Recently, SpringWorks Therapeutics Inc. (SWTX:NASDAQ) announced FDA approval of OGSIVEO (nirogacestat) for treating progressing desmoid tumors (DT) in adult patients based on Phase 3 DeFi trial results.
H.C. Wainwright analyst Robert Burns and Dr. Raghuram Selvaraju noted OGSIVEO showed clinically meaningful improvements on key efficacy endpoints, including progression-free survival, response rate, symptom severity, and quality of life versus placebo.
First FDA-Approved Option for Devastating Disease
With no therapies previously approved for DT, a rare fibroblastic proliferative disorder, analysts view OGSIVEO as establishing a new standard of care.
The robust efficacy and safety data enable it to disrupt the existing paradigm of watchful waiting.
Compelling Data Across All Key Metrics
The Phase 3 data showed OGSIVEO achieved a 71% reduction in risk of disease progression or death versus placebo. It also posted a significantly higher response rate of 41% versus 8% for placebo.
Further, OGSIVEO delivered statistically significant improvements in patient-reported pain, symptom severity, and quality of life.
Commercial Launch Underway; Peak Sales Forecast Raised
With the launch now starting, H.C. Wainwright has raised its model price target for SpringWorks to US$64 based on higher penetration and pricing assumptions for the newly approved treatment. The firm sees further upside from the broader pipeline, including mirdametinib. Multiple upcoming catalysts over the next 18 months provide opportunities to realize value.
Given the strong efficacy and safety profile demonstrated, analysts view OGSIVEO as well-positioned for rapid adoption. With commercial efforts ramping up and additional pivotal readouts approaching, SpringWorks appears favorably positioned heading into 2023.
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Disclosures for H.C. Wainwright & Co., SpringWorks Therapeutics Inc., November 28, 2023
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H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Robert Burns and Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of SpringWorks Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of October 31, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of SpringWorks Therapeutics, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. Mr. Selvaraju, who is [the][an] author of this report, is the Chairman of and receives compensation from Relief Therapeutics Holding SA, a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis ("Relief"). You should consider Mr. Selvaraju's position with Relief when reading this research report.
The firm or its affiliates received compensation from SpringWorks Therapeutics, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from SpringWorks Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in SpringWorks Therapeutics, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request.
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