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geht hier was

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15.03.12 22:06
6

5346 Postings, 3854 Tage toni1111geht hier was

Die Biotechnologie-Firma MondoBiotech kämpft ums Überleben. Nun erhofft sich CEO Ruggero Gramatica Rettung aus Italien. Das im Kloster Stans eingemietete KMU steckt in Übernahmeverhandlungen mit Pierrel. Die Mailänder Firma befasst sich auf Kundenauftrag mit Dienstleistungen rund um die Entwicklung von Pharmazeutika. Zudem werden nördlich von Neapel, genauer in Capua, für Dritte Medikamente produziert.

Falls sich die beiden Seiten einigen können, soll MondoBiotech mit Pierrel Research International in Thalwil zusammengelegt werden. Beim Schweizer Ableger handelt es sich um jene Firma, die auf Kundenauftrag forscht. Doch Anfragen am Hauptsitz sind unerwünscht. Auf die Frage, wie viele Personen in Thalwil arbeiten, wurde der Telefonhörer aufgelegt.

Nach der Fusion hielte Pierrel die Mehrheit. Damit wäre Präsident Canio Mazzaro der neue starke Mann; er hält ein Viertel der Aktien an der Mailänder Firma. Woran die Italiener interessiert sind, ist nicht klar. MondoBiotech hat seit der Gründung 2001 primär heisse Luft und Riesenverluste produziert. Alleine im ersten Halbjahr 2011 ist ein Fehlbetrag von 54 Millionen angefallen. Jüngst wurde das Unternehmen stark redimensioniert, gegenwärtig stehen noch neun Namen auf der Gehaltsliste ? davon fünf Manager. Der Aktienkurs ist seit dem IPO um sage und schreibe 99 Prozent abgestürzt.

Möglicherwiese will sich Pierrel einfach einen Aktienmantel umhängen, um so ohne Umwege den Sprung an die speziell bei italienischen Pharmaunternehmen beliebte Schweizer Börse zu schaffen. Die Firma könnte frischen Wind gebrauchen; ihre in Mailand kotierten Aktien haben seit 2007 über 80 Prozent an Wert eingebüsst, die Gesellschaft wird von der Börse noch mit 26 Millionen Euro bewertet. Über die letzten Jahre sind einige Dutzend Millionen an Verlusten angefallen.

Muss MondoBiotech in Stans die Lichter löschen, falls die Fusion platzt? «Die Firma ist in der Lage, ihr Kerngeschäft in diesem Jahr weiterzuführen», behauptet CEO Gramatica.

Am MondoBiotech-Hauptsitz im Kloster Stans arbeiten noch neun Personen ? inklusive CEO Ruggero Gramatica.

http://www.bilanz.ch/unternehmen/mondobiotech-lichterloeschen

zur info ich bin noch nicht drinn  
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1521 Postings ausgeblendet.

13.09.21 08:44

771 Postings, 628 Tage IneosDanke Paioneer :-)

Hier noch mal in Deutsch :-) und als Adhoc
Relief Therapeutics gibt ein Update zu den regulatorischen Interaktionen im Vereinigten Königreich und in der Europäischen Union in Bezug auf den führenden Medikamentenkandidaten RLF-100 (Aviptadil)

