Heart Failure-Focused scPharmaceuticals Secures FDA Approval For Expanded Use Of Furoscix, Receives Funding To Expand Commercialization

Monday, the FDA approved scPharmaceuticals Inc.’s SCPH Supplemental New Drug Application, seeking to expand the Furoscix indication for heart failure patients.

At approval, Furoscix was only indicated for congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.

The new indication now includes patients with NYHA Class IV chronic heart failure, who represent the most symptomatic patients, and those with the greatest limitation on physical activity, comprising approximately 10% of all heart failure patients nationally.

scPharmaceuticals also announced non-dilutive financings on Monday of up to $125 million from Perceptive Advisors.

Proceeds from the transactions will be used to repay existing debt and fund activities related to the ongoing commercialization of Furoscix.

scPharmaceuticals received $75 million through a combination of debt and royalty financings at close, with access to an additional $50 million.

The term loan refinances existing debt principal, lowers coupon, extends the interest-only period for four additional years, and lowers the minimum cash requirement to $5 million.

Monday, scPharmaceuticals also released topline results from the pharmacokinetic (PK) study of SCP-111, an investigational, low-volume, pH-neutral formulation of furosemide administered via an autoinjector as an alternative to the current on-body infusor used with Furoscix.

The objectives of the study were to estimate the bioavailability and describe the PK and pharmacodynamics (PD) of SCP-111 administered as a subcutaneous injection via an autoinjector compared with the equivalent dose of furosemide administered as two 40mg IV injections administered over 1-to-2 minutes, two hours apart and to describe the safety and tolerability of the SCP-111 injection.

Key highlights of the topline results from the study:

• SCP-111 demonstrated a bioavailability of 107.3%.
• Participants who received SCP-111 had similar urine output, urinary sodium excretion, and urinary potassium excretion at 6, 8, and 12 hours compared to IV furosemide.
• Participants reported a median pain score of 0 across all time points assessed.
• The most common adverse events with SCP-111 were localized to the injection site, and systemic adverse events were consistent with those reported in the prescribing information for intravenous and oral furosemide.

Concurrently, the company announced a proposed underwritten public offering of shares and pre-funded warrants. Additional terms were not disclosed.

Price Action: SCPH stock is down 5.77% at $4.08 during the premarket session at last check Monday.

Photo via Shutterstock

Read Next:

• Eli Lilly’s Q2 Sales Surge 36%, Analysts Cautious On Future Supply, Market Dynamics; Optimistic About Next-Gen Oral Weight-Loss Drug.

Don’t miss the opportunity to dominate in a volatile market at the Benzinga SmallCAP Conference on Oct. 9-10 at the Chicago Marriott Downtown Magnificent Mile. Get exclusive access to CEO presentations, 1:1 meetings with investors, and valuable insights from top financial experts. Whether you’re a trader, entrepreneur, or investor, this event offers unparalleled opportunities to grow your portfolio and network with industry leaders. Secure your spot and get your tickets today!