Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage (Seite 2252)

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Novavax Initiates Pivotal Phase 3 Clinical Trial of NanoFlu

Novavax, Inc.: Novavax Initiates Pivotal Phase 3 Clinical Trial of NanoFlu Influenza Vaccine in Older Adults
First participants enrolled in pivotal Phase 3 clinical trial of NanoFlu
Top-line clinical data expected in the first quarter of 2020
Phase 3 results expected to support a future BLA and licensure of NanoFlu using the FDA's accelerated approval pathway

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New Data from Novavax Phase 3 Prepare™ Trial of ResVax™ Presented at 2019 IDSOG Annual Meeting

Data demonstrate significant vaccine efficacy against infant pneumonia through the first year of life

GAITHERSBURG, Md., Aug. 12, 2019 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the presentation of new data from the company’s Prepare™ trial, a global Phase 3 clinical trial of ResVax™, an aluminum adjuvanted respiratory syncytial virus (RSV) fusion (F) protein recombinant nanoparticle vaccine. Geeta K. Swamy, M.D., Associate Professor of Obstetrics and Gynecology and Vice Dean and Associate Vice Provost for Scientific Integrity at Duke University, made the presentation at the 2019 IDSOG Annual Meeting held in Big Sky, Montana.

Dr. Swamy’s presentation included new observations based on the recently completed analyses of the 1-year safety data, including a 59.6% (95% CI 34.5, 71.7%) reduction in the incidence of serious adverse events (SAEs) diagnosed as pneumonia, with confirmation by chest x-ray, that extended through the first year of life. A similar efficacy of approximately 50% (95% CI 31.3, 62.7%) was found for all SAEs with a clinical diagnosis of pneumonia, also extending over a year. When x-ray-confirmed pneumonia SAEs associated with detection of RSV were considered, efficacy was 72.9% (95% CI. 45.7, 86.5%) through 180 days of life, the last time point at which active detection of RSV was carried out.

“Ongoing analysis of the Prepare trial data is teaching us more about how and where the vaccine was most efficacious in reducing RSV infections and its most severe complications,” said Louis F. Fries III, M.D., Chief Medical Officer of Novavax. “Based on the incidence rate for clinical pneumonia SAEs in placebo subjects in the Prepare trial and the vaccine’s efficacy in reducing this rate, ResVax could have a public health impact, in terms of vaccine-preventable disease incidence or number of women needed to vaccinate to prevent one case of infant pneumonia, that is similar or in excess of pneumococcal conjugate vaccines for similar outcomes. Such insights are valuable as we explore potential regulatory and clinical development paths forward to deliver an effective vaccine to address a serious global unmet need.”

Please click here to view a PDF of Dr. Swamy’s presentation along with other scientific presentations.

About ResVax™ and the Prepare Trial

ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. In February 2019, Novavax announced top-line data from Prepare™, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom have received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

About Novavax

Novavax, Inc. (NVAX), is a late-stage biotechnology company that drives improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. ResVax™, its RSV vaccine for infants via maternal immunization, is the only vaccine in a Phase 3 clinical program and is designed to prevent severe lower respiratory tract infection which is the second leading cause of death in children under one year of age worldwide. Novavax is also advancing NanoFlu™, its quadrivalent influenza nanoparticle vaccine, to address key factors that can lead to the poor effectiveness of currently approved flu vaccines. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.
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https://finance.yahoo.com/news/data-novavax-phase-3-prepare-…


Gute Studienergebnisse. Kann Novavax irgendwann seinen investoren mal was zurückzahlen? Ich mag noch nicht so recht dran glauben...

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Updates zu den globalen Lizenzierungspfaden für ResVax

http://ir.novavax.com/news-releases/news-release-details/nov…

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http://ir.novavax.com/news-releases/news-release-details/nov…

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Ebola - Impfstoff

https://www.openpr.com/news/1729638/Ebola-Vaccine-Market-Str…

...und Novavax ist mit dabei!

Kongo
:
Zahl der Ebola-Fälle seit Ende März um fast 50 Prozent gestiegen

https://www.zeit.de/wissen/2019-05/kongo-ebola-epidemie-anst…

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Reverse-Split

http://ir.novavax.com/news-releases/news-release-details/nov…

Google-Übersetzung:

Novavax gibt Aktiensplit der Stammaktien bekannt

GAITHERSBURG, Md., 08. Mai 2019 (GLOBE NEWSWIRE) - Novavax, Inc. (Nasdaq: NVAX) gab heute bekannt, dass ein Aktiensplit der ausgegebenen und ausstehenden Stammaktien im Verhältnis eins zu zwanzig durchgeführt wird. Die Aktionäre von Novavax genehmigten eine Änderung der zweiten geänderten und angepassten Gründungsurkunde von Novavax (die geänderte Urkunde), um den Aktiensplit bei einer Sondersitzung der Aktionäre am 8. Mai 2019 durchzuführen. Der Aktiensplit soll Novavax einen größeren Umfang verleihen Flexibilität bei der Berücksichtigung und Planung zukünftiger potenzieller Geschäftsanforderungen und Erhöhung des Börsenkurses der Novavax-Stammaktien je Aktie, damit Novavax die Mindestpreisanforderungen für die fortgesetzte Notierung am Nasdaq Global Select Market erfüllen kann. Gemäß dem geänderten Zertifikat wird der umgekehrte Aktiensplit am 10. Mai 2019 um 00:01 Uhr Eastern Time wirksam. Novavax geht davon aus, dass seine Stammaktien bei der Eröffnung des Handels am 10. Mai 2019 an der Nasdaq gehandelt werden Global Select Market auf splitbereinigter Basis unter dem aktuellen Handelssymbol „NVAX“ und der neuen CUSIP-Nummer 670002 401.