Genf, Schweiz, 13. September 2021 - RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) ("Relief"), ein biopharmazeutisches Unternehmen, das Patienten therapeutische Linderung bei schweren Krankheiten mit hohem ungedecktem Bedarf verschaffen will, teilte heute mit, dass es von der britischen Arzneimittelbehörde MHRA (Medicines and Healthcare products Regulatory Agency) eine wissenschaftliche Beratung zu seinem führenden Prüfpräparat RLF-100TM (Aviptadil) für die Behandlung von Atemwegserkrankungen aufgrund von schwerem COVID-19 erhalten hat.
Der Leitfaden, der im Rahmen eines kürzlichen Treffens von Relief mit der MHRA erstellt wurde, enthielt Ratschläge zum geeigneten Weg für die Einreichung eines Antrags auf bedingte Marktzulassung (CMA)1 für die intravenöse Formulierung von RLF-100, vorbehaltlich der Bereitstellung aller Daten aus der Phase-2b/3-Studie in den USA, die von Reliefs Kooperationspartner, NeuroRx, Inc. ("NeuroRx")
Nach Ansicht der MHRA wäre eine CMA im Rahmen einer rollierenden Prüfung oder eines beschleunigten Prüfungsverfahrens ein geeigneter Weg, um einen raschen Zugang zu nützlichen Behandlungen für mit COVID-19 infizierte Patienten zu gewährleisten.
Eine rollierende Prüfung ermöglicht es der MHRA, mit der Prüfung der verschiedenen Abschnitte eines Antrags zu beginnen, sobald diese von Relief vervollständigt und der MHRA vorgelegt werden.
Relief teilte heute außerdem mit, dass es Gespräche mit der Europäischen Arzneimittelagentur (EMA) über den weiteren Zulassungsweg für RLF-100 in der Europäischen Union geführt hat.
Relief hat die EMA darüber informiert, dass es den Dialog mit der MHRA fortsetzen wird, sobald es wichtige Informationen über die Durchführung der Studie, die klinischen Daten und das Arzneimittel zusammengestellt hat.

Relief teilte außerdem mit, dass NeuroRx ihm bisher nicht alle Daten aus seiner US-Phase-2b/3-Studie zur Bewertung von intravenös verabreichtem Aviptadil für die Behandlung von Atemversagen bei schwerkranken Patienten mit COVID-19 zur Verfügung gestellt hat.

Es kann nicht garantiert werden, dass NeuroRx die erforderlichen Informationen zur Verfügung stellen wird.

1 Im Interesse der öffentlichen Gesundheit kann eine CMA für Arzneimittel auf der Grundlage weniger umfassender klinischer Daten als normalerweise erforderlich erteilt werden, wenn der Nutzen der sofortigen Verfügbarkeit des Arzneimittels das Risiko überwiegt, das sich aus der Tatsache ergibt, dass noch zusätzliche Daten erforderlich sind. Humanarzneimittel kommen in Frage, wenn sie für die Behandlung, Vorbeugung oder Diagnose von zu Invalidität führenden oder lebensbedrohenden Krankheiten bestimmt sind. Dazu gehören auch Arzneimittel für seltene Leiden. Ihre Verwendung ist auch für einen Notfall im Bereich der öffentlichen Gesundheit (z. B. eine Pandemie) vorgesehen.


 
Ad hoc announcement pursuant to Art. 53 LR  
1

Relief Therapeutics Provides Update on Regulatory Interactions in the United
Kingdom and European Union Relating to Lead Drug Candidate, RLF-100
(Aviptadil)
Geneva, Switzerland, September 13, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(“Relief”),  a  biopharmaceutical  company  seeking  to  provide  patients  therapeutic  relief  from  serious
diseases with high unmet need, reported today that it has received scientific advice from the Medicines
and  Healthcare  products  Regulatory  Agency  (MHRA)  in  the  United  Kingdom  (UK)  relating  to  its  lead
investigational  drug,  RLF-100TM  (aviptadil),  for  the  treatment  of  respiratory  deficiency  due  to  severe
COVID-19. The guidance, which was provided in the context of a recent meeting that Relief held with the
MHRA,  included  advice  on  the  appropriate  pathway  for  submission  of  an  application  for  conditional
marketing  approval  (CMA)1  for  the  intravenous  formulation of  RLF-100,  subject  to  provision  of  all  data
from  the  U.S. Phase  2b/3 study  conducted  by  Relief’s  collaboration  partner,  NeuroRx,  Inc.  ("NeuroRx")
According  to  the  MHRA,  a  CMA  through  rolling  review  or  expedited  review  process  would  be  an
appropriate pathway to ensure speedy access to beneficial treatments for patients infected with COVID-
19.  A  rolling  review  allows  the  MHRA  to  start  review  of  various  sections  of  a  submission  as  they  are
completed by Relief and provided to the MHRA.  
Relief  also  reported  today  that  it  has  held  discussions  with  the  European  Medicines  Agency  (EMA)
pertaining to the regulatory path forward for RLF-100 in the European Union.  Relief has informed EMA
that it will proceed with further dialogue with the MHRA once it has compiled critical information related
to the study conduct, clinical data and the drug product.
Relief also reported that, to date, NeuroRx has not provided it with all of the data from its U.S. Phase 2b/3
study evaluating intravenously administered aviptadil for the treatment of respiratory failure in critically
ill patients with COVID-19. There can be no assurance that NeuroRx will provide the required information.  



1  In  the  interest  of  public  health,  a  CMA  may  be  granted  for  medicines  on  less  comprehensive  clinical
data than normally required, where the benefit of immediate availability of the medicine outweighs the
risk inherent in the fact that additional data are still required. Medicines for human use are eligible if they
are intended for treating, preventing or diagnosing seriously debilitating or life-threatening diseases. This
includes orphan medicines. Its use is also intended for a public health emergency (e.g., a pandemic).


 
Ad hoc announcement pursuant to Art. 53 LR  
2


ABOUT RELIEF
Relief  focuses  primarily  on  clinical-stage  programs  based  on molecules with  a  history  of  clinical  testing
and  use  in  human  patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,  
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders  and  Maple  Syrup  Urine  Disease.  In  addition,  Relief's  recently  completed  acquisitions  of  APR
Applied  Pharma  Research  SA  and  AdVita  Lifescience  GmbH  bring  a  diverse  pipeline  of  marketed  and
development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the  U.S.  on  OTCQB  under  the  symbol  RLFTF.    For  more  information,  visit  www.relieftherapeutics.com.  
Follow us on LinkedIn.


CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer  
Mail: contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:  
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

Disclaimer:  This  communication  expressly  or  implicitly  contains  certain  forward-looking  statements
concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks,
uncertainties and other factors, including (i) whether NeuroRx will provide Relief with the data from its
Phase 2b/3 study, (ii) whether  aviptadil will ever be approved in the  UK or the EU for the  treatment of
respiratory failure in critically ill patients with COVID-19,  and (iii)  those  risks discussed in Relief's filings
with the SIX, which could cause the actual results, financial condition, performance or achievements of
RELIEF  THERAPEUTICS  Holding  SA  to  be  materially  different  from  any  future  results,  performance  or
achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding
SA is providing this communication as of this date and do not undertake to update any forward-looking
statements contained herein as a result of new information, future events or otherwise.


 

13.09.21 13:24

771 Postings, 628 Tage IneosAPR stockt Personal auf :-)

hier geht mehr : https://www.linkedin.com/feed/update/...activity:6843089836925063168/

Jetzt aktuell ist ja seitens Relief/Neurox die 3 Tägige Konferenz am laufen . Mal schauen was dabei
heraus kommt . :-)  

17.09.21 04:08

771 Postings, 628 Tage Ineosneues Video Dr. Joey Johnson :-)

17.09.21 14:24

771 Postings, 628 Tage Ineosmehr von Dr. Joey Johnson :-)

17.09.21 18:26

771 Postings, 628 Tage IneosEndspurt Orderbook SIX :-)

Detailinformationen
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Weniger anzeigen
 

18.09.21 11:11

131 Postings, 623 Tage stoam@Ineos

Und was sagt uns das?  

18.09.21 18:19

Clubmitglied, 487 Postings, 682 Tage Regi51@stoam, Ineos zeichnet den Endspurt auf.

21.09.21 08:24

771 Postings, 628 Tage IneosAd hoc :-)


 
1


Ad hoc announcement pursuant to Art. 53 LR  
Relief  Therapeutics’  Wholly  Owned  Subsidiary,  APR  Applied  Pharma  Research,
Reports  Data  Published  in  the  Peer  Reviewed  Journal,  Nutrients,  Indicating
Additional Potential Benefits of Its Physiomimic™ Technology

• Data In Healthy Volunteers Suggests That APR’s Controlled Release Amino Acid Mix, PKU
GOLIKE®,  May  Be  Key  To  Reducing  Catabolic  Events  In  Patients  With  Phenylketonuria
(“PKU”), Improving Utilization Of Amino Acids And Quality Of Life  

Geneva, Switzerland, September 21, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(“Relief”),  a  biopharmaceutical  company  seeking  to  provide  patients  therapeutic  relief  from  serious
diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma
Research  SA  (“APR”), reported data published in  the peer reviewed  journal, Nutrients, indicating
additional potential benefits of the company’s Physiomimic™ Technology to the management of patients
suffering from phenylketonuria (“PKU”).  

