Idiopathic hypersomnia

KemPharm to Report First Quarter 2022 Financial Results

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水曜日, 5月 4, 2022
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CELEBRATION, Fla., May 04, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH), a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (CNS) diseases, today announced that the Company will host a conference call and live audio webcast on Thursday, May 12, 2022, at 5:00 p.m. ET, to discuss its corporate and financial results for the first quarter 2022.

Key Points: 
  • Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Thursday, May 12, 2022, 5:00 p.m.
  • ET, to discuss its corporate and financial results for the first quarter 2022.
  • It is recommended that the registration process be completed at least 15 minutes prior to the start of the call.
  • KemPharms prodrug product candidate pipeline is focused on the high need areas of idiopathic hypersomnia (IH) and other CNS/rare diseases.

Jazz Pharmaceuticals and Sumitomo Pharma Announce Exclusive License Agreement to Develop and Commercialize DSP-0187, a Potent, Highly Selective Oral Orexin-2 Receptor Agonist

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水曜日, 5月 4, 2022
Sleep, Neuroscience, Jazz Pharmaceuticals, Narcolepsy, Psychiatry, Twitter, Health, EDS, Pharmacokinetics, Sleep paralysis, NASDAQ, Idiopathic hypersomnia, Excessive daytime sleepiness, Safety, Drug discovery, Patient, Commission, Risk, Orexin, Annual report, DNS, U.S. Securities and Exchange Commission, Sleep disorder, Neurology, Wakefulness, Cataplexy, Research, Head, Neuropeptide, Pharmaceutical industry, TSE, Jazz

DUBLIN and OSAKA, Japan, May 4, 2022 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President, and CEO: Hiroshi Nomura; Securities Code: 4506, Prime Market of TSE) today announced that the companies have entered into an exclusive licensing agreement under which Jazz has acquired development and commercialization rights in the United States, Europe and other territories for Sumitomo Pharma's investigational DSP-0187, a potent, highly selective oral orexin-2 receptor agonist with potential application for the treatment of narcolepsy, idiopathic hypersomnia and other sleep disorders. Jazz has designated this molecule JZP441.

Key Points: 
  • Sumitomo Pharma initiated a Phase 1 trial in Japan of DSP-0187 in November 2021 to evaluate safety, tolerability and pharmacokinetics in healthy volunteers.
  • "Orexin agonism is an exciting area of sleep disorder research and an approach that may be complementary to oxybate therapy.
  • "DSP-0187 is a potent, highly selective oral orexin-2 receptor agonist, which is a novel small molecule compound originally created by Sumitomo Pharma by utilizing our advanced expertise in drug discovery for central nervous system disorders.
  • DSP-0187 is a potent, highly selective orexin-2 receptor agonist designed to activate orexin signaling.

FDA Grants 510(k) Clearance to Onera STS, a System for At-Home and In-Lab Polysomnography Studies

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木曜日, 4月 28, 2022
Technology, Managed Care, Medical Devices, Hospitals, Science, Clinical Trials, FDA, Biotechnology, Alternative Medicine, Health, Other Science, Research, Software, Internet, Mobile, Wireless, Hardware, Data Management, US Foods, Sleep, CEO, Patient, FDA, Idiopathic hypersomnia, Food, Quality of life, Health, Jazz Pharmaceuticals, Diagnosis, Hospital, Multimedia, Physician, Stanford University Medical Center, Trial of the century, Neuro, Narcolepsy, PSG, Medical device, Pharmaceutical industry, Medicine, Polysomnography, ONERA

The FDA determined that Oneras product was substantially equivalent to a system widely used in todays in-lab PSG studies, marketed by the medical device manufacturer Natus Medical Inc.

Key Points: 
  • The FDA determined that Oneras product was substantially equivalent to a system widely used in todays in-lab PSG studies, marketed by the medical device manufacturer Natus Medical Inc.
  • Achieving FDA clearance is an exciting and critical milestone to our commitment to helping our customers deliver better access to care for their patients, says Ruben de Francisco, Founder and CEO of Onera.
  • Our end-to-end solution has the potential to improve the sleep and ultimately overall health of millions of patients, explains de Francisco.
  • Onera Health will present its latest clinical study results at SLEEP 2022, from 4th-8th June 2022 in Charlotte, NC.

