geht hier was

 

Die Party ist doch vorbei.
Geld machen wir kleinen doch hier nicht mehr.
 

Gilead stellt klinische Entwicklung inhalativen Formulierung ein

Gilead Sciences (NASDAQ:GILD) hat beschlossen, die klinische Entwicklung einer inhalativen Formulierung seines Blockbuster-Medikaments COVID-19 Remdesivir einzustellen.
Daniel O'Day, CEO von Gilead, sagte bei der Telefonkonferenz im Anschluss an die Veröffentlichung der Ergebnisse des zweiten Quartals 2021 am Donnerstag, dass die Entscheidung auf den Daten einer Proof-of-Concept-Studie basiere, die auf eine unterdurchschnittliche Anreicherung des Medikaments in der Lunge hinweise,
"Wir haben beschlossen, eine inhalative Formulierung von Remdesivir aufgrund der Ergebnisse unserer ersten Proof-of-Concept-Studie, die auf eine suboptimale Ablagerung des Medikaments in der Lunge hindeutet, nicht weiter zu verfolgen", sagte O'Day.Gilead  

die Party fängt gerade erst an ! Habe selber schon gezweifelt aber mich entschlossen
Relief als Longinvest mit allen Höhen und Tiefen zu halten . Mein EK liegt nun mit
Zukäufen bei 7,8 Rappen . Zum Kurs hoffe ich bis Ende des Jahres auf einen Franken .
In XX Jahren gehts in die Rente und ich hoffe das ich bis dahin über Relief ein schönes
monatliches Zusatzeinkommen erziele . Kann dann jeden Monat über 20 Jahre lang
1000 Stück verkaufen :-) . Wir werden sehen was noch kommt aber die Zukunfts-
aussichten sind so schlecht nicht :-) !!  

und der Bekanntheitsgrad steigt . Hoffe auch der Druck auf die FDA !!! :-)

https://www.nasdaq.com/articles/...ing-severe-covid-so-far-2021-07-31  

Bei deinen 240 000 Stück wäre ich sehr Nervös.
Ich hab bei ca 50 Rappen verkauft, leider habe ich bei 27 Rappen wieder gekauft.
Ich traue der Firma nicht mehr, war das selbe Spiel 2014 mit Therametrics.
Gute Nachrichten + Kapitalerhöhungen.
Für die Menschen wäre es aber gut wenn die Corona Medikamente wirken.
 

Du bist der nervöse ich habe 500000 Stück und werde jeden die weiter einkaufen. Es dauert eben und wer die Geduld nicht hat sollte sich eine andere Aktie suchen. Jeder ist für sein Handeln selbst verantwortlich und jammert nicht immer rum hält man ja kaum aus.  

Jeden dip  

Möglich dass ich nervös bin.
Mit so einer hohen Position könnte ich nicht ruhig  schlafen.
Welcher Kurs ist dein nachkaufkurs?
 

RELIEF THERAPEUTICS Holding AG: Relief Announces Receipt of U.S. FDA Orphan Drug Designation for the use of RLF-100 (aviptadil) in the Treatment of Sarcoidosis
Relief now has Orphan Drug Designations for Its Sarcoidosis, Epidermolysis Bullosa (EB) and Phenylketonuria (PKU) Product Candidates

RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that, via its newly acquired subsidiary, AdVita Lifescience GmbH, the Company has been granted Orphan Drug Designation by the U.S. Food and Drug Administration ("FDA") for RLF-100 (aviptadil), an inhaled formulation in development for the treatment of sarcoidosis. RLF-100 is a synthetic form of vasoactive intestinal peptide. In open label exploratory clinical experience in sarcoidosis patients, RLF-100 has been shown to be well tolerated and safe, and to produce favorable immunoregulatory effects in the lungs that have been associated with symptom relief in a significant proportion of the patients.

"Receipt of our third Orphan Drug Designation is another important milestone for the Company, as it underscores the potential strength of our pipeline and the high need for better treatments for rare diseases such as sarcoidosis," stated Raghuram (Ram) Selvaraju, Chairman of the Board of Directors of Relief. "The timing of this newest Orphan Drug Designation comes on the heels of our just closed acquisition of AdVita Lifescience GmbH and supplements those we have for our drug candidates for EB and PKU, which we added to our pipeline through our recent acquisition of APR Applied Pharma Research SA, consistent with our strategy to become a fully integrated diversified commercial-stage pharmaceutical company."

Orphan Drug Designation is granted for products that are intended to treat life-threatening or chronically debilitating conditions affecting less than 200,000 patients in the U.S. and no more than five in 10,000 persons in the European Union. Further criteria include the potential of the product to provide significant patient benefit over available treatment, or to fill an unmet medical need where no treatment exists.

Orphan Drug Designation confers numerous benefits to the development of new products, including clinical protocol assistance and, upon marketing authorization, assures marketing exclusivity for a period of up to seven years in the U.S. and up to ten years in the EU once the medicine is on the market.  

Ich kaufe jeden kleinen Dip nach. Kann sehr gut schlafen. Die 1 Million möchte ich noch voll bekommen. Habe mit Helium HNT viel Geld verdient und tue es auch weiter. Aktien sind bei mir nur passiv als Altersrente. Bis dahin habe ich noch 23 Jahre. Wünsche dir und allen anderen hier in Relief gute Erfolgschancen auch wenn alles manchmal nicht so läuft wie wir es uns vorstellen.  

ist ja schön und gut, aber damit sind ja noch lange nicht Umsätze garantiert.
Man kriegt einfach ein Exklusivrecht für eine gewisse Zeit.


Aber trotzdem tolle News und ein weiterer Schritt in die richtige Richtung.  

die 0.2 zu halten, mehr jedoch nicht...  

https://www.vfa.de/de/wirtschaft-politik/...an-drugs-schnell-erklaert  

https://ir.nrxpharma.com/news-events/...-with-mannkind-corporation-to  

Bald sind wir unter 20 Rappen.
Painoneer hatte wohl doch ned so unrecht.  

wie sieht es denn damit aus, any news ? Ansonsten wird die Luft dünn.......  

https://www.basg.gv.at/marktbeobachtung/...ur-behandlung-von-covid-19  

ich rechne damit, dass die Wirkung der Impfstoffe nachlassen wird,
es wird ein Medikament gebraucht,
aber wie heißt es???
Und wann kommt es raus???  

Da es noch kein zugelassenes Wirksames Medikament gibt, kann dir das niemand sagen.
Relief selbst wurde ja auch noch bei weitem nicht zugelassen.
Reliefs Medikament ist zwar schon raus, aber irgendwie ist da was faul an der Sache.
Ich bleibe drin mit meinen bescheidenen Stücken, habe diese aber schon  auf 0 abgeschrieben.  

https://poseidon01.ssrn.com/...22085095084&EXT=pdf&INDEX=TRUE  

https://www.finanznachrichten.de/...ags-fuer-acer-001-zur-beh-022.htm  

danke Stadtjunge
 
Ad hoc announcement pursuant to Art. 53 LR  
1

Acer Therapeutics and Relief Therapeutics Announce Submission of a
New Drug Application to the U.S. FDA for ACER-001 for Treatment of
Urea Cycle Disorders

NEWTON,  MA  and  GENEVA,  SWITZERLAND  –  August  9,  2021  –  Acer  Therapeutics  Inc.  (Nasdaq:  ACER)
(“Acer”), a pharmaceutical company focused on the acquisition, development and commercialization of
therapies  for  serious  rare  and  life-threatening  diseases  with  significant  unmet  medical  needs,  and  RELIEF
THERAPEUTICS  Holding  AG    (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to
provide  patients  therapeutic  relief  from  serious diseases  with high  unmet need,  today announced the
submission of a New Drug  Application (NDA)  to  the U.S. Food and Drug Administration (FDA)  for ACER-001
(sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs).  ACER-001 is a  nitrogen-binding
agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving
deficiencies  of  carbamylphosphate  synthetase  (CPS),  ornithine  transcarbamylase  (OTC),  or  argininosuccinic
acid synthetase (AS).
Based  on  standard  FDA  review  timelines,  Acer  expects  to  receive  notification  from  FDA  on  the  potential
acceptance of the NDA for filing within 60 days of submission and subsequent substantive review.
The 505(b)(2) NDA submission is supported by results from two previously announced bioequivalence (BE)
trials in which ACER-001 showed similar relative bioavailability for both phenylbutyrate (PBA) and
phenylacetate  (PAA),  the  active  metabolite  of  sodium  phenylbutyrate,  compared  to  BUPHENYL®  (sodium
phenylbutyrate). Acer has also received an Agreement Letter from FDA in response to the Company’s initial
Pediatric  Study  Plan  (iPSP)  which  outlines  an  agreed  upon  approach  that  addresses  the  needs  of  pediatric
patients with UCDs.  
“The submission of our NDA for ACER-001 marks an important step toward bringing this potential alternative
treatment option to patients with UCDs,” said Chris Schelling, Chief Executive Officer and Founder of Acer.
“We look forward to working with the FDA through the review process and will continue advancing our
preparations for a potential launch of ACER-001, while also assisting Relief toward regulatory submissions in
Europe.”
Jack Weinstein, Chief Financial Officer and Treasurer of Relief Therapeutics, added, “We are excited about
the progress made to date in support of a potential regulatory approval of ACER-001 for UCDs in the U.S. With
the NDA now submitted, we will continue our efforts to back ACER-001’s development in Europe by targeting
submission of a Marketing Authorization Application (MAA) for the treatment of UCDs in Europe by the end of
2021.”
ACER-001  is  an  investigational  product  candidate  which  has  not  been  approved  by  FDA  or  the  European
Medicines Agency (EMA). There is no guarantee that this product candidate will  be accepted for substantive
review, or if accepted, receive regulatory authority approval in any territory, or become commercially available
for the indications under investigation.
 