The paper, entitled, “Nitrogen Balance after the Administration of a Prolonged-Release Protein Substitute
for Phenylketonuria as a Single Dose in Healthy Volunteers,” provides a further evaluation of published
data  from  APR’s previously  reported,  randomized,  controlled,  single-dose  crossover  trial  in  healthy
volunteers which showed that a prolonged-release amino acid (AA) mixture, formulated with Physiomimic
Technology,  significantly  slowed  down  the  release  and  reduced  the  peak  plasma  concentrations  of
essential AAs compared with a free AA mixture. Authors of the current paper, including Anita MacDonald,
Ph.D. and Ania C. Muntau, M.D, renowned experts in the field of metabolic diseases, concluded that the
controlled release amino acid mix (PKU GOLIKE®), given its ability to prolong the release of AAs, appears
to be key to reducing catabolic events in patients with PKU, resulting in a more efficient utilization of AAs
for protein synthesis and, therefore, an improved quality of life.  

“The paper’s conclusions reaffirm our belief as to the benefits of our patented Physiomimic Technology,
the distinct advantages of our PKU GOLIKE® family of products, and the potential additional advantages
conferred by the product’s  unique  ability  to  prolong  the  release  of  AAs,” stated Paolo Galfetti, Chief
Executive Officer of APR and President of Relief Europe. “The  Physiomimic  Technology  allows  for  a
formulation of AAs which we believe leads to a physiological absorption profile more closely resembling
the absorption profile of natural proteins. Based on the results published in the paper, we plan to explore
 
2

additional  clinical  assessments  to  support  the  benefits  of  AAs  physiological  absorption  associated  with
PKU GOLIKE and the patented pharmaceutical Physiomimic Technology behind it.”

“The strong clinical results are a testament to the potential benefits of PKU GOLIKE® as compared to non-
prolonged  release  AA  supplementation,” stated Raghuram  (Ram)  Selvaraju,  Chairman  of  the  Board  of
Relief. “PKU GOLIKE® has been granted Orphan Drug Designation in the U.S. and further clinical studies
on  the  benefits  of  the  Physiomimic  Technology  will  help  as  we  pursue  PKU  GOLIKE®  as  a  prescription
product.  In  the  meantime,  we  will  focus  on  the  commercial  expansion  and  refinement  of  marketing
activities to facilitate the growth of this product line in Europe.”

About PKU GOLIKE
The  PKU  GOLIKE  family  of  products  are  food  for  special  medical  purposes  (FSMP)  consisting  of  a
phenylalanine-free  amino  acid  mix  in  granules.  Engineered  with  the  Company’s patented  Physiomimic
Technology platform, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a
special coating that ensures a better physiological absorption of the amino acids, while also masking their
unpleasant taste, odor and aftertaste.  

About Phenylketonuria or PKU
PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine,
leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive
levels  of  phenylalanine  in  the  blood  cause  accumulation  in  the  brain,  which  hampers  proper  brain
development  and  results  in  neurophysiological  dysfunction.  Treatment  of  PKU  is  lifelong,  requiring
patients  to  follow  a  strict  diet  that  severely  limits  phenylalanine  (and,  thus,  protein)  content.    This
necessitates supplementation of amino acid-based foods for special medical purposes (FSMP) to prevent
protein deficiency and optimize metabolic control.  

ABOUT RELIEF
Relief  focuses  primarily  on  clinical-stage  programs  based  on molecules with  a  history  of  clinical  testing
and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,  
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders  and  Maple  Syrup  Urine  Disease.  In  addition,  Relief's  recently  completed  acquisitions  of  APR
Applied  Pharma  Research  SA  and  AdVita  Lifescience  GmbH  bring  a  diverse  pipeline  of  marketed  and
development-stage programs.

