The US Food and Drug Administration, FDA, approves NeuroVive’s IND (Investigational New Drug) application, enabling clinical studies in the US with the company’s drug candidate NeuroSTAT.
Focus on genetic mitochondrial diseases
STOCKHOLM, Aug. 21, 2019 /PRNewswire/ --
Important events April – June
- The US Food and Drug Administration, FDA, approves NeuroVive’s IND (Investigational New Drug) application, enabling clinical studies in the US with the company’s drug candidate NeuroSTAT.
- The Supreme Court delivers its ruling concerning arbitration between NeuroVive and CicloMulsion AG. The Supreme Court rejects NeuroVive’s appeal.
- Annual General Meeting in NeuroVive was held on 25 April in Lund.
Important events after the reporting period
- NeuroVive initiates second part of its ongoing KL1333 Phase Ia/b clinical study.
- NeuroSTAT has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.
Financial information Second quarter (April-June 2019)
- Net revenues: KSEK 85 (0)
- Other operating income: KSEK 1 000 (1 278)
- Loss before tax: KSEK -20,769 (-25,481)
- Loss per share*: SEK -0,14 (-0,40)
- Diluted loss per share**: SEK -0,14 (-0,40)
Financial information First six months (January-June 2019)
- Net revenues: KSEK 85 (0)
- Other operating income: KSEK 1,000 (1,452)
- Loss before tax: KSEK -34,591 (-38,534)
- Loss per share*: SEK -0,23 (-0,61)
- Diluted loss per share**: SEK -0,23 (-0,61)
* Profit/loss for the period divided by average number of shares before dilution at the end of the period.
** Profit/loss for the period divided by average number of shares after dilution at the end of the period.
Please find the complete interim report attached, or through our website www.neurovive.com.
The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CEST on 21 August 2019.
About NeuroVive
NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine, with one project in clinical phase I (KL1333) for chronic treatment of genetic mitochondrial diseases and one project, in preparation for clinical trials (NV354), for treatment of genetic mitochondrial diseases with Complex I deficiency. NeuroSTAT for traumatic brain injury is another clinical phase project. The R&D portfolio also consists of projects for mitochondrial myopathy, NASH and cancer. NeuroVive’s ambition is to take drugs for rare diseases through clinical development and all the way to market, with or without partners. For projects for common indications the goal is out-licensing in preclinical phase. A subset of compounds under NeuroVive’s NVP015 program has been licenced to Fortify Therapeutics, a BridgeBio company, for local treatment development of Leber’s Hereditary Optic Neuropathy (LHON). NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF).
For more information, please contact:
Catharina Johansson
CFO, IR & Communications
+46 (0)46-275-62-21
ir@neurovive.com
NeuroVive Pharmaceutical AB (publ)
Medicon Village
SE-223 81 Lund, Sweden
Tel: +46 (0)46-275-62-20 (switchboard)
info@neurovive.com
www.neurovive.com
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The following files are available for download:
| NeuroVive Pharmaceutical AB Interim Report January - June 2019 |
View original content:http://www.prnewswire.com/news-releases/neurovive-pharmaceutical-ab-interim-report-january---june-2019-300904966.html
SOURCE NeuroVive Pharmaceutical
Company Codes: Berlin:NTP, Bloomberg:NVP@SS, ISIN:SE0002575340, LSE:0QDU, OTC-PINK:NEVPF, RICS:NVP.ST, Stockholm:NVP, Frankfurt:NTP, Stuttgart:NTP
