Sectornieuws - biotech

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Sanofi wil krap 12 miljard dollar ophalen met verkoop belang in Regeneron

FONDS KOERS VERSCHIL VERSCHIL % BEURS
Sanofi
86,72 0,19 0,22 % Euronext Paris
Sanofi
86,51 -0,22 -0,25 % Gruppo Borsa Italiana
Sanofi nominatif adm
86,72 0,19 0,22 % Euronext Paris

(ABM FN) Sanofi is van plan 11,7 miljard dollar op te halen met de verkoop van bijna het gehele belang van 20,6 procent in het Amerikaanse biotechbedrijf Regeneron Pharmaceuticals. Dit maakte de Franse farmaceut dinsdagavond laat bekend.

Sanofi verkoopt 11,8 miljoen aandelen in het Amerikaanse bedrijf tegen een bedrag van 515 dollar per stuk. Daarnaast zal Regeneron zelf ook nog eens 9,8 miljoen aandelen terugkopen van Sanofi voor ongeveer 5 miljard dollar.

De Franse farmaceut heeft vervolgens nog de optie om 1,2 miljoen aandelen extra te verkopen, indien er voldoende interesse is.

Als deze overtoewijzing volledig wordt uitgevoerd, dan zal Sanofi na afloop nog slechts 400.000 aandelen in Regeneron bezitten.

Sanofi wil de verkoopopbrengst gebruiken om de innovatie en groei binnen het bedrijf verder aan te jagen.

Door: ABM Financial News.
pers@abmfn.be
Redactie: +32(0)78 486 481

© Copyright ABM Financial News B.V. All rights reserved.
Jesse Livermore
0

Novavax Initiates Phase 1/2 Clinical Trial of COVID-19 Vaccine

First participants enrolled in Phase 1 portion of clinical trial of NVX-CoV2373
Preliminary immunogenicity and safety results expected in July 2020
Phase 2 portion to begin promptly following successful Phase 1 results

GAITHERSBURG, Md., May 25, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX-CoV2373 includes Novavax’ proprietary Matrix-M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.

“Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial.”

The Phase 1/2 clinical trial is being conducted in two parts. The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX-CoV2373, both adjuvanted with Matrix-M and unadjuvanted. The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix-M and without.

The Phase 2 portion is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety and COVID-19 disease reduction in a broader age range. This Phase 1/2 approach allows for rapid advancement of NVX-CoV2373 during the pandemic. The trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).

Novavax identified NVX-CoV2373 as its lead SARS-CoV-2 candidate following pre-clinical testing that demonstrated high immunogenicity and high levels of neutralizing antibodies. These results provide strong evidence that the vaccine candidate will be highly immunogenic in humans, potentially leading to protection from COVID-19 and thus helping to control the spread of this disease.

Dr. Richard Hatchett, CEO of CEPI said, “Entering clinical trials is an important step on the path to delivering a safe, effective and globally accessible vaccine against COVID-19. Vaccines provide our best hope of permanently defeating this pandemic, so it is encouraging to see rapid progress being made in the development of Novavax’ vaccine candidate. CEPI’s priority in building our portfolio has been to focus on vaccine candidates with the potential to be developed at speed and scale and made globally accessible. Our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine, so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay.”

For more information about the trial, read here on clinicaltrials.gov.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil society organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programs will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.

Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

About NVX-CoV2373

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX-CoV2373 demonstrated efficient binding with receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX-CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected in July 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million of funding to advance clinical development of NVX-CoV2373.

About Matrix-M™

Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit www.novavax.com



Source: Novavax, Inc.
Jesse Livermore
0

Novavax Expands Large-Scale Global Manufacturing Capacity

Novavax acquires Praha Vaccines in Czech Republic
Annual operating capacity of over 1 billion doses of COVID-19 vaccine antigen

GAITHERSBURG, Md., May 27, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the acquisition of Praha Vaccines a.s., part of the Cyrus Poonawalla Group, in an all cash transaction of approximately $167 million. The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic. The facility is expected to provide an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. NVX-CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix-M™ adjuvant.

“Manufacturing capacity is a critical component of our strategy to deliver a vaccine for the COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “This acquisition provides the vital assets required to produce more than 1 billion doses per year. In parallel with ramping up production at Bohumil, we will continue efforts to expand antigen capacity in the U.S. and Asia, and increase production of Matrix-M to match antigen capacity at multiple sites globally.”

The acquisition includes a 150,000-square foot state of the art vaccine and biologics manufacturing facility and other support buildings, along with the existing employees and all related and required infrastructure. The facility is completing a renovation that includes Biosafety Level-3 (BSL-3) capabilities. As part of the transaction, approximately 150 employees with significant experience in vaccine manufacturing and support have joined Novavax.

The acquisition of Praha Vaccines is supported by Novavax’ funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI), enabling Novavax to dramatically expand its manufacturing capacity. Novavax will work collaboratively with the Serum Institute of India (SII), part of the Cyrus Poonawalla Group, to increase production levels at the Bohumil facility by the end of 2020.

“We believe Novavax and Praha reflect the ideal complement of capabilities and expertise to advance innovative vaccines that are vitally needed at this critical time,” said Cyrus Poonawalla, Chairman and Founder of the Cyrus Poonawalla Group. “We are confident that the technologies and employees are in good hands and look forward to continuing our collaborations with Novavax.”

About Cyrus Poonawalla Group

Cyrus Poonawalla Group is the parent company of Serum Institute of India Pvt. Ltd., (SII), founded in 1966 by Dr. Cyrus Poonawalla with the aim of manufacturing life-saving immuno-biologicals. SII is the flagship company of the group based in India and is now the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses per annum), which include Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, Pentavalent, BCG, r-Hepatitis B, Measles, Mumps and Rubella, and Rotavirus vaccines. It is estimated that approximately 65 percent of children globally receive at least one vaccine manufactured by Serum Institute. Vaccines manufactured by the Serum Institute are accredited by the World Health Organization, Geneva and are being used in around 170 countries across the globe in their national immunization programs, saving millions of lives throughout the world.

In March 2020, SII and Novavax announced a commercial license agreement for the use of Novavax’ proprietary Matrix-M™ vaccine adjuvant with SII’s malaria vaccine candidate, currently in a Phase 2b clinical trial.

About NVX-CoV2373

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX-CoV2373 demonstrated efficient binding with receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX-CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected in July 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million of funding to advance clinical development of NVX-CoV2373.

About Matrix-M™

Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit www.novavax.com

Source: Novavax, Inc.
Jesse Livermore
0
Covid Report: Why Moderna's Vaccine Prodded A Mass Biotech Selloff

Moderna (MRNA) prodded a biotech sell-off Wednesday as investors digested a report regarding side effects tied to the company's experimental coronavirus vaccine.

Ian Haydon, a 29-year-old volunteer from Seattle, reportedly experienced a systemic adverse reaction to the vaccine, according to a Stat News report issued Tuesday. Haydon developed a fever, sought medical attention and fainted all within a day of receiving a second dose.

That puts Haydon among three patients who experienced Grade 3 systemic symptoms after receiving the highest dose of Moderna's coronavirus vaccine. On the scale of side effects, Grade 3 is considered severe but not life threatening. And Moderna isn't moving that dose into additional testing.

Although the news came out Tuesday, makers of coronavirus vaccines tumbled Wednesday. Moderna stock sank 9.6%. Novavax (NVAX) fell 5.6% and Inovio Pharmaceuticals (INO) dropped 8.8%. Translate Bio (TBIO) toppled 6.6%. BioNTech (BNTX) lost 6.5%.

Coronavirus Vaccine Safety Questioned

Collectively, biotech stocks slumped a fraction.

The hunt for a coronavirus vaccine has put biotech and pharmaceutical companies in the hot seat over the last several months. Massive drug developers like GlaxoSmithKline (GSK), Pfizer (PFE), Merck (MRK) and Johnson & Johnson (JNJ) are in the race.

Among biotech companies, Moderna is the undisputed leader. That's because Moderna already has an interim cut of Phase 1 data. On May 18, Moderna said eight participants in the Phase 1 study began showing antibodies against the new coronavirus after the vaccine.

