IMNM

New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) in April 2026 seeking approval of varegacestat for the treatment of adults with desmoid tumors Detailed Phase 3 RINGSIDE data selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting Phase 1 study ongoing for IM-1021, with initial lymphoma data expected in 2026 Investigational New Drug (IND) clearance received in April 2026 for IM-1617, a potential first-in-class solid tumor antibody-drug conjugate (ADC) BOTHELL, Wash., May 12, 2026--(BUSINESS WIRE)--Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the quarter ended March 31, 2026, and provided a business update. "This quarter reflects the progress we are making in building Immunome into a multi-program targeted oncology company," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "The NDA submission for varegacestat is an important milestone that reflects our commitment to improving the lives of patients with desmoid tumors, for whom new treatment options are still needed. We are also pleased that detailed Phase 3 RINGSIDE data were selected for oral presentation at ASCO. In parallel, we continue to advance our ADC pipeline, with IM-1021 progressing in Phase 1 and IM-1617 recently receiving IND clearance." Pipeline Highlights Varegacestat: In April 2026, Immunome submitted an NDA to the U.S. FDA for varegacestat for the treatment of adults with desmoid tumors. Immunome plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026. Data from RINGSIDE, the global, Phase 3, randomized, placebo-controlled trial of varegacestat in patients with progressing desmoid tumors, have been selected for presentation in an oral abstract session at the 2026 ASCO Annual Meeting. In December 2025, Immunome announced positive topline results from RINGSIDE: The registrational trial met its primary endpoint of improving progression-free survival vs. placebo, with a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death (hazard ratio = 0.16, p<0.0001). The trial also met all key secondary endpoints, including achieving an objective res...

Exelixis (EXEL) came out with quarterly earnings of $0.87 per share, beating the Zacks Consensus Estimate of $0.75 per share. This compares to earnings of $0.62 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +15.55%. A quarter ago, it was expected that this drug developer would post earnings of $0.77 per share when it actually produced earnings of $0.94, delivering a surprise of +22.08%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Exelixis, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $610.81 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 0.29%. This compares to year-ago revenues of $555.45 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Exelixis shares have added about 0.8% since the beginning of the year versus the S&P 500's gain of 5.2%. While Exelixis has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Exelixis was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Bu...

Techne (TECH) came out with quarterly earnings of $0.53 per share, missing the Zacks Consensus Estimate of $0.55 per share. This compares to earnings of $0.56 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -2.75%. A quarter ago, it was expected that this maker of medical testing and diagnostic products would post earnings of $0.43 per share when it actually produced earnings of $0.46, delivering a surprise of +6.98%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Techne, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $311.42 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 2.36%. This compares to year-ago revenues of $316.18 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Techne shares have lost about 3.6% since the beginning of the year versus the S&P 500's gain of 6%. While Techne has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Techne was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks...

New Drug Application submission for varegacestat in patients with desmoid tumors planned for 2Q 2026 IM-1021 Phase 1 ongoing with initial data expected in 2026 Three IND submissions for solid tumor-targeted ADC programs planned in 2026 Underwritten public offering in December 2025 raised $460.5 million in gross proceeds, extending projected cash runway into 2028 BOTHELL, Wash., March 03, 2026--(BUSINESS WIRE)--Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the full year ended December 31, 2025, and provided a business update. "Immunome made substantial progress in 2025. The positive Phase 3 RINGSIDE results represent a significant milestone for patients living with desmoid tumors and will support our planned NDA submission for varegacestat in the second quarter of 2026," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We are focused on the regulatory, manufacturing, and commercial readiness activities necessary to position the program for approval and launch." "We continue to advance our antibody-drug conjugate pipeline, with the Phase 1 study of IM-1021 ongoing. Over the course of 2026, we expect to submit INDs for three differentiated solid tumor ADCs. These programs have substantial potential to benefit cancer patients, and we intend to rapidly advance them." Pipeline Highlights Varegacestat: In December 2025, Immunome announced positive topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors. The registrational trial met its primary endpoint of improving progression-free survival vs. placebo, with a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death (hazard ratio = 0.16, p<0.0001). The trial also met all key secondary endpoints, including achieving an objective response rate of 56% vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review. In an exploratory analysis, varegacestat demonstrated a median best change in tumor volume of -83% vs. +11% with placebo, as assessed by blinded independent central review. Varegacestat was generally well tolerated with a manageable safety profile, consistent with the gamma secretase inhibitor class. Immunome plan...

Immunome (IMNM) just cleared a major clinical hurdle, reporting statistically meaningful Phase 3 RINGSIDE data for varegacestat in desmoid tumors that sharply reduced progression risk and improved symptoms, a milestone the market is taking seriously. See our latest analysis for Immunome. That breakout Phase 3 readout has supercharged sentiment, with a 1 day share price return of 15.7 percent capping a 90 day share price return of 151.8 percent. The 3 year total shareholder return above 500 percent shows momentum has been building for some time. If this kind of clinical inflection has you rethinking your watchlist, it is worth exploring other innovative names in healthcare stocks that could be setting up for their own next catalyst. With shares still trading at a sizeable discount to consensus targets despite a multiyear run up, investors now face a tougher question: is Immunome still mispriced or is the market already baking in years of growth? Immunome's recent close at $22.64 comes with a rich price-to-book ratio of 7.9 times, signaling the market is paying up versus peers. The price-to-book ratio compares a company's market value to its net assets, which is a common yardstick for early stage, loss making biotechs where earnings are not yet meaningful. For Immunome, a premium price-to-book multiple indicates investors are assigning substantial value to its pipeline and future cash flow potential, despite current negative earnings and reported losses over the past five years. In that context, Immunome's 7.9 times price-to-book looks expensive compared to the US Biotechs industry average of 2.7 times and even above the peer group average of 5.8 times, suggesting expectations are materially higher than the sector norm. See what the numbers say about this price — find out in our valuation breakdown. Result: Price-to-Book of 7.9x (OVERVALUED) However, clinical and regulatory setbacks for varegacestat or other pipeline assets, along with ongoing operating losses, could quickly unwind enthusiasm and pressure the stock. Find out about the key risks to this Immunome narrative. If you see the numbers differently or want to stress test your own assumptions, you can build a custom view of Immunome in just a few minutes, Do it your way. A great starting point for your Immunome research is our analysis highlighting 1 key reward and 3 important warning signs that could i...

BOTHELL, Wash., November 06, 2025--(BUSINESS WIRE)--Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the quarter ended September 30, 2025, and provided a business update. "Immunome’s pipeline continues to advance," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We anticipate the release of topline data for the RINGSIDE trial of varegacestat before the end of this year, to be followed by an NDA submission if warranted." "I am particularly pleased to share that we have observed objective responses at multiple dose levels in B-cell lymphoma patients treated with IM-1021. The clinical activity and safety we’ve seen underscore the potential of HC74, our proprietary TOP1 inhibitor ADC payload. We plan to present initial data for that program in 2026." Pipeline Highlights Varegacestat: Immunome expects to report topline data for the Phase 3 RINGSIDE Part B study before the end of 2025. IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with objective responses observed in B-cell lymphoma patients at multiple dose levels. Immunome expects to present initial data for IM-1021 in 2026. HC74: In October, Immunome presented a poster entitled "HC74, a novel topoisomerase I inhibitor payload for antibody-drug conjugates that overcomes multi-drug resistance" at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. HC74 is the payload included in IM-1021 and additional Immunome ADC programs. Highlights of the poster include: Over-expression of drug efflux transporters such as ABCC1 and ABCB1 drives primary and acquired resistance to approved ADC payloads and standard chemotherapies but not to HC74 HC74 exhibits high membrane permeability, leading to enhanced cytotoxicity and robust bystander activity ADCs incorporating HC74 show meaningful efficacy in multiple preclinical tumor models, including: Colorectal cancer refractory to trastuzumab-DXd and irinotecan Models with acquired resistance to trastuzumab-DXd Non-small cell lung cancer with heterogenous target expression IM-3050: Immunome received IND clearance for IM-3050 in April 2025 and plans to initiate a Phase 1 study in early 2026 after delivery of third-party diagnostic radiotracer supply. Preclinical Pipeli...

BOTHELL, Wash., August 06, 2025--(BUSINESS WIRE)--Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the quarter ended June 30, 2025 and provided a business update. "Immunome made substantial progress in the second quarter of 2025, underscored by the continued advancement of our clinical programs towards key milestones," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We look forward to sharing topline data for the RINGSIDE trial of varegacestat before the end of this year, and we are well-positioned to support a new drug application submission for that program as appropriate." "We recently dosed the third cohort of patients in the dose escalation study of IM-1021, our ROR1 ADC. We are excited by the profile of HC74, the proprietary TOP1 inhibitor payload contained in IM-1021, and are making progress towards IND submission for three additional ADCs utilizing that technology." Pipeline Highlights Varegacestat: Immunome expects to report topline data for the Phase 3 RINGSIDE Part B study before the end of 2025. Two additional analyses of the Phase 2 RINGSIDE Part A study were presented at 2025 ASCO Annual Meeting in June 2025, both of which can be found in the Investors portion of Immunome’s website: Subgroup Analysis of the Phase 2 Part of the RINGSIDE Phase 2/3 Trial of Varegacestat for Treatment of Desmoid Tumors Change in T2-Weighted Signal Intensity, Change in Tumor Volume, and Exposure-Response Analysis in the RINGSIDE Phase 2 Study of Varegacestat in Patients with Desmoid Tumors The European Medicines Agency granted Orphan Drug Designation to varegacestat in July 2025. Varegacestat previously received Orphan Drug Designation from the U.S. Food and Drug Administration in November 2023. IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with patients recently dosed at the third dose level. The trial is an open-label, multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid tumors. IM-3050: Immunome received IND clearance for IM-3050 in April 2025 and expects to initiate a Phase 1 clinical trial before the end of 2025. Preclinical Pipeline: Immunome’s three preclinical ADCs against solid tumor targets, IM-1617, IM...

Revenue: US$2.93m (up 184% from 1Q 2024). Net loss: US$41.6m (loss narrowed by 68% from 1Q 2024). US$0.52 loss per share (improved from US$2.51 loss in 1Q 2024). Our free stock report includes 2 warning signs investors should be aware of before investing in Immunome. Read for free now. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates significantly. Earnings per share (EPS) also surpassed analyst estimates by 21%. Looking ahead, revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are up 3.7% from a week ago. You should learn about the 2 warning signs we've spotted with Immunome (including 1 which shouldn't be ignored). Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

BOTHELL, Wash., May 12, 2025--(BUSINESS WIRE)--Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the quarter ended March 31, 2025 and provided a business update. "Immunome continued to build momentum in the first quarter of 2025," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "We remain on track to share topline data for the RINGSIDE trial of varegacestat in the second half of 2025, and we are optimistic that varegacestat will demonstrate differentiated efficacy across multiple endpoints. "Varegacestat is complemented by a robust pipeline of differentiated programs with first-in-class or best-in-class potential. The dose escalation portion of the Phase 1 clinical trial of IM-1021, our ROR1 ADC, is ongoing in solid tumors and lymphoma. Following the recent clearance of the IND for IM-3050, our FAP radiotherapy, we expect to start a clinical trial for that program in the second half of this year. We are making progress on IND-enabling manufacturing for IM-1617, IM-1335 and IM-1340, each of which incorporate our differentiated TOP1 inhibitor, HC74." Pipeline Highlights Varegacestat: Full enrollment for the Phase 3 RINGSIDE Part B study of varegacestat for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing the manufacturing and pharmacology work required to support a new drug application filing for varegacestat. IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with the first patient dosed in February 2025. The trial is an open-label, multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid tumors. IM-3050: Immunome received IND clearance for IM-3050 in April 2025 and expects to initiate a Phase 1 clinical trial in the second half of 2025. Preclinical Pipeline: Immunome’s three preclinical ADCs against solid tumor targets, IM-1617, IM-1340 and IM-1335, each of which incorporates HC74, are currently undergoing IND-enabling work. Additional undisclosed ADCs are in discovery and lead optimization. First Quarter 2025 Financial Results As of March 31, 2025, cash, cash equivalents and marketable...

In the opening 90 minutes of the evening session, U.S. stock futures are up marginally – S&P500 is up 0.1% while Nasdaq 100 is up 0.2%. Earlier on Tuesday, Consumer Discretionary and Communications Services were the best performing sectors in the S&P500 – Google (GOOGL), Meta (META), and Netflix (NFLX) had over 1% gains among the mega-caps – while defensively-oriented Healthcare and Utilities underperformed. Investors have also shrugged the disappointing Consumer Confidence data with sentiment turning more upbeat on expectations of a more tempered tariff implementation by the White House and translating into 3rd consecutive session of gains. Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. In Commodities, WTI Crude Oil contract remains bid above the $