NASDAQ OMX

Karolinska Development's portfolio company Modus Therapeutics' sevuparin granted Rare Pediatric Disease Designation from FDA for the treatment of sickle cell disease

Dela

STOCKHOLM, 18 April, 2018. Karolinska Development's portfolio company Modus Therapeutics candidate drug sevuparin has been granted rare pediatric disease designation by the US Food & Drug Administration (FDA) for the treatment of children with sickle cell disease (SCD).

 

The Rare Pediatric Disease Priority Review Voucher Program provides incentive for the development of treatments for rare pediatric diseases. A drug qualifies for this category if the entire prevalence of the disease in the US is below 200,000 and the serious or life-threatening manifestations of the disease primarily affect individuals from birth to age 18.

If a drug candidate with a rare pediatric disease designation receives marketing approval in the US, the FDA may issue a Priority Review Voucher to the sponsor company. This voucher can be redeemed to provide Priority Review of a subsequent marketing application for a different product from Modus Therapeutics or another company.

"FDA:s decision to grant sevuparin a rare pediatric disease designation has potential to facilitate the process of providing children with SCD with a more effective pharmaceutical treatment", said Viktor Drvota CEO of Karolinska Development.

Children with SCD suffer from some of the most serious and life-threatening consequences of the disease including stroke, splenic sequestration and aplastic anemia. Mortality is a significant concern in children suffering from SCD globally, with 92% of newborns dying in the first few years of life due to lack of early diagnosis.

There is currently no pharmaceutical product available that targets the underlying cause of the vaso-occlusive crises that leads to the severe consequences of SCD. Modus Therapeutics is currently conducting a Phase II study with sevuparin, with estimated completion in late 2018.

For more information about the Priority Review Voucher Program, please visit http://priorityreviewvoucher.org/

For further information, please contact:

Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com

TO THE EDITORS

About Karolinska Development AB
Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders.

Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success.

Karolinska Development has established a portfolio of nine companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases.

The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network.

For more information, please visit www.karolinskadevelopment.com




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Karolinska Development AB (publ) via Globenewswire

Om

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

BIMobject AB: Interim Report April - June 201815.8.2018 08:00Pressmeddelande

Second quarter 2018 Billing increased by 83 percent to SEK 33 (18) million. The Group's net sales increased by 75 percent to SEK 28 (16) million. The distribution between projects and web services (subscriptions) was 40/60 (60/40) percent. The gross margin increased to 86 (81) percent. The Group's operating profit improved to SEK -15 (-17) million. Basic earnings per share amounted to SEK -0.29 (-0.31). Cash flow from operating activities was SEK -18 (-15) million. The accumulated number of users increased to approximately 845,000. The accumulated number of downloads amounted to 25.5 million. The number of manufacturers was 1,230. The Board decided to initiate the process of listing the Company on Nasdaq Stockholm. Significant events during the second quarter BIMobject forms strategic partnership with Pipe Retail Solution to streamline digital planning of retail spaces. BIMobject signs Letter of Intent with leading US 3D media company Matterport. CEO's comments EQT Ventures' investment

BIMobject AB: Offentliggörande av delårsrapport april - juni 201815.8.2018 08:00Pressmeddelande

Den fullständiga rapporten finns även tillgänglig på bolagets hemsida (info.bimobject.com). Andra kvartalet 2018 Faktureringen ökade med 83 procent och uppgick till 33 MSEK (18). Koncernens nettoomsättning ökade med 75 procent och uppgick till 28 MSEK (16). Fördelning mellan projekt och webservices (prenumerationer) var 40/60 procent (60/40). Bruttomarginalen ökade till 86 procent (81). Koncernens rörelseresultat förbättrades och uppgick till -15 MSEK (-17). Resultat per aktie uppgick till -0,29 SEK (-0,31) före utspädning. Kassaflödet från löpande verksamheten uppgick till -18 MSEK (-15). Ackumulerat antal användare ökade och uppgick till cirka 845 000. Ackumulerat antal nedladdningar uppgick till 25,5 miljoner. Antalet tillverkare uppgick till 1230. Styrelsen beslutade att påbörja processen för notering av bolaget vid Nasdaq Stockholm. Viktiga händelser andra kvartalet BIMobject ingår samarbete med Pipe Retail Solution för att effektivisera digital butiksplanering. BIMobject tecknar

Immunicum AB (publ) presenterar prekliniska data för ilixadencel i kombination med checkpointhämmare och immunaktiverare på 2018 års ESMO-kongress13.8.2018 08:00Pressmeddelande

