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KemPharm Inc (KMPH.OQ)

KMPH.OQ on NASDAQ Stock Exchange Global Market

3.85USD
15 Dec 2017
Change (% chg)

$0.10 (+2.67%)
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Volume
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Latest Key Developments (Source: Significant Developments)

KemPharm says completed meeting with FDA on KP415
Thursday, 16 Nov 2017 

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
Friday, 10 Nov 2017 

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 

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 files IND application to begin human clinical trials for KP201/IR
Tuesday, 25 Oct 2016 

Kempharm Inc : Kempharm files IND for KP201/IR, a single-entity benzhydrocodone HCL immediate release abuse-deterrent prodrug for the treatment of acute pain . We intend to initiate human clinical trials of KP201/IR in first half of 2017 .Remain on target for a potential submission in 2018 of KP201/IR new drug application.  Full Article

Kempharm files for potential mixed shelf of upto $150 mln
Monday, 3 Oct 2016 

Kempharm Inc :Kempharm Inc files for potential mixed shelf of upto $150 million - SEC filing.  Full Article

KemPharm Q2 loss per share $0.58
Wednesday, 10 Aug 2016 

KemPharm Inc : Kempharm Inc reports second quarter 2016 results .Q2 loss per share $0.58.  Full Article

KemPharm Prodrug KP511 demonstrates comparable oral pharmacokinetics to hydromorphone in Phase 1 trial
Wednesday, 29 Jun 2016 

KemPharm Inc : KemPharm’s prodrug of hydromorphone, kp511, demonstrates comparable oral pharmacokinetics to hydromorphone in phase 1 trial . Plans to seek approval of KP511/ER under section 505(b)(2) of federal food, drug and cosmetic act with anticipated NDA submission in 2018 .In trial, KP511 demonstrated similar safety profile as dilaudid and was well-tolerated.  Full Article

Kempharm says FDA issues complete response letter for apadaz NDA
Tuesday, 14 Jun 2016 

KemPharm Inc : FDA issues complete response letter for apadaz new drug application .Currently evaluating points raised in CRL and intend to request an end of review meeting with agency to determine pathway forward for apadaz.  Full Article

KemPharm files NDA amendment request with FDA for pain drug Apadaz
Thursday, 9 Jun 2016 

Kempharm Inc : Kempharm files nda amendment request with fda for apadaz™ . Amendment is focused on providing to fda additional information kempharm seeks to include in fda's current review of apadaz nda .Fda determination is anticipated to impact previously announced target action date for apadaz of june 9, 2016 under pdufa.  Full Article

Kempharm reports Q1 shr loss $0.20
Friday, 13 May 2016 

Kempharm Inc : Kempharm, inc. reports first quarter 2016 results . Q1 loss per share $0.20 .Q1 earnings per share view $-0.49 -- Thomson Reuters I/B/E/S.  Full Article

BRIEF-KemPharm posts Q3 loss per share $0.68

* KemPharm reports third quarter 2017 results and provides corporate update