved
FDA Approval announced June 15, 2020.
Solriamfetol (JZP-110)
Excessive sleepiness associated with narcolepsy
Approved
Approved
FDA Approval announced March 20, 2019.
Defibrotide
CAR-T associated neurotoxicity in diffuse large B-cell lymphoma (DLBCL) patients
Phase 2
Phase 2
Phase 2 commencement of enrolment announced October 10, 2019.
Xyrem
Pediatric narcolepsy patients with cataplexy
Approved
Approved
FDA Approval announced October 26, 2018.
JZP-110
Excessive sleepiness associated with obstructive sleep apnea
Phase 3
Phase 3
Phase 3 data released March 20, 2017 - primary endpoints met.
JZP-6
Fibromyalgia
Approved
Approved
CRL received October 11, 2010.

Latest News

  1. PRINCETON, N.J., April 05, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced the appointment of an additional member to its Board of Directors.

    Effective immediately, George Eliades, Ph.D, current Senior Vice President, Corporate Development and Chief Transformation Officer of Jazz Pharmaceuticals (NASDAQ:JAZZ), will join Oyster Point's Board of Directors and serve as a member of the Compensation Committee.

    "We are excited to welcome George to our Board of Directors as we build the commercial infrastructure of Oyster Point Pharma…

    PRINCETON, N.J., April 05, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced the appointment of an additional member to its Board of Directors.

    Effective immediately, George Eliades, Ph.D, current Senior Vice President, Corporate Development and Chief Transformation Officer of Jazz Pharmaceuticals (NASDAQ:JAZZ), will join Oyster Point's Board of Directors and serve as a member of the Compensation Committee.

    "We are excited to welcome George to our Board of Directors as we build the commercial infrastructure of Oyster Point Pharma," said President and CEO Jeffrey Nau, Ph.D., M.M.S. "George has extensive experience developing global sales and marketing strategies for numerous therapies in biotech and pharma, and we look forward to his insights and contributions as we work to bring transformative therapies to patients with ocular surface diseases."

    "I look forward to helping Oyster Point Pharma transform from a development company to a high growth commercial organization that has the potential to address unmet needs in the ocular surface disease area for both patients and eye care professionals," said Dr. Eliades. "I look forward to being part of Oyster Point Pharma's growth as the company prepares for the potential launch of OC-01 nasal spray and working closely with Jeff and the rest of the Board."

    About George Eliades

    George Eliades has served as Senior Vice President, Corporate Development and Chief Transformation Officer of Jazz Pharmaceuticals, a global biopharmaceutical company, since December 2020. From November 2007 to December 2020, Dr. Eliades was a partner at Bain & Company, where he focused primarily on advising biopharmaceutical clients. Dr. Eliades has advised multiple clients on their transformation agendas, including strategy, cost, M&A and digital driven transformation.

    About Oyster Point Pharma

    Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Oyster Point Pharma's lead product candidate, OC-01 (varenicline) nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. In pre-clinical and clinical studies, OC-01 (varenicline) nasal spray was shown to have a novel mechanism of action via activation of the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit. OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not previously been established.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions and on information currently available to us. The forward-looking statements in this press release represent our views as of the date of this press release. These statements may include but are not limited to express or implied statements regarding potential marketing approvals for OC-01 or regarding other future events, including future development and commercialization plans. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Important factors that could cause our actual results to differ materially include our ability to obtain and maintain regulatory approvals of our product candidates; our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates, and other factors as detailed from time to time in the "Risk Factors" section in reports we file with the Securities and Exchange Commission, copies of which are posted on our website and are available from us without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties.

    Investor Contact: 

    Tim McCarthy 

    LifeSci Advisors, LLC 

    (212) 915-2564 

    Media Contact: 

    Sheryl Seapy, W2O Group

    (213) 262-9390



    Primary Logo

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  2. DUBLIN, March 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older. The approval of Vyxeos for this indication is supported by safety data from two single-arm trials: AAML1421, conducted by the Children's Oncology Group (COG) and CPX-MA-1201, conducted by Cincinnati Children's Hospital (CCH) and evidence of effectiveness from an adequate and well-controlled study in adults.

