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Ampio Pharmaceuticals Inc (AMPE.A)

AMPE.A on American Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Ampio receives guidance from the FDA
Monday, 27 Feb 2017 08:30am EST 

Ampio Pharmaceuticals Inc : Ampio receives guidance from the FDA and proposes a path for approval for single-injection ampion™ for the treatment of pain due to severe osteoarthritis of the knee . Says ampio has proposed a small pre-approval study, randomized 6 to 1 on patients with severe oak . Says study will be completed concurrently with preparation for biologicals licensing application (bla) submission .Says Ampio has requested expedited review/approval for this serious medical condition with an unmet medical need.  Full Article

Ampio says met with FDA for Ampion biological license
Thursday, 29 Sep 2016 02:50pm EDT 

Ampio Pharmaceuticals Inc: Ampio updates clinical and regulatory activity . Has met with CBER division of FDA to seek guidance on best path forward to obtain a biological license for Ampion .Reported completion of enrollment for AP-011 sudy to evaluate safety of single intra-articular injection of Ampion for basal thumb arthritis.  Full Article

Ampio Pharmaceuticals announces pricing of registered direct offering
Monday, 29 Aug 2016 11:07am EDT 

Ampio Pharmaceuticals Inc : Ampio Pharmaceuticals, Inc. announces pricing of registered direct offering . Entered into securities purchase agreement providing for registered sale of 5 million shares, warrants to purchase up to 5 million shares . Gross proceeds to company from offering will approximate $3.8 million .Says warrants are immediately exercisable and have a term of five years from date of issuance.  Full Article

Ampio launches clinical trial of ampion
Tuesday, 10 May 2016 08:50am EDT 

Ampio Pharmaceuticals Inc :Ampio launches clinical trial of ampion for the treatment of osteoarthritis of the hand.  Full Article

Ampio Pharmaceuticals Inc announces positive study results on Optina for treatment of diabetic macular edema
Thursday, 21 May 2015 08:00am EDT 

Ampio Pharmaceuticals Inc:Says positive results of OptimEyes trial for DME.Says OptimEyes trial was a multiple site, randomized, placebo controlled, parallel, double masked study to evaluate the safety and efficacy of two doses of oral Optina (adjusted to body mass index-BMI) in adult patients with Diabetic Macular Edema (DME).OptimEyes trial, with FDA guidance, was designed to include a wide variety of DME patients, some of whom had no therapeutic options and were progressing to blindness.Intraocular injections may have been contraindicated in these patients (example-patients with glaucoma, prior vitrectomy etc...and were included in our trials).Goal of study was to assess safety and efficacy of oral Optina, identify patients who respond and the ideal dose.  Full Article

Ampio Pharmaceuticals Inc announces Ampion STRIDE study results
Monday, 20 Apr 2015 08:45am EDT 

Ampio Pharmaceuticals Inc:Says the multiple injection STRIDE study AP008 did not reach its primary endpoint against the saline control even though there was a statistically significant reduction in pain compared to baseline for patients receiving Ampion (WOMAC A: p < 0.001).This pain reduction with Ampion was consistent across all sites and with previously reported studies (SPRING and STRUT).Ampion is safe and well tolerated.In the STRIDE study the saline control arm varied well out of a normal range, when compared to previous Ampion studies and from the published results for other OA drugs.In the STRIDE study, the percentage change in WOMAC A for the saline control arm ranged from 12 to 60 pct from site to site.This is more than twice the range previously seen in studies.Historically, in larger studies, the response to saline has been reported to be in a range of 30-35 pct.68 pct of subjects in the STRIDE study had severe disease (Kellgren-Lawrence 4) versus 38 pct in the STRUT study and 23 pct in the SPRING study.  Full Article

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BRIEF-Ampio pharmaceuticals provides corporate update

* Ampio pharmaceuticals - plans to advance all necessary biologic license application activities in parallel to expedite path to potential FDA approval