KemPharm Doses First Subject in Phase 1 Clinical Trial Evaluating Cardiovascular Safety of Serdexmethylphenidate (SDX)

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火曜日, 4月 19, 2022
ECG, Sleep, KMPH, Clinical trial, Pharmacokinetics, Population, U.S. Securities and Exchange Commission, Paracetamol, Security (finance), Twitter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SDX, Food, Heart rate, Private Securities Litigation Reform Act, CNS, Central nervous system, YouTube, GLOBE, Ligand, ADHD, Patient, LinkedIn, Hydrocodone, Uncertainty, Idiopathic hypersomnia, Sleep disorder, Technology, Company, Drug discovery, IH, Benzhydrocodone, Volunteering, Forward-looking statement, Safety, Narcolepsy, Blood pressure, Facebook, FDA, Industry, Nasdaq, Risk, API, Dietary supplement, Pharmaceutical industry, IND

CELEBRATION, Fla., April 19, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (CNS) diseases, today announced that the first subject has been dosed in a Phase 1 clinical trial designed to assess the relative cardiovascular safety of serdexmethylphenidate (SDX) compared to immediate-release and long-acting formulations of Ritalin® (racemic methylphenidate), a commonly prescribed CNS stimulant. SDX, KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH), is the sole active pharmaceutical ingredient (API) in KP1077, which KemPharm is developing as a treatment for idiopathic hypersomnia (IH), a rare sleep disorder.

Key Points: 
  • As we hope to demonstrate in this trial, we believe that observing limited cardiovascular side-effects represents the key product differentiator for both the safety and potential efficacy of KP1077 compared to existing stimulant treatments.
  • KemPharm anticipates filing an Investigational New Drug (IND) application for KP1077 with the U.S. Food and Drug Administration (FDA) as early as this quarter.
  • Upon acceptance of the IND, KemPharm plans to initiate a Phase 2 clinical trial of KP1077 in patients with IH later this year and a second trial in patients with narcolepsy as early as the second half of 2022.
  • KemPharm expects to receive topline results from this cardiovascular safety trial as early as the third quarter of 2022.

KemPharm Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Corporate Updates

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水曜日, 3月 30, 2022
Total, Company, Private Securities Litigation Reform Act, Risk, Nasdaq, LinkedIn, Therapy, Contract, Investment, Forward-looking statement, Hydrocodone, ID, Pharmacokinetics, Clinical trial, PK, Benzhydrocodone, Central nervous system, IND, CNS, Investor relations, KMPH, Webcast, Conference, Paracetamol, IH, Food, U.S. Securities and Exchange Commission, Drug discovery, Security (finance), Idiopathic hypersomnia, Industry, Safety, Technology, Twitter, Ligand, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, Narcolepsy, Income, Facebook, Sleep disorder, YouTube, ADHD, Share repurchase, FDA, Uncertainty, Conference call, SDX, Pharmaceutical industry, Cryptocurrency, Corium

CELEBRATION, Fla., March 30, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (CNS) diseases, today reported its financial results for the fourth quarter and year ended December 31, 2021.

Key Points: 
  • Reported quarter ended December 31, 2021 (Q4 2021) revenue of $2.6 million and FY 2021 revenue of $28.7 million; and
    Total cash, cash equivalents and long-term investments was $127.8 million as of December 31, 2021.
  • KemPharm advanced on multiple fronts during the fourth quarter of 2021 and into early 2022, cementing the past twelve months as the most substantial in KemPharms history, stated Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm.
  • Q4 and Full-Year 2021 Financial Results:
    KemPharms revenue for Q4 2021 was $2.6 million, as compared to Q4 2020 revenue of $2.4 million.
  • ET, to discuss its corporate and financial results for the fourth quarter of 2021 and fiscal year of 2021.

KemPharm to Participate in Maxim’s 2022 Virtual Growth Conference

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木曜日, 3月 24, 2022
LinkedIn, Hydrocodone, Benzhydrocodone, CNS, Paracetamol, IH, Food, Idiopathic hypersomnia, Technology, Twitter, Ligand, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Facebook, YouTube, ADHD, FDA, SDX, Pharmaceutical industry

KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT (Ligand Activated Therapy) technology.

Key Points: 
  • KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT (Ligand Activated Therapy) technology.
  • KemPharm utilizes its proprietary LAT technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications.
  • KemPharms prodrug product candidate pipeline is focused on the high need areas of idiopathic hypersomnia (IH) and other CNS/rare diseases.
  • In addition, the U.S. Food and Drug Administration (FDA) has approved AZSTARYS, a new once-daily treatment for ADHD in patents age six years and older containing KemPharms prodrug, serdexmethylphenidate (SDX), which is being commercialized by Corium, Inc. in the U.S., and APADAZ, an immediate-release combination product containing benzhydrocodone, KemPharms prodrug of hydrocodone, and acetaminophen, which is being commercialized by KVK-Tech, Inc. in the U.S. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter , LinkedIn , Facebook and YouTube .

KemPharm Announces Full Data Set from Higher-Dose Serdexmethylphenidate (SDX) Phase 1 Clinical Trial

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月曜日, 3月 21, 2022
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CELEBRATION, Fla., March 21, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (the Company or KemPharm), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that the Company has completed its analysis of the full data set from its Phase 1 clinical trial exploring the safety and pharmacokinetics (PK) of serdexmethylphenidate (SDX) delivered at doses higher than those previously studied. SDX, KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH), is the sole active pharmaceutical ingredient (API) in KP1077, which KemPharm is developing as a treatment for idiopathic hypersomnia (IH).

