Scpharmaceutical Stock Price, News & Analysis

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.

scPharmaceuticals (Nasdaq: SCPH) announced that its CEO, John Tucker, will present at the Jefferies Global Healthcare Conference on June 5, 2024. The presentation will occur at 5:00 PM ET, with Tucker also engaging in meetings with investors throughout the day. The webcast of the presentation will be accessible via the company’s Investor Relations section on its website.

scPharmaceuticals (SCPH) reported first quarter 2024 financial results, with notable achievements in FUROSCIX®. The company generated $6.1 million in net FUROSCIX revenue, despite a 10% dose impact from the Change Healthcare cyberattack. There was a 28% increase in total doses written and a 15% rise in doses filled compared to Q4 2023. The company ended Q1 with $58.4 million in cash and equivalents. Key developments include enrolling the first patient in a PK study for an 80mg/1mL auto-injector and submitting a sNDA to expand FUROSCIX's indication to NYHA Class IV heart failure patients, with a PDUFA date set for August 2024. However, scPharmaceuticals reported a net loss of $14.1 million for the quarter, with increased R&D and SG&A expenses.

scPharmaceuticals (Nasdaq: SCPH) will participate in the H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ World Headquarters in New York on May 20, 2024, at 11:00AM ET.

John Tucker, President & CEO, will present and meet with investors. The company's focus is on developing and commercializing products to optimize the delivery of infused therapies, improve patient care, and reduce healthcare costs. The presentation will be webcast and available in the Investor Relations section of the company's website.

scPharmaceuticals Inc. will announce its first-quarter 2024 financial results on Tuesday, May 14, 2024. The company will host a conference call and webcast at 4:30 p.m. ET to discuss the financial results and provide a business update. Participants can access the call by dialing 1-800-717-1738 (domestic) or 1-646-307-1865 (international) with the conference code 89054. The webcast and replay will be available on the Investor Relations section of the company's website.