 
Ad hoc announcement pursuant to Art. 53 LR  
2

ABOUT UCDS
UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes
that  catalyze  the  urea  cycle,  which  can  lead  to  an  excess  accumulation  of  ammonia  in  the  bloodstream,  a
condition  known  as  hyperammonemia.  Acute  hyperammonemia  can  cause  lethargy,  somnolence,  coma,  and
multi-organ  failure,  while  chronic  hyperammonemia  can  lead  to  headaches,  confusion,  lethargy,  failure  to
thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic
hyperammonemia also include seizures and psychiatric symptoms.1,2   The current treatment of UCDs consists
of dietary management to limit ammonia production in conjunction with medications that provide alternative
pathways  for  the  removal  of  ammonia  from  the  bloodstream.  Some  patients  may  also  require  individual
branched-chain amino acid supplementation.
Current medical treatments for UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the
active pharmaceutical ingredients are glycerol phenylbutyrate (GPB) and sodium phenylbutyrate, respectively.
According  to  a  2016  study  by  Shchelochkov  et  al.,  published  in Molecular  Genetics  and  Metabolism  Reports,
while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels
in  some  patients  with UCDs,  non-compliance with treatment  is  common.  Reasons referenced  for non-
compliance  associated  with  some  available  medications  include  unpleasant  taste,  frequency  with  which
medication must be taken, required number of pills, and the high cost of the medication.3

ABOUT ACER-001
ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of
metabolism,  including  UCDs  and  MSUD.  ACER-001  is  a  nitrogen-binding  agent  in  development  for  use  as
adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of
carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase
(AS).  The  formulation  is  a  multi-particulate  dosage  formulation  for  oral  administration  consisting  of  a  core
center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste in the mouth while
quickly dissolving in the low pH of the stomach. ACER-001’s taste-masked formulation is aimed to improve the
palatability of sodium phenylbutyrate. Acer is also being developed for Maple Syrup Urine Disease (MSUD) and
has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is an investigational
product candidate which has not been approved by FDA or the European Medicines Agency (EMA).

ABOUT ACER THERAPEUTICS INC.
Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies
for  serious  rare  and  life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes
four  programs:  ACER-001  (sodium  phenylbutyrate)  for  treatment  of  various  inborn  errors  of  metabolism,
including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for
treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1)
mutation;  ACER-801  (osanetant)  for  treatment  of  induced  Vasomotor  Symptoms  (iVMS);  and  ACER-2820
(emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s
product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable
 
Ad hoc announcement pursuant to Art. 53 LR  
3

safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for
development through specific programs and procedures established by the FDA. In March 2021, Acer entered
into a Collaboration and License Agreement with Relief Therapeutics for development and commercialization
of ACER-001. For more information, visit www.acertx.com.

ABOUT RELIEF THERAPEUTICS HOLDING AG
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-100™ (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 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 acquisition of APR Applied Pharma Research SA brings a
diverse pipeline of marketed and development-stage programs.
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.
For more information, visit www.relieftherapeutics.com.
Follow Relief on LinkedIn.