 

23.09.21 11:21

771 Postings, 628 Tage IneosStudie Prof. Dr. Leuppi abgeschlossen

die Ergebnisse stehen noch aus !! Hoffe auf positiv !! :-)

https://www.kofam.ch/en/snctp-portal/...-a-clinical-trial/?sid=134145  

24.09.21 07:11

771 Postings, 628 Tage IneosAd hoc von Heute ! :-)







 
Ad hoc announcement pursuant to Art. 53 LR

1

Relief Reports Half-Year 2021 Results and Provides Corporate
Update  

Geneva, Switzerland, September 24, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(“Relief”),  a  biopharmaceutical  company  seeking  to  provide  patients  therapeutic  relief  from  serious
diseases  with  high  unmet  need,  today  reported  its  results  for  the  half-year  ended  June  30,  2021  and
provided a corporate update.
“While we await the FDA’s decision on the Emergency Use Authorization (EUA) for IV RLF-100 (aviptadil),
filed by our collaboration partner NeuroRx, Inc. (NeuroRx), we have successfully transformed Relief into
a  fully-integrated,  multi-product,  revenue-generating biopharmaceutical company,” stated Raghuram
Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. “A critical component of our success so far
this year was the acquisition of APR Applied Pharma Research SA (APR), which expanded and diversified
our specialty drug pipeline, added a number of key commercialized products, including the PKU GOLIKE®
family of products for the treatment of phenylketonuria (PKU), provided a European based commercial
infrastructure that we hope  to  leverage  for future product  launches, including ACER-001, and offers an
internal R&D capability that we plan to use for the development our own products as well as for third-
party products on a fee for service basis.”
Dr. Selvaraju continued, “Through our collaboration with Acer Therapeutics, we recently filed a New Drug
Application (NDA) with the U.S. Food and Drug Administration (FDA) for ACER-001, a proprietary powder
formulation of sodium phenylbutyrate (NaPB), designed to be both taste-masked and immediate release,
for the treatment of urea cycle disorders (UCDs) and maple syrup urine disease (MSUD). We look forward
to the potential acceptance of the filing for regulatory review, which we expect to receive next month.”
“Also important was our recent acquisition of AdVita Lifescience GmbH (AdVita), from which we gained
key pending intellectual property that may cover an improved inhaled formulation of RLF-100 (aviptadil),
in development for a number of lung diseases, including acute respiratory distress syndrome (ARDS), and
checkpoint  inhibitor-induced  pneumonitis  (CIP).  In  parallel,  IV  RLF-100  continues  to  be  evaluated  as  a
treatment for severely ill COVID-19 patients, while the inhaled formulation is being tested in two clinical
trials, one for patients with critical COVID-19 and another for moderate and severe COVID-19 patients. As
we look ahead, and with a firm financial footing in place, we will maintain our commitment to pursuing
additional strategic opportunities, both in-license and acquisition related, in order to aggressively expand
and diversify our business.”







