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KemPharm, a specialty pharmaceutical company, has submitted an Investigational New Drug (IND) application to the FDA to initiate a Phase 2 clinical trial for KP1077, targeting idiopathic hypersomnia (IH), a rare sleep disorder. Following a successful pre-IND meeting, the company is confident about KP1077's potential due to favorable data from previous clinical trials involving serdexmethylphenidate (SDX), the active ingredient. If approved, the trial could start in the second half of 2022, alongside ongoing Phase 1 assessments related to cardiovascular safety of SDX.
KemPharm, Inc. (NasdaqGS: KMPH) will host a conference call and audio webcast on May 12, 2022, at 5:00 p.m. ET to discuss its Q1 2022 corporate and financial results. The presentation will highlight the company’s efforts in developing novel treatments for rare CNS diseases using its proprietary LAT® platform technology. Notable products include AZSTARYS® for ADHD and APADAZ® for pain management. Participants can register for the call through an online form. Archived access to the webcast will be available for 90 days post-event.
KemPharm, Inc. (NasdaqGS: KMPH) announced the dosing of the first subject in a Phase 1 clinical trial evaluating cardiovascular safety of serdexmethylphenidate (SDX) against Ritalin.
The trial aims to support the development of KP1077 for idiopathic hypersomnia (IH). KemPharm plans to submit an IND application for KP1077 and initiate a Phase 2 trial later this year.
The Phase 1 trial will enroll up to 15 volunteers to assess cardiovascular responses and tolerability of SDX. Results are expected by Q3 2022.
KemPharm, a specialty pharmaceutical company, reported Q4 2021 revenue of $2.6 million, up from $2.4 million in Q4 2020. Full-year revenue reached $28.7 million, driven by milestone and royalty revenues for AZSTARYS. The net loss for Q4 2021 was ($2.7 million), improving from ($4.9 million) in the same period last year. As of December 31, 2021, cash and investments stood at $127.8 million. KemPharm is advancing KP1077 for idiopathic hypersomnia and initiating a Phase 2 trial in 2022, with an IND filing expected this quarter.
KemPharm, a specialty pharmaceutical company, will be featured at Maxim's 2022 Virtual Growth Conference from March 28-30, 2022. Dr. Travis C. Mickle, President and CEO, will present a pre-recorded session highlighting the company’s achievements and future milestones. Registered investors can also engage in one-on-one meetings with management. KemPharm focuses on developing proprietary prodrugs for serious medical conditions, including treatments for ADHD and idiopathic hypersomnia. For more information, visit www.kempharm.com.
KemPharm has announced positive results from its Phase 1 trial of higher-dose SDX, a prodrug of d-methylphenidate, indicating it may be a viable treatment for idiopathic hypersomnia (IH). The study showed that doses of 240 mg and 360 mg were well-tolerated and increased wakefulness and alertness in participants. The company aims to file an IND for KP1077 by Q2 2022 and initiate a Phase 2 trial in IH patients by the end of 2022, with results on cardiovascular safety expected in the same timeframe.
KemPharm, Inc. (KMPH) announced a $1.975 million fee following the FDA's approval of Corium's ADLARITY® on March 11, 2022, a transdermal treatment for Alzheimer's dementia. The fee is due within 30 days as part of a master development agreement with Corium. KemPharm’s IND for KP1077, targeting sleep disorders, is expected to be filed in Q2 2022. This reinforces KemPharm's strategy to enhance its pipeline in CNS-related therapeutic areas.
KemPharm, a specialty pharmaceutical company focused on prodrug development, will host a conference call and live audio webcast on March 30, 2022, at 5:00 p.m. ET to discuss its corporate and financial results for the fourth quarter and full-year 2021. Interested participants can register for telephone access through this link. The webcast will also be accessible via KemPharm's Investor Relations site, with an archive available for 90 days post-event.
KemPharm, Inc. (KMPH) announced the successful completion of its pre-IND meeting with the FDA regarding KP1077, aimed at treating idiopathic hypersomnia (IH). The company plans to submit an IND application for KP1077 by mid-2022, with potential initiation of a Phase 2 trial as early as Q3 2022. The FDA confirmed that additional non-clinical studies are unnecessary, citing existing data from KemPharm's other product KP415. This could lead to significant cost and time savings in KP1077's development.
KemPharm announced a strategic focus on Central Nervous System (CNS) and Rare Disease indications, highlighting KP1077 as its lead candidate for idiopathic hypersomnia. This follows favorable clinical trial data showing promising results for higher doses of SDX, the active ingredient in AZSTARYS.
With a strong balance sheet of $127.8 million in cash as of December 31, 2021, KemPharm aims to leverage its resources to advance product development and capture market share in the idiopathic hypersomnia treatment landscape.
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