Pressmeddelande 13 augusti 2018 Immunicum AB (publ) presenterar prekliniska data för ilixadencel i kombination med checkpointhämmare och immunaktiverare på 2018 års ESMO-kongress Immunicum AB (publ; IMMU.ST) tillkännagav idag att bolaget kommer att presentera en poster om sin ledande produktkandidat, ilixadencel, på 2018 års kongress för European Society for Medical Oncology (ESMO) , som hålls den 19-23 oktober 2018 i München i Tyskland. Immunicum kommer att offentliggöra fullständiga data i ett pressmeddelande som följer efter presentationen. En sammanfattning av postern kommer också att publiceras i ESMO 2018 Congress Abstract Book, ett komplement till ESMO:s officiella årsbok, Annals of Oncology. Posterinformation: Titel: Intratumoral administration of pro-inflammatory allogeneic, "off-the-shelf", dendritic cells in combination with anti-PD-1 or anti-CD137 has a synergistic anti-tumor effect (Intratumoral administration av pro-inflammatoriska allogena dendritiska celler som kan lagr

Immunicum AB (publ) to Present Preclinical Data on Ilixadencel in Combination with CPIs and Immune Enhancers at ESMO 2018 Congress13.8.2018 08:00Pressmeddelande

Press Release 13 August 2018 Immunicum AB (publ) to Present Preclinical Data on Ilixadencel in Combination with CPIs and Immune Enhancers at ESMO 2018 Congress Immunicum AB (publ; IMMU.ST) announced today that the company will present a poster on its lead development candidate, ilixadencel, at the European Society for Medical Oncology (ESMO) 2018 Congress, held October 19-23, 2018 in Munich, Germany. Immunicum will announce the complete data through a press release following the presentation. The poster abstract will also be published in the ESMO 2018 Congress Abstract Book, a supplement to the official ESMO journal, Annals of Oncology. Poster Information: Title: Intratumoral administration of pro-inflammatory allogeneic, "off-the-shelf", dendritic cells in combination with anti-PD-1 or anti-CD137 has a synergistic anti-tumor effect Presentation Number: 440P Presenter: Dr. Alex Karlsson-Parra, Chief Scientific Officer Date & Time: Monday, October 22, 2018; 12.45 - 13.45 CET Location: H

Corline Biomedical AB: Läkemedelsverket ger tillstånd till klinisk prövning av Renaparin®6.8.2018 15:29Pressmeddelande

Corline Biomedical AB ("Corline") har i beslutsbrev från Läkemedelsverket erhållit tillstånd att genomföra klinisk prövning av läkemedelskandidaten Renaparin®. Läkemedelsverkets tillståndsmeddelande innebär att samtliga formella krav är uppfyllda för genomförande av studien RENAPAIR 01, som är en säkerhetsstudie i fas 1 omfattande totalt 18 patienter. Renaparin® är under utveckling för att förbättra njurtransplantation och administreras till njuren före transplantation i syfte att minska njurskador som annars kan uppstå då den mottagande patientens blodflöde kopplas ihop med donator-njuren. Corline meddelade i juni 2018 att man till Läkemedelsverket inlämnat ansökan om att få genomföra klinisk prövning av Renaparin® i en placebo-kontrollerad studie (RENAPAIR 01, Eudra-CT 2017-002075-25) där 9 patienter transplanteras med njurar som erhållit aktiv substans och 9 patienter får overksam placebo. Denna ansökan har nu godkänts av Läkemedelsverket. Studien inleds i Uppsala och genomförs däre

Cisco Schedules Conference Call for Q4 and Fiscal Year 2018 Financial Results1.8.2018 22:30Pressmeddelande

SAN JOSE, Calif., Aug. 01, 2018 (GLOBE NEWSWIRE) -- Cisco has scheduled a conference call for Wednesday, August 15, 2018, at 1:30 PM (PT); 4:30 PM (ET) to announce its fourth quarter and fiscal year 2018 financial results for the period ending Saturday, July 28, 2018. Financial results will be released over GlobeNewswire via US National, European Technology Trade Media and Western Europe distribution circuits, after the close of the market on Wednesday, August 15, 2018. Cisco's quarterly earnings press release will be posted at www.cisco.com under the "Newsroom" section. Date: Wednesday, August 15, 2018 Time: 1:30 PM (PT); 4:30 PM (ET) To Listen via Telephone: 888-848-6507 212-519-0847 (for International Callers) RSVP: No RSVP is necessary To Listen via the Internet: We are pleased to offer a live and replay audio broadcast of the conference call with corresponding slides at https://investor.cisco.com. Replay: A telephone playback of the Q4 and FY2018 conference call is scheduled to be

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum