14 sep: Ambu-aktien sætter rekord: Short-investorer trækker sig ud
15 sep: Bavarian Nordics forsøg med prostatakræft-medicin stoppes
14-09-2017 22:02:13

Independent Data Monitoring Committee Recommends Discontinuation of Bavarian Nordic's Phase 3 Study of PROSTVAC in Metastatic Prostate Cancer

Relateret indhold
11:43 - 
Aktier/middag: Ambu og Danske ryger til bunds i nervøst..
21 sep - 
Aktier/åbning: Danske Bank skraber bunden i positivt el..
19 sep - 
Aktier/åbning: Danske og Borgen falder efter hvidvaskko..
Relateret debat
13:01 - 
Bavarian - hvad er deres pipeline værd .... kort før Pr..
12:36 - 
Vil være en fordel at de mange kursmål bliver udmeldt F..
12:15 - 
Kunne være dejligt...

  • Conference call scheduled for 2:00 PM CEST / 8:00 AM EDT tomorrow, Friday, September 15

COPENHAGEN, Denmark, September 14, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that an independent Data Monitoring Committee (DMCB) has determined, based on a preplanned interim analysis, that continuation of the Phase 3 PROSPECT study of PROSTVAC® in patients with metastatic castration-resistant prostate cancer (mCRPC) is futile.

"We are extremely disappointed for patients that this study of PROSTVAC as monotherapy was not successful," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic. "On behalf of Bavarian Nordic, I want to express our gratitude to the PROSPECT investigators, patients and families who participated in this trial. While this is certainly not the desired outcome, we remain steadfast believers in the power of combination treatments, including immunotherapies, to transform the future of cancer therapies."

The contents of this announcement do not affect the Company's expectations for the financial results for 2017.

Conference call and webcast

The management of Bavarian Nordic will host a conference call tomorrow, Friday, September 15 at 2 PM CEST (8 AM EDT) to discuss the outcome of the interim analysis. Dial-in numbers and link to a live and archived webcast of the conference call will become available at https://www.bavarian-nordic.com/investor/events.aspx?event=5307 during the morning.

About the PROSPECT study

PROSPECT was a global, randomized, double-blind, placebo-controlled Phase 3 study conducted under a Special Protocol Assessment (SPA) from the FDA. The objective of the study was to determine whether PROSTVAC alone or in combination with GM-CSF could prolong overall survival in men with asymptomatic or minimally symptomatic mCRPC. The study enrolled 1,297 patients at more than 200 sites in 15 countries.

About PROSTVAC

PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec, or "rilimogene") is a prostate specific antigen (PSA)-targeted immunotherapy candidate designed to enhance or stimulate the body's immune response, specifically T cells that will home to and kill prostate cancer cells, altering the course of the disease and improving overall survival of patients with prostate cancer. PROSTVAC employs two poxviruses (vaccinia and fowlpox) in a prime-boost vaccine regimen. A robust data package has been established that includes 19 ongoing or completed clinical studies, comprising more than 2,000 patients, the majority of which have been actively treated with PROSTVAC, which has been generally well-tolerated.

PROSTVAC is being developed in collaboration with the National Cancer Institute under a Cooperative Research and Development Agreement.

About Bavarian Nordic

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases, based on the Company's live virus vaccine platform. Through long-standing collaborations, including a collaboration with the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for infectious diseases, including the non-replicating smallpox vaccine, IMVAMUNE®, which is stockpiled for emergency use by the United States and other governments. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its strategic partner Janssen are developing an Ebola vaccine regimen, and therapeutic vaccines for HPV, HBV and HIV. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies, including PROSTVAC®, which is currently in Phase 3 clinical development for the treatment of advanced prostate cancer. The company has partnered with Bristol-Myers Squibb for the potential commercialization of PROSTVAC. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.