 
Ad hoc announcement pursuant to Art. 53 LR

2

Clinical Development Highlights:
RLF-100 (aviptadil), IV
• In March 2021, Relief’s collaboration partner, NeuroRx, Inc. (NeuroRx) announced top-line 60-day
results for the phase 2b/3 trial of RLF-100™ for the treatment of patients with critical COVID-19
respiratory failure. These findings formed the basis for NeuroRx’s Emergency Use Authorization
(EUA) application to the U.S. Food and Drug Administration (FDA).
• In  April  2021,  NeuroRx  announced  that  RLF-100  had  been  selected  for  inclusion  in  TESICO
(Therapeutics  for  Severely  Ill  Inpatients  with  COVID-19),  an  international,  phase  3,  multicenter
clinical trial being sponsored by the U.S. National Institutes of Health (NIH).
• In June 2021, NRx Pharmaceuticals Inc. (NRx), the parent company of NeuroRx, announced that
NeuroRx had submitted its EUA application to the FDA for the use of RLF-100 in the treatment of
critically ill COVID-19 in patients with respiratory failure.  NeuroRx also reported that it plans to
submit a New Drug Application (NDA) to the FDA.
• In June 2021, NRx announced additional positive results from the RLF-100 U.S. Expanded Access
Protocol (EAP). These EAP data were then submitted to the FDA and were characterized by NRx
as “real world” evidence in support of the findings from the phase 2b/3 trial.    
• In July 2021, NRx reported that it identified a statistically significant effect of RLF-100 in preventing
the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. The
data was collected as part of the ongoing U.S. phase 2b/3 trial and NeuroRx reported that it had
submitted these findings to the FDA as a supplement to the pending EUA application.  
• In July 2021, NRx announced the successful validation of the commercial formulation of RLF-100
for IV use, allowing for high volume manufacture, with an anticipated one year or greater stability,
under appropriate storage conditions.
• In July 2021, NRx announced that the Nation of Georgia's Prime Minister and Minister of Health
had issued an EUA for RLF-100.
• In  August  2021,  NRx  provided  a  safety  update on  RLF-100  which  is  being  tested  in  the  ACTIV-3
Critical Care phase 3 study sponsored by the NIH, designed to evaluate RLF-100 and remdesivir in
critical COVID-19 patients, as a monotherapy and in combination against placebo. They reported
that  the  study's  Data  Safety  Monitoring  Board  found  no  new  safety  concerns  in  the  trial  and
recommended continued enrollment.  
• In August 2021, NRx reported a new analysis showing that patients with acute respiratory failure
due  to Critical COVID-19 who were  treated with aviptadil demonstrated improvement in blood
oxygen, indicative of improved lung function, within a day of starting treatment. NRx noted that
this  analysis  appears  to  support  its  plan  to  submit  an  application  for  Breakthrough  Therapy
Designation  to  the  FDA  and  that,  if  granted,  could  confer  Priority  Review  to the  aviptadil  NDA,
when submitted.

 

24.09.21 12:20
1

Clubmitglied, 487 Postings, 682 Tage Regi51Löschung


Moderation
Zeitpunkt: 26.09.21 16:41
Aktion: Löschung des Beitrages
Kommentar: Regelverstoß - Regelverstoß - Quellenangabe fehlt

 

 

25.09.21 11:37
1

771 Postings, 628 Tage IneosRattenfänger ?? :-)

Moin Regi ! Wieso Rattenfänger ? Alle Infos die ich hier teile sind verlinkt und zum
nachlesen . Unter Rattenfängerei verstehe ich das verbreiten von Unwahrheiten
oder sehe ich hier was falsch ? Jeder sollte im Stande sein sich eine eigene
Meinung bilden zu können . Rattenfängerei sieht wahrlich anders aus . Euch
Allen noch ein schönes Wochenende zum relaxen !! :-)  

25.09.21 11:55
1

208 Postings, 2528 Tage Der HobbyaktionärRattenfänger

Hallo Zusammen,
bin mit einer Minniposition investiert und normalerweise nur stiller Mitleser. Ich bin Ineos dankbar für
seine Recherchen und den dafür benötigten Zeitaufwand den er dafür erbringt.
Ich weiß überhaupt nicht, wie er an all diese Informationen kommt, sie bringen mich aber dazu meine
Vorgehensweise in diesem Wert zu prüfen und auch etwas zu steuern.
Aber für alle meine Entscheidungen bin ich allein verantwortlich, egal ob Verkauf, oder Kauf, kein Ineos, oder irgend ein proffssioneller Anlageberater.
Aus diesem Grund ist er für mich kein Rattenfänger.

Allen Mitstreitern ein schönes Wochenende und gute Anlageentscheidungen

Grüße aus dem Vordertaunus  

26.09.21 10:19

771 Postings, 628 Tage Ineosguter Artikel :-)

27.09.21 15:07

771 Postings, 628 Tage IneosNews NeuroRX :-)

NRx Pharmaceuticals Announces Improved Survival at One Year in Highly Comorbid COVID-19 Patients Treated with ZYESAMI (aviptadil)  :-)
 

27.09.21 15:09

771 Postings, 628 Tage IneosNeuroRX :-)


NRx Pharmaceuticals, Inc.