    "At Jazz Pharmaceuticals, we believe…

    DUBLIN, March 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older. The approval of Vyxeos for this indication is supported by safety data from two single-arm trials: AAML1421, conducted by the Children's Oncology Group (COG) and CPX-MA-1201, conducted by Cincinnati Children's Hospital (CCH) and evidence of effectiveness from an adequate and well-controlled study in adults.

    "At Jazz Pharmaceuticals, we believe all patients living with complex conditions deserve solutions, and work diligently to expand the science behind our therapies to ensure the greatest number of patients can benefit from our medicines," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer of Jazz Pharmaceuticals. "While pediatric patients represent a relatively small percentage of total AML patients, there is a critical need for more effective therapies in this setting. With the expansion of the Vyxeos label to include the pediatric population, Jazz demonstrates our continued commitment to broadening our cancer research and focusing on the people for whom we can have the greatest impact." 

    Safety and pharmacokinetics of Vyxeos in children and young adults were established in two clinical studies that enrolled patients with AML or relapsed/refractory hematologic malignancies. Thirty-eight pediatric patients aged one to 21 years of age with AML in first relapse were enrolled in the Phase 1/2 AAML1421 study conducted by COG, and 27 patients aged one to 19 years with relapsed/refractory hematologic malignancies were enrolled in the Phase 1 CPX-MA-1201 study conducted by CCH. Both studies found no differences in the safety profile based on age. 1 The use of Vyxeos for this indication is supported by evidence of effectiveness from study CPX351-301 in adult patients.

    Vyxeos has a Boxed Warning as it cannot be substituted with other daunorubicin and/or cytarabine-containing products. In the Phase 3 study, the most common adverse reactions (incidence ≥ 25%) were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders and vomiting.2

    "The expansion of the Vyxeos label to include children is a welcome and necessary advancement in support of some of our most vulnerable patients," said Dr. Edward Anders Kolb, M.D., director of the Center for Cancer and Blood Disorders at Nemours/Alfred I. DuPont Hospital for Children and chair of myeloid disease committee at COG. "Jazz has been a wonderful partner in pediatric drug development and we are grateful for the continued work being done to provide safe and effective therapies for children."

    About Vyxeos® (daunorubicin and cytarabine)

    Vyxeos is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. For more information about Vyxeos in the United States, please visit https://vyxeos.com.

    More information about Vyxeos, including Full Prescribing Information, BOXED Warning and Medication Guide, is available here.

    Important Safety Information

    WARNING: VYXEOS has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute VYXEOS for other daunorubicin and/or cytarabine-containing products.

    VYXEOS should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine, or any of its ingredients.

    VYXEOS can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with VYXEOS. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

    VYXEOS can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:

    • shortness of breath or trouble breathing
    • swelling or fluid retention, especially in the feet, ankles, or legs
    • unusual tiredness

    VYXEOS may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:

    • trouble breathing
    • severe itching
    • skin rash or hives
    • swelling of the face, lips, mouth, or tongue

    VYXEOS contains copper and may cause copper overload in patients with Wilson's disease or other copper-processing disorders.

    VYXEOS can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site.

    VYXEOS can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving VYXEOS. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of VYXEOS.

    The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.

    Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

    About AML

    Acute myeloid leukemia (AML) is a type of cancer in which the bone marrow makes abnormal myeloblasts (a type of white blood cell), red blood cells, or platelets.3 It can sometimes spread to other parts of the body including the lymph nodes, liver, spleen, central nervous system (brain and spinal cord), and testicles.4 AML is a relatively rare disease representing 1.1 percent of all new cancer cases.5 It is estimated that more than 19,500 people will be diagnosed with AML in the United States this year with the potential for more than 11,000 people to die from the disease.6 The median age at diagnosis is 68 years old,6 with rising age associated with a progressively worsening prognosis.7 AML in children makes up a small portion of the overall AML population (4.5% occurs in patients < 20 years old). Further, t-AML and AML-MRC in pediatric AML are very rare subtypes of this group accompanied by poor prognosis.5 There is also a reduced tolerance for intensive chemotherapy as patients age.8 AML has the lowest survival rate of any other form of leukemia.5 Patients with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes may have a particularly poor prognosis.9-11 A hematopoietic stem cell transplant may be a curative treatment option for patients.12

    About Jazz Pharmaceuticals plc

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases — often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic malignancies and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

    Jazz Pharmaceuticals "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

    This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' expectations regarding broadening our cancer research; expanding the science behind our therapies; the estimated completion date of clinical trials and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: risks related to the impact of COVID-19 pandemic on our research activities; and other risks and uncertainties affecting Jazz Pharmaceuticals, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Annual Report on Form 10-K for the year ended December 31, 2020 and future filings and reports by the company. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect the company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

    References:

    1. Cooper TM, Absalon MJ, Alonzo TA, et al. Phase I/II Study of CPX-351 Followed by Fludarabine, Cytarabine, and Granulocyte-Colony Stimulating Factor for Children With Relapsed Acute Myeloid Leukemia: A Report From the Children's Oncology Group. J Clin Oncol. 2020 Jul 1;38(19):2170-2177. doi: 10.1200/JCO.19.03306. Epub 2020 May 13. PMID: 32401633; PMCID: PMC7325367.
    2. Vyxeos (daunorubicin and cytarabine) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc
    3. National Cancer Institute. Adult acute myeloid leukemia treatment (PDQ®) –patient version. https://www.cancer.gov/types/leukemia/patient/adult-aml-treatment-pdq. Updated March 6, 2020. Accessed March 30, 2021. 
    4. American Cancer Society. What is acute myeloid leukemia(AML)?https://www.cancer.org/cancer/acute-myeloid-leukemia/about/what-is-aml.html.  Updated August 21, 2018. Accessed March 30, 2021.
    5. SEER Stat Facts: AML. 2020.
    6. American Cancer Society. Key statistics foracute myeloid leukemia(AML).https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html. Updated January 8, 2020. Accessed March 30, 2021.
    7. Baer MR,George SL, Larson RAet al. Leukemia.2011 May;25(5):10.1038/eu.2011.9.
    8. Klepin HD. Hematology Am Soc Hematol Educ Program. 2014;2014(1):8-13.
    9. Goldstone AH, Burnett AK, AviviI et al. Secondary acute myeloid leukemia has a worse outcome than de novo AML, even taking into account cytogenetics and age. AML10,11, 12 MRC Trials. Blood.2002;100(88a):(Abstr 322).
    10. Schiller GJ.Hematol Educ Program.2013:201-208.
    11. Kern W, Haferlach T, Schnittger S, Hiddemann W, Schoch C. Prognosis in therapy-related acute myeloid leukemia and impact of karyotype.J Clin Oncol.2004 Jun 15;22(12):2510-1.
    12. Peccatori, J and Ciceri, F. Haematologica. 2010 Jun; 95(6):857–859. doi:0.3324/haematol.2010.023184.

     

    Jazz Pharmaceuticals Media and Investor Relations Contact

    Media Contact:



    Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations

    Ireland +353 1 697 2141

    U.S. +1 215 867 4910





    Investor Contact:



    Andrea N. Flynn, Ph.D., Vice President, Head, Investor Relations

    Ireland +353 1 634 7887

    U.S. +1 650 496 2717

     

    Jazz Pharmaceuticals Logo (PRNewsFoto/Jazz Pharmaceuticals plc) (PRNewsFoto/Jazz Pharmaceuticals plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-fda-approval-of-additional-indication-for-vyxeos-daunorubicin-and-cytarabine-for-the-treatment-of-secondary-acute-myeloid-leukemia-in-pediatric-patients-301259059.html

    SOURCE Jazz Pharmaceuticals plc

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  3. DUBLIN, March 22, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the company will webcast its corporate presentation at the 10th Annual J.P. Morgan Napa Valley Forum.

    Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update on Monday, March 29, 2021, at 12:00 p.m. EST / 5:00 p.m. GMT

    A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

    An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company's website at www.jazzpharmaceuticals.com.

    About Jazz Pharmaceuticals
    Jazz…

    DUBLIN, March 22, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the company will webcast its corporate presentation at the 10th Annual J.P. Morgan Napa Valley Forum.

    Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update on Monday, March 29, 2021, at 12:00 p.m. EST / 5:00 p.m. GMT

    A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

    An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company's website at www.jazzpharmaceuticals.com.

    About Jazz Pharmaceuticals

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing and commercializing life-changing medicines that transform the lives of patients with serious diseases — often with limited or no options.  We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas.  Our focus is in neuroscience, including sleep and movement disorders, and in oncology, including hematologic malignancies and solid tumors.  We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies.  Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.  For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

     

    Jazz Pharmaceuticals Contacts:







    Investors: 

    Andrea N. Flynn, Ph.D.

    Vice President, Head, Investor Relations

    U.S. +1 561 306 4035

     

     

    Media:

    Jacqueline Kirby

    Vice President, Corporate Affairs & Government Relations

    Ireland +353 1 697 2141

    U.S. +1 215 867 4910

     

    Jazz Pharmaceuticals Logo (PRNewsFoto/Jazz Pharmaceuticals plc) (PRNewsFoto/Jazz Pharmaceuticals plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-participation-at-the-10th-annual-jp-morgan-napa-valley-forum-301253001.html

    SOURCE Jazz Pharmaceuticals plc

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  4. Investors selling PAO Group, Inc. (USOTC: PAOG) stock at current levels may be missing a big part of its story. But, as they say, there’s a buyer for every seller, so the opportunity is not going entirely unnoticed. In-play are at least two recently announced deals targeting a red-hot CBD sector at the right time. 

    The first deal is with Puration, Inc. (OTC:PURA) to accelerate a collaborative effort to develop various cannabis-centric applications through a partnership that started when PAOG acquired PURA’s cannabis cultivation business in 2020. Importantly, although taken longer than expected, a dividend distribution of PAOG stock is included in the transaction, and the company said they are awaiting FINRA approval to complete the transaction…

    Investors selling PAO Group, Inc. (USOTC: PAOG) stock at current levels may be missing a big part of its story. But, as they say, there’s a buyer for every seller, so the opportunity is not going entirely unnoticed. In-play are at least two recently announced deals targeting a red-hot CBD sector at the right time. 

    The first deal is with Puration, Inc. (OTC:PURA) to accelerate a collaborative effort to develop various cannabis-centric applications through a partnership that started when PAOG acquired PURA’s cannabis cultivation business in 2020. Importantly, although taken longer than expected, a dividend distribution of PAOG stock is included in the transaction, and the company said they are awaiting FINRA approval to complete the transaction. While the transaction may be more bullish to PURA shareholders, PAO Group still delivers expertise to the deal. Thus, it’s a long-term win-win.

    The two are already advancing a significant project to develop PURA’s Farmersville Brands project. With PAOG’s contribution, Puration is building a 70-acre facility designed to provide interactive, demonstrable education on hemp’s potential to provide environmentally sustainable alternatives to over $1 trillion in existing industrial products. The planned facility is an instrumental part of a cooperative strategy to capitalize on a hemp-derived product’s market expected $15 billion market size by 2027. Over the past several years, hemp has become far more understood in its commercial applications. Moreover, it’s considered the ideal and optimum replacement candidate for products and services currently damaging the environment due to their design. 

    PAOG’s stake is to assist in the construction and operation of indoor, pharmaceutical grade, hemp growing facilities and maintain a substantial role in the cannabis extraction lab’s operations. Notably, the two will be joined by North American Cannabis Holdings, Inc. (OTC:USMJ) and Alkame Holdings, Inc. (OTC:ALKM) to enhance PURA’s Farmersville Hemp Brand strategy.

    Thus, seller’s remorse could be in the cards. Moreover, updates on several projects could fuel a rally back toward highs set in February, especially with investors embracing risk back into portfolios after a sector-wide decline last month. 

    Record Revenues And A Transformative Acquisition

    Moreover, PAOG comes with an advantage over most of its nano-cap peers. They are generating revenues. Better still, the expected $300,000 in sales from its cannabis cultivation subsidiary puts PAOG in an enviable position to increase its exposure in other areas of the booming CBD-based therapeutics and nutraceutical sector. In fact, PAOG is already capitalizing on emerging opportunities in each market segment through recent partnerships and acquisitions.

    A big boost to its product portfolio came in 2020 when PAOG acquired RespRx. That asset has earned professional praise and puts PAOG in an enviable position to develop CBD-based therapeutics targeting the treatment of patients with symptoms associated with Chronic Obstructive Pulmonary Disorder (COPD). 

    The debilitating disease is a chronic one and affects more than 60 million people and has an addressable treatment market that surpassed $10 billion in 2016. It’s now the third leading cause of death worldwide, and the market is expected to reach $14.1 billion by 2025. CBD-based treatment could be an alternative therapy that is effective and safer than current pharmaceutical alternatives. That could bode well for PAOG. 

    Investors embraced the acquisition of RespRx from Kali-Extracts as a potentially transformative deal. And a year later, PAOG is making strides to monetize RespRx through arrangements that could deliver substantial returns in the next few quarters. Remember, like other therapeutics, time to develop is needed, and the process can be daunting. However, as seen in Jazz Pharmaceuticals’ (NASDAQ:JAZZ) purchase of GW Pharma (NASDAQ:GWPH) for $7.2 billion earlier this year, the rewards from patience can be substantial. And it’s important to note that while RespRx is currently targeting COPD, it also has the potential to treat multiple indications where a better and safer standard of care is needed. 

    Video Link: https://www.youtube.com/embed/mlG8HDv06uk

    HODL Can Be Rewarding

    Notably, holding GW Pharma stock through the years was no easy task either. But after years of trials and errors, its breakthrough CBD-based epilepsy drug, Epidiolex, took the market by storm. It also changed regulators and big pharma’s views, who initially shrugged off CBD-based pharmaceuticals as a passing fad. That’s no longer the case, and JAZZ may have started a consolidation phase where even the smallest companies can be included. But, to be included, a company needs assets. And PAOG does.

    In fact, RespRx has earned patent protection for its innovative cannabis extraction process. Thus, it could become a revenue-generating asset without the need to bring a single product to market. In fact, in a recent interview, the extraction process’s inventor said that his extraction method was professionally recognized as producing better quality CBD extracts than GW Pharma. That news shouldn’t stay unnoticed for long, especially with JAZZ potentially igniting a bidding war for patent-protected extraction processes. 

    Better still, PAOG owns other assets and agreements in place that invite multiple shots on goal. In fact, beyond its COPD pharmaceutical initiatives, PAOG is advancing a nutraceutical product line that they believe can effectively compete against already marketed, higher-priced brands. 

    Deals in place are advancing the mission.

    Nutraceuticals Program Gets A Boost

    Notable for its size, PAOG is engaging with the Puerto Rico Consortium for Clinical Investigation (PRCCI) to develop its proprietary Cannabidiol (CBD) extract into a nutraceutical product. The agreement adds value and, more importantly, positions PAOG to benefit from additional PRCCI expertise that can help accelerate potential nutraceutical marketing approvals. If they are successful in doing so, PAOG, despite its small size, could very well be positioned to market a CBD-based treatment to replace addictive and often harmful prescription drugs.

    And with CBD-based therapeutics becoming more mainstream, PAOG believes that through its association with PRCCI, it can earn expedited review and hopeful approval from regulatory agencies. 

    Thus, the roughly 340% gain in share price since the start of the year may be just the start of a more sustained move higher. Its deals with other companies could help to appreciate its value. 

