Welcome to our dedicated page for Scpharmaceutical news (Ticker: SCPH), a resource for investors and traders seeking the latest updates and insights on Scpharmaceutical stock.
scPharmaceuticals Inc. (SCPH) delivers innovative subcutaneous therapies that transform intravenous treatment protocols for heart failure and related conditions. This dedicated news hub provides investors and healthcare professionals with essential updates on clinical developments, regulatory milestones, and strategic initiatives.
Access timely announcements about FUROSCIX advancements, partnership agreements, and research breakthroughs. Our curated collection includes earnings reports, FDA submissions, and analyses of the company’s unique drug-device integration strategy in cardiorenal care.
Discover how SCPH’s subcutaneous delivery platform addresses healthcare cost reduction through outpatient treatment solutions. Stay informed about trial results, manufacturing updates, and market expansion efforts shaping this clinical-stage biopharma’s trajectory.
Bookmark this page for consolidated access to verified SCPH developments, carefully sourced to support informed decision-making in dynamic pharmaceutical markets.
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), a pharmaceutical company specializing in optimized delivery of infused therapies, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. John Tucker, the company's President & CEO, is scheduled to present on Wednesday, September 11 at 10:00AM ET.
In addition to the presentation, Mr. Tucker will be engaging in investor meetings throughout the day. Interested parties can access a webcast of the presentation via a provided link or through the 'News & Events' section of scPharmaceuticals' official website.
This event provides an opportunity for scPharmaceuticals to showcase its progress in developing products aimed at advancing patient care and reducing healthcare costs through innovative infusion therapy delivery methods.
scPharmaceuticals Inc. (Nasdaq: SCPH) reported strong Q2 2024 financial results and business updates. Key highlights include:
- Net FUROSCIX revenue of $8.1 million, up 33% sequentially from Q1
- Approximately 9,300 FUROSCIX doses filled, a 15% increase from Q1
- Completed financings of up to $175 million, extending cash runway through expected profitability
- FDA approval to expand FUROSCIX indication for NYHA Class IV chronic heart failure patients
- Positive topline PK/PD data for FUROSCIX autoinjector
- FDA acceptance of sNDA for FUROSCIX label expansion to include CKD patients
The company's focus on commercial growth and lifecycle management initiatives positions FUROSCIX as a key part of a new heart failure treatment paradigm.
scPharmaceuticals Inc. (Nasdaq: SCPH) has announced the pricing of a public offering of 12,000,000 shares of common stock at $4.00 per share and pre-funded warrants for up to 500,000 shares at $3.999 per underlying share. The offering aims to raise approximately $50.0 million in gross proceeds. The company has also granted underwriters a 30-day option to purchase up to an additional 1,875,000 shares. The offering, expected to close on August 13, 2024, is being made pursuant to a shelf registration statement. Leerink Partners and TD Cowen are acting as joint book-running managers, with Craig-Hallum as lead manager and Maxim as manager.
scPharmaceuticals Inc. (SCPH) has secured non-dilutive financings totaling up to $125 million with Perceptive Advisors. The deal includes a $75 million senior secured loan and a $50 million revenue interest financing. Key benefits include:
1. Refinancing of existing debt with improved terms
2. Lower interest rate and extended interest-only period
3. Reduced minimum cash requirement to $5 million
4. Additional funding for FUROSCIX commercialization
The revenue interest financing involves tiered single-digit royalties on FUROSCIX global net sales, capped at 1.6x to 2.0x the purchase price. This partnership aims to support FUROSCIX's potential in reducing unnecessary hospital utilization for heart failure patients while generating cost savings for healthcare payers.
scPharmaceuticals (Nasdaq: SCPH) announced FDA approval of its Supplemental New Drug Application for FUROSCIX, expanding its indication to include NYHA Class IV chronic heart failure patients. This expansion covers the most symptomatic patients with the greatest limitation on physical activity, representing about 10% of all heart failure patients nationally.
FUROSCIX is now indicated for treating congestion due to fluid overload in adult patients with chronic heart failure, regardless of NYHA functional class. This approval builds on FUROSCIX's established efficacy and safety profile, potentially preventing heart failure-related hospital admissions or readmissions.
The company views this expansion as a foundation for driving sustained long-term growth, complementing the growing adoption of FUROSCIX among cardiologists and heart failure specialists.
scPharmaceuticals Inc. (SCPH) announced positive topline results from a pharmacokinetic study of SCP-111, an investigational furosemide autoinjector. The study achieved its primary and secondary endpoints, demonstrating 107.3% bioavailability compared to IV furosemide. SCP-111 showed similar urine output and electrolyte excretion to IV furosemide, with minimal pain reported at injection sites. The company aims to submit a Supplemental New Drug Application (sNDA) to the FDA by year-end 2024.
The study involved 21 healthy volunteers aged 45-80 in a randomized, two-way crossover design. If approved, SCP-111 could provide an alternative to the current FUROSCIX on-body infusor, potentially offering greater treatment flexibility for cardiologists and heart failure patients.
scPharmaceuticals Inc. (Nasdaq: SCPH) has announced a proposed underwritten public offering of shares of its common stock and pre-funded warrants. The company, focused on optimizing infused therapies delivery, aims to advance patient care and reduce healthcare costs. Leerink Partners and TD Cowen are acting as joint book-running managers for the offering.
The offering includes:
- Common stock shares
- Pre-funded warrants to purchase shares
- 30-day option for underwriters to purchase up to 15% additional shares
The offering is subject to market conditions, with no assurance of completion or final terms. It is being made pursuant to a shelf registration statement on Form S-3, filed with the SEC on March 13, 2024, and declared effective on March 22, 2024.
scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on optimizing infused therapy delivery, will announce its second quarter 2024 financial results on Wednesday, August 14, 2024. The company's management will host a conference call and audio webcast at 4:30 p.m. ET to discuss the financial results and provide a business update.
Participants can join the call by dialing 1-877-407-9208 (domestic) or 1-201-493-6784 (international) with the conference code 13747259. A new Call me™ feature is available to avoid operator wait times. The live webcast and replay can be accessed through the company's website under the Investor Relations section.
scPharmaceuticals Inc. (Nasdaq: SCPH) announced that the FDA has accepted their Supplemental New Drug Application (sNDA) to expand FUROSCIX indication to include treatment of edema due to fluid overload in patients with chronic kidney disease (CKD). The FDA has set a PDUFA target action date of March 6, 2025.
Key points:
- No additional clinical studies needed for indication expansion
- CKD affects more than 1 in 7 U.S. adults
- Estimated $3 billion addressable market
- Company preparing to deploy additional commercial resources if sNDA is approved
FUROSCIX is currently indicated for treating congestion due to fluid overload in adult patients with NYHA Class II and III chronic heart failure.