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NRx Pharmaceuticals Announces Improved Survival at One Year in Highly Comorbid COVID-19 Patients Treated with ZYESAMI (aviptadil)
September 27, 2021 7:04am EDT
Download as PDF
- ZYESAMI™ (aviptadil) Has Previously Demonstrated a Statistically Significant Increase in Survival of Highly Comorbid COVID-19 Patients in Two 60-day Trials
- In a Study of Highly Comorbid Patients, ZYESAMI Provided a Threefold, Statistically Significant Increase in Likelihood of Survival at One Year

RADNOR, Pa., Sept. 27, 2021 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP), a clinical stage, biopharmaceutical company, today announced top line data demonstrating improved outcomes at one year in highly comorbid patients with COVID-19 who were treated with ZYESAMI™.

(PRNewsfoto/NeuroRx)

"These latest data are encouraging and will help those of us on the frontlines treat the sickest COVID patients, potentially providing new treatment options and strategies," said Dr. J. Georges Youssef.

Between June and September 2020, a trial was conducted at a leading tertiary care hospital involving patients with Critical COVID-19 whose level of comorbidity excluded them from the randomized phase 2b/3 clinical trial of ZYESAMI. A statistically significant difference in both survival and recovery from respiratory failure was reported at 28 days. Those findings are soon to be published in a peer-reviewed journal.

Participants in this trial have now been followed for one year from initial enrollment. Top-line results show a statistically significant (P<.0001) 3-fold advantage in likelihood of being alive at one year post treatment (60% vs. 20%) among those treated with ZYESAMI, in addition to standard of care, compared to those who received the standard of care alone. Assignment to ZYESAMI in the trial was based on the specific medical team which admitted the patient to the intensive care unit (ICU). Once in the ICU, all patients were cared for by the same medical team, and according to the same treatment protocols.

"We are still learning so much about COVID-19, especially in patients already managing chronic medical conditions, and continuing to recover from COVID-19" said Dr. J. Georges Youssef, the Principal Investigator who serves as Head of Academic Pulmonary Medicine at Houston Methodist Hospital and as Assistant Professor of Clinical Medicine at Weill Cornell Medical College.  "These latest data are encouraging and will help those of us on the frontlines treat the sickest COVID patients, potentially providing new treatment options and strategies."

These one-year findings are consistent with the increased odds of 60-day survival seen in the previously reported results from the phase 2b/3 randomized controlled trial of ZYESAMI.  ZYESAMI Remains Under Review by the US Food and Drug Administration for Emergency Use Authorization in Patients Suffering Critical Covid-19 with Respiratory Failure.

About ZYESAMI™ (aviptadil)/VIP in COVID-19

ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP). Aviptadil binds specifically to the alveolar type II cell (AT2) in the air sac (alveolus) of the lung, where it has demonstrated potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury and inflammation. Aviptadil stimulates AT2 cells to produce the surfactant that coats the lining of the lungs to facilitate oxygen exchange with blood. Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.

COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The AT2 cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. Coronavirus infection of the AT2 cell shuts down surfactant production, triggers the formation of inflammatory cytokines, and causes cell death (cytopathy). Aviptadil is shown to upregulate surfactant production, block Coronavirus replication in the AT2 cell, block cytokine synthesis, and prevent viral-induced cell death (cytopathy). Other than ZYESAMI™, no currently proposed treatments for COVID-19 specifically target this mechanism of action.

About NRx Pharmaceuticals

NRx Pharmaceuticals (www.nrxpharma.com) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing Phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority, a part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. NRx also has the BriLife™ vaccine for COVID-19 in clinical trials and holds the exclusive worldwide license to commercialize the vaccine. The BriLife vaccine was first developed by the Israel Institute for Biological Research.

NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

Cautionary Note Regarding Forward-Looking Statements

This announcement of NRx Pharmaceuticals Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.  

The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.

MEDIA CONTACT                      
                
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INVESTOR RELATIONS

                
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Jack Hirschfield                                        
                
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John Mullaly

Head of External Affairs, NRx                    
                
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LifeSci Advisors

jhirschfield@nrxpharma.com                      
          

jmullaly@lifesciadvisors.com
§
512-674-5163                                              
          

617-429-3548

§

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/...-aviptadil-301385474.html

SOURCE NRx Pharmaceuticals

Released September 27, 2021

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© 2021 NRx Pharmaceuticals, Inc.
 

