NRX Pharmaceuticals Inc
WKN: A4091K / ISIN: US6294442099NRX Pharmaceuticals
| eröffnet am: | 22.07.21 13:40 von: | kurshunter |
| neuester Beitrag: | 04.03.24 22:24 von: | axolot |
| Anzahl Beiträge: | 50 | |
| Leser gesamt: | 17743 | |
| davon Heute: | 3 | |
bewertet mit 0 Sternen |
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22.07.21 13:40
#1
kurshunter
NRX Pharmaceuticals
NRX Pharmaceuticals mit guten Ergebnissen bei der Behandlung von Covid-19.
https://www.ariva.de/news/...sents-evidence-zyesami-aviptadil-9668580
"The anti-cytokine effect of ZYESAMI was additionally associated with a significant decrease in 60-day mortality."
Habe mir gestern ein paar zu 9 Euro ins Depot gelegt. Sehr spannend.
https://www.ariva.de/news/...sents-evidence-zyesami-aviptadil-9668580
"The anti-cytokine effect of ZYESAMI was additionally associated with a significant decrease in 60-day mortality."
Habe mir gestern ein paar zu 9 Euro ins Depot gelegt. Sehr spannend.
24 Postings ausgeblendet.
29.12.21 13:23
#26
axolot
hier die great covid news
NRXP COVID NEWS https://www.stocktitan.net/news/NRXP/...ion-request-djy3m1g4ikqw.html
01.02.22 13:27
#27
Vassago
NRX 2.97$
25 Mio. $ Privatplatzierung
https://ir.nrxpharma.com/news-events/...-25-million-private-placement
31.03.22 19:43
#28
Vassago
NRXP 2.35$
Zahlen für 2021
- keine Umsätze
- Verlust 93 Mio. $
- Cash 28 Mio. $
- MK 157 Mio. $
https://ir.nrxpharma.com/news-events/...s-business-update-and-reports
08.04.22 13:40
#29
Ineos
Javitt
und das gesamte NRXP-Management hat sich verzockt und die
Firma in den Ruin getrieben . Selbst bei erfolgreicher Mediation
ist ein irreperabler Schaden entstanden . Wer will mit so einer
Firma noch zusammenarbeiten ? Mein Mitgefühl gilt den Aktionären
hier die durch Lügereien hinters Licht geführt wurden . Bin selber
nicht zu knapp in Relief investiert und glaube immer noch an unser
Medikament aber NRXP wird keine grosse Rolle mehr spielen in der
Vermarktung bzw. Gewinnverteilung . Wie lange hält NRXP noch
durch oder steht bereits eine Insolvenz an ?
Firma in den Ruin getrieben . Selbst bei erfolgreicher Mediation
ist ein irreperabler Schaden entstanden . Wer will mit so einer
Firma noch zusammenarbeiten ? Mein Mitgefühl gilt den Aktionären
hier die durch Lügereien hinters Licht geführt wurden . Bin selber
nicht zu knapp in Relief investiert und glaube immer noch an unser
Medikament aber NRXP wird keine grosse Rolle mehr spielen in der
Vermarktung bzw. Gewinnverteilung . Wie lange hält NRXP noch
durch oder steht bereits eine Insolvenz an ?
09.04.22 11:35
#30
Ineos
Untersuchung gegen NRx Pharmaceuticals
Der ehemalige Generalstaatsanwalt von Louisiana, Charles C. Foti, Jr., Esq. und Partner der Anwaltskanzlei Kahn Swick & Foti, LLC ("KSF"), gibt bekannt, dass KSF eine Untersuchung gegen NRx Pharmaceuticals (NasdaqGM: NRXP) eingeleitet hat.
