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Relief therapeutics Holding

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ik weet niet alles
0
Ik heb ook nog vergeten te melden dat het de CEO en een bestuurslid van ACER Therapeutics zelf waren die de 1,5 miljoen hebben gegeven.Als dat geen teken van vertrouwen is.
Bert-Jan
0
quote:

DeZwarteRidder schreef op 8 december 2022 14:06:

[...]

Het maakt geen bal verschil uit voor de koers.

Dit aandeel wordt een fraaie opvolger voor Oxurion.
Nee, maar dit is wel een voorwaarde om een notering aan de Nasdaq te krijgen
Bert-Jan
0
quote:

ik weet niet alles schreef op 8 december 2022 14:19:

Ik heb ook nog vergeten te melden dat het de CEO en een bestuurslid van ACER Therapeutics zelf waren die de 1,5 miljoen hebben gegeven.Als dat geen teken van vertrouwen is.
Zeker! Ze hadden ook ''gewoon'' extra aandelen uit kunnen geven.
DeZwarteRidder
0
quote:

Bert-Jan schreef op 8 december 2022 14:22:

[...]Nee, maar dit is wel een voorwaarde om een notering aan de Nasdaq te krijgen
Waarom denk je dat ze zo'n notering nodig hebben......????

Juist ja, om veel nieuwe aandelen te kunnen dumpen........!!!!
ik weet niet alles
0
ik weet niet alles
0
En hoeveel van de opbrengst van ACER-001 gaat naar Relief?
60% in USA , Canada, Brasil,Turkey, Japan
85% in Europa en de rest van de wereld.

Analist Vernon Bernardino, die Acer volgt voor H.C. Wainwright, steekt ook zijn optimisme voor het aandeel niet onder stoelen of banken en is duidelijk over waarom Acer goede vooruitzichten heeft

"Zonder verdere zorgen over de goedkeuring zijn wij positief over de vooruitzichten van ACER-001 op goedkeuring door de FDA op of voor 15 januari 2023. Wij verwachten dus dat ACER-001 een commercieel succes wordt en schatten dat ACER-001 tegen 2028 een jaarlijkse omzet van ongeveer $750 miljoen kan halen als behandeling voor UCD's. Wij geloven dat de prestaties van Acer bij het aangaan van de uitdagingen om zijn NDA te bevorderen, en het potentieel voor ACER-001 om op korte termijn commercieel succes te boeken, onderschat worden," schreef Bernardino
ik weet niet alles
0
De rechtbank heeft nog eens tot 19 december verschoven.
Ik weet niet hoe die rechtbanken daar werken, maar die kunnen blijkbaar blijven schuiven. Laat ons maar van begin volgend jaar uitgaan als die nog eens kunnen opschuiven.
En 1 miljard aandelen uit het goedgekeurde kapitaal gaan er waarschijnlijk bijkomen.
relieftherapeutics.com/newsblog-detai...

Prettig is anders
DeZwarteRidder
0
Relief Therapeutics Announces Issuance of Shares from Authorized Capital

Relief Therapeutics Holding SA / Key word(s): Capital Increase

13-Dec-2022 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.

Relief Therapeutics Announces Issuance of Shares from Authorized Capital

Geneva, Dec. 13, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent-protected products in select specialty, rare and ultra-rare disease areas on a global basis, today reported that its board of directors approved an increase of the Company's share capital from 4,616,334,617 to 5,616,334,617 shares through the issuance of 1,000,000,000 shares from its authorized capital. The new shares are fully subscribed at par value by the Company’s wholly owned subsidiary, Relief Therapeutics International SA, and will be listed on the SIX Swiss Exchange on or around Dec. 22, 2022. Following this issuance, Relief expects to hold approximately 1.2 billion shares that will be maintained in treasury for future financing transactions. Until placement of the treasury shares, the number of outstanding shares remains unchanged.
 
DeZwarteRidder
0
quote:

DeZwarteRidder schreef op 8 december 2022 15:39:

[...]Waarom denk je dat ze zo'n notering nodig hebben......????
Juist ja, om veel nieuwe aandelen te kunnen dumpen........!!!!
Er zullen slechts een miljard aandelen gedumpt gaan worden..........!!!

