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KemPharm Inc (KMPH.OQ)

KMPH.OQ on NASDAQ Stock Exchange Global Market

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20 Jul 2018
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Latest Key Developments (Source: Significant Developments)

Kempharm Announces Top Line Results From KP415.E01 Efficacy And Safety Trial In Children With ADHD
Monday, 9 Jul 2018 07:00am EDT 

July 9 (Reuters) - KemPharm Inc ::KEMPHARM ANNOUNCES TOP LINE RESULTS FROM KP415.E01 EFFICACY AND SAFETY TRIAL IN CHILDREN WITH ADHD.KEMPHARM INC - RESULTS FROM TRIAL (KP415.E01) INDICATED THAT KP415 SUCCESSFULLY MET PRIMARY EFFICACY ENDPOINT.KEMPHARM INC - KP415 WAS GENERALLY WELL-TOLERATED WITH ADVERSE EVENTS (AES) TYPICAL OF STIMULANT THERAPY.KEMPHARM - ANTICIPATE DEVELOPING ADDITIONAL CLINICAL DATA FOR KP415 THROUGHOUT 2018, INCLUDING COMPLETION OF ONGOING ORAL & INTRANASAL HUMAN ABUSE POTENTIAL STUDIES.KEMPHARM - COMPLETING ANALYSIS OF FULL DATA SET FROM KP415.E01 TRIAL & OTHER STUDIES WILL ALLOW TO SUBMIT NDA FOR KP415 WITH FDA IN Q1 OF 2019.KEMPHARM INC - SUBJECTS WHO RECEIVED KP415 MET TRIAL'S PRIMARY AND SECONDARY EFFICACY ENDPOINT, SHOWING STATISTICALLY SIGNIFICANT IMPROVEMENT.  Full Article

KemPharm Reports Q1 Loss Per Share $1.77
Thursday, 10 May 2018 04:05pm EDT 

May 10 (Reuters) - KemPharm Inc ::KEMPHARM ANNOUNCES POSITIVE, TOPLINE RESULTS FROM AN INTRAVENOUS HUMAN ABUSE POTENTIAL TRIAL WITH KP415 PRODRUG; REPORTS Q1 2018 RESULTS.Q1 LOSS PER SHARE $1.77.Q1 EARNINGS PER SHARE VIEW $-0.70 -- THOMSON REUTERS I/B/E/S.NO STATISTICALLY SIGNIFICANT DIFFERENCE IN MEAN DRUG LIKING E(MAX) BETWEEN KP415 PRODRUG (57 POINTS) AND PLACEBO (54 POINTS).KP415 PRODRUG DEMONSTRATED STATISTICALLY SIGNIFICANT DIFFERENCES COMPARED TO D-METHYLPHENIDATE HYDROCHLORIDE IN PRIMARY ENDPOINT.  Full Article

Kempharm Announces Positive Topline Results From KP415 Pharmacokinetic Study In Children And Adolescents With ADHD
Tuesday, 20 Mar 2018 07:30am EDT 

March 20 (Reuters) - Kempharm Inc ::KEMPHARM ANNOUNCES POSITIVE TOPLINE RESULTS FROM KP415 PHARMACOKINETIC STUDY IN CHILDREN AND ADOLESCENTS WITH ADHD.KEMPHARM INC - ‍ANTICIPATE ADDITIONAL CLINICAL DATA THROUGHOUT 2018, INCLUDING TOPLINE RESULTS FROM ON-GOING PIVOTAL EFFICACY STUDY BY MID-YEAR​.  Full Article

