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scPharmaceuticals Inc. Reports Third Quarter 2020 Financial Results and Provides Business Update
Commercialization preparedness activities continuing ahead of December 30 PDUFA date for FUROSCIX® (furosemide injection) for subcutaneous administration
Enrolled first patient in FREEDOM-HF Phase 3 clinical trial
Projected annual net loss for 2020 narrows to $34-37M
BURLINGTON, Mass. November 16, 2020 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 financial results for the third quarter ended September 30, 2020 and provided a business update.
Continued FUROSCIX commercialization preparedness activities in advance of the companys December 30, 2020 Prescription Drug User-Fee Act (PDUFA) target action date
Submitted 12-month drug stability data to the U.S. Food and Drug Administration (FDA). Pursuant to an agreement with the FDA, the company was permitted to submit its New Drug Application (NDA) with nine months of drug stability data and submit the remaining three months of drug stability data during the FDAs review of the FUROSCIX NDA. All drug stability data has now been submitted.
Participated in three virtual poster presentations at the Heart Failure Society of America Virtual Annual Scientific Meeting 2020
Hosted a successful Key Opinion Leader webinar. The webinar featured presentations by Dan Bensimhon, M.D. of Cone Health Medical Group and Nihar Desai, M.D., MPH from the Yale School of Medicine who discussed FUROSCIX, the current treatment landscape and the unmet medical need that exists in treating patients with worsening heart failure due to congestion.
Enrolled the first patient in FREEDOM-HF (Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure), a prospective Phase 3 clinical trial evaluating overall and heart failure-related costs for subjects treated with FUROSCIX for 30 days post-discharge from the emergency department compared to patients who remain in the hospital for 24 to 72 hours following hospitalization. Data is expected in the second quarter of 2021 to support the planned commercial launch of FUROSCIX, if approved.
Ended the third quarter with cash, cash equivalents, restricted cash and investments of $114.5 million
The following information was filed by Scpharmaceuticals Inc. (SCPH) on Monday, November 16, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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