Core Insights - SpringWorks Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, with a live conference call scheduled for November 12, 2024, to report third quarter financial results and discuss business updates [1][2] Company Overview - SpringWorks Therapeutics applies a precision medicine approach to develop life-changing medicines for patients with severe rare diseases and cancer [2] - The company’s first FDA-approved therapy is OGSIVEO® (nirogacestat), which is used for treating adult patients with progressing desmoid tumors requiring systemic treatment [2] - SpringWorks has a diversified pipeline targeting solid tumors and hematological cancers, with programs ranging from preclinical development to advanced clinical trials [2] - The company has established multiple collaborations with industry and academic innovators to enhance its portfolio and create more solutions for patients [2]

A month has gone by since the last earnings report for SpringWorks Therapeutics (SWTX) . Shares have added about 11.7% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is SpringWorks Therapeutics due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. SpringWorks Q2 Earnings B ...

SpringWorks Therapeutics (SWTX) closed the last trading session at $40.98, gaining 20.8% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $66 indicates a 61.1% upside potential. The average comprises eight short-term price targets ranging from a low of $52 to a high of $77, with a standard deviation of $9.13. While the lowest estimate indicates an increase of 26.9% from the current ...

Core Viewpoint - SpringWorks Therapeutics, Inc. (SWTX) has received FDA acceptance for its new drug application (NDA) for mirdametinib, aimed at treating neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) in both pediatric and adult patients, with a decision expected by February 28, 2025 [1][2]. Group 1: Drug Development and Regulatory Approvals - The FDA has granted priority review for the NDA of mirdametinib, and the European Medicines Agency (EMA) has validated its marketing authorization application for the same indication [2]. - Mirdametinib is positioned to potentially be the first approved therapy for adult patients and a best-in-class therapy for children with NF1-PN, addressing a significant unmet medical need [2]. - The NDA submission was based on data from the pivotal phase IIb ReNeu study, which involved patients aged two years and above suffering from NF1-associated PN [3]. Group 2: Financial Performance and Market Position - SpringWorks' stock has outperformed the industry, gaining 12.9% year-to-date, while the industry has seen a decline of 0.1% [3]. - The company generated $61.2 million in net product revenues from its newly approved drug Ogsiveo (nirogacestat) in the first half of 2024, indicating strong commercial uptake and demand [6]. - Ogsiveo is the first approved drug for treating desmoid tumors, and its marketing authorization application is currently under review with the EMA, which could further enhance sales [7]. Group 3: Market Recognition - Mirdametinib has received Orphan Drug designation from both the FDA and the European Commission for the treatment of NF1 [4]. - SpringWorks currently holds a Zacks Rank 2 (Buy), indicating positive market sentiment towards the company's stock [8].

– PDUFA target action date of February 28, 2025 – – EU Marketing Authorization Application also validated by European Medicines Agency – STAMFORD, Conn., Aug. 28, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for mirdametinib, an investigational MEK inhibitor, for the treatment ...

SpringWorks Therapeutics' (SWTX) oral gamma-secretase inhibitor, Ogsiveo (nirogacestat), was approved by the FDA for treating adult patients with progressing desmoid tumors in November 2023. Following the FDA nod, not only Ogsiveo became the first approved product in the company's portfolio but it also became the first approved drug for treating desmoid tumors, a rare, aggressive tumor of the soft tissues. Ogsiveo has witnessed a strong initial uptake so far. The company's efforts to expand the drug's label ...

SpringWorks Therapeutics (SWTX) closed the last trading session at $36.96, gaining 0.4% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $65.75 indicates a 77.9% upside potential. The mean estimate comprises eight short-term price targets with a standard deviation of $8.81. While the lowest estimate of $52 indicates a 40.7% increase from the current price level, the most optimistic ...

SpringWorks Therapeutics, Inc. (SWTX) incurred a loss of 54 cents per share in the second quarter of 2024, which was significantly narrower than the Zacks Consensus Estimate of a loss of $1.12. The company had reported a loss of $1.25 per share in the year-ago quarter. In the second quarter, total revenues were $59.7 million, which also comprehensively beat the Zacks Consensus Estimate of $35 million. Total revenues comprised net product sales of Ogsiveo (nirogacestat) and other revenues. The company did no ...

l T T l James O'Neil Topline Summary and Update The market has been much more confident in the outlook for SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) than I was in my first coverage of the company back in December immediately following their first drug approval. Indeed, multiple analysts have since presented articles echoing that SWTX maintains an unclear risk to reward potential, given the potential market size for their main drug relative to the multi-billion dollar market valuation. Today, we have the ...

Q2 2024 Financial Results and Business Update August 7, 2024 之 Spring 2 Today's Agenda | --- | --- | |----------------------------|--------------------------------------------| | Sections | Presenter(s) | | Opening Remarks | Saqib Islam Chief Executive Officer | | OGSIVEO for Desmoid Tumors | Bhavesh Ashar Chief Commercial Officer | | Mirdametinib for NF1-PN | Jim Cassidy, MD, PhD Chief Medical Officer | | Financial Results | Frank Perier, Jr. Chief Financial Officer | | Looking Ahead | Saqib Islam Chief Ex ...