    Therefore, the stock’s recent weakness could present an opportunity, especially to investors willing to invest with a long-term investment horizon. Remember, despite the significant advances and popularity, CBD-based medicine is a new science. However, interest by “big pharma” and the approval by the FDA for Epidiolex does send a message that CBD-based therapeutics work, they are safe, and they can be approved for marketing when effective. Many analysts in the space suggest that the FDA will soon embrace the totality of benefits offered by this natural compound. 

    And that puts PAOG in the right space at the right time. Moreover, like GWPH, they have a similar potential to succeed. Giving time, and having patience, could be very well rewarded.

     

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  5. DUBLIN, March 18, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) and the Hypersomnia Foundation today announced the launch of I Have IH, a disease awareness campaign that aims to increase understanding of the debilitating sleep disorder, idiopathic hypersomnia (IH), and empower patients to recognize their symptoms and improve conversations with their care teams.

    Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8830051-jazz-pharmaceuticals-hypersomnia-foundation-i-have-ih/

    IH is an often debilitating neurologic sleep disorder characterized by chronic excessive daytime sleepiness (the inability to stay awake and alert during the day resulting in the irrepressible need to sleep or…

    DUBLIN, March 18, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) and the Hypersomnia Foundation today announced the launch of I Have IH, a disease awareness campaign that aims to increase understanding of the debilitating sleep disorder, idiopathic hypersomnia (IH), and empower patients to recognize their symptoms and improve conversations with their care teams.

    Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8830051-jazz-pharmaceuticals-hypersomnia-foundation-i-have-ih/

    IH is an often debilitating neurologic sleep disorder characterized by chronic excessive daytime sleepiness (the inability to stay awake and alert during the day resulting in the irrepressible need to sleep or unplanned lapses into sleep or drowsiness). In addition to excessive daytime sleepiness, symptoms may include severe sleep inertia (prolonged difficulty waking with frequent reentries into sleep, confusion and irritability), a core symptom of IH, as well as prolonged, non-restorative nighttime sleep and long and unrefreshing naps.1,2,3,4

    People living with IH face challenges in managing their condition as healthcare providers underdiagnose IH and there is a current lack of U.S. Food and Drug Administration (FDA)-approved therapies. Jazz and the Hypersomnia Foundation have partnered together on this campaign to help increase awareness and knowledge of IH within the health and larger sleep community and to activate people who have or may have IH to initiate insightful conversations with their physicians.

    To better determine physicians' understanding of IH, as part of the campaign, Jazz and the Hypersomnia Foundation conducted a survey of 305 healthcare providers, measuring their perceptions and knowledge of IH.

    The results from the online survey, conducted by Toluna Analytics, underscore the need for more education and awareness of IH among healthcare providers. Only 36% of physicians reported that they believe other healthcare providers have a sufficient understanding of IH, while more than 90% said that physicians need more education about the sleep disorder.5

    Healthcare providers' low familiarity with IH may contribute to patients experiencing long delays in receiving an accurate diagnosis—up to 10 to 15 years in some cases.6,7 Notably, 87% of the surveyed physicians stated that diagnosing IH can be challenging, with more than half of healthcare providers (57%) reporting that they have personally misdiagnosed IH as another condition before providing the correct diagnosis. Also, a strong majority of providers (86%) reported that they think that patients who have IH are often misdiagnosed with depression and/or anxiety.5

    "I'm happy to see that Jazz and the Hypersomnia Foundation are committed to this community and working to help physicians and patients, as well as their supporters, better understand this debilitating neurologic sleep disorder, with the aim of strengthening dialogues between patients and their doctors," said Richard K. Bogan, MD, FCCP, FAASM, associate clinical professor at the University of South Carolina School of Medicine. "As a sleep specialist, the findings from this survey do not come as a shock. I am well aware that some specialties that often are the first to encounter IH patients don't have enough awareness of the sleep disorder or the diagnosing process to accurately diagnose them, often causing missed diagnoses."