https://flashalert.me/...tors-of-NRx-Pharmaceuticals-Inc.---NRXP.html
https://flashalert.me/...tors-of-NRx-Pharmaceuticals-Inc.---NRXP.html
26.05.22 11:56
#31
Vassago
NRXP 0.98$ (vorbörslich -29%)
„Das DSMB empfahl, die weitere Randomisierung auf Aviptadil einzustellen, da Aviptadil die im vorab genehmigten Analyseplan festgelegten Richtlinien zur Nichtigkeit nicht erfüllt. Der primäre Endpunkt (90-Tage-Ordinalwert in 6 Kategorien) war nicht unterstützend (OR 1,10; 0,79 – 1,54; p = 0,56), und der sekundäre 90-Tage-Mortalitätsendpunkt war mit 37 % Mortalität in der Aviptadil-Gruppe gegenüber 36 % ebenfalls nicht unterstützend. in der Placebogruppe; HF 1,04 (0,77-1,41); p = 0,79. Es gab keine Sicherheitsbedenken, die bekannten Nebenwirkungen von Aviptadil (hauptsächlich Durchfall und Hypotonie) wurden mit den bestehenden Protokollen gut behandelt.“
https://www.nrxpharma.com/...-zyesami-aviptadil-in-critical-covid-19/
26.05.22 16:07
#32
Vassago
NRXP 0.58$ (-58%)
Der letzte macht das Licht aus.
https://seekingalpha.com/news/...s-after-setback-for-covid-19-therapy
https://seekingalpha.com/news/...s-after-setback-for-covid-19-therapy
07.11.22 20:32
#33
Ineos
für allgemeine Unternehmenszwecke zu verwenden.
RADNOR, Pa., 7. November 2022 - NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, "NRx Pharmaceuticals" oder das "Unternehmen"), ein biopharmazeutisches ZNS-Unternehmen im klinischen Stadium, gab heute bekannt, dass es von Streeterville Capital, LLC, einer Gesellschaft mit beschränkter Haftung aus Utah, eine ungesicherte Fremdfinanzierung in Höhe von ca. 11 Millionen US-Dollar (die "Anleihe") erhalten hat. Das Unternehmen beabsichtigt, den Nettoerlös aus der Anleihe (ca. 10 Mio. $) zur Unterstützung seiner NRX-101-Entwicklungsprogramme für die Behandlung von bipolarer Depression und PTBS sowie für allgemeine Unternehmenszwecke zu verwenden.
"In den Vereinigten Staaten unternimmt alle 27 Sekunden jemand einen Selbstmordversuch, und die einzige zugelassene Behandlung für suizidale bipolare Depression ist nach wie vor die Elektroschocktherapie. Wir freuen uns, dass Streeterville Capital das außerordentliche Potenzial von NRX-101 erkannt hat, das bequem als orales Medikament verabreicht werden kann, um den ungedeckten medizinischen Bedarf dieser Patientengruppe zu decken. Diese Finanzierung wird zusammen mit unseren Barmitteln die Phase-3-Studie unterstützen, die in unserem Special Protocol Agreement mit der U.S. Food and Drug Administration für Patienten mit bipolarer Depression und akuter Suizidalität beschrieben ist", sagte Stephen Willard, CEO von NRx Pharmaceuticals.
Die Anleihe wird mit 9 % p.a. verzinst und hat eine Laufzeit von 18 Monaten. Das Unternehmen hat die Möglichkeit, die Anleihe während der Laufzeit vorzeitig zu tilgen, indem es einen Betrag in Höhe von 110 % des Kapitals, der Zinsen und der Gebühren zum Zeitpunkt der vorzeitigen Tilgung zahlt. Der Anleihegläubiger hat das Recht, bis zu 1.000.000 $ des ausstehenden Saldos der Anleihe pro Monat, beginnend 6 Monate nach dem Ausgabedatum, zu tilgen. Die Zahlungen können vom Unternehmen nach eigenem Ermessen wie folgt geleistet werden: (i) in bar, (ii) in Aktien des Unternehmens oder (iii) in einer Kombination aus Bargeld und Aktien des Unternehmens. Das Recht des Unternehmens, den Rückzahlungsbetrag in Stammaktien zu begleichen, unterliegt bestimmten Bedingungen. Weitere Einzelheiten zum Kauf und zu den Bedingungen der Schuldverschreibungen sind dem aktuellen Bericht des Unternehmens auf Formular 8-K zu entnehmen, der bei der Securities and Exchange Commission eingereicht wird.
