Biopharma looks to expand new drug brand on the way :: InvestMacro

ScPharm Pharmaceuticals Inc. has released. Just preliminary results from a phase 2 pilot study support a drug developer seeking to expand the label of new drugs, a HC Wainwright & Co.

ScPharm Pharmaceuticals Inc. (SCPH: NASDAQ) He gained support for the “value proposition” and “future addition to the label” of its drug Furoscix, from preliminary results of AT-HOME, a phase II pilot study in heart failure, HC Wainwright & Co analyst Douglas Cao reported in a July 13 research note.

Furoscix is ​​currently under FDA review as a treatment for fluid-induced congestion in adult patients with chronic heart failure, who do not require hospitalization and who respond poorly to oral diuretics.

“We expect to approve the date of the PDUFA on October 8” (this year), Cao commented.

The purpose of the AT-HOME trial was twofold. Its purpose was to evaluate the clinical outcomes and safety of Furoscix against those of ‘treatment as usual’. This approach typically involves increasing the patient’s oral dose of furosemide or adding metolazone to the treatment regimen, Cao wrote.

Cao noted that AT-HOME’s second goal is to inform the design of a potentially larger study to be used as support for future expansion of approved Furoscix uses. The biopharmaceutical company plans to meet with the US Food and Drug Administration to discuss such a trial.

Cao noted that AT-HOME was not supported to evaluate Furoscix for statistically significant efficacy in patients with chronic heart failure, but its preliminary results showed just that, versus “treatment as usual.”

Specifically, of note, the analyst reported that patients treated with Furoscix versus those treated ‘as usual’ showed a positive trend at the primary endpoint. It was a 30-day hierarchical composite of cardiovascular death, hospitalization for heart failure, emergency department visits for heart failure, and change in percentage of N terminal-pro BNP from baseline on day 7, as determined using the Finkelstein-Schoenfeld win ratio.

Also, Cao reported that on day 30, patients treated with Furosex had a 37% lower risk of hospitalization associated with heart failure compared to patients who received “treatment as usual.” The Furoscix group also fared better on secondary endpoints, including improvements in crowding, quality of life, and functional status.

In light of this new data, HC Wainwright maintained its buy rating and $15 share price target on Pharmaceuticals. By comparison, its stock today is trading at about $5.08 per share.

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Disclosures for HCWainwright & Co. scPharm Pharmaceuticals Inc. July 13, 2022

HC Wainwright & Co, LLC (the “Company”) is a member of FINRA, SIPC, and a US registered broker-dealer.

I, Douglas Cao, certify that 1) all opinions expressed in this report accurately reflect my personal opinions about any and all securities or issuers under discussion; and 2) no part of my salary was or would be directly or indirectly related to the specific recommendation or opinions expressed in this research report; 3) Neither I nor any of my family members is an official, director, or member of the advisory board of these companies.

Neither the research analyst nor the research analyst family has a financial interest in the securities of scPharm Pharmaceuticals Inc. (including, without limitation, any option, right, security, or future, long or short position).

As of June 30, 2022, neither the Company nor its affiliates beneficially owns 1% or more of any class of scPharm Pharmaceuticals Inc.’s common securities.. Neither the research analyst nor the Company knows or has reason to know of any other material conflict of interest in the At the time of publication of this research report.

The research analyst primarily responsible for preparing the report does not receive compensation based on any specific investment banking services or transactions, but is compensated based on factors including total revenue and the company’s profitability, a large part of which is derived from investment banking services. The Company or its affiliates have received compensation from scPharm Pharmaceuticals for non-investment banking services in the past 12 months.

The Company or its subsidiaries did not receive compensation from scPharm Pharmaceuticals for investment banking within twelve months prior, but will seek compensation from scPharm Pharmaceuticals for investment banking within three months after publication of the research report.

The company does not create a market in scPharm Pharmaceuticals Inc. As of the date of this research report.

The securities of the company discussed in this report may not be suitable for investors depending on their specific investment objectives and financial situation. Past performance is not a guarantee of future results. This report is provided for informational purposes only, and does not constitute an offer or a solicitation to buy or sell any securities discussed herein in any jurisdiction where this is prohibited. This research report is not intended to provide tax advice or be used to provide tax advice to anyone. Electronic versions of HC Wainwright & Co., LLC’s research reports are made available to all customers simultaneously.

HC Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and does not take into account the specific investment objectives, financial situation and special needs of any particular person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing the investment strategies discussed or recommended in this research report.

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HC Wainwright & Co., LLC and its affiliates and their officers, directors and employees, excluding its analysts, will from time to time have long or short positions in the securities or derivatives (including options and warrants) of the included companies referenced in this research report.

The information here is based on sources we believe to be reliable but we do not guarantee it to be accurate nor purport to be a complete statement or summary of the available data about the company, industry, or security discussed in the report. All opinions and estimates contained in this report constitute the judgment of the analyst as of the date of this report and are subject to change without notice.

Securities and other financial instruments discussed in this research report: may lose value; Not insured by the Federal Deposit Insurance Corporation; They are subject to investment risks, including potential loss of the principal amount invested.

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