27.09.21 22:05

771 Postings, 628 Tage IneosDruck auf FDA steigt :-)

Amerika > 10% im plus ! Hoffe mal auf eine Kehrtwende :-)


dreifache, statistisch signifikante Überlebenswahrscheinlichkeit

Hier der Originallink: https://ir.nrxpharma.com/news-events/...eases/detail/88/nrx-pharma...

Short-Facts:

- ZYESAMI™ (Aviptadil) hat in zwei 60-Tage-Studien zuvor eine statistisch signifikante Erhöhung des Überlebens von COVID-19-Patienten mit hoher Komorbidität gezeigt.

- In einer Studie mit hochkomorbiden Patienten ergab ZYESAMI eine dreifache, statistisch signifikante Erhöhung der Überlebenswahrscheinlichkeit nach einem Jahr.

- Diese Ergebnisse werden demnächst in einer von Fachleuten begutachteten Zeitschrift veröffentlicht.



RADNOR, Pa., Sept. 27, 2021 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP), ein biopharmazeutisches Unternehmen in der klinischen Phase, gab heute Top-Line-Daten bekannt, die eine Verbesserung der Ergebnisse nach einem Jahr bei stark komorbiden Patienten mit COVID-19 zeigen, die mit ZYESAMI™ behandelt wurden.

Zwischen Juni und September 2020 wurde an einem führenden Tertiärkrankenhaus eine Studie mit Patienten mit kritischem COVID-19 durchgeführt, deren Komorbidität sie von der randomisierten klinischen Phase-2b/3-Studie mit ZYESAMI ausschloss. Nach 28 Tagen wurde ein statistisch signifikanter Unterschied sowohl bei der Überlebensdauer als auch bei der Erholung vom Atemversagen festgestellt. Diese Ergebnisse werden demnächst in einer von Fachleuten begutachteten Zeitschrift veröffentlicht.
Die Teilnehmer an dieser Studie wurden nun ein Jahr lang ab dem Zeitpunkt der Aufnahme in die Studie beobachtet. Die ersten Ergebnisse zeigen einen statistisch signifikanten (P<.0001) dreifachen Vorteil bei der Wahrscheinlichkeit, ein Jahr nach der Behandlung noch am Leben zu sein (60 % gegenüber 20 Wacko bei denjenigen, die zusätzlich zur Standardbehandlung mit ZYESAMI behandelt wurden, im Vergleich zu denjenigen, die nur die Standardbehandlung erhielten. Die Zuteilung zu ZYESAMI in der Studie erfolgte auf der Grundlage des medizinischen Teams, das den Patienten in die Intensivstation (ICU) aufnahm. Auf der Intensivstation wurden alle Patienten von demselben medizinischen Team und nach denselben Behandlungsprotokollen betreut.
"Wir lernen immer noch viel über COVID-19, insbesondere bei Patienten, die bereits chronische Erkrankungen haben und sich von COVID-19 weiter erholen", sagte Dr. J. Georges Youssef, der leitende Prüfarzt, der als Leiter der akademischen Lungenheilkunde am Houston Methodist Hospital und als Assistenzprofessor für klinische Medizin am Weill Cornell Medical College tätig ist. "Diese neuesten Daten sind ermutigend und werden uns an der Front bei der Behandlung der kränksten COVID-Patienten helfen und möglicherweise neue Behandlungsmöglichkeiten und -strategien bieten."
Diese Ein-Jahres-Ergebnisse stehen im Einklang mit den erhöhten Chancen auf ein 60-Tage-Überleben, die in den zuvor berichteten Ergebnissen der randomisierten kontrollierten Phase-2b/3-Studie mit ZYESAMI festgestellt wurden. Die US-Arzneimittelbehörde FDA prüft nach wie vor die Zulassung von ZYESAMI für die Notfallbehandlung von Patienten mit kritischem Covid-19 mit Atemstillstand.

Übersetzt mit www.DeepL.com/Translator (kostenlose Version)

Ein Plan bringt Stabilität. Auf festem Boden lässt sich Erfolg aufbauen.
Es gibt nichts Gutes oder Schlechtes, nur das Denken macht es so.
Immer besser werden wollen- in allem, was wir tun.

 

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