Diese Pressemitteilung stellt weder ein Verkaufsangebot noch eine Aufforderung zur Abgabe eines Kaufangebots dar, noch werden diese Wertpapiere in einer Rechtsordnung verkauft, in der ein solches Angebot, eine solche Aufforderung oder ein solcher Verkauf vor der Registrierung oder Qualifizierung gemäß den Wertpapiergesetzen der betreffenden Rechtsordnung ungesetzlich wäre.
RADNOR, Pa., 7. November 2022 - NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, "NRx Pharmaceuticals" oder das "Unternehmen"), ein biopharmazeutisches ZNS-Unternehmen im klinischen Stadium, gab heute bekannt, dass es von Streeterville Capital, LLC, einer Gesellschaft mit beschränkter Haftung aus Utah, eine ungesicherte Fremdfinanzierung in Höhe von ca. 11 Millionen US-Dollar (die "Anleihe") erhalten hat. Das Unternehmen beabsichtigt, den Nettoerlös aus der Anleihe (ca. 10 Mio. $) zur Unterstützung seiner NRX-101-Entwicklungsprogramme für die Behandlung von bipolarer Depression und PTBS sowie für allgemeine Unternehmenszwecke zu verwenden.
"In den Vereinigten Staaten unternimmt alle 27 Sekunden jemand einen Selbstmordversuch, und die einzige zugelassene Behandlung für suizidale bipolare Depression ist nach wie vor die Elektroschocktherapie. Wir freuen uns, dass Streeterville Capital das außerordentliche Potenzial von NRX-101 erkannt hat, das bequem als orales Medikament verabreicht werden kann, um den ungedeckten medizinischen Bedarf dieser Patientengruppe zu decken. Diese Finanzierung wird zusammen mit unseren Barmitteln die Phase-3-Studie unterstützen, die in unserem Special Protocol Agreement mit der U.S. Food and Drug Administration für Patienten mit bipolarer Depression und akuter Suizidalität beschrieben ist", sagte Stephen Willard, CEO von NRx Pharmaceuticals.
Die Anleihe wird mit 9 % p.a. verzinst und hat eine Laufzeit von 18 Monaten. Das Unternehmen hat die Möglichkeit, die Anleihe während der Laufzeit vorzeitig zu tilgen, indem es einen Betrag in Höhe von 110 % des Kapitals, der Zinsen und der Gebühren zum Zeitpunkt der vorzeitigen Tilgung zahlt. Der Anleihegläubiger hat das Recht, bis zu 1.000.000 $ des ausstehenden Saldos der Anleihe pro Monat, beginnend 6 Monate nach dem Ausgabedatum, zu tilgen. Die Zahlungen können vom Unternehmen nach eigenem Ermessen wie folgt geleistet werden: (i) in bar, (ii) in Aktien des Unternehmens oder (iii) in einer Kombination aus Bargeld und Aktien des Unternehmens. Das Recht des Unternehmens, den Rückzahlungsbetrag in Stammaktien zu begleichen, unterliegt bestimmten Bedingungen. Weitere Einzelheiten zum Kauf und zu den Bedingungen der Schuldverschreibungen sind dem aktuellen Bericht des Unternehmens auf Formular 8-K zu entnehmen, der bei der Securities and Exchange Commission eingereicht wird.
Diese Pressemitteilung stellt weder ein Verkaufsangebot noch eine Aufforderung zur Abgabe eines Kaufangebots dar, noch werden diese Wertpapiere in einer Rechtsordnung verkauft, in der ein solches Angebot, eine solche Aufforderung oder ein solcher Verkauf vor der Registrierung oder Qualifizierung gemäß den Wertpapiergesetzen der betreffenden Rechtsordnung ungesetzlich wäre.
