Posts by Aurum
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Heute verlieren weitere Aktionäre die Geduld / Nerven - Absolut verständlich, unschön gestern nach Zulassung knapp CHF 22.00, am Ende des Tages sogar im Minus und heute weitere 4% im Minus. Schade für Idorsia nach der ersten Zulassung Ihrer Firmengeschichte.
Ich bin heute Morgen vorerst auch raus, einfach Gewinn genommen.Ich bin weiterhin optimistisch aber möchte lieber später zu tieferen Kursen wieder ein paar ins Depot holen.
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Aurum hat am 14.12.2021 15:04 geschrieben:
QuoteDisplay MoreHeute wollen noch ein paar raus als SANN..
Folgendes gilt zu bedenken, d.h Chancen bei / für SANN wenn Sie das nötige Kapital vorerst sichern:1.) Verkauf Raxone in LHON (USA/CAN+Frankreich)
2.) Deal mit Chiesi - Raxone LHON (49 Mio. EUR)
3.) Partner-Deal zu vamorolone in weiteren Indikationen (ausserhalb DMD & BMD)
4.) Lizenz-Deal zu vamorolone in DMD RoW (speziell China)
5.) Partner-Deal zu lonodelestat in CF bzw. weiteren Indikationen
6.) Verkauf Omigapil in CMD (will man ja eh nicht weiterentwickeln)Punkt 4 - Check.
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Valneva Announces Positive Homologous Booster Data for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001
December 16, 2021
- Initial results show excellent immune response after third dose of VLA2001 administered 7 to 8 months after the second dose of primary vaccination
- Antibody titers increased 42- to 106-fold two weeks after booster dose vs pre-booster levels
- Antibody titers four-fold higher compared to two weeks after primary immunization
- Evaluating sera from boosted participants for cross-neutralization against Variants of Concern, including Omicron
Saint Herblain (France), December 16, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive homologous booster data from the Phase 1/2 study, of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Initial results confirm that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination.
77 of the 153 original Phase 1/2 study participants, aged 18-55 years, received a booster dose seven to eight months after completion of their primary immunization with either a low, medium or high dose of VLA2001. All participants received a single booster vaccination with VLA2001 at the same (high) dose level used in the pivotal Phase 3 “Cov-Compare” trial.[1] IgG antibody titers (spike protein-based) were measured at the time of the booster as well as two weeks after the booster dose. 45 of the 77 boosted participants were included in the final analysis.[2]
A third dose of VLA2001 elicited an excellent anamnestic response, with similar antibody levels observed whether participants were initially vaccinated with a low, medium or high dose (GMT 9699.3 (95%CI: 8497.76, 11070.71)). This represents a strong boosting effect, increasing levels of antibodies against the Wuhan virus 42- to 106-fold, depending on the pre-boosting levels of antibodies.
Antibody levels measured two weeks after the booster dose were approximately four-fold higher compared to those observed two weeks after primary immunization.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented: “We are extremely pleased to report our first booster data, confirming that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination and regardless of the initial neutralizing antibody level at the time of boosting. Boostering several months, typically six months or more, after primary immunisation is generally effective for inactivated, adjuvanted vaccines. Our teams are working diligently on our rolling review regulatory submissions so that we can quickly deploy our vaccine and ensure it reaches the people who need it. I would like to thank again the trial investigators, participants and collaborators, especially the National Institute for Health Research and the clinical teams within the NHS Research Centres.”
In addition to these initial booster data, Valneva expects to report further homologous booster data from the Phase 3 Cov-Compare study. In parallel, the Company is preparing to launch a dedicated heterologous booster trial, which will evaluate a VLA2001 booster shot provided at least six months after primary vaccination with other vaccines or following natural infection. This study is expected to commence in early 2022.
Valneva will also evaluate the sera from the boosted participants for cross-neutralization against Variants of Concern, including Omicron.
About Phase 1/2 Trial VLA2001-201
VLA2001-201 is a randomized, dose-finding trial to evaluate the safety, tolerability and immunogenicity of the inactivated, adjuvanted SARS-CoV-2 virus vaccine candidate VLA2001 in healthy subjects. VLA2001-201 is the first-in-human Phase 1/2 trial evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 153 healthy young adults aged 18 to 55 years were recruited in the trial. VLA2001-201 is being conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208).77 subjects from the 153 study participants originally included in the Phase 1/2 trial received a booster dose approximately 7-8 months after completion of their primary vaccination series.
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Verwässern ist unausweichlich, wäre diese heute abgelehnt worden, wäre dies einem Kollaps der Firma gleich gekommen sofern Sie keinen Käufer gefunden hätten.
