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 [/b] NEWTON, Mass. and GENEVA, Aug. 09, 2021 (GLOBE NEWSWIRE) -- 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.
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 de
das wäre für mich noch einmal ein Grund nachzulegen . Immer noch zu 100% überzeugt das hier mächtig was kommt im positiven Sinne . Wenn du dir in verschiedenen Foren und insbesondere im Yahooforum umschaust da wimmelt es geradezu von Bashern und Shorties . Tragisch wenn einige viel Geld aktuell verlieren oder gezwungenermassen jetzt verkaufen müssen weil das Geld benötigt wird . Wir haben Studien laufen mit positiven Ergebnissen und das einzig negative sind die Quereleien mit NeuroRX . Was solls ich bin wie bereits erwähnt auf Long und schaue mir das tiefenentspannt an . Wünsche uns Allen aber möglichst schnell mal eine Reaktion seitens FDA bzw. WHO damit den Schwerkranken endlich geholfen werden kann . Heute um ca. 14:00 Uhr ist ja noch eine PR von NRXP angesagt . Bin gespannt was dabei herauskommt . Stoam halte durch !! :-)
NRx Pharmaceuticals gibt positiven Sicherheitsbericht für ZYESAMI™ (Aviptadil) in der von den NIH geförderten ACTIV-3 Critical Care Studie bei Patienten mit lebensbedrohlichem COVID-19 bekannt - Nach der Überprüfung von etwa 140 Patienten in der ACTIV-3 Critical Care-Studie wurden vom unabhängigen Data Safety Monitoring Board keine neuen Sicherheitsbedenken geäußert; die Studie wird fortgesetzt, um mehr als 600 Patienten zu rekrutieren
- ACTIV-3 Critical Care ist eine öffentlich-private Partnerschaft, die von den US National Institutes of Health zur Behandlung von COVID-19 gefördert wird
- ACTIV-3 Critical Care prüft ZYESAMI™ und Remdesivir bei kritischen COVID-19-Patienten als Monotherapie und in Kombination mit Placebo.
Relief Reports that its U.S. Collaboration Partner has Announced a Positive Safety Report for ZYESAMI™ (aviptadil) in NIH Sponsored ACTIV-3 Critical Care Study in Patients with Life-Threatening COVID-19
Geneva, Switzerland, August 19, 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 the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”) provided a safety update on ZYESAMI™ (aviptadil) which is being tested in the ACTIV-3 Critical Care Phase 3 study sponsored by the National Institutes of Health (NIH). The related NRx press release can be accessed through the following link.
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 firstname.lastname@example.org FOR MEDIA/INVESTOR INQUIRIES: Rx Communications Group Michael Miller +1-917-633-6086 email@example.com
Ad hoc announcement pursuant to Art. 53 LR 2
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.
VIP ermöglicht noch viel mehr in Zukunft ! MS, Alzheimer , Transplantionen usw . Covid ist der Einstieg in einen riesigen Markt . Immer mehr das Gefühl das hier was ganz Grosses entsteht . Der Kurs beeindruckt mich weniger und jeder der mit Pennystocks schon gehandelt hat weiss das hier Kursschwankungen bis zu 10% am Tag durchaus möglich sind . Für mich der erste Pennystock der zum Longinvest gereift ist . Euch allen noch ein schönes Wochenende !! :-)
Sarcoidosis Drugs Market 2021 Size, Share, Growth Till 2030 with Top Key Players Relief Therapeutics Holding SA, Firststring Research, Bellus Health, Araim Pharmaceuticals, Inc, Merck & Co., Inc, Novartis AG 08-20-2021 02:40 PM CET | Health & Medicine Press release from: Allied Market Research / PR Agency: Allied Market Research Sarcoidosis Drugs Market 2021 Size, Share, Growth Till 2030 with
Allied Market Research published a latest report titled, “Sarcoidosis Drugs Market: Global Opportunity Analysis and Industry Forecast 2021-2030’’.
