KemPharm Inc (OTCMKTS: KMPH) has been racing up the charts in recent weeks since a brief dip below the $0.25 mark earlier this year. KMPH is quickly emerging as an investors favorite and volume leader in small caps.
KMPH recently reported revenue of $6.9 million for Q2 2020 which includes a $5 million milestone payment for NDA acceptance on May 1, 2020, and $1.9 million from research and development consulting services. The Company recently received Day-74 Letter for KP415 NDA; FDA has set PDUFA date of March 2, 2021. KMPH also announced Corium, Inc., a portfolio company of GPC, will lead all commercialization activities for KP415.
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 consists of SDX co-formulated with immediate-release d-MPH and 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. In addition, results from the various Human Abuse Potential trials for the SDX component of KP415 suggest that the prodrug alone may have lower abuse potential than relevant d-MPH comparators.
KP484 is KemPharm’s co-lead clinical development candidate being developed for the treatment of ADHD in patients that respond best when a very long duration of therapy is required. Similar to KP415, KP484 is based on SDX. Preclinical and clinical studies of KP484 have demonstrated that the prodrug may produce a longer duration release of d-MPH compared to the most prescribed methylphenidate products. KP484 has the potential to be the first new methylphenidate-based product being developed with the intent to address the specific needs of the adult ADHD population.
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Last month KMPH reported its financial results for the second quarter ended June 30, 2020. The Company reported Q2 2020 revenue of $6.9 million, including $5 million milestone payment for NDA acceptance on May 1, 2020, and $1.9 million from research and development consulting services. Q2 2020 net income of $0.01 per basic share and diluted share compared to a net loss of $0.33 per basic and diluted share for Q2 2019. During the quarter the Company received Day-74 Letter for KP415 NDA; FDA has set PDUFA date of March 2, 2021. KMPH also announced Corium, Inc., a portfolio company of GPC, will lead all commercialization activities for KP415. During the quarter KMPH was issued two additional U.S. patents governing KP415 and KP484.
On August 14 KMPH announced the Company participated in a mid-cycle communication meeting on August 13, 2020, with the U.S. Food and Drug Administration (FDA) regarding the ongoing review of the New Drug Application (NDA) for KP415, KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). The FDA did not raise any substantive issues at the meeting and indicated that no major safety concerns have been noted at this point in their review. Additionally, the PDUFA date of March 2, 2021, was re-affirmed.
The FDA also tentatively scheduled a late-cycle communication meeting to be held on December 1, 2020, if needed. Since KP415 is based on the new molecular entity, serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), the KP415 NDA is subject to the provisions of “the Program” under the Prescription Drug User Fee Act (PDUFA) VI, which provides for several communication meetings to be held between the FDA and the NDA sponsor throughout the review process to aid the FDA in their review and to provide timely feedback to the sponsor.
— Transcript Daily (@TranscriptDaily) August 15, 2020
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Currently trading at a $49 million market valuation KMPH is an exciting story developing in small caps; KMPH recently reported revenue of $6.9 million for Q2 2020 which includes a $5 million milestone payment for NDA acceptance on May 1, 2020, and $1.9 million from research and development consulting services. The Company recently received Day-74 Letter for KP415 NDA; FDA has set PDUFA date of March 2, 2021. KMPH also announced Corium, Inc., a portfolio company of GPC, will lead all commercialization activities for KP415. CEO Travis Mickle, Ph.D., recently stated: “The mid-cycle review meeting with the FDA provided us with some insights into the review process so far, and we are pleased that no substantive issues and no major safety concerns were raised during the meeting. This meeting marks the halfway point of the KP415 NDA review process, and with approximately six months until the PDUFA date, we remain optimistic about the potential outcome.” 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.