05.06.23 08:03
#36
axolot
mal gucken, ob es vorbörslich bereits nach oben
geht ..... https://ih.advfn.com/stock-market/NASDAQ/...ceuticals-NRXP/stock-news
Freitag wurde ja schon kräftig gesammelt, als es in Sekunden über einen Dollar schnipste
Freitag wurde ja schon kräftig gesammelt, als es in Sekunden über einen Dollar schnipste
05.06.23 08:53
#37
Siebi2015
NRx Pharmaceuticals to Host Corporate ...
... and Strategic Update Conference Call on Monday, June 5, 2023
https://ih.advfn.com/stock-market/NASDAQ/...st-corporate-and-strategi
https://ih.advfn.com/stock-market/NASDAQ/...st-corporate-and-strategi
05.06.23 14:49
#43
axolot
nrxp oder hier übersetzt
$NRXP - Als Gegenleistung für die Lizenzgewährung und die Beteiligung von NRx an den unten beschriebenen Entwicklungs-, Regulierungs- und kommerziellen Aktivitäten wird Alvogen NRx bis zu 330 Millionen US-Dollar an Meilensteinzahlungen in bar zahlen, einschließlich einer ersten Barzahlung
in Höhe von 10 Millionen US-Dollar $NRXP ! Boom sehr gute 8K aus
https://ih.advfn.com/stock-market/NASDAQ/...current-report-filing-8-k
$NRXP - Nur der Anfang
: Mit dem Update um 8:30 Uhr könnte es sehr eng werden. Leichter Schwimmer ebenfalls.
$NRPX - Als Gegenleistung für die Lizenzerteilung und die Beteiligung von NRx an den unten beschriebenen Entwicklungs-, Regulierungs- und kommerziellen Aktivitäten wird Alvogen NRx Meilensteinzahlungen in Höhe von insgesamt bis zu 330 Millionen US-Dollar in bar leisten, einschließlich einer ersten Barzahlung
in Höhe von 10 Millionen US-Dollar imho
in Höhe von 10 Millionen US-Dollar $NRXP ! Boom sehr gute 8K aus
https://ih.advfn.com/stock-market/NASDAQ/...current-report-filing-8-k
$NRXP - Nur der Anfang
: Mit dem Update um 8:30 Uhr könnte es sehr eng werden. Leichter Schwimmer ebenfalls.
$NRPX - Als Gegenleistung für die Lizenzerteilung und die Beteiligung von NRx an den unten beschriebenen Entwicklungs-, Regulierungs- und kommerziellen Aktivitäten wird Alvogen NRx Meilensteinzahlungen in Höhe von insgesamt bis zu 330 Millionen US-Dollar in bar leisten, einschließlich einer ersten Barzahlung
in Höhe von 10 Millionen US-Dollar imho
04.03.24 19:33
#45
axolot
$NRXP News: NRx Pharmaceuticals (NASDAQ: NRXP)
$NRXP News: NRx Pharmaceuticals (NASDAQ: NRXP) Announces Last Patient, Last Visit in its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression
Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar Depression
The study database is being cleaned and locked; statistical analysis and top-line data to follow shortly thereafter
Study maintained 95% concordance rate between study sites and central raters on primary endpoint. No unexpected Serious Adverse Events were reported.
Positive data and FDA comment would trigger the next $4 million milestone payment from partners Alvogen and Lotus and their assumption of development costs; agreement provides for up to $329 million in milestone payments and a royalty on Net Sales in the mid-teens
RADNOR, Pa., March 4, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the 74th and last evaluable patient has completed their day 42 visit in its Phase 2b/3 study of NRX-101, the Company's patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression. The database is being cleaned, finalized, and locked; statistical analysis will then be performed, with top-line data to follow shortly thereafter. As previously disclosed, positive data from this trial triggers a milestone payment from Alvogen. Alvogen will then be responsible for further development and commercialization costs for this program.
NRX-101 has been awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of suicidal bipolar depression. It is the only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it.
