KMPH - KMPH STOCK NEWS

KemPharm, a company focused on rare disease therapeutics, has promoted Sven Guenther to Chief Scientific Officer and Christal Mickle to Chief Product Development Officer. These promotions are part of KemPharm's strategy to evolve into a leading rare disease company. CEO Richard W. Pascoe emphasized the importance of these leaders in advancing the company’s pipeline, especially with the upcoming NDA resubmission for arimoclomol and ongoing product development. Both have played crucial roles in previous product approvals and bring extensive experience in the pharmaceutical industry.

KemPharm, a rare disease therapeutics company, announced significant leadership changes as part of its strategic transformation. Effective immediately, Matthew R. Plooster becomes Chairman of the Board, while Richard W. Pascoe transitions from Executive Chairman to Chief Executive Officer. Travis C. Mickle, Ph.D., moves from CEO to President, and Joshua Schafer is appointed Chief Commercial Officer and Executive Vice President of Business Development. These shifts aim to enhance the company’s commercial capabilities and development pipeline, particularly focusing on the arimoclomol NDA resubmission and advancing their drug candidates.

KemPharm has initiated a Phase 2 clinical trial for KP1077, a treatment for idiopathic hypersomnia (IH), a rare neurological sleep disorder. The trial is designed as a multi-center, double-blind study involving 48 adult patients across over 30 U.S. centers. It aims to assess the safety, efficacy, and optimal dosing of KP1077, which consists of serdexmethylphenidate (SDX). SDX has received Orphan Drug Designation from the FDA. Interim efficacy and safety data are expected by Q3 2023. The potential market for IH treatment is estimated at 37,000 diagnosed patients, suggesting significant commercial opportunity.

KemPharm, Inc. (KMPH) announced the appointment of Christopher Posner to its Board of Directors. Posner, a 24-year global pharmaceutical executive and CEO of Cara Therapeutics, brings extensive experience in commercial product launches. His expertise is expected to enhance KemPharm's strategic transformation and bolster its clinical activities, specifically for the KP1077 and arimoclomol programs. KemPharm anticipates starting a Phase 2 clinical trial for KP1077 in idiopathic hypersomnia soon and plans to resubmit an NDA for arimoclomol in Q3 2023.

KemPharm (KMPH) announced that the FDA granted Orphan Drug Designation for serdexmethylphenidate (SDX) to treat idiopathic hypersomnia (IH), a rare neurological disorder. This designation enables KP1077, the company's lead candidate for IH and narcolepsy, to benefit from regulatory advantages, including potential market exclusivity after approval. KemPharm plans to initiate a Phase 2 clinical trial for KP1077 in IH by the end of 2022, followed by another trial for narcolepsy in 2023. This regulatory milestone is seen as pivotal for addressing the unmet needs in IH treatment.

KemPharm, a biotechnology firm, reported Q3 2022 financial results, highlighting significant advancements in its lead programs. Arimoclomol, aimed at treating Niemann-Pick Type C, is set for NDA resubmission as early as Q3 2023, following positive FDA interactions and new safety data. Concurrently, KP1077 for idiopathic hypersomnia is on track for a Phase 2 clinical trial initiation by year-end 2022. The company holds $107.4 million in cash, ensuring operations into 2026, and anticipates revenue from AZSTARYS® sales milestones.

KemPharm, a biotechnology firm focused on rare diseases, announced a conference call on November 9, 2022, at 5:00 p.m. ET, to discuss its Q3 2022 corporate and financial results. The call will be accessible via the Investor Relations section of its website. The company’s product pipeline includes arimoclomol for Niemann-Pick disease and KP1077 for idiopathic hypersomnia, among others. KemPharm's approved products include AZSTARYS and APADAZ, both being commercialized in the U.S.

KemPharm, a biotechnology company, announced its support for Niemann-Pick Awareness Month and Global Niemann-Pick Awareness Day in October. The company recognizes the crucial role of organizations like NNPDF and INPDA in raising awareness of Niemann-Pick disease type C (NPC). Currently, there are no approved treatments for NPC in the U.S., highlighting the disease's diagnostic complexities and significant delays in recognition. KemPharm's pipeline includes arimoclomol, an investigational product for NPC, and KP1077 for idiopathic hypersomnia. The company also has FDA-approved products for ADHD and pain management.

KemPharm, Inc. announced Phase 1 trial results for serdexmethylphenidate (SDX), its prodrug of d-methylphenidate, indicating it is well-tolerated at doses of 80 mg and 200 mg. The trial confirmed SDX's cardiovascular safety and pharmacokinetics compared to Ritalin. KemPharm plans to initiate a Phase 2 trial for KP1077, targeting idiopathic hypersomnia, by year-end 2022, aiming for higher efficacy without increased cardiovascular risk. The study involved 15 volunteers and showed that the 200 mg SDX dose provided prolonged exposure to d-MPH, promising advancements in treatment efficacy.