Der umgekehrte Aktiensplit betrifft alle ausgegebenen und ausstehenden Aktien der Novavax-Stammaktien. Der Nennwert der Stammaktien von Novavax bleibt nach dem Aktiensplit unverändert bei 0,01 USD je Aktie. Der umgekehrte Aktiensplit wirkt sich einheitlich auf alle Aktionäre aus und verändert nicht den prozentualen Anteil der Aktionäre am Novavax-Aktienkapital, mit Ausnahme des Ausmaßes, dass der umgekehrte Aktiensplit dazu führt, dass einige Aktionäre anstelle von Bruchteilen von Aktien Bargeld erhalten, wie nachstehend beschrieben.

Im Zusammenhang mit dem Reverse Split werden keine Anteilsbruchteile ausgegeben. Aktionäre, die andernfalls Anspruch auf einen Spitzenbetrag hätten, erhalten stattdessen eine Barzahlung als Ersatz für diesen Spitzenbetrag, der dem vom Verwaltungsrat von Novavax nach Treu und Glauben festgestellten Marktwert dieser Spitzenbeträge entspricht.

Die Computershare Trust Company, N.A., fungiert als Börsen- und Transferstelle für den Aktiensplit. Aktionäre, die ihre Aktien elektronisch in Buchform halten, müssen keine Maßnahmen ergreifen, um Aktien nach dem Split zu erhalten. Computershare wird den Aktionären mit physischen Zertifikaten Anweisungen bezüglich des Verfahrens zum Umtausch ihrer vorgeteilten Aktienzertifikate gegen Bucheintragung der entsprechenden Anzahl von Post-Split-Aktien und zum Erhalt der Zahlung für etwaige Teilaktien erteilen. Aktionären, die Aktien über eine Bank, einen Broker oder einen anderen Nominee besitzen, werden ihre Positionen angepasst, um den umgekehrten Aktiensplit widerzuspiegeln. Sie erhalten eine Zahlung für gebrochene Aktien gemäß den Angaben ihrer jeweiligen Bank, Broker oder Nominee .......

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Can Novavax Convince the FDA Its Vaccine Deserves a Chance?

Kann Novavax die FDA überzeugen, dass der Impfstoff eine Chance verdient?

https://www.fool.com/investing/2019/03/01/can-novavax-convin…

[Magnetfeldfredy]

Ich bleib dabei, vollles Risiko sicher nicht, die Endpunkte wurden nicht erreicht, das ist Fakt!
Jedoch gibt es vielleicht eine Hintertüre für Novavax.......

[jemand]

Einstieg? Volles Risiko, vielleicht erholt sie sich wieder etwas...?

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Ganz Tod ist Novavax noch nicht, scheintod:

Another PhIII RSV failure thumps beleaguered Novavax, but execs claim there’s a way forward

by Amber Tong

— on February 28, 2019 09:25 AM EST

PDF

Back in November 2016, when Novavax was picking up the scraps from a Phase III crash of its RSV vaccine in older adults, the company pointed to the Gates Foundation-backed program to test the vaccine in infants as a “significant commercial opportunity.” It went on to become the lead program as Novavax mounted an arduous comeback campaign for RSV-F vaccine.

But today, execs conceded that the infant trial has suffered the same late-stage fate.

Stanley Erck

Investors showed little patience for a company that’s been quick with explanations but slow to deliver. The stock $NVAX tanked more than 65% in pre-market trading to $2.13.

As it turned out, immunizing mothers with ResVax while they are pregnant did not prevent medically significant lower respiratory tract infections caused by RSV in infants for the first three months of their lives — the primary endpoint.

To be sure, Novavax is operating in a tough field littered with setbacks, including a flop from Regeneron (which has since dropped its RSV antibody). In a rare win, AstraZeneca recently secured expedited reviews in the US and EU for a different approach — a single dose long-acting drug for a broad swath of newborns.

What the treatment did achieve — and this is the silver lining that execs are holding onto as they try to beat down a path to approval — was protecting infants from “some of the most serious consequences of RSV, including RSV LRTI hospitalizations and RSV LRTI with severe hypoxemia,” CEO Stanley Erck said in a statement.

In other words, execs elaborated on a conference call, while the vaccine was not deemed effective for common — but less severe — manifestations of the respiratory syncytial virus, it appears to protect the small group of infants who get the worst attacks.

They also suggested that vaccinating mothers at an earlier stage of gestation (from 28 to 33 weeks) might increase efficacy — potentially a key point in their pitch to regulators.

Novavax offered a peek on the data, which it plans to unveil at a medical meeting. Respectively, the efficacy rates of ResVax in per-protocol infants were as follows::

39% against medically significant RSV LRTI (97.5%CI, -1% to 64%)
44% against RSV LRTI hospitalizations (95%CI, 20% to 62%)
48% against RSV LRTI with severe hypoxemia (95%CI, -8% to 75%)