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KemPharm Announces Appointment of Christopher Posner as New Independent Director

Retrieved on: 
Tuesday, November 29, 2022

CELEBRATION, Fla., Nov. 29, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a biotechnology company focused on the discovery, development and commercialization of novel treatments for rare central nervous system (CNS) and neurodegenerative diseases, lysosomal storage disorders and related treatment areas, today announced the appointment of Christopher Posner to serve on the Company’s Board of Directors.

Key Points: 
  • Mr. Posner is currently the president and CEO of Cara Therapeutics (Nasdaq: CARA), a commercial-stage biopharmaceutical company.
  • He brings more than 20 years of global pharmaceutical experience to KemPharm, including expertise in preparing and executing commercial product launches.
  • Prior to joining Cara Therapeutics, Mr. Posner was President and Chief Executive Officer of LEO Pharma, Inc., the U.S. subsidiary of LEO Pharma A/S.
  • I welcome the opportunity to join KemPharm at a very exciting period for the company, said Mr. Posner.

KemPharm Receives FDA Orphan Drug Designation for Serdexmethylphenidate (SDX) for the Treatment of Idiopathic Hypersomnia (IH)

Retrieved on: 
Friday, November 18, 2022

CELEBRATION, Fla., Nov. 18, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a biotechnology company focused on the discovery, development and commercialization of novel treatments for rare central nervous system (CNS) and neurodegenerative diseases, lysosomal storage disorders and related treatment areas, today announced that the U.S. Food and Drug Administration (FDA) has granted the Orphan Drug Designation to serdexmethylphenidate (SDX), KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH), for the treatment of idiopathic hypersomnia (IH), a rare neurological sleep disorder.

Key Points: 
  • SDX is the sole active pharmaceutical ingredient (API) in KP1077, KemPharms lead clinical candidate being developed as a treatment for IH and narcolepsy.
  • We appreciate the FDAs decision to grant Orphan Drug Designation to SDX for IH, a rare sleep disorder characterized by multiple, debilitating symptoms for which few treatment options exist, stated Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm.
  • Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition.
  • Among the other benefits of Orphan Drug Designation are tax credits for certain research and a waiver of the NDA application user fee.

KemPharm to Report Third Quarter 2022 Financial Results

Retrieved on: 
Tuesday, November 1, 2022

ET, to discuss its corporate and financial results for the third quarter 2022.

Key Points: 
  • ET, to discuss its corporate and financial results for the third quarter 2022.
  • The audio webcast with slide presentation will be accessible via the Investor Relations section of the Companys website, http://investors.kempharm.com/ .
  • An archive of the webcast and presentation will be available for 90 days beginning at approximately 6:00 p.m.
  • KemPharm has a diverse product portfolio, combining a clinical-stage development pipeline with NDA-stage and commercial assets.

KemPharm Supports Niemann-Pick Awareness Month During October and Global Niemann-Pick Awareness Day on October 19th

Retrieved on: 
Tuesday, October 4, 2022

CELEBRATION, Fla., Oct. 04, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc.(NasdaqGS: KMPH) (KemPharm, or the Company), a biotechnology company focused on the discovery, development and commercialization of novel treatments for rare diseases, announced its support for Niemann-Pick Awareness Month, which is the month of October, and Global Niemann-Pick Awareness Day, which is October 19th.

Key Points: 
  • CELEBRATION, Fla., Oct. 04, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc.(NasdaqGS: KMPH) (KemPharm, or the Company), a biotechnology company focused on the discovery, development and commercialization of novel treatments for rare diseases, announced its support for Niemann-Pick Awareness Month, which is the month of October, and Global Niemann-Pick Awareness Day, which is October 19th.
  • KemPharm supports and unites with these groups in advocating for those affected by NPC and their families and in seeking new therapeutic options for NPC where no satisfactory alternative treatments currently exist.
  • KemPharm is a biotechnology company focused on the discovery, development and commercialization of novel treatments for rare diseases.
  • KemPharm has a diverse product portfolio, combining a clinical-stage development pipeline with NDA-stage and commercial assets.

KemPharm Announces Positive Topline Data from Phase 1 Clinical Trial Evaluating Cardiovascular Safety of Serdexmethylphenidate (SDX)

Retrieved on: 
Wednesday, September 28, 2022

CELEBRATION, Fla., Sept. 28, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a specialty pharmaceutical company focused on the discovery, development and commercialization of novel treatments for rare central nervous system (CNS), neurodegenerative and lysosomal storage diseases, today announced topline data from its exploratory Phase 1 clinical trial confirming the relative cardiovascular effects and pharmacokinetics 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, a potential treatment for idiopathic hypersomnia (IH), a rare sleep disorder.

Key Points: 
  • KemPharm expects to initiate a Phase 2 clinical trial of KP1077 in patients with IH prior to year-end 2022 and a second trial in patients with narcolepsy in 2023.
  • We are pleased with the initial results from the Phase 1 cardiovascular safety trial of SDX, which demonstrated the potential for higher dose formulations of SDX to be safe and well-tolerated.
  • Overall, the data suggest that SDX can be safely dosed at levels higher than current products, which is expected to result in improved efficacy.
  • Maximal plasma concentrations (Cmax) of d-MPH were similar for both Ritalin treatments that were administered at equal doses of 80mg.

KemPharm to Present at the H.C. Wainwright 24th Annual Global Investment Conference

Retrieved on: 
Thursday, September 1, 2022

In addition, management will be available for virtual one-on-one investor meetings during the conference.

Key Points: 
  • In addition, management will be available for virtual one-on-one investor meetings during the conference.
  • Registered investors will be able to view the pre-recorded presentation by Dr. Mickle highlighting KemPharms business and recent corporate achievements, as well as anticipated milestones.
  • KemPharm has a diverse product portfolio, combining a clinical-stage development pipeline with NDA-stage and commercial assets.
  • Eligibility for participation in any such program is at the discretion of the treating physician.

KemPharm Reports Second Quarter 2022 Financial Results and Corporate Updates

Retrieved on: 
Thursday, August 11, 2022

CELEBRATION, Fla., Aug. 11, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a specialty pharmaceutical company focused on the discovery, development and commercialization of novel treatments for rare central nervous system (CNS), neurodegenerative and lysosomal storage diseases, today reported its financial results for the second quarter ended June 30, 2022.

Key Points: 
  • We expect to initiate the Phase 2 trial of KP1077 in IH by the end of 2022, with a second trial focused on narcolepsy commencing soon thereafter.
  • Additionally, we expect to report topline results from the cardiovascular safety study involving serdexmethylphenidate (SDX) as soon as Q3 2022.
  • In addition, KemPharm recognized $17.7 million of expense during Q2 2022 related to acquired in-process research and development from the arimoclomol asset acquisition during the quarter, which was immediately expensed.
  • ET, to discuss its corporate and financial results for the second quarter of 2022.

KemPharm Appoints Nichol Ochsner as Vice President, Investor Relations and Corporate Communications

Retrieved on: 
Tuesday, August 9, 2022

We are very pleased to welcome Nichol to KemPharm and look forward to benefitting from her more than 20 years experience developing investor relations and corporate communications strategies in the biopharmaceutical industry, stated Travis Mickle, Ph.D., President and CEO of KemPharm.

Key Points: 
  • We are very pleased to welcome Nichol to KemPharm and look forward to benefitting from her more than 20 years experience developing investor relations and corporate communications strategies in the biopharmaceutical industry, stated Travis Mickle, Ph.D., President and CEO of KemPharm.
  • Prior to joining KemPharm, Ms. Ochsner served as Executive Vice President of Investor Relations and Corporate Communications with Statera Biopharma.
  • Previously, Ms. Ochsner served as Vice President, Investor Relations and Corporate Communications at TherapeuticsMD.
  • Prior to TherapeuticsMD, she was Executive Director, Investor Relations and Corporate Communications at Aralez Pharmaceutical, and, before that, served as Senior Director, Investor Relations and Corporate Communications at Auxilum until its acquisition by Endo International plc for $2.6 billion.

KemPharm to Report Second Quarter 2022 Financial Results

Retrieved on: 
Thursday, August 4, 2022

ET, to discuss its corporate and financial results for the second quarter 2022.

Key Points: 
  • ET, to discuss its corporate and financial results for the second quarter 2022.
  • The audio webcast with slide presentation will be accessible via the Investor Relations section of the Companys website, http://investors.kempharm.com/ .
  • An archive of the webcast and presentation will be available for 90 days beginning at approximately 6:00 p.m.
  • KemPharm has a diverse product portfolio, combining a clinical-stage development pipeline with revenue-generating NDA-stage and commercial assets.

KemPharm to Present at the Canaccord Genuity 42nd Annual Growth Conference

Retrieved on: 
Tuesday, August 2, 2022

Management will be available for one-on-one meetings with registered attendees.

Key Points: 
  • Management will be available for one-on-one meetings with registered attendees.
  • A live webcast of the presentation will be available under the Events & Presentations within the Investor Relations section of the Companys website at http://www.kempharm.com .
  • KemPharm is a specialty pharmaceutical company focused on the discovery, development and commercialization of novel treatments for rare central nervous system (CNS), neurodegenerative and lysosomal storage diseases.
  • KemPharm has a diverse product portfolio, combining a clinical-stage development pipeline with revenue-generating NDA-stage and commercial assets.