Moderna stock rocketed 20% on the news, helping push other coronavirus vaccine makers higher. But after the stock market closed, Moderna announced a public offering and shares slipped. Since then, Moderna stock has tumbled nearly 28% as of Tuesday's close.

The Stat News article further prodded shares down Wednesday. Haydon, the volunteer from Seattle, says he recovered from his symptoms within a day. Moderna didn't immediately respond to a request for comment on the systemic side effects seen in the study.

www.investors.com/news/technology/cor...


De Corona vaccin hype heeft ook z'n negatieve effecten; vandaag een massale verkoop van BioTech aandelen.


Groeten,

Jesse Livermore
Berdientje
0
AMSTERDAM (AFN) - Verschillende schuldeisers van het failliete biotechbedrijf Esperite vorderen bij elkaar ruim 1,4 miljoen euro van het bedrijf. Dat staat in het faillissementsverslag waarover het Financiële Dagblad berichtte. Onder meer de fiscus wil geld zien.

Het beursgenoteerde bedrijf ging in april failliet. Het werd eerder ook beboet door de Autoriteit Financiële Markten (AFM) omdat de financiële cijfers van 2017 en 2018 te lang op zich lieten wachten.

Topman Frédéric Amar werd eerder in Zwitserland aangeklaagd voor fraude. Het bedrijf kwam eerder ook negatief in het nieuws door het verlies van navelstrengbloedmonsters bij transporten uit België en Zwitserland naar Polen.
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1,4 miljoen eisen van een failliet bedrijf?
voda
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Nieuwe data Kiadis bij ISCT-presentatie

Gepubliceerd op 28 mei 2020 09:36 | Views: 104

Kiadis Pharma 09:26
1,87 +0,04 (+2,36%)

AMSTERDAM (AFN) - Biotechnoloog Kiadis Pharma presenteert donderdag ook nieuwe gegevens over zijn NK-celtherapie op het virtuele jaarcongres van de International Society of Cell & Gene Therapy (ISCT). Het bedrijf maakte eerder al bekend dat een samenvatting is geaccepteerd.

De informatie die Kiadis zal presenteren toont volgens wetenschapsdirecteur Robert Friesen aan dat het Kiadis-platform nog verder kan worden verbeterd.
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Galapagos verhoogt kapitaal

FONDS KOERS VERSCHIL VERSCHIL % BEURS
Galapagos
186,60 0,00 0,00 % Euronext Amsterdam

(ABM FN-Dow Jones) Galapagos heeft zijn kapitaal donderdag verhoogd door de uitgifte van 435.540 nieuwe aandelen, in verband met de uitoefening van inschrijvingsrechten door onder meer CEO Onno van de Stolpe. Dit meldde het biotechbedrijf donderdagavond.

Hiermee bedraagt het maatschappelijk kapitaal bijna 353 miljoen euro, aldus Galapagos.

Door: ABM Financial News.
info@abmfn.nl
Redactie: +31(0)20 26 28 999

© Copyright ABM Financial News B.V. All rights reserved.
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Kiadis Pharma presenteert nieuwe data over K-NK-celtherapie

Gepubliceerd op 29 mei 2020 14:40 | Views: 1.529

Kiadis Pharma 16:56
1,78 -0,05 (-2,79%)

AMSTERDAM (AFN) - Biotechnoloog Kiadis Pharma heeft vrijdag weer nieuwe gegevens over zijn K-NK-celtherapie gepresenteerd. De gelegenheid daarvoor was de jaarlijkse bijeenkomst van American Society of Clinical Oncology (ASCO), die virtueel plaatsvond.

Kiadis Pharma presenteerde drie studies voor het gebruik van K-NK-celtherapie voor de behandeling van terugkerende acute myeloïde leukemie. Het gaat om gegevens uit een fase I/II-studie bij patiënten die acute myeloïde leukemie en een aandoening aan het zenuwstelsel hebben en een fase 1-studie naar de veiligheid van zogeheten Natural Killer-cellen. Ook worden er gegevens van een preklinische studie getoond.
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Vertraagd 29 mei 2020 17:35
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