REFERENCES
1. Ah  Mew  N,  et  al.  Urea  cycle  disorders  overview.  Gene  Reviews.  Seattle,  Washington:  University  of
Washington, Seattle; 1993.
2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet
Journal of Rare Diseases. 2012;7(32).
3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of
patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

ACER FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for
purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements,
other than statements of historical facts, included in  this press release regarding strategy, future operations,
timelines,  future  financial  position,  future  revenues,  projected  expenses,  regulatory  submissions,  actions  or
approvals,  cash position,  liquidity, prospects,  plans  and  objectives  of  management  are  forward-looking
statements. Examples of such statements include, but are not limited to, statements relating to the potential for
our  product  candidates  to  safely  and  effectively  treat  diseases  and  to  be  approved  for  marketing;  the
commercial or market opportunity of any of our product candidates in any target indication and any territory;
 
Ad hoc announcement pursuant to Art. 53 LR  
4

our  ability  to  secure  the  additional  capital  necessary  to  fund  our  various  product  candidate  development
programs;  the  adequacy  of  our  capital  to  support  our  future  operations  and  our  ability  to  successfully  fund,
initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property
rights; our strategy and business focus; and the development, expected timeline and commercial potential of
any  of  our  product  candidates.  We  may  not  actually  achieve  the  plans,  carry  out  the  intentions  or  meet  the
expectations  or  projections  disclosed  in  the  forward-looking  statements  and  you  should  not  place  undue
reliance on these forward-looking  statements.  Such  statements  are  based  on  management’s  current
expectations and involve risks and uncertainties. Actual results and performance could differ materially from
those  projected  in  the  forward-looking  statements  as  a  result  of  many  factors,  including,  without  limitation,
risks  and  uncertainties  associated  with  the  ability  to  project  future  cash  utilization  and  reserves  needed  for
contingent future liabilities and business operations, the availability of sufficient resources to fund our various
product candidate development programs and to meet our business objectives and operational requirements,
the  fact  that  the  results  of  earlier  studies  and  trials  may  not  be  predictive  of  future  clinical  trial  results,  the
protection and market exclusivity provided by our intellectual property, risks related to the drug development
and  the  regulatory  approval  process,  including  the  timing  and  requirements  of  regulatory  actions,  and  the
impact of competitive products and technological changes. We disclaim any intent or obligation to update these
forward-looking  statements  to  reflect  events  or  circumstances  that  exist  after  the  date  on  which  they  were
made.  You  should  review  additional  disclosures  we  make  in  our  filings  with  the  Securities  and  Exchange
Commission,  including  our  Quarterly  Reports  on  Form  10-Q and  our  Annual  Report  on  Form  10-K.  You  may
access these documents for no charge at http://www.sec.gov.

RELIEF FORWARD-LOOKING STATEMENTS
This  communication  expressly  or  implicitly  contains  certain  forward-looking  statements  concerning  RELIEF
THERAPEUTICS Holding AG and its businesses. The results reported herein may or may not be indicative of the
results of future and larger clinical trials for ACER-001 for the treatment of UCDs and MSUD, nor whether the
ongoing clinical trials of Relief’s lead compound, RLF-100™ (aviptadil) in advanced clinical development  to
treat  respiratory  deficiency  due to COVID-19, will be successful. Such statements  involve certain known and
unknown  risks,  uncertainties  and  other  factors,  which  could  cause  the  actual  results,  financial  condition,
performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future
results,  performance  or  achievements  expressed  or  implied  by  such  forward-looking  statements.  RELIEF
THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update
any forward-looking statements contained herein as a result of new information, future events or otherwise.
 
 
Ad hoc announcement pursuant to Art. 53 LR  
5


CORPORATE CONTACTS
Acer Therapeutics Inc.
Jim DeNike
+1 844-902-6100
jdenike@acertx.com  


RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer  
contact@relieftherapeutics.com

INVESTOR RELATION CONTACTS
Acer Therapeutics Inc.
Hans Vitzthum
LifeSci Advisors
+1 617-430-7578
hans@lifesciadvisors.com  

RELIEF THERAPEUTICS Holding AG
Michael Miller
Rx Communications Group  
+1-917-633-6086
mmiller@rxir.com
 
#  #  #

 

Heute wieder mal im Angebot, Relief Therapeutics unter 0,20 :-)

Zulassungsanträge Studien etc. sind ja schön und gut, damit ist aber noch lange nicht Geld in die Kasse gespült....  

Kann mir sogar vorstellen, dass eine EUA nicht mehr gross hilft.
Einzig und allein zählen nur noch Finanzzahlen.
Ohne Umsatz / Gewinn wird es schlecht aussehen.

Die +40'000% vom letzten Jahr waren schön und gut, werden aber in dieser Form nie mehr kommen.