Scpharmaceutical Stock Price, News & Analysis

scPharmaceuticals (Nasdaq: SCPH) announced that it is progressing with the FUROSCIX New Drug Application (NDA) following a favorable Type C meeting with the FDA. The FDA has not required any modifications to the device. The company targets a resubmission of the NDA in Q4 2021, expecting a six-month FDA review. The completion of bench testing for the SmartDose® Gen II device is ongoing. The recent enrollment in the FREEDOM-HF study may provide data demonstrating cost savings for heart failure treatment. As of Q1 2021, scPharmaceuticals has $96.5 million to fund operations into 2023.

scPharmaceuticals Inc. (Nasdaq: SCPH) announced that CEO John Tucker will present at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 3:30 PM EDT. The presentation aims to highlight the company's efforts to enhance the delivery of infused therapies, improve patient care, and reduce healthcare costs. Interested parties can access a live webcast through the investor relations section of scPharmaceuticals' website. The company focuses on subcutaneous, self-administration treatments for heart failure and infectious diseases.

scPharmaceuticals Inc. (SCPH) reported its Q1 2021 financial results, ending with $96.5 million in cash, sufficient to fund operations into 2023. The company is preparing to resubmit the FUROSCIX NDA by fall 2021 after recent productive discussions with the FDA. The FREEDOM-HF clinical trial is progressing, with topline results expected in Q3 2021. Despite a net loss of $7.1 million for Q1 2021, the company anticipates a full-year net loss between $32.0 million and $36.0 million.

scPharmaceuticals (SCPH) announced a strong financial position with $105.3 million in cash and equivalents as of Q4 2020, sufficient to fund operations through 2023 pending FUROSCIX's approval. The company plans to resubmit its New Drug Application (NDA) for FUROSCIX in Q3 2021, following a productive FDA meeting. The ongoing FREEDOM-HF clinical trial aims to assess healthcare cost savings for heart failure patients treated with FUROSCIX post-emergency department discharge, with topline results also expected in Q3 2021. The net loss for Q4 2020 was $7.8 million, an improvement from $10.8 million in Q4 2019.

scPharmaceuticals (Nasdaq: SCPH) announced that CEO John Tucker will participate in two investor conferences: the Cowen 41st Annual Healthcare Conference on March 4 at 10:30 AM EDT and the H.C. Wainwright Global Life Sciences Conference from March 9 to March 10. A webcast of Tucker's presentation will be available on-demand starting March 9 at 7 AM ET. The company focuses on developing products that enhance the delivery of infused therapies and aims to reduce healthcare costs.

scPharmaceuticals Inc. (Nasdaq: SCPH) announced on February 19, 2021, that it received FDA Type A meeting minutes regarding the FUROSCIX® NDA resubmission. No additional clinical efficacy or safety data is required, but the FDA seeks further bench testing and Pre-Approval Inspections. The company aims to resubmit the NDA in Q3 2021. As of December 31, 2020, scPharmaceuticals had approximately $105 million in cash, sufficient to fund operations into 2023. The ongoing Phase 3 FREEDOM trial evaluates FUROSCIX for heart failure patients.

scPharmaceuticals (Nasdaq: SCPH) announced the appointment of Dr. William T. Abraham to its Board of Directors. Dr. Abraham, an expert in heart failure, aims to enhance the company's focus on FUROSCIX®, a treatment for fluid overload in heart failure patients. CEO John Tucker expressed optimism about Dr. Abraham's contributions, as the company seeks regulatory approval for FUROSCIX® to address significant healthcare needs. The drug aims to provide outpatient treatment alternatives for patients showing reduced responsiveness to oral diuretics.

scPharmaceuticals Inc. (Nasdaq: SCPH) announced that CEO John Tucker will present at the 10th Annual SVB Leerink Global Healthcare Conference on February 24 at 11:20 EDT. The company focuses on optimizing infused therapies to enhance patient care and reduce healthcare costs, particularly for heart failure and infectious diseases. A live webcast of the presentation will be available on their website. For more details, visit scpharmaceuticals.com.

scPharmaceuticals Inc. (SCPH) announced on December 3, 2020, that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for FUROSCIX®. The CRL cited the need for pre-approval inspections at third-party manufacturing facilities that could not be conducted due to travel restrictions. Additionally, the FDA raised questions about testing, labeling, and other features of the product. The company will request a Type A meeting with the FDA to address these issues. As of Q3, scPharmaceuticals reported cash holdings sufficient to fund operations into 2023.