Section 13

Supernus Announces FDA Approval of Qelbree® for the Treatment of ADHD in Adults

Retrieved on: 
Monday, May 2, 2022
Clinical Global Impression, U.S. Securities and Exchange Commission, Section 13, Epilepsy, Private Securities Litigation Reform Act, Associate, Nasdaq, Torticollis, CNS, Company, Securities Exchange Act of 1934, Food, Safety, Depression, Dyskinesia, ADHD, Central nervous system disease, Patient, Security (finance), Parkinson's disease, Government, Risk, Adult, FDA, Prescription, Regulation of tobacco by the U.S. Food and Drug Administration, MAOI, Ageing, Attention deficit hyperactivity disorder, CEO, News, Research, Migraine, Growth, Central nervous system, Phase, Pharmaceutical industry, PD, Viloxazine

The FDA has now approved Qelbree for the treatment of ADHD in children (starting at age 6), adolescents and adults.

Key Points: 
  • The FDA has now approved Qelbree for the treatment of ADHD in children (starting at age 6), adolescents and adults.
  • While manychildren with ADHDoutgrow it, up to 90% of those diagnosed with ADHD in childhood continue to have ADHD as adults.
  • The approval is based on positive results from a randomized, double blind, placebo-controlled Phase III study of Qelbree in adults with ADHD and represents the first approval of a novel nonstimulant treatment for adults in 20 years.
  • "Today's approval marks a major advancement in the treatment of ADHD and is an important milestone just one year after the approval of Qelbree to treat pediatric patients.

Supernus Announces FDA Approval of Qelbree® for the Treatment of ADHD in Adults

Retrieved on: 
Saturday, April 30, 2022
Adult, U.S. Securities and Exchange Commission, CEO, MAOI, Securities Exchange Act of 1934, Patient, Nasdaq, FDA, GLOBE, Central nervous system, ADHD, Private Securities Litigation Reform Act, Migraine, Central nervous system disease, Food, Growth, Risk, Associate, Company, Section 13, M.D, Security (finance), Ageing, Epilepsy, Depression, News, Clinical Global Impression, Dyskinesia, Phase, Attention deficit hyperactivity disorder, Torticollis, Government, Regulation of tobacco by the U.S. Food and Drug Administration, Prescription, CNS, Safety, Pharmaceutical industry, PD, Viloxazine

The FDA has now approved Qelbree for the treatment of ADHD in children (starting at age 6), adolescents and adults.

Key Points: 
  • The FDA has now approved Qelbree for the treatment of ADHD in children (starting at age 6), adolescents and adults.
  • While manychildren with ADHDoutgrow it, up to 90% of those diagnosed with ADHD in childhood continue to have ADHD as adults.
  • The approval is based on positive results from a randomized, double blind, placebo-controlled Phase III study of Qelbree in adults with ADHD and represents the first approval of a novel nonstimulant treatment for adults in 20 years.
  • Todays approval marks a major advancement in the treatment of ADHD and is an important milestone just one year after the approval of Qelbree to treat pediatric patients.

Supernus Reports Final Audited Fourth Quarter and Full Year 2021 Financial Results

Retrieved on: 
Wednesday, April 13, 2022
Prescription, GAAP, U.S. Securities and Exchange Commission, Adult, Security (finance), Risk, Migraine, Torticollis, Dyskinesia, Private Securities Litigation Reform Act, CNS, Central nervous system, Depreciation, ADHD, Patient, Securities Exchange Act of 1934, Growth, Review, Company, Depression, Safety, Income, Section 13, Central nervous system disease, Epilepsy, Government, Pharmaceutical industry, Viloxazine, Adamantas, PD

The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP.

Key Points: 
  • The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP.
  • We mitigate these limitations by reconciling the non-GAAP financial measures to the most comparable GAAP financial measures.
  • The Companys 2022 financial guidance is also being provided on both a reported and a non-GAAP basis.
  • Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Progressive Care Gains SEC Reporting Status

Retrieved on: 
Tuesday, April 12, 2022
Form 10-K, Medication therapy management, Compliance, GLOBE, Sale, Securities Exchange Act of 1934, MTM, Mark (given name), Social media, Company, OTCQB, SEC, Section, Section 13, Sumathi Best Television Current Reporting Award, U.S. Securities and Exchange Commission, Security (finance), Pharmaceutical industry