Kempharm Announces FDA Approval Of Apadaz
Friday, 23 Feb 2018 02:00pm EST 

Feb 23 (Reuters) - Kempharm Inc ::KEMPHARM SAYS U.S. FDA APPROVED NDA FOR APADAZ FOR SHORT-TERM MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE OPIOID ANALGESIC.KEMPHARM SAYS U.S. DRUG ENFORCEMENT ADMINISTRATION INDICATED INTENT TO SCHEDULE APADAZ AS A C-II PRODUCT.KEMPHARM ANNOUNCES FDA APPROVAL OF APADAZ (BENZHYDROCODONE AND ACETAMINOPHEN) FOR SHORT-TERM MANAGEMENT OF ACUTE PAIN.  Full Article

Kempharm Initiates Pivotal Efficacy Trial Of KP415
Monday, 8 Jan 2018 07:30am EST 

Jan 8 (Reuters) - Kempharm Inc ::KEMPHARM INITIATES PIVOTAL EFFICACY TRIAL OF KP415.KEMPHARM INC - ENROLLMENT IN TRIAL IS EXPECTED TO TOTAL APPROXIMATELY 140 PATIENTS ACROSS FIVE CLINICAL SITES IN UNITED STATES.  Full Article

KemPharm says completed meeting with FDA on KP415
Thursday, 16 Nov 2017 07:30am EST 

Nov 16 (Reuters) - KemPharm Inc -:KemPharm completes successful end-of-Phase 2 meeting on KP415 with FDA.KemPharm - held meeting to discuss status of proposed clinical, non-clinical,abuse liability studies, among others for submission of NDA for KP415​.KemPharm - ‍meeting with FDA helped confirm remain on schedule in KP415 development program, including work required to complete other standard protocols​.  Full Article

KemPharm posts Q3 loss per share $0.68
Thursday, 9 Nov 2017 04:05pm EST 

Nov 9 (Reuters) - KemPharm Inc :KemPharm reports third quarter 2017 results and provides corporate update.Q3 loss per share $0.68.Q3 earnings per share view $-0.67 -- Thomson Reuters I/B/E/S.  Full Article

KemPharm says KP484 allowed to proceed to clinical studies​
Thursday, 2 Nov 2017 07:30am EDT 

Nov 2 (Reuters) - Kempharm Inc :kempharm’s kp484 for the treatment of adhd, an investigational prodrug of methylphenidate, allowed to proceed to clinical studies.Kempharm inc - ‍u.s. Food and drug administration has completed its safety review of investigational new drug application for kp484​.  Full Article

Kempharm and Genco Sciences announce technology licensing agreement to develop prodrug-based therapy for tourette’s syndrome with ADHD
Wednesday, 4 Oct 2017 07:30am EDT 

Oct 4 (Reuters) - Kempharm Inc : :Kempharm and Genco Sciences announce technology licensing agreement to develop prodrug-based therapy for potential rare pediatric indications of tourette’s syndrome with ADHD.Kempharm Inc says ‍Kempharm will be responsible for financing and managing all product development​.Says ‍in exchange, co will retain full intellectual property and commercial ownership of any product developed as a result of the agreement​.Says ‍Genco eligible to receive certain milestone and royalty-based or value share payments​.Says ‍additional details about agreement were not disclosed​.  Full Article

KemPharm files IND application for KP484 for the treatment of ADHD
Wednesday, 20 Sep 2017 07:30am EDT 

Sept 20 (Reuters) - KemPharm Inc :KemPharm files IND for KP484 for the treatment of ADHD, an investigational prodrug of methylphenidate.KemPharm - ‍Kempharm's IND proposal is to develop KP484 along similar clinical trial pathway as KP415,with efficacy studies of KP484 initiating in 2018​.KemPharm Inc - ‍anticipates that data for KP484 will be leveraged from KP415 research, which could allow a potential NDA submission with FDA in 2019.  Full Article

BRIEF-KemPharm Reports Q1 Loss Per Share $1.77

* KEMPHARM ANNOUNCES POSITIVE, TOPLINE RESULTS FROM AN INTRAVENOUS HUMAN ABUSE POTENTIAL TRIAL WITH KP415 PRODRUG; REPORTS Q1 2018 RESULTS