scPharmaceuticals to Host Key Opinion Leader (KOL) Webinar on October 22, 2024
scPharmaceuticals Inc. (Nasdaq: SCPH) has announced a Key Opinion Leader (KOL) webinar scheduled for October 22, 2024, at 1:00 PM ET. The webinar will focus on a nephrologist's perspective on using FUROSCIX for treating fluid overload in heart failure and its potential use in chronic kidney disease (CKD) patients.
The event will feature Dr. Michael Aaronson from Lincoln Nephrology and Hypertension. The FDA has set a PDUFA target action date of March 6, 2025, for scPharmaceuticals' Supplemental New Drug Application (sNDA) to expand FUROSCIX's indication to include CKD-related fluid overload treatment.
scPharmaceuticals' management will provide updates on long-term growth initiatives, including the FDA-approved expansion of FUROSCIX for NYHA Class IV heart failure patients and the development of a low volume autoinjector. A live Q&A session will follow the presentation.
scPharmaceuticals Inc. (Nasdaq: SCPH) ha annunciato un webinar con un Key Opinion Leader (KOL) programmato per 22 ottobre 2024, alle 13:00 ET. Il webinar si concentrerà sulla prospettiva di un nefrologo sull'uso di FUROSCIX per il trattamento dell'eccesso di fluidi nell'insufficienza cardiaca e sul suo potenziale utilizzo nei pazienti con malattia renale cronica (CKD).
L'evento vedrà la partecipazione del Dr. Michael Aaronson della Lincoln Nephrology and Hypertension. La FDA ha fissato una data target di azione PDUFA per il 6 marzo 2025 per la Supplemental New Drug Application (sNDA) di scPharmaceuticals, per espandere l'indicazione di FUROSCIX al trattamento dell'eccesso di fluidi nei pazienti con CKD.
Il management di scPharmaceuticals fornirà aggiornamenti sulle iniziative di crescita a lungo termine, inclusa l'espansione approvata dalla FDA di FUROSCIX per i pazienti con insufficienza cardiaca NYHA Classe IV e lo sviluppo di un autoiniettore a basso volume. Seguirà una sessione di domande e risposte in diretta.
scPharmaceuticals Inc. (Nasdaq: SCPH) ha anunciado un seminario web con un Líder de Opinión Clave (KOL) programado para 22 de octubre de 2024, a la 1:00 PM ET. El seminario web se centrará en la perspectiva de un nefrólogo sobre el uso de FUROSCIX para tratar la sobrecarga de líquidos en la insuficiencia cardíaca y su uso potencial en pacientes con enfermedad renal crónica (ERC).
El evento contará con el Dr. Michael Aaronson de Lincoln Nephrology and Hypertension. La FDA ha establecido una fecha objetivo de acción PDUFA para el 6 de marzo de 2025 para la Solicitud de Nuevo Medicamento Suplementaria (sNDA) de scPharmaceuticals para ampliar la indicación de FUROSCIX para el tratamiento de la sobrecarga de líquidos relacionada con la ERC.
La dirección de scPharmaceuticals proporcionará actualizaciones sobre las iniciativas de crecimiento a largo plazo, incluida la expansión aprobada por la FDA de FUROSCIX para pacientes con insuficiencia cardíaca NYHA Clase IV y el desarrollo de un autoinyector de bajo volumen. Seguirá una sesión de preguntas y respuestas en vivo.
scPharmaceuticals Inc. (Nasdaq: SCPH)는 2024년 10월 22일 오후 1시 ET에 예정된 주요 의견 리더(KOL) 웨비나를 발표했습니다. 이 웨비나는 심부전으로 인한 유체 과다 치료를 위한 FUROSCIX의 사용에 대한 신장 전문의의 관점과 만성 신장 질환 (CKD) 환자에서의 잠재적 사용에 초점을 맞출 것입니다.
이 행사에는 Lincoln Nephrology and Hypertension의 Michael Aaronson 박사가 참여할 예정입니다. FDA는 scPharmaceuticals의 FUROSCIX를 CKD 관련 유체 과다 치료로 확대하기 위한 보충 신약 신청서(sNDA)에 대해 2025년 3월 6일 목표 행동 날짜를 설정했습니다.
scPharmaceuticals의 경영진은 NYHA Class IV 심부전 환자를 위한 FUROSCIX의 FDA 승인 확대와 저용량 자가 주입기 개발을 포함한 장기 성장 이니셔티브에 대한 업데이트를 제공할 예정입니다. 발표 후에는 라이브 Q&A 세션이 진행됩니다.
scPharmaceuticals Inc. (Nasdaq: SCPH) a annoncé un webinaire avec un Leader d'Opinion Clé (KOL) prévu pour le 22 octobre 2024 à 13h00 ET. Le webinaire se concentrera sur la perspective d'un néphrologue concernant l'utilisation de FUROSCIX pour traiter la surcharge liquidienne dans l'insuffisance cardiaque et son utilisation potentielle chez les patients atteints de maladie rénale chronique (MRC).
L'événement mettra en vedette le Dr Michael Aaronson de Lincoln Nephrology and Hypertension. La FDA a fixé une date cible d'action PDUFA au 6 mars 2025 pour la Demande de Médicament Nouveau Supplémentaire (sNDA) de scPharmaceuticals pour élargir l'indication de FUROSCIX au traitement de la surcharge liquidienne liée à la MRC.
La direction de scPharmaceuticals fournira des mises à jour sur les initiatives de croissance à long terme, y compris l'expansion approuvée par la FDA de FUROSCIX pour les patients atteints d'insuffisance cardiaque NYHA Classe IV et le développement d'un auto-injecteur à faible volume. Une session de questions-réponses en direct suivra la présentation.
scPharmaceuticals Inc. (Nasdaq: SCPH) hat ein Webinar mit einem Key Opinion Leader (KOL) angekündigt, das für 22. Oktober 2024, 13:00 Uhr ET geplant ist. Das Webinar wird sich auf die Perspektive eines Nephrologen zur Verwendung von FUROSCIX bei der Behandlung von Flüssigkeitsüberladung bei Herzinsuffizienz und seinem potenziellen Einsatz bei chronischen Nierenerkrankungen (CKD) konzentrieren.
Die Veranstaltung wird Dr. Michael Aaronson von Lincoln Nephrology and Hypertension präsentieren. Die FDA hat ein Zieltermin für die PDUFA-Aktion am 6. März 2025 für den Supplemental New Drug Application (sNDA) von scPharmaceuticals festgelegt, um die Indikation von FUROSCIX auf die Behandlung von CKD-bedingter Flüssigkeitsüberladung zu erweitern.
Das Management von scPharmaceuticals wird Updates zu langfristigen Wachstumsinitiativen geben, einschließlich der von der FDA genehmigten Erweiterung von FUROSCIX für NYHA Klasse IV Herzinsuffizienzpatienten und der Entwicklung eines niedrigvolumigen Autoinjektors. Auf die Präsentation folgt eine Live-Frage- und Antwort-Sitzung.
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Webinar to focus on a nephrologist’s perspective on the use of FUROSCIX for fluid overload in heart failure and potential use in chronic kidney disease
BURLINGTON, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that it will host a KOL webinar focused on a nephrologist’s perspective on the use of FUROSCIX for treating fluid overload in heart failure and potential use for patients with chronic kidney disease (CKD) on Tuesday, October 22, 2024 at 1:00 PM ET. To register, click here.
https://lifescievents.com/event/scpharmaceuticals/
The event will feature Dr. Michael Aaronson, MD (Lincoln Nephrology and Hypertension, Lincoln, NE).
The FDA has assigned a PDUFA target action date of March 6, 2025, to consider scPharmaceuticals’ Supplemental New Drug Application (sNDA) seeking to expand the FUROSCIX indication to include the treatment of fluid overload in CKD.
scPharmaceuticals’ management will also provide a corporate update focused on the company’s long-term growth initiatives, including the FDA-approved expansion of the FUROSCIX indication to include New York Heart Association (NYHA) Class IV heart failure patients, the potential expansion of the FUROSCIX indication to include treatment of fluid overload in CKD patients, and the ongoing development of a low volume autoinjector designed to provide physicians and patients with additional treatment flexibility.
A live question and answer session will follow the formal presentation.
About Dr. Michael Aaronson, MD
Dr. Michael Aaronson, MD, is board-certified in nephrology and internal medicine and has been practicing for over 21 years. He currently serves as partner of Lincoln Nephrology and Hypertension in Lincoln, NE, and as Medical Director of O Street: DCL, Dialysis Clinics of Lincoln in Lincoln NE. In addition, he teaches nephrology rotations for the Lincoln Family Medicine Residency Program in Lincoln, NE (affiliated with the University of Nebraska Medical School in Omaha, Nebraska). Dr. Aaronson graduated from the University of Connecticut School of Medicine and completed both his residency (internal medicine) and his fellowship (nephrology and hypertension) at the University of Minnesota.
FUROSCIX® (furosemide injection) 80 mg/10mL for subcutaneous use
FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with chronic heart failure.
IMPORTANT SAFETY INFORMATION
FUROSCIX is contraindicated in patients with anuria, patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation or medical adhesives and in patients with hepatic cirrhosis.
Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.
Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.
Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.
Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.
In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.
Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.
The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.
For more details, please read the full Prescribing Information at FUROSCIX.com/prescribing-information.pdf and Instructions for Use at FUROSCIX.com/instructions-for-use.pdf.
About scPharmaceuticals
scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the development and commercialization of products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs; the PDUFA target action date of March 6, 2025, to consider scPharma’s s NDA seeking to expand the FUROSCIX indication to include the treatment of fluid overload in CKD; and participation in upcoming events and presentations. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include but are not limited to, our dependence on the commercial success of FUROSCIX and, if approved, our other product candidates; risks related to the receipt of regulatory approval for our product candidates; risks related to our ability to manufacture, or the ability of third parties to deliver, sufficient product for commercialization of FUROSCIX or any of our product candidates, if approved; risks related to our history of operating losses, we have a history of significant operating losses and expect to incur significant and increasing losses for the foreseeable future; we may never achieve or maintain profitability; we may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts; the terms of our credit facility place restrictions on our operating and financial flexibility, and we may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due; clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and any difficulties or delays in the commencement or completion, or the termination or the potential for the results from any clinical trials to support submission of sNDAs or comparable regulatory applications; and the risk that global economic factors and uncertainties will impact the Company’s operations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www.sec.gov, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
Katherine Miranda
scPharmaceuticals Inc., 781-301-6869
kmiranda@scpharma.com
Investors:
PJ Kelleher
LifeSci Advisors, 617-430-7579
pkelleher@lifesciadvisors.com
FAQ
When is scPharmaceuticals (SCPH) hosting the KOL webinar on FUROSCIX?
Who is the featured speaker at the SCPH webinar on October 22, 2024?
What is the PDUFA target action date for SCPH's sNDA for FUROSCIX?
What new indications is SCPH seeking for FUROSCIX?
What recent FDA approval did SCPH receive for FUROSCIX?