Miami, FL, April 12, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Progressive Care, Inc. (OTCQB: RXMD) (the “Company”), a personalized healthcare services and technology provider, today announced that, effective April 11, 2022, its Registration Statement on Form 10 filed with the U.S. Securities and Exchange (the “SEC”) to register its shares of common stock under Section 12(g) of the Securities Exchange Act of 1934 (the “Exchange Act”) became automatically effective.The effective Form 10 obligates the Company to file Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, in addition to complying with all other obligations under the Exchange Act. In addition, management and certain shareholders are subject to the beneficial ownership reporting requirements of Section 13 and 16 of the Exchange Act.Alan Jay Weisberg, Chairman and Chief Executive Officer of the Company, said, “For me, it was always important to have the Company become fully reporting with the SEC. I know how critical it is for individual and institutional investors to have the Company file its financial reports with the SEC as it provides a higher level of confidence in the information reported by the Company and a superior level of transparency. I believe that the Company’s compliance with the Exchange Act will ultimately help drive shareholder value and enable us to access higher quality institutional capital. We remain committed to strong corporate governance and steadfast in pursuit of our journey to Nasdaq.”To view the Form 10 filling, please click:https://www.sec.gov/Archives/edgar/data/0001402945/000149315222009357/fo... Care, Inc.Progressive Care, Inc. (OTCQB: RXMD), through its subsidiaries, is a Florida health services organization and provider of prescription pharmaceuticals, compounded medications, provider of tele-pharmacy services, the sale of anti-retroviral medications, medication therapy management (MTM), the supply of prescription medications to long-term care facilities, and health practice risk management.

Key Points: 
  • In addition, management and certain shareholders are subject to the beneficial ownership reporting requirements of Section 13 and 16 of the Exchange Act.
  • Alan Jay Weisberg, Chairman and Chief Executive Officer of the Company, said, For me, it was always important to have the Company become fully reporting with the SEC.
  • I believe that the Companys compliance with the Exchange Act will ultimately help drive shareholder value and enable us to access higher quality institutional capital.
  • For more information about Progressive Care, please visit the companys website.

Supernus Provides Update on Filing of Annual Report and Reiterates Full Year 2022 Financial Guidance

Retrieved on: 
Monday, April 4, 2022
Private Securities Litigation Reform Act, Company, Dyskinesia, Government, Risk, Growth, GAAP, Migraine, Adult, Central nervous system, CNS, Torticollis, Prescription, U.S. Securities and Exchange Commission, Safety, Review, Depreciation, Securities Exchange Act of 1934, Epilepsy, Income, Section 13, ADHD, Central nervous system disease, Depression, Patient, Security (finance), Pharmaceutical industry, Viloxazine, PD, Adamantas

The Companys 2022 financial guidance in this press release contains a financial measure, non-GAAP operating earnings, which does not comply with United States generally accepted accounting principles (GAAP).

Key Points: 
  • The Companys 2022 financial guidance in this press release contains a financial measure, non-GAAP operating earnings, which does not comply with United States generally accepted accounting principles (GAAP).
  • The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP.
  • We mitigate these limitations by reconciling the non-GAAP financial measures to the most comparable GAAP financial measures.
  • Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

EQS-News: Mayr-Melnhof Karton AG: Invitation to the General Meeting according to art. 107 para. 3 Companies Act

Retrieved on: 
Friday, April 1, 2022
General Data Protection Regulation, Company, Exercise, Attention, 43, Proxy, Mission statement, EEA, Group, Section 118 of the Constitution of Australia, Financial Oversight and Management Board for Puerto Rico v. Aurelius Investment, LLC, CEST, Aktiengesellschaft, GDPR, Address, Name, Hand, ISIN, Article, Section 120 of the Constitution of Australia, THE, Intention, Section 3, Person, Email, Disclosure, Time, Information privacy, Chair, Supervisory board, PDF, Section 13, Complaint, Reproduction, Efficiency, SWIFT, Auction, Online gambling, Holding company, Bank, Property management, Online shopping, Lease, Security (finance)

Mr. Stephan Sweerts-Sporck, or by e-mail, with a qualified electronic signature to [email protected] or by SWIFT to the address GIBAATWGGMS.

Key Points: 
  • Mr. Stephan Sweerts-Sporck, or by e-mail, with a qualified electronic signature to [email protected] or by SWIFT to the address GIBAATWGGMS.
  • The agenda item and the proposed resolution, but not its justification, must in any case also be written in German.
  • Mayr-Melnhof Karton Aktiengesellschaft employs external service businesses such as notaries, attorneys, banks and IT service providers in order to hold the Ordinary Shareholders' Meeting.
  • At the time the Ordinary Shareholders' Meeting is convened, the Company does not hold any own shares.

