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Monday, October 18, 2021

KP415 & KP484; the Rise of KemPharm Inc (OTCMKTS: KMPH)

KemPharm Inc (OTCMKTS: KMPH) is making a powerful move up the charts recently surpassing its $.90 highs from earlier this year and moving over $1. There is a lot to get excited about on KMPH as the Company updates shareholders on its expected filing of the Investigational New Drug (IND) application for KP879 with the FDA prior to year-end 2020, and the introduction of a new prodrug candidate to its pipeline, KP1077; KemPharm’s newly developed investigational product candidate for the treatment of IH, a neurological disorder marked by significant, detrimental effects on nighttime sleep as well as daytime sleepiness/wakefulness.

The Company has scheduled an online investor event hosted along with its partner, Corium, Inc., on December 2, 2020, beginning at 10:00 a.m. ET. Management plans to provide insights into the KP415 market opportunity and commercialization strategy ahead of the anticipated March 2, 2021 PDUFA date for KP415. KMPH is considering a reverse split in order to meet the listing requirements for NASDAQ.

KemPharm Inc (OTCMKTS: KMPH) 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. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder. KemPharm’s co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles. In addition, KemPharm has received FDA approval for APADAZ®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen.

KP415 is KemPharm’s investigational product candidate for the treatment of ADHD. KP415 consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. KP415 is designed to address unmet needs with the most widely-prescribed methylphenidate ADHD treatments, including earlier onset of action and longer duration of therapy, while avoiding unnecessary spikes in d-MPH concentrations that may be associated with adverse events. The NDA for KP415 is currently under review with the FDA with an anticipated PDUFA date of March 2, 2021. Corium, a portfolio company of Gurnet Point Capital (GPC), is leading all commercialization activities for KP415. In September 2019, KemPharm entered into a license agreement with an affiliate of GPC, for the exclusive worldwide rights to develop, manufacture and commercialize certain of KemPharm’s product candidates containing SDX, including KemPharm’s ADHD product candidates, KP415 and KP484.

Earlier this year KMPH reported its financial results for the third quarter ended September 30, 2020. For Q3 2020, KemPharm reported revenue of $1.9 million, which was primarily derived from service fee revenue, as compared to Q2 2020 revenue of $6.9 million which is comprised of a $5.0 million milestone payment received based on the acceptance of the KP415 NDA by the FDA.

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On November 23 KMPH provided an update to its prodrug development pipeline, including the expected filing of the Investigational New Drug (IND) application for KP879 with the FDA prior to year-end 2020, and the introduction of a new prodrug candidate to its pipeline, KP1077; KemPharm’s newly developed investigational product candidate for the treatment of IH, a neurological disorder marked by significant, detrimental effects on nighttime sleep as well as daytime sleepiness/wakefulness. KemPharm is developing KP879 as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD).  KP879 utilizes serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH). There are currently no products in the market which are designed or approved to treat SUD.

KMPH CEO Travis C. stated: “We believe that both KP879 and KP1077 showcase several important future opportunities for KemPharm. First, these product candidates may allow us entry into orphan disease indications, which are underserved, and as a result, may qualify for both Fast-Track status and Orphan Drug designation from the FDA.   Second, each product candidate leverages our LAT® approach, which we believe demonstrates the versatility of the technology, and, in the case of SDX, its unique ability to serve as a product platform.”

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Currently making a powerful move up the charts recently surpassing its $.93 highs from earlier this year, KMPH is an exciting story developing in small caps that already has FDA approval for APADAZ®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. The Company recently updated shareholders on its  expected filing of the Investigational New Drug (IND) application for KP879 with the FDA prior to year-end 2020, and the introduction of a new prodrug candidate to its pipeline, KP1077; KemPharm’s newly developed investigational product candidate for the treatment of IH, a neurological disorder marked by significant, detrimental effects on nighttime sleep as well as daytime sleepiness/wakefulness.  The Company has scheduled an online investor event hosted along with its partner, Corium, Inc., on December 2, 2020, beginning at 10:00 a.m. ET. Management plans to provide insights into the KP415 market opportunity and commercialization strategy ahead of the anticipated March 2, 2021 PDUFA date for KP415. We will be updating on KMPH when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with KMPH.

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Disclosure: we hold no position in KMPH either long or short and we have not been compensated for this article.

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