scPharmaceuticals Inc. - SCPH STOCK NEWS

scPharmaceuticals (SCPH) announced progress in its FUROSCIX NDA resubmission, aligning with the FDA, requiring no additional clinical data or device changes. Targeting Q4 resubmission, the company presented positive FREEDOM-HF study results, showing a $17,753 reduction in heart failure costs per patient. Ending Q2 with $90.2 million in cash, the firm is poised to fund operations through 2023, lowering its 2021 net loss guidance to $30-34 million. The FREEDOM-HF data supports potential market adoption if FUROSCIX is approved.

scPharmaceuticals Inc. (SCPH) announced positive top-line results from the FREEDOM-HF study, showing a reduction of $17,753 in heart failure-related costs per patient (p<0.0001) for those treated with FUROSCIX^® compared to traditional IV treatment. The study was halted early due to significant cost savings identified in an interim analysis. In contrast to 100% hospitalization in the comparator group, none of the FUROSCIX patients were hospitalized initially. The company is set to resubmit its NDA later this year, aiming to address outpatient care for chronic heart failure.

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.