Relief Therapeutics Holdings AG / (six/OTC)

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Relief Therapeutics Holdings AG / (six/OTC)

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vandaag nieuws , kan iets interessant zijn voor sommigen.
Relief Therapeutics Holdings AG / Key word(s): Miscellaneous
23.09.2020 / 07:02

Relief partner NeuroRx submits request for Emergency Use Authorization for RLF-100(TM) (aviptadil) in the treatment of patients with Critical COVID-19 and Respiratory Failure who have exhausted approved therapy

Emergency Use Authorization request targets the same population as is currently permitted under FDA Expanded Access Protocol

Geneva, Switzerland, and Radnor, PA, September 23, 2020 - RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company") and NeuroRx, Inc. today announce that NeuroRx, Inc. has submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100(TM) aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments. RLF-100 is being developed by NeuroRx as part of a global partnership with Relief. The submission is based on a case-control study that compared patients who were treated with RLF-100(TM) (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff. Patients treated with RLF-100(TM) demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement. Hypotension was seen in two aviptadil patients and was successfully managed with pressors. Diarrhea was seen in 4/21 aviptadil-treated patients and 3/30 control patients. The results have been submitted to a peer-reviewed journal.

"The EUA application covers the same type of patients whom FDA has already allowed to receive treatment under the Expanded Access protocol authorized by the Agency in July. Tragically, we have found that many patients who might benefit from the Expanded Access protocol are hospitalized in centers that do not allow patients access to investigational drugs," said Jonathan Javitt, MD, MPH, Chairman and CEO of NeuroRx, "Our staff is working around the clock to address requests for RLF-100(TM) under the appropriate mechanism. All too often, patients of color and those of lower socioeconomic status are denied access."

FDA's guidance to industry identifies the criteria for EUA as safe and "may be effective," in contrast to the far more stringent requirement of "safe and effective" required for traditional drug approval. EUA may only be granted in circumstances where the Secretary of Health and Human Services has declared a Public Health Emergency, as is true in the COVID-19 pandemic.

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, said: "We continue to work tirelessly with our partner NeuroRx to bring this potentially life-saving drug to patients afflicted with severe complications of COVID-19 infection as quickly as possible. The pursuit of EUA status is a crucial component of this effort."
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Wanneer de mensen succes hebben, wijten ze het aan hun bekwaamheden, wanneer zij falen, wijten zij het aan het toeval.







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Re: Relief Therapeutics Holdings AG / (six/OTC)

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even updaten


https://relieftherapeutics.com/neurorx- ... iptadil-2/

Geneva, Switzerland, and Radnor, PA, September 30, 2020 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief” or the “Company“) and NeuroRx, Inc. have established supply chain agreements and ordered sufficient drug substance (RLF-100TM) to prepare to treat 1 million patients with COVID-19, should the pandemic continue.



RLF-100™ is still in FDA-approved phase 2b/3 clinical trials for the treatment of critical COVID-19 in the US. A readout by the study’s Data Monitoring Committee is expected within the next month. European trials with RLF-100TM are in preparation and are scheduled to start in Q1 2021.



The development partners, NeuroRx and Relief, are leading US and EU commercialization plans, respectively. They have now contracted with Nephron Pharmaceuticals, Inc. to manufacture commercial supplies of RLF-100™, in order to ensure that adequate drug inventory will be immediately available, should the clinical trials demonstrate safety and efficacy.



NeuroRx and Relief have similarly contracted with Bachem Americas (www.bachem.ch) to manufacture sufficient RLF-100TM drug substance to treat 1 million patients. Bachem was the first peptide manufacturer to synthesize RLF-100TM and has played a leading role in the development of the drug substance over the past 20 years.



NeuroRx and Relief have additionally contracted with a leading nationwide pharmaceutical logistics partner in order to ensure overnight supply to US hospitals, should RLF-100™ continue to succeed in clinical trials.



“In normal circumstances, it would be prudent to wait until all the data are in before initiating commercial scale-up. However, in an environment where more than 40,000 Americans are contracting COVID-19 daily and 800 are dying each day, there is not a moment to lose in ensuring that sufficient quantities of RLF-100™ will be available, should the clinical trials succeed in proving safety and efficacy,” said Dr. Jonathan Javitt, CEO and Chairman of NeuroRx, Inc.



Dr. Raghuram (Ram) Selvaraju, Chairman of the Board of Relief continued: “We are living in unprecedented times, which call for flexibility and innovative thinking, in and outside the clinic. Therefore, we have taken the necessary steps to match the rapid clinical development of RLF-100TM by establishing a supply chain capable of scaling up to meet the urgent medical needs of critical COVID-19 patients.”



About VIP in Lung Injury

Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type 2 cell, which is critical to the transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.



COVID-19-related death is primarily caused by Respiratory Failure. Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells. These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the route of entry for the SARS-CoV-2 into the cells. Coronaviruses are shown to replicate in alveolar type 2 cells, but not in the more numerous type 1 cells. These same type 2 alveolar cells have high concentrations of VIP receptors on their cell surfaces giving rise to the hypothesis that VIP could specifically protect these cells from injury.



Injury to the type 2 alveolar cells is an increasingly plausible mechanism of COVID-19 disease progression. (Mason 2020). These specialized cells replenish the more common type 1 cells that line the lungs. More importantly, type 2 cells manufacture surfactant that coats the lung and is essential for oxygen exchange. Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.



About RLF-100

RLF-100 (Aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Dr. Said’s original work at Stony Brook University, for which Stony Brook was awarded an FDA Orphan Drug Designation in 2001. VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant. FDA has now granted IND authorization for intravenous and inhaled delivery of RLF-100 for the treatment of COVID-19 and awarded Fast Track designation. RLF-100 is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Since July 2020, severe COVID-19 patients have been treated with RLF-100 under U.S. FDA Emergency Use Investigational New Drug (IND) authorization for treatment of individual patients, and an Expanded Access Protocol IND authorization for the treatment of respiratory failure in COVID-19.



About RELIEF THERAPEUTICS Holding AG

Relief focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Relief holds orphan drug designations from the U.S. FDA and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a patent issued in the U.S. and multiple other countries covering potential formulations of RLF-100.



RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF.



About NeuroRx, Inc.

NeuroRx draws upon more than 100 years of collective drug development experience and is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca, PPD. In addition to its work on RLF-100, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. Javitt, MD, MPH, who has served as a health advisor to four Presidential administrations and worked on paradigm-changing drug development projects for Merck, Allergan, Pharmacia, Pfizer, Novartis, and Mannkind, together with Robert Besthof, MIM, who served as the Global Vice President (Commercial) for Pfizer’s Neuroscience and Pain Division. Its Board of Directors and Advisors includes Hon. Sherry Glied, former Assistant Secretary, U.S. Dept. of Health and Human Services; Mr. Chaim Hurvitz, former President of the Teva International Group, Lt. Gen. HR McMaster, the 23rd National Security Advisor, Wayne Pines, former Associate Commissioner of the U.S. Food and Drug Administration, Judge Abraham Sofaer, and Daniel Troy, former Chief Counsel, U.S. Food and Drug Administration.

aub.
Wanneer de mensen succes hebben, wijten ze het aan hun bekwaamheden, wanneer zij falen, wijten zij het aan het toeval.

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Re: Relief Therapeutics Holdings AG / (six/OTC)

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nu Donald covid heeft, is een vaccin in deze fase (voor potus) te laat.

komt de redding van relief? spannende tijden.

succes;

gr,

AKB
Wanneer de mensen succes hebben, wijten ze het aan hun bekwaamheden, wanneer zij falen, wijten zij het aan het toeval.

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Re: Relief Therapeutics Holdings AG / (six/OTC)

Bericht door Alwimo »

Al sinds maart-april een mooi aantal in portefeuille.
Wat is jullie mening over Aviptadil (Rlf100)

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Re: Relief Therapeutics Holdings AG / (six/OTC)

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zo, dit moet het dan maar doen als opvolging. succes voor de mensen die het hebben.
't beste

GENEVA and RADNOR, Pa., Oct. 13, 2020 /PRNewswire/ -- RELIEF THERAPEUTICS Holding AG (SIX: RLF,OTCQB: RLFTF) ("Relief" or the "Company") and NeuroRx, Inc., today announced topline results from 45 patients assessed in an open-label prospective study where 21 patients admitted to an intensive care unit (ICU) with critical COVID-19 and respiratory failure were treated with RLF-100™(aviptadil) and compared to 24 control patients treated in the same setting. All patients had severe comorbidities that rendered them ineligible for the ongoing randomized controlled phase 2b/3 trial being conducted to ascertain safety and efficacy of RLF-100™, and all patients were deteriorating despite treatment with approved therapies for COVID-19.

Overall, 81% of RLF-100™-treated patients survived beyond 60 days, compared to 17% of control patients. Patients treated with RLF-100™ demonstrated a 9-fold increased probability of survival and recovery from respiratory failure, with a high degree of statistical significance. Statistical analysis was performed by Prof. Phil Lavin, FASA, FRAPS of the Boston Biostatistical Research Foundation.

"We are encouraged by these initial results in highly comorbid patients with COVID-19 respiratory failure, and we are pleased that the majority of these patients have returned safely to their families. We look forward to the upcoming results from the randomized, double-blind, prospective trial in less severely comorbid patients for confirmation of these results," said Jihad Georges Youssef, MD, section chief of General Academic Pulmonary Medicine at the Houston Methodist Hospital, who serves as the study's principal investigator at Houston Methodist and also serves as national co-chair for the ongoing randomized controlled trial.

"The patients included in this study are representative of those who are too ill to be included in the clinical trials of any known treatment for COVID-19," said Dr. Jonathan Javitt, CEO and Chairman of NeuroRx, Inc. "We are grateful to Dr. Youssef and to the Houston Methodist Hospital for having the courage to treat and study patients at this level of risk. The results suggest that there may be substantial hope to mitigate the attack of the coronavirus on the delicate cells that line the lung with a natural peptide that has been protecting the lung's lining since humans first walked the earth. While the number of patients treated at Houston Methodist is modest, the initial results in our nationwide expanded access program suggest similarly encouraging survival with RLF-100™. We continue to closely monitor treatment with RLT-100TM in other hospitals."