The market report features the factors and top market trends that fuel the growth of the market.
The report includes the frontrunners in the market including Relief Therapeutics Holding SA, Firststring Research, Bellus Health, Araim Pharmaceuticals, Inc, Merck & Co., Inc, Novartis AG. These market players have incorporated several strategies including partnership, expansion, collaboration, joint ventures, and others to prove their flair in the industry.
The study on the global Sarcoidosis Drugs Market encompasses 250+ pages report that doles out notable information along with underlining the drivers, restraints, and opportunities of the market. The analysis also intends to offer an all-inclusive information on the latest market trends, approaches, and strategies adopted by the market players in the global market. The research covers both the historical and estimated data during the forecast period along with other aspects including product overview and growth prospects.
Covid-19 Impact on the Global Sarcoidosis Drugs Market:
The outbreak of covid-19 has radically affected most industry verticals across the world and the Sarcoidosis Drugs Market is also not an exception in this regard. The report takes in the impact of the pandemic on the sector, offering an explicit analysis of the same.
Get detailed COVID-19 impact analysis on the Market @
The research provides a detailed segmentation of the global Sarcoidosis Drugs Market based on Application, Form, Distribution Channel, and Region. It also provides a complete analyzation of sales, revenue, growth rate, and market share of each throughout the forecast period.
Sarcoidosis Drugs Market Geographical Analysis:
The report also offers a geographical analysis of the market along with the competitive landscape in each region. The study covers regions including North America (the United States, Canada, and Mexico), Europe (Germany, France, UK, Russia, and Italy), Asia-Pacific (China, Japan, Korea, India, and Southeast Asia), South America (Brazil, Argentina, and Colombia), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa). These acumens assist the market players to frame respective strategies and pave the way for lucrative opportunities to achieve their goal.
Our Report Offers: • Detailed inquiry of market estimations for all the segments • Thorough market analysis from the viewpoint of the leading market players • Strategic approaches for new entrants • Market forecasts on regional basis for the next decade • Competitive analysis of the current market trends • Company profiling along with an explicit strategy and economic developments
About Allied Market Research: Allied Market Research (AMR) is a full-service market research and business-consulting wing of Allied Analytics LLP based in Portland, Oregon. Allied Market Research provides global enterprises as well as medium and small businesses with unmatched quality of “Market Research Reports” and “Business Intelligence Solutions.” AMR has a targeted view to provide business insights and consulting services to assist its clients to make strategic business decisions and achieve sustainable growth in their respective market domains. AMR offers its services across 11 industry verticals including Life Sciences, Consumer Goods, Materials & Chemicals, Construction & Manufacturing, Food & Beverages, Energy & Power, Semiconductor & Electronics, Automotive & Transportation, ICT & Media, Aerospace & Defense, and BFSI. We are in professional corporate relations with various companies and this helps us in digging out market data that helps us generate accurate research data tables and confirms utmost accuracy in our market forecasting. Each and every data presented in the reports published by us is extracted through primary interviews with top officials from leading companies of domain concerned. Our secondary data procurement methodology includes deep online and offline research and discussion with knowledgeable professionals and analysts in the industry.
So Leute das hier Beiträge nicht bewertet werden ist eine Sache aber das wir wie ein Mäuschen im Loch sitzen darf nicht sein . Wer soll uns bzw. Relief kennen wenn wir nicht unter Topforen gelistet sind ? Geht doch bitte mal hin und bewertet unsern Anfangspost von Toni 1111 , damit wir gelistet werden . Vieleicht findet sich dann noch der eine oder andere Interessent oder ??? :-)
Aviptadil hat eine EU-Zulassung gegen Erektionsstörungen . Zeigt aber schon mal die gute Verträglichkeit an . Ist aber nicht so der Burner oder eher was für Sadomisten da du deinem Freund da unten ne Spritze verpassen must ! ( Darf gar nicht dran denken :-) ) Mann Leute wo bleiben die Sterne für den Anfangsthread ???? Geht hier was ???????????? :-)