Your email has been successfully added to our mailing list.

×
0 0 0 0 -0.0441176470588236 -0.0441176470588236 0.0588235294117646 0.0588235294117646
Stock impact report

Osmotica Pharmaceuticals US LLC Submits Amended NDA for Arbaclofen Extended Release Tablets to U.S. Food and Drug Administration

Osmotica Pharmaceuticals Plc (OSMT)  More Company Research Source: GlobeNewswire
Last osmotica pharmaceuticals plc earnings: 3/18 04:05 pm Check Earnings Report
PDF -- Submission based on world’s largest database of patients treated for spasticity associated with Multiple Sclerosis -- -- Demonstrated efficacy, tolerability and one-year safety results on 80 mg/day -- BRIDGEWATER, N.J., June 30, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (Nasdaq: OSMT) through its subsidiary Osmotica Pharmaceutical US LLC (“Osmotica” or the “Company”), a fully integrated biopharmaceutical company, announced today that the Company has resubmitted its New Drug Application (“NDA”) for arbaclofen extended release (“ER”) tablets for the alleviation of spasticity in Multiple Sclerosis (“MS”) patients to the U.S. Food and Drug Administration (“FDA”). “We are excited to have resubmitted our NDA for arbaclofen ER, our novel treatment, using the Osmodex technology, for MS spasticity. With the recent completion of our 12-month open-label study – assessing the long-term safety and tolerability of arbaclofen ER 80 mg/day - this resubmission also includes the ful [Read more]
Impact snapshot Event time: OSMT
Last Price
Price Change
Price Change %
Volume Shares
Max Up
Max Down
Volume Ratio
%
Performance comparison Updated
Event Day
Stock performance from the time of news release until the following 4pm ET market close
Last price at news event
Since Event
Multi-day stock performance from the time of the news release
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
LAST
PRICE AT
NEWS EVENT
SINCE EVENT
Multi-day stock performance from the time of the news release
Last price
VWAP
High:
Max up
High:
Low:
Max down
Low:
%
Post news range
%
Price change

Price Change Percentage


S&P 500
(SPX)

%

Volume ratio
%

Volume
Ticks

Avg transaction size

Opt-in for
OSMT alerts
from News Quantified
Opt-in for
OSMT alerts

from News Quantified
Opt-in for
OSMT alerts

from News Quantified