    Given the misdiagnosis and delay in diagnosis, more education and awareness of IH is needed within the sleep community. Nearly all healthcare providers (92%) said they agree that the negative impact of IH is significantly underestimated and that it deserves greater recognition among sleep disorders.5

    "We're very pleased to be partnering with Jazz to raise awareness of idiopathic hypersomnia.  We know that patients in the IH community face many challenges—and one of those challenges is that most physicians do not have a deep understanding of this sleep disorder," said Diane Powell, board chair and chief executive officer of the Hypersomnia Foundation. "The results of this survey make it clear that the understanding of IH is very limited. Thus, it is vital for the entire sleep community to continue working to increase awareness of IH, both among physicians and the general population."

    Survey respondents were also asked about their patients' perceptions, with a strong majority of healthcare providers saying that people living with IH are frustrated with the healthcare community (87%) and their disease management (95%). They also said patients feel their condition is not understood by the general public (66%).5 

    "As a person living with IH, I can't stress enough how important it is that physicians and the greater public understand the disorder," said Meghan M. "I went nearly 5 years without a definitive diagnosis of what was causing my relentless need for sleep and extreme difficulty waking up, but when I was finally told by my doctor that I had IH, I felt a sense of relief. There needs to be more education and awareness of the disorder so other people who are living with it don't have to struggle as long as I did to receive a diagnosis."   

    Jazz and the Hypersomnia Foundation will continue to seek different perspectives within the IH community and will survey people living with this disorder and their supporters in the future as part of the I Have IH campaign.

    "At Jazz, we are committed to raising awareness of IH and are proud to be partnering with the Hypersomnia Foundation on this initiative," said Robert Iannone, executive vice president, R&D and chief medical officer, Jazz Pharmaceuticals. "The Hypersomnia Foundation gives voice to patients and their unmet needs, making them the ideal partner for the I Have IH campaign. Based on results from this survey, it's clear that work needs to be done to help ensure prompt and accurate diagnosis of this serious condition. We hope these survey results will encourage people to learn more about what IH is, and empower people experiencing symptoms to talk with a doctor."

    Jazz and the Hypersomnia Foundation are committed to bringing more awareness to IH and other serious sleep disorders and helping people with these conditions at every stage of their journey—from education and diagnosis to treatment and patient assistance.

    About the Survey

    This survey was conducted online by Toluna Analytics on behalf of Jazz Pharmaceuticals and the Hypersomnia Foundation between February 5 and February 12, 2021 among a nationally representative sample of 305 healthcare providers, including self-identified sleep specialists (n=4), neurologists (n=67), psychiatrists (n=82), pulmonologists (n=90) and primary care physicians (n=62). About half of the sample (49%) are board certified in sleep medicine; thus, there were 148 sleep doctors and 157 non-sleep doctors among the neurologists, psychiatrists, pulmonologists, and primary care physicians who responded to the survey. The survey is a part of the I Have IH campaign, a partnership between Jazz Pharmaceuticals and the Hypersomnia Foundation, which aims to raise awareness of idiopathic hypersomnia within the sleep community. As a part of the campaign, Jazz and the Hypersomnia Foundation will continue to explore perspectives within the idiopathic hypersomnia community and will survey patients and their supporters and/or caregivers.   

    About Idiopathic Hypersomnia

    Idiopathic hypersomnia is an often debilitating neurologic sleep disorder characterized by chronic excessive daytime sleepiness (the inability to stay awake and alert during the day resulting in the irrepressible need to sleep or unplanned lapses into sleep or drowsiness) that is not caused by other medical, behavioral or psychiatric conditions.1,2,3,4 Symptoms may also include a prolonged main sleep episode of more than 9 hours or a sleep duration of 11 hours or longer over a 24-hour period, prolonged, non-restorative nighttime sleep and long and unrefreshing naps, and severe sleep inertia (prolonged difficulty waking, with frequent reentries into sleep, confusion and irritability).1,2,3,4 Although there are overlapping clinical features with narcolepsy, idiopathic hypersomnia is a condition with its own specific diagnostic criteria.1,2,8 Idiopathic hypersomnia is a debilitating illness that can significantly affect social, school and occupational functioning.9,10,11,12 Insurance claims data suggest the number of people diagnosed with idiopathic hypersomnia and actively seeking healthcare is 37,000 patients in the U.S.; however, given that idiopathic hypersomnia is often misdiagnosed, in addition to the lack of an FDA-approved treatment, many people with idiopathic hypersomnia remain undiagnosed indicating that the unmet need may be significantly greater.6,7,8,12,13

    About Hypersomnia Foundation

    The Hypersomnia Foundation engages, informs and champions our global community to improve the lives of people with idiopathic hypersomnia and related sleep disorders.