De koers gaat dus richting 1 cent of lager.
ik weet niet alles
0
[Modbreak IEX: Gelieve op de inhoud van uw berichten te letten, bericht is bij dezen verwijderd. Deze account is geschorst.]
Rush
4
Bedankt om de newsflow stop te zetten he mods.
Jij ook bedankt hé Zwarte Ridder.
Forecast2006
2
Relief Therapeutics Holding SA and NRx Pharmaceuticals, Inc. Announce Close of Definitive Settlement Agreements

GENEVA and RADNOR, PA., DECEMBER 20, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief"), and NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”), a clinical-stage central nervous system biopharmaceutical company, today announced the close of the definitive settlement agreements to resolve the pending litigation between Relief and NRx Pharmaceuticals' wholly owned subsidiary, NeuroRx, Inc (NeuroRx). Per the terms of the settlement, (i) NeuroRx has transferred to Relief all of the assets it used in the NRx aviptadil development program, including the regulatory filings, patent applications, clinical data, and the formulation of the aviptadil product it was previously developing, (ii) Relief now has the exclusive right and control going forward and the obligation to use commercially reasonable efforts to develop and commercialize an aviptadil product, (iii) Relief has agreed to use commercially reasonable efforts to continue the existing Right to Try Program for aviptadil in the U.S. for at least two years, (iv) Relief will pay NeuroRx milestone payments if it can successfully obtain commercial approval of an aviptadil product (whether for COVID-19 or any other indication), (v) Relief will pay NeuroRx royalties based on a percentage of future sales of an aviptadil product (whether for COVID-19 or any other indication), up to a maximum of $30 million in the aggregate, (vi) NRx and NeuroRx have agreed not to compete in the development of an aviptadil product in the future, and (vii) Relief and NeuroRx have dismissed their pending litigation.

Kind regards,

Forecast
Forecast2006
0
quote:

ik weet niet alles schreef op 9 december 2022 18:15:

En hoeveel van de opbrengst van ACER-001 gaat naar Relief?
60% in USA , Canada, Brasil,Turkey, Japan
85% in Europa en de rest van de wereld.

Analist Vernon Bernardino, die Acer volgt voor H.C. Wainwright, steekt ook zijn optimisme voor het aandeel niet onder stoelen of banken en is duidelijk over waarom Acer goede vooruitzichten heeft

"Zonder verdere zorgen over de goedkeuring zijn wij positief over de vooruitzichten van ACER-001 op goedkeuring door de FDA op of voor 15 januari 2023. Wij verwachten dus dat ACER-001 een commercieel succes wordt en schatten dat ACER-001 tegen 2028 een jaarlijkse omzet van ongeveer $750 miljoen kan halen als behandeling voor UCD's. Wij geloven dat de prestaties van Acer bij het aangaan van de uitdagingen om zijn NDA te bevorderen, en het potentieel voor ACER-001 om op korte termijn commercieel succes te boeken, onderschat worden," schreef Bernardino
Met deze verdeling kan het een heeeel mooi jaar worden voor Relief Therapeutics.

Kind regards,

Forecast
Forecast2006
0
quote:

Bert-Jan schreef op 24 december 2022 01:32:

Acer-001 goedgekeurd in de US!
NEWTON, MASS. and GENEVA – Dec. 27, 2022 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), today announced that the U.S. Food and Drug Administration (FDA) has approved OLPRUVA™ (sodium phenylbutyrate) for oral suspension in the U.S. for the treatment of certain patients living with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).

“The FDA’s approval of OLPRUVA™, an innovative formulation of sodium phenylbutyrate packaged for the first time in single-dose envelopes, marks the culmination of our ongoing dedication to develop new and differentiated treatment options for those affected by rare diseases,” said Chris Schelling, chief executive officer and founder of Acer. “Patients who are living with UCDs now have an alternative treatment option with OLPRUVA™, to address some of the challenges they may have with existing therapy. We are pleased to be able to provide a new, approved treatment choice for those living with this challenging disease.”

Mr. Schelling continued, “This approval represents the first FDA-approved product for Acer, validating our ability to identify and develop treatments where science can be applied in novel ways and make them available to patients as quickly and efficiently as possible. In addition, this approval unlocks our Marathon debt funding option and provides us with resources to advance our pipeline of investigational product candidates.”

“The daily challenges of living with a UCD can be overwhelming and emotionally draining for patients and their families,” said Tresa Warner, president of the National Urea Cycle Disorders Foundation. “We welcome new treatment options that can help patients, caregivers and their healthcare teams manage UCDs.”

OLPRUVA’s™ approval triggers the availability of a $42.5 million term loan to Acer under the previously announced March 2022 loan agreement the Company entered into with affiliates of Marathon Asset Management L.P. If Acer requests and receives the loan proceeds, management believes it will have sufficient resources to fund current operations into H2 2023.

OLPRUVA™ has been approved as an oral suspension by the FDA for the treatment of patients with UCDs. UCDs are a group of rare, genetic disorders that can cause harmful ammonia to build up in the blood, potentially resulting in brain damage and neurocognitive impairments, if ammonia levels are not controlled.1 Any increase in ammonia over time is serious. Therefore, it is important to adhere to any dietary protein restrictions and have alternative medication options to help control ammonia levels.

“This FDA approval is a significant milestone for patients with UCDs in the U.S., offering an additional choice to manage their condition,” added Jack Weinstein, chief executive officer of Relief. “We look forward to building on OLPRUVA™’s approval in the U.S. and expanding its availability into other territories outside of the U.S.”

OLPRUVA™ received FDA approval under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FDCA), a regulatory pathway that allows applicants to rely, at least in part, on third party data for approval. In its New Drug Application (NDA), Acer cited preclinical and clinical safety and efficacy data from the reference listed drug (RLD), BUPHENYL® powder, which is approved as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of CPS, OTC or AS. In its NDA, Acer also provided additional data including studies that evaluated the bioavailability and bioequivalence of OLPRUVA™ compared to BUPHENYL® powder. The data from these studies, presented at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting in April 2022 and the Genetic Metabolic Dieticians International (GMDI) Conference in May 2022, showed that OLPRUVA™ was bioequivalent to BUPHENYL® powder.

Commitment to Patient Access

Acer intends to offer Navigator by Acer Therapeutics, a suite of integrated patient support services designed to facilitate access to therapy. Navigator by Acer Therapeutics is designed to assist UCD patients with support, access, education, and adherence.

Financial Outlook

Acer is not currently providing specific revenue or operating expense guidance for OLPRUVA™. Based on current forecasted operating expenses and revenue, and assuming receipt of the $42.5 million term loan funds from its March 2022 term loan arrangement with Marathon (less the amount to repay the bridge loan and fees), and Acer’s existing cash and equivalents, Acer believes its cash resources will be sufficient to fund its operations into H2 2023. Further information with respect to Acer’s March 2022 term loan arrangement, as well as a bridge loan facility (as amended in August 2022) and a convertible note financing which also funded in March 2022 can be found in the SEC Filings section of Acer’s website.

About OLPRUVA™

OLPRUVA™ is a prescription medicine used along with certain therapy, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a body surface area (BSA) of 1.2 m2 or greater, with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS). OLPRUVA™ is not used to treat rapid increase of ammonia in the blood (acute hyperammonemia), which can be life-threatening and requires emergency medical treatment.

Important Safety Information

Certain medicines may increase the level of ammonia in your blood or cause serious side effects when taking during treatment with OLPRUVA™. Tell your doctor about all the medicines you or your child takes specially if you or your child takes corticosteroids, valproic acid, haloperidol, and/or probenecid.

OLPRUVA™ can cause serious side effects, including: 1) nervous system problems (neurotoxicity). Symptoms include sleepiness, tiredness, lightheadedness, vomiting, nausea, headache, confusion, 2) low potassium levels in your blood (hypokalemia) and 3) conditions related to swelling (edema). OLPRUVA™ contains salt (sodium), which can cause swelling from salt and water retention. Tell your doctor right away if you or your child get any of these symptoms. Your doctor may do certain blood tests to check for side effects during treatment with OLPRUVA™. If you have certain medical conditions such as heart, liver or kidney problems, are pregnant/planning to get pregnant or breast-feeding, your doctor will decide if OLPRUVA™ is right for you.

The most common side effects of OLPRUVA™ include absent or irregular menstrual periods, decreased appetite, body odor, bad taste or avoiding foods you ate prior to getting sick (taste aversion). These are not all of the possible side effects of OLPRUVA™. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

We gaan los.

Kind regards,

Forecast
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