"This is the first clinical trial, to the company's knowledge, conducted among patients with suicidal bipolar depression in the outpatient setting. Our previous trial measured the ability of NRX-101 to maintain the anti-depressant and anti-suicidal effect of ketamine administered in the hospital setting. These patients, whose clinical need is urgent and extraordinary have routinely been excluded from the clinical trials of all previously-known anti-depressant drugs. said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. Although there were patients whose depression worsened and required hospitalization (we don't yet know whether they were on NRX-101 or comparator), patient safety was maintained, and no trial participant suffered a serious unexpected adverse outcome. Our thanks go out to our investigators, clinics, partners and, most importantly, our amazing patients and their families for seeing this study through to this important milestone," "
The Phase 2b/3 trial (www.clinicaltrials.gov NCT 03395392) is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary efficacy endpoint is reduction in depression as measured on the MADRS scale and the secondary endpoint is reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS). As previously disclosed, treatment compliance and concordance of local raters to central raters scores was in excess of 94%, well above the industry standard that is normally seen in CNS trials.
Top-line results are expected around the end of this quarter.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
https://c212.net/c/img/favicon.png?sn=CL51263&sd=2024-03-04 View original content to download multimedia:https://www.prnewswire.com/news-releases/...depression-302078041.html
SOURCE NRx Pharmaceuticals, Inc.
Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar Depression
The study database is being cleaned and locked; statistical analysis and top-line data to follow shortly thereafter
Study maintained 95% concordance rate between study sites and central raters on primary endpoint. No unexpected Serious Adverse Events were reported.
Positive data and FDA comment would trigger the next $4 million milestone payment from partners Alvogen and Lotus and their assumption of development costs; agreement provides for up to $329 million in milestone payments and a royalty on Net Sales in the mid-teens
RADNOR, Pa., March 4, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the 74th and last evaluable patient has completed their day 42 visit in its Phase 2b/3 study of NRX-101, the Company's patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression. The database is being cleaned, finalized, and locked; statistical analysis will then be performed, with top-line data to follow shortly thereafter. As previously disclosed, positive data from this trial triggers a milestone payment from Alvogen. Alvogen will then be responsible for further development and commercialization costs for this program.
NRX-101 has been awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of suicidal bipolar depression. It is the only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it.
"This is the first clinical trial, to the company's knowledge, conducted among patients with suicidal bipolar depression in the outpatient setting. Our previous trial measured the ability of NRX-101 to maintain the anti-depressant and anti-suicidal effect of ketamine administered in the hospital setting. These patients, whose clinical need is urgent and extraordinary have routinely been excluded from the clinical trials of all previously-known anti-depressant drugs. said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. Although there were patients whose depression worsened and required hospitalization (we don't yet know whether they were on NRX-101 or comparator), patient safety was maintained, and no trial participant suffered a serious unexpected adverse outcome. Our thanks go out to our investigators, clinics, partners and, most importantly, our amazing patients and their families for seeing this study through to this important milestone," "
The Phase 2b/3 trial (www.clinicaltrials.gov NCT 03395392) is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary efficacy endpoint is reduction in depression as measured on the MADRS scale and the secondary endpoint is reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS). As previously disclosed, treatment compliance and concordance of local raters to central raters scores was in excess of 94%, well above the industry standard that is normally seen in CNS trials.
Top-line results are expected around the end of this quarter.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
https://c212.net/c/img/favicon.png?sn=CL51263&sd=2024-03-04 View original content to download multimedia:https://www.prnewswire.com/news-releases/...depression-302078041.html
SOURCE NRx Pharmaceuticals, Inc.
04.03.24 19:33
#46
axolot
NRXP news raus und sieht geht hoch
$NRXP News: NRx Pharmaceuticals (NASDAQ: NRXP) Announces Last Patient, Last Visit in its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression
Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar Depression
The study database is being cleaned and locked; statistical analysis and top-line data to follow shortly thereafter
Study maintained 95% concordance rate between study sites and central raters on primary endpoint. No unexpected Serious Adverse Events were reported.