Key Points: 
  • The full data and detailed results are expected to be submitted for presentation at future scientific conferences and publication in peer-reviewed journals.
  • KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT (Ligand Activated Therapy) platform technology.
  • KemPharms prodrug product candidate pipeline is focused on the high need areas of idiopathic hypersomnia (IH) and other CNS/rare diseases.
  • This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.

KemPharm Earns $1.975 Million Fee from Corium Following FDA Approval of the Corium Product ADLARITY® (donepezil transdermal system)

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水曜日, 3月 16, 2022
Ligand, Twitter, LinkedIn, Dementia, Technology, GLOBE, Facebook, U.S. Securities and Exchange Commission, Patient, CNS, Private Securities Litigation Reform Act, Calendar, Uncertainty, FDA, Risk, SDX, ADHD, Forward-looking statement, Benzhydrocodone, Idiopathic hypersomnia, KMPH, Sleep, Nasdaq, Security (finance), IND, Food, Company, IH, CEO, Alzheimer's disease, Industry, New Drug Application, Paracetamol, Hydrocodone, Achievement, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, YouTube, Pharmaceutical industry, Corium

CELEBRATION, Fla., March 16, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (the Company, or KemPharm), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that the Company has earned a $1.975 million fee from Corium, Inc., (Corium), a portfolio company of Gurnet Point Capital, following the approval of Corium’s product ADLARITY® (donepezil transdermal system) by the U.S. Food and Drug Administration (FDA) on March 11, 2022. ADLARITY is an innovative new treatment option for patients with mild, moderate, or severe dementia of the Alzheimer's type.  

Key Points: 
  • ADLARITY is an innovative new treatment option for patients with mild, moderate, or severe dementia of the Alzheimer's type.
  • KemPharm is due to receive the fee, within thirty (30) calendar days following FDA approval of ADLARITY, pursuant to a master development services agreement entered into with Corium in July 2020, under which KemPharm provided development and regulatory assistance related to Coriums resubmission of its New Drug Application for ADLARITY.
  • We are pleased to have been able to assist Corium in obtaining FDA approval of ADLARITY, and we congratulate them on this significant achievement, said Travis C. Mickle, Ph.D., President and CEO of KemPharm.
  • KemPharms prodrug product candidate pipeline is focused on the high need areas of idiopathic hypersomnia (IH) and other CNS/rare diseases.

KemPharm to Report Fourth Quarter and Full-Year 2021 Results

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木曜日, 3月 10, 2022
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CELEBRATION, Fla., March 10, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that the Company will host a conference call and live audio webcast on Wednesday, March 30, 2022, at 5:00 p.m. ET, to discuss its corporate and financial results for the fourth quarter and full-year 2021.

Key Points: 
  • ET, to discuss its corporate and financial results for the fourth quarter and full-year 2021.
  • To access the conference call telephonically, interested participants and investors will be required to register via the following online form: http://www.directeventreg.com/registration/event/8038872 .
  • It is recommended that the registration process be completed at least 15 minutes prior to the start of the call.
  • For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter , LinkedIn , Facebook and YouTube .

KemPharm Completes KP1077 Pre-IND Meeting Process with FDA

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水曜日, 2月 23, 2022
GLOBE, Risk, IH, U.S. Securities and Exchange Commission, Benzhydrocodone, Narcolepsy, Regulation of tobacco by the U.S. Food and Drug Administration, Twitter, Investigational New Drug, Hydrocodone, KMPH, Uncertainty, Industry, SDX, Excessive daytime sleepiness, Facebook, Ligand, Private Securities Litigation Reform Act, Nasdaq, New Drug Application, Food, Idiopathic hypersomnia, ADHD, API, IND, LinkedIn, Paracetamol, Brain, EDS, FDA, YouTube, Forward-looking statement, Patient, Technology, NDA, CNS, Pharmaceutical industry

CELEBRATION, Fla., Feb. 23, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced the successful completion of its pre-IND (Investigational New Drug) meeting process with the U.S. Food and Drug Administration (FDA) for KP1077. KemPharm is developing KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological sleep disorder whose symptoms include excessive daytime sleepiness (EDS), extreme difficulty waking (sleep inertia), severe brain fog, and falling asleep unintentionally or at inappropriate times (narcolepsy).  

Key Points: 
  • CELEBRATION, Fla., Feb. 23, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc.(NasdaqGS: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced the successful completion of its pre-IND (Investigational New Drug) meeting process with the U.S. Food and Drug Administration (FDA) for KP1077.
  • Per recent interactions with the FDA, KemPharm has confirmed that it may proceed with the submission of an IND application for KP1077, which the company expects to submit by mid-year 2022.
  • SDX is KemPharms proprietary prodrug of d-methylphenidate (d-MPH) and the sole active pharmaceutical ingredient (API) for KP1077.
  • The successful completion of the pre-IND meeting process with the FDA for KP1077 affirms our plan to submit the IND application by mid-year 2022 and, following that, potentially initiate a Phase 2 trial of KP1077 in IH as early as the third quarter of 2022, stated Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm.