It has been about a month since the last earnings report for SpringWorks Therapeutics (SWTX) . Shares have added about 14.5% 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 its most recent earnings report in order to get a better handle on the important catalysts. SpringWorks' Q3 Lo ...

SpringWorks Therapeutics, Inc. (SWTX) incurred a loss of 72 cents per share in the third quarter of 2024, which was narrower than the Zacks Consensus Estimate of a loss of 76 cents. The company had reported a loss of $1.27 per share in the year-ago quarter.In the third quarter, total revenues were $49.3 million, which missed the Zacks Consensus Estimate of $54 million. Total revenues comprised net product sales of Ogsiveo (nirogacestat), SpringWorks’ only marketed drug. The company did not generate any reve ...

– Achieved $49.3 million in OGSIVEO® (nirogacestat) net product revenue in the third quarter – – Long-term follow-up data from the Phase 3 DeFi trial of nirogacestat in adults with desmoid tumors highlight further reductions in tumor size, increase in ORR, sustained improvement in desmoid tumor symptoms, and consistent safety profile – – Granted FDA Priority Review on NDA and received validation of EU Marketing Authorization Application for mirdametinib for the treatment of adults and children with NF1-PN – ...

Core Insights - SpringWorks Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer [3] - The company will participate in a fireside chat at Guggenheim's Inaugural Healthcare Innovation Conference on November 13, 2024 [1] - SpringWorks has developed OGSIVEO® (nirogacestat), the first FDA-approved therapy for adult patients with progressing desmoid tumors [3] Company Overview - SpringWorks applies a precision medicine approach to develop life-changing medicines for patients with severe rare diseases and cancer [3] - The company has a diversified pipeline targeting solid tumors and hematological cancers, with programs at various stages from preclinical to advanced clinical trials [3] - SpringWorks collaborates with industry and academic innovators to enhance its portfolio and create more solutions for patients [3] Event Information - The fireside chat will take place in Boston, Massachusetts at 1:00 p.m. ET [1] - A live webcast of the event can be accessed on the company's website, with a replay available for a limited time afterward [2]

Biotech Forum Discussion - The Biotech Forum has been dominated by discussions on lucrative buy-write or covered call opportunities on selected biotech stocks over the past several months [1] - The forum offers real-time trading ideas and insights from seasoned biotech investors [1] SpringWorks Therapeutics Overview - SpringWorks Therapeutics Inc (NASDAQ: SWTX) is now a "commercial" stage biotech firm focused on the development of medicines [2] - The company was last analyzed in-depth in July 2023 [2] Biotech Forum Services - The Biotech Forum provides a model portfolio featuring 12-20 high upside biotech stocks [2] - The forum offers live chat for discussing trade ideas, weekly research, and option trades [2] - Market commentary and portfolio updates are provided every weekend [2] Analyst Position - The analyst holds a beneficial long position in SWTX through stock ownership, options, or other derivatives [3]

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]

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].

SpringWorks Therapeutics (SWTX) came out with a quarterly loss of $0.54 per share versus the Zacks Consensus Estimate of a loss of $1.12. This compares to loss of $1.25 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 51.79%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1.17 per share when it actually produced a loss of $1.18, delivering a surprise of -0.85%. Over the last four quart ...

– Achieved $40.2 million in OGSIVEO® (nirogacestat) net product revenue in the second quarter – – Completed submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Presented Phase 2b ReNeu trial results and additional analyses from Phase 3 DeFi trial at the 2024 ASCO Annual Meeting – – Initiated Phase 1a trial of SW-682 in patients with Hippo mutant solid tumors – STAMFORD, Conn., Aug. 07, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), ...

– Achieved $40.2 million in OGSIVEO® (nirogacestat) net product revenue in the second quarter – – Completed submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Presented Phase 2b ReNeu trial results and additional analyses from Phase 3 DeFi trial at the 2024 ASCO Annual Meeting – – Initiated Phase 1a trial of SW-682 in patients with Hippo mutant solid tumors – STAMFORD, Conn., Aug. 07, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), ...