Noch gibt es Chancen, zumindest für einen Risiko-Trade.
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Heute wollen noch ein paar raus als SANN..
Folgendes gilt zu bedenken, d.h Chancen bei / für SANN wenn Sie das nötige Kapital vorerst sichern:1.) Verkauf Raxone in LHON (USA/CAN+Frankreich)
2.) Deal mit Chiesi - Raxone LHON (49 Mio. EUR)
3.) Partner-Deal zu vamorolone in weiteren Indikationen (ausserhalb DMD & BMD)
4.) Lizenz-Deal zu vamorolone in DMD RoW (speziell China)
5.) Partner-Deal zu lonodelestat in CF bzw. weiteren Indikationen
6.) Verkauf Omigapil in CMD (will man ja eh nicht weiterentwickeln) -
Valneva Signs Advance Purchase Agreement with Bahrain for Inactivated COVID-19 Vaccine VLA2001
December 8, 2021
Saint-Herblain (France), December 8, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of an advance purchase agreement with the Kingdom of Bahrain for the supply of one million doses of the Company’s inactivated COVID-19 vaccine candidate VLA2001. This is the second purchase agreement Valneva has secured for VLA2001 since reporting positive data for its Phase 3 clinical trial Cov-Compare.
Valneva has initiated a rolling submission process with the Bahraini National Health Regulatory Authority (NHRA).
Franck Grimaud, Chief Business Officer of Valneva, commented, “We are grateful to the Bahraini government for their trust and confidence in our vaccine and are eager to work with them to start helping to address the pandemic evolution in the Middle-East. Subject to regulatory review and approval, we plan to start deliveries in the first quarter of 2022.”
A Bahraini government spokesperson stated, “Bahrain is once again at the forefront on adopting new measures to protect the health of citizens and residents against the threat of COVID-19. Subject to approval, Bahraini citizens and residents will have the ability to choose from a variety of vaccines in Bahrain that will have a positive impact on driving up vaccinations rates with 93% of the eligible population now fully vaccinated in the Kingdom.”
Last month, Valneva announced that the European Commission signed an advanced purchase agreement for up to 60 million doses of VLA2001[1]. Valneva reported positive Phase 3 results for VLA2001 in October 2021[2].
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EMA starts rolling review of Valneva’s COVID-19 vaccine VLA2001
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Rückblickend:
UK PM Johnson: disappointing that Valneva COVID-19
LONDON, Nov 24 (Reuters) - British Prime Minister Boris Johnson said on Wednesday he was disappointed that Valneva's COVID-19 vaccine had not gained approval in Britain, two months after the government cancelled a supply deal for the shot.
Britain had secured options for hundreds of millions of doses of the vaccine, but it cancelled the supply deal, worth 1.4 billion euro ($1.57 billion), in September.
Health minister Sajid Javid had said commercial considerations played into the decision, but he had added it was clear Valneva's shot would not be approved in Britain. read more
His statement was later corrected to say that the shot had not gained approval and may not gain it. read more
"I was personally very disappointed when we couldn't get approval for the Valneva vaccine in the way that we had hoped," Johnson told lawmakers on Wednesday after he was asked about the vaccine in parliament.
"What we are doing is investing massively in this country's vaccine capability across the country so that we are prepared for the next pandemic and I very much hope that Valneva will be part of that."
Valneva said it was still working with the Medicines and Healthcare products Regulatory Agency (MHRA), the independent medicines regulator, and was hopeful of UK approval.
"We continue to work closely with the UK MHRA on the rolling submission for initial approval of our inactivated COVID-19 vaccine, VLA2001, and hope that it could receive approval by the end of 2021," a Valneva spokesperson said in a statement.
"We regret the decision made by HMG (UK government) to end the UK Government's supply contract with Valneva, and remain hopeful that HMG will seek an amicable resolution."
The MHRA did not respond to a request for comment.
Earlier this month, Valneva secured a 60 million dose supply deal with the European Commission. read more
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Kapitalerhöhungen gehören bei Biotech's dazu und bei Santhera absehbar.
Vom Zeitpunkt her lieber jetzt nach den beiden positiven News als wenn der Kurs schön gelaufen wäre und wieder zusammensackt.
Zudem lässt sich die Kapitalerhöhung ich denke gut verkaufen mit den vermeintlich positiven Aussichten.
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Upcoming milestones
• Q4-2021: Completion of vamorolone 48-week VISION-DMD study providing additional safety data
Check Positiv
• Q4-2021: Conclusion of Raxone PAMs (post-authorization measures)
Raxone kann Santhera noch bis 49Mio. Milestones bringen