    To find out more about idiopathic hypersomnia and related disorders, please visit https://www.hypersomniafoundation.org or follow us on Twitter, Instagram or Facebook.

    About Jazz Pharmaceuticals plc

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases — often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic malignancies and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

    Media Contact:

    Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations

    Ireland +353 1 697 2141 U.S. +1 215 867 4910

    Investor Contact:

    Andrea N. Flynn, Ph.D., Vice President, Head, Investor Relations

    Ireland +353 1 634 7887 U.S. +1 650 496 2717

    References:

    1. Billiard M, Sonka K. Idiopathic hypersomnia. Sleep Med Rev. 2016 Oct;29:23-33. doi: 10.1016/j.smrv.2015.08.007
    2. Trotti LM. Idiopathic Hypersomnia. Sleep Med Clin. 2017;12(3):331-344. doi:10.1016/j.jsmc.2017.03.009
    3. American Academy of Sleep Medicine. The International Classification of Sleep Disorders. Third Edition (ICSD-3). 2014.
    4. Khan Z, Trotti LM. Central Disorders of Hypersomnolence: Focus on the Narcolepsies and Idiopathic Hypersomnia. Chest. 2015;148(1):262-273. doi:10.1378/chest.14-1304
    5. Idiopathic Hypersomnia Survey. Conducted by Toluna Analytics for Jazz Pharmaceuticals and the Hypersomnia Foundation, February 2021.
    6. Anderson KN, Pilsworth S, Sharples LD, Smith IE, Shneerson JM. Idiopathic hypersomnia: a study of 77 cases. Sleep. 2007 Oct;30(10):1274-81. doi: 10.1093/sleep/30.10.1274. PMID: 17969461; PMCID: PMC2266276.
    7. Masri TJ, Gonzales CG, Kushida CA. Idiopathic Hypersomnia. Sleep Medicine Clinics. 2012 June;7(2):283-289. doi: https://doi.org/10.1016/j.jsmc.2012.03.012
    8. Jazz Pharmaceuticals, Inc, Data on file. JZP258-2020-047-29 Oct 2020.
    9. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition (DSM-5). 2020.
    10. Evangelista E, Lopez R, Dauvilliers Y. Update on treatment for idiopathic hypersomnia. Expert Opin Investig Drugs. 2018 Feb;27(2):187-192. doi: 10.1080/13543784.2018.1417385. Epub 2018 Jan 3. PMID: 29250981.
    11. Ozaki A, Inoue Y, Hayashida K, Nakajima T, Honda M, Usui A, Komada Y, Kobayashi M, Takahashi K. Quality of life in patients with narcolepsy with cataplexy, narcolepsy without cataplexy, and idiopathic hypersomnia without long sleep time: comparison between patients on psychostimulants, drug-naïve patients and the general Japanese population. Sleep Med. 2012 Feb;13(2):200-6. doi: 10.1016/j.sleep.2011.07.014. Epub 2011 Dec 3. PMID: 22137109.
    12. Hess G, Mehra R, Carls G, et al. 0625 US Prevalence of Narcolepsy and Other Sleep Disorders From 2013–2016: A Retrospective, Epidemiological Study Utilizing Nationwide Claims. Sleep. 2018 Apr;41(suppl_1):A232-A232. doi: 10.1093/sleep/zsy061.624
    13. Jazz Pharmaceuticals, Inc, Data on file.

     

    Meghan M. Patient Profile

     

    Survey Results Infographic

     

    Impact of IH

     

    Impact of IH

     

    Jazz_Pharmaceuticals_Logo

     

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    SOURCE Jazz Pharmaceuticals plc; Hypersomnia Foundation

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