Forward-looking statements

This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Contacts

Rolf Sass Sørensen

Vice President Investor Relations (EU)

Tel: +45 61 77 47 43

Seth Lewis

Vice President Investor Relations (US)

Tel: +1 978 341 5271

Company Announcement no. 26 / 2017

2017-26-en


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: Bavarian Nordic A/S via Globenewswire

Vedhæftet fil: 816546.pdf

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
21 sep
BAVA
Det er ikke så svært at finde grunden. Rigtig ofte vinder hedgefondene på deres shorts. Nogle gange ..
9
19 sep
BAVA
Hej alle, Nu er videoen oppe fra Investordagen i går. Den kan ses her: https://getvisualtv.net..
9
18 sep
BAVA
Hvad med om moderator bare sletter hele tråden! Den er jo kun startet for at skabe splid!
6
21 sep
BAVA
Jeg havde en frygt for, at BAVA kunne møde modstand her ved 175, og det ser meget aktuelt ud. Ved si..
5
21 sep
BAVA
Du har da ret i, at når Wace fonden for nyligt har øget i Bavarian, er det ikke sket til 250. Men je..
4
17 sep
BAVA
AXSchmidt, du mangler i højeste grad selvreflektion. Evnen til at debattere er tåkrummende lav. D..
4
20 sep
BAVA
BAVARIAN NORDIC LEVERER KOPPEVACCINER TIL ENGLANDS BEREDSKAB I FORBINDELSE MED AKTUELLE TILFÆLDE AF ..
3
20 sep
BAVA
Det ser ud til den har nået bunden i denne omgang og kører modsat - gennemgangen på aktionærforening..
3
19 sep
BAVA
Bavarian Nordic leverer koppevacciner til Englands beredskab i forbindelse med aktuelle tilfælde af ..
3
19 sep
BAVA
måske. Også det er uden for min vidensfære...   https://www.whitehouse.gov/briefings-statements/pres..
3

Alm. Brand og Topdanmark hæves til "køb" af Danske Markets - NY

24-09-2018 10:03:34
Danske Markets hæver anbefalingen af aktierne i de to forsikringsselskaber Alm. Brand og Topdanmark.I begge tilfælde er anbefalingen hævet til "køb" fra tidligere "hold", fremgår det af Bloomberg News. Kursmålet for Topdanmark-aktien er justeret op til 320 kr. fra før 300 kr., mens 12-måneders kursmålet for Alm. Brands aktie er fastholdt på 64 kr. Danske Markets gentager i øvrigt en købsanbefaling..

Aktier/tendens: Mærsk og Coloplast i fokus midt i handelskonflikt

24-09-2018 08:26:39
Coloplast og Mærsk kan komme i rampelyset mandag morgen, hvor de fortsatte handelsstridigheder mellem USA og Kina også vil være et af dagens store samtaleemner efter nye tariffer og en kinesisk afvisning af at deltage i nye handelsforhandlinger.Det tyder også på, at de danske eliteaktier skal en tur ned mandag morgen, hvor markedet igen er præget af den seneste udvikling i handelsstriden mellem US..

Danske: Moody's ser risiko for sænkning af kreditvurderingen - NY

21-09-2018 15:14:23
Moody's Investors Service er gået i gang med at kigge kreditvurderingen af Danske Bank efter i sømmene og forudser, at der er risiko for en nedjustering. Det oplyser ratinginstituttet fredag, hvor udsigten for Danske Banks kreditvurdering er sænket til "negativ" fra "stabil".Ændringen kommer, efter at banken har offentliggjort rapporten om hvidvask i sin estiske filial tidligere på ugen, skriver M..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Danske Bank-investorer sætter aktien på vippen - citat
2
Danske Bank er millimeter fra at udpege ny topchef - citat
3
Aktier/tendens: Mærsk og Coloplast i fokus midt i handelskonflikt
4
Hvidvasksag kan true Danmarks "AAA"-rating - citat
5
Fusion i mineindustrien skaber gigant på 18 mia. dollar

Relaterede aktiekurser

Bavarian Nordic A/S 177,25 2,0% Stigning i aktiekurs
Bavarian Nordic Ord Shs 177,25 2,0% Stigning i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Berlingske Media 2018  Handelsbetingelser  |  Cookiedeklaration  |  Cookie- og Privatlivspolitik  |  Ophavsret og vilkår
Aktieinformation leveres af Morningstar.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
24. september 2018 13:19:49
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20180919.1 - EUROWEB6 - 2018-09-24 13:19:49 - 2018-09-24 13:19:49 - 1 - Website: OKAY