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief commented: "The encouraging EAP topline data give us continued motivation to remain focused on the rapid clinical development of RLF-100™. We look forward to topline results from our randomized, placebo-controlled study this quarter. We remain dedicated to our goal of providing therapeutic relief to critical COVID-19 patients as quickly as possible."

Scientific findings of the analysis have been submitted for peer review.
Wanneer de mensen succes hebben, wijten ze het aan hun bekwaamheden, wanneer zij falen, wijten zij het aan het toeval.

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Re: Relief Therapeutics Holdings AG / (six/OTC)

Bericht door KdeMaesschalk »

Tja, het is niet echt nieuws maar een bevestiging van goede resultaten (9x!)
Het blijft wachten op echte resultaten (FDA) voor een echte koerssprong.

Ik zit er maar van half augustus in en heb buiten een rit van 0,35 naar 0,60 enkel maar bijgekocht (5 keer).
Als ik lees dat er al mensen van april inzitten vraag ik me af waarom ze niet al (deels) verkocht hebben op de piek tot 0,8

Lijkt me in elk geval toch een stuk meer zenuwslopend voor deze mensen om nu geduldig te wachten op goed nieuws
ABI BAR CYAD EURN FUR IVA RDSA RLF AAL GE NAK SONN TSLA XPEV

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Re: Relief Therapeutics Holdings AG / (six/OTC)

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zeer juist, bevestiging. wederom.
uea zal wel snel komen, dan kan het zeer snel gaan. afwachten ook wat de yanks straks gaan doen, ze duwden gisteren weer fel naar beneden, kan hun zuur opbreken.

ik kocht net nog wat bij

Gem. aankoopkoers 0,53446 CHF

koopje, hopelijk.

gltu
Wanneer de mensen succes hebben, wijten ze het aan hun bekwaamheden, wanneer zij falen, wijten zij het aan het toeval.

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Re: Relief Therapeutics Holdings AG / (six/OTC)

Bericht door KdeMaesschalk »

Ik heb er nu 60000 aan een gak van 0,47.
Voor mij had het nieuws van vandaag nog niet moeten komen want heb nog een order klaar staan van 10000 stuks op 0,45 en vrees dat we dat niet meer gaan zien.

Ergens deze maand wel nieuws van FDA te verwachten denk ik. De grote vraag is waar we naar toe gaan bij FDA approval... en ook of we dan best verkopen of vast houden voor groter potentieel (ook toepassingen naast COVID-19)

In de koffiekamer van het belegger forum wordt dit aandeel een stuk korter opgevolgd en ik volg dit ook op Twitter onder $rlftf (OTC)

Een aandeel dat op minder dan een jaar tijd x1000 ging heeft wel de aandacht van heel wat beleggers. Als je ziet wat voor effect het bericht van vandaag op de koers heeft kan je wel stiekem dromen van een once in a lifetime koerssprong bij FDA full approval :shock:

Het maakt volgens mij ook weinig uit of je nu een gak van 0,4 of een van 0,6 hebt als je naar de potentiële multiple kijkt. Dit zijn volgens mij de laatste mooie instapmomenten voor wie de boot niet wil missen.
ABI BAR CYAD EURN FUR IVA RDSA RLF AAL GE NAK SONN TSLA XPEV

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Re: Relief Therapeutics Holdings AG / (six/OTC)

Bericht door Alwimo »

Ik zit er in aan een gemiddelde van 0,11 Zwitserse frank ( 62000 stuks).
Laat ons hopen op a once in a life time.
Naar mijn gevoel zit het goed, maar tijd zal het uitwijzen.
Waar kan het naartoe volgens jullie op korte en lange termijn?

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Re: Relief Therapeutics Holdings AG / (six/OTC)

Bericht door KdeMaesschalk »

Proficiat, dat is zeer mooi aangekocht :clap:

Men verwacht nog redelijk wat goed nieuws en mogelijk uplisting. Ik denk dat tussen 3 en 5 CHF ambitieus maar haalbaar is.
Op sommige fora wordt er gedroomd van 10, 20 tot zelfs 100 dollar per stuk. Aantal uitstaande aandelen en mogelijke marktwaarde in beschouwing genomen vrees ik dat het niet erg realistisch is. Anderzijds is logica en ratio tegenwoordig vaak ver te zoeken als we naar sommige aandelen kijken. Ook niet te vergeten dat COVID-19 een wereldwijd probleem is en daardoor niet te onderschatten hoeveel beleggers proberen in te zetten op het vaccin of geneesmiddel dat hier een einde aan kan maken. Het blijft een werking van vraag en aanbod en zoals men zegt : het is wat de zot ervoor wil geven.

Ik denk 3, hoop 10 en droom 100 :D
ABI BAR CYAD EURN FUR IVA RDSA RLF AAL GE NAK SONN TSLA XPEV


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