Supernus Receives Notice Assigning Early October 2022 PDUFA for SPN-830 Apomorphine Infusion Device NDA

Retrieved on: 
Tuesday, February 22, 2022
GLOBE, Central nervous system, Migraine, Depression, Prescription, Government, Regulation of tobacco by the U.S. Food and Drug Administration, Growth, OFF, Risk, Securities Exchange Act of 1934, Dyskinesia, Section 13, Security (finance), Torticollis, Central nervous system disease, Company, Private Securities Litigation Reform Act, Safety, Accounting Standards Review Board, U.S. Securities and Exchange Commission, Review, Epilepsy, New Drug Application, Food, Adult, ADHD, PDUFA, FDA, Nasdaq, Patient, NDA, CNS, Pharmaceutical industry, PD

Supernus will work closely with the FDA as it reviews the SPN-830 NDA.

Key Points: 
  • Supernus will work closely with the FDA as it reviews the SPN-830 NDA.
  • The Company is preparing for the commercial launch of SPN-830 in the first quarter of 2023 assuming timely approval by the FDA.
  • Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
  • These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations.

Government of Vanuatu Engages CS Global Partners to Reform its Citizenship by Investment Programme

Retrieved on: 
Tuesday, January 18, 2022
Dominica citizenship by investment programme, Citizenship Act, Legislation, Government, Program, IMF, Investment, FACT, Solution, Nation, Section 13, Crime, School, Common Law Admission Test, Housing, Industry, Marketing, EB-5 visa, CBI, Commonwealth, Lawyer, Partnership, Awareness, Renewable energy, Private investigator

CS Global Partners will help the nation restructure and rebrand its Citizenship by Investment (CBI) programme.

Key Points: 
  • CS Global Partners will help the nation restructure and rebrand its Citizenship by Investment (CBI) programme.
  • CS Global Partners is the worlds leading government advisory and marketing firm, specialising in residency and citizenship by investment solutions.
  • Governments around the globe partner with CS Global Partners, relying on our in-depth expertise about the citizenship by investment market.
  • CS Global Partners provides tailored guidance and advice with a global physical presence and an expert legal advisory and marketing team.

Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device

Retrieved on: 
Wednesday, December 8, 2021
U.S. Securities and Exchange Commission, Central nervous system, Apomorphine, NDA, ADHD, Company, Torticollis, GLOBE, OFF, Refusal, Letter, Prescription, Growth, Security (finance), Safety, Private Securities Litigation Reform Act, Food, Patient, CEO, Securities Exchange Act of 1934, New Drug Application, Epilepsy, Migraine, Depression, CNS, Central nervous system disease, Adult, FDA, NASDAQ, Regulation of tobacco by the U.S. Food and Drug Administration, Section 13, Risk, Dyskinesia, Government, RTF, Pharmaceutical industry

The FDA provided additional clarity related to the contents of the November 2020 RTF letter and the requirements for resubmission during a Type A meeting with Supernus in March 2021.

Key Points: 
  • The FDA provided additional clarity related to the contents of the November 2020 RTF letter and the requirements for resubmission during a Type A meeting with Supernus in March 2021.
  • SPN-830 is an important product candidate which, if approved by the FDA, represents a novel approach for PD patients, said Jack Khattar, President and CEO of Supernus Pharmaceuticals.
  • We believe the continuous subcutaneous infusion of apomorphine for the treatment of motor fluctuations (OFF episodes) can be an attractive alternative for patients who are seeking less invasive options.
  • Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Supernus Pharmaceuticals Completes Acquisition of Adamas Pharmaceuticals

Retrieved on: 
Wednesday, November 24, 2021
Transfer, Section 13, Nasdaq, Milestone, Company, Central nervous system, ADHD, Risk, GLOBE, Central nervous system disease, Depression, Â, CNS, Securities Exchange Act of 1934, Private Securities Litigation Reform Act, Security (finance), CEO, LLP, Time, Achievement, CVR Partners, DGCL, Torticollis, U.S. Securities and Exchange Commission, Amantadine, CVR, Cooley LLP, Contingent value rights, Dyskinesia, Secretary of State of Delaware, Prescription, LLC, Adult, Tablet, FDA, Government, Delaware General Corporation Law, Growth, Patient, Safety, Acquisition, Jefferies Group, Capsule, ADMS, Tax, Topiramate, Epilepsy, Migraine, NASDAQ, Fine chemical, Pharmaceutical industry

ROCKVILLE, Md., Nov. 24, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) today announced that it has successfully completed its previously announced acquisition of Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS).

Key Points: 
  • ROCKVILLE, Md., Nov. 24, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) today announced that it has successfully completed its previously announced acquisition of Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS).
  • Adamas fits squarely within our corporate development strategy, adding a late-stage commercial product with significant revenue, said Jack Khattar, President and CEO of Supernus Pharmaceuticals.
  • Following the completion of the Offer, Supernus completed the acquisition of Adamas through the merger of Reef with and into Adamas, without a vote of Adamas stockholders in accordance with Section251(h) of the General Corporation Law of the State of Delaware (DGCL), with Adamas surviving the merger as a wholly-owned subsidiary of Supernus.
  • Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.