Positive data and FDA comment would trigger the next $4 million milestone payment from partners Alvogen and Lotus and their assumption of development costs; agreement provides for up to $329 million in milestone payments and a royalty on Net Sales in the mid-teens
RADNOR, Pa., March 4, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the 74th and last evaluable patient has completed their day 42 visit in its Phase 2b/3 study of NRX-101, the Company's patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression. The database is being cleaned, finalized, and locked; statistical analysis will then be performed, with top-line data to follow shortly thereafter. As previously disclosed, positive data from this trial triggers a milestone payment from Alvogen. Alvogen will then be responsible for further development and commercialization costs for this program.
NRX-101 has been awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of suicidal bipolar depression. It is the only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it.
"This is the first clinical trial, to the company's knowledge, conducted among patients with suicidal bipolar depression in the outpatient setting. Our previous trial measured the ability of NRX-101 to maintain the anti-depressant and anti-suicidal effect of ketamine administered in the hospital setting. These patients, whose clinical need is urgent and extraordinary have routinely been excluded from the clinical trials of all previously-known anti-depressant drugs. said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. Although there were patients whose depression worsened and required hospitalization (we don't yet know whether they were on NRX-101 or comparator), patient safety was maintained, and no trial participant suffered a serious unexpected adverse outcome. Our thanks go out to our investigators, clinics, partners and, most importantly, our amazing patients and their families for seeing this study through to this important milestone," "
The Phase 2b/3 trial (www.clinicaltrials.gov NCT 03395392) is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary efficacy endpoint is reduction in depression as measured on the MADRS scale and the secondary endpoint is reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS). As previously disclosed, treatment compliance and concordance of local raters to central raters scores was in excess of 94%, well above the industry standard that is normally seen in CNS trials.
Top-line results are expected around the end of this quarter.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE NRx Pharmaceuticals, Inc.
Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar Depression
The study database is being cleaned and locked; statistical analysis and top-line data to follow shortly thereafter
Study maintained 95% concordance rate between study sites and central raters on primary endpoint. No unexpected Serious Adverse Events were reported.
Positive data and FDA comment would trigger the next $4 million milestone payment from partners Alvogen and Lotus and their assumption of development costs; agreement provides for up to $329 million in milestone payments and a royalty on Net Sales in the mid-teens
RADNOR, Pa., March 4, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the 74th and last evaluable patient has completed their day 42 visit in its Phase 2b/3 study of NRX-101, the Company's patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression. The database is being cleaned, finalized, and locked; statistical analysis will then be performed, with top-line data to follow shortly thereafter. As previously disclosed, positive data from this trial triggers a milestone payment from Alvogen. Alvogen will then be responsible for further development and commercialization costs for this program.
NRX-101 has been awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of suicidal bipolar depression. It is the only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it.
"This is the first clinical trial, to the company's knowledge, conducted among patients with suicidal bipolar depression in the outpatient setting. Our previous trial measured the ability of NRX-101 to maintain the anti-depressant and anti-suicidal effect of ketamine administered in the hospital setting. These patients, whose clinical need is urgent and extraordinary have routinely been excluded from the clinical trials of all previously-known anti-depressant drugs. said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. Although there were patients whose depression worsened and required hospitalization (we don't yet know whether they were on NRX-101 or comparator), patient safety was maintained, and no trial participant suffered a serious unexpected adverse outcome. Our thanks go out to our investigators, clinics, partners and, most importantly, our amazing patients and their families for seeing this study through to this important milestone," "
The Phase 2b/3 trial (www.clinicaltrials.gov NCT 03395392) is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary efficacy endpoint is reduction in depression as measured on the MADRS scale and the secondary endpoint is reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS). As previously disclosed, treatment compliance and concordance of local raters to central raters scores was in excess of 94%, well above the industry standard that is normally seen in CNS trials.
Top-line results are expected around the end of this quarter.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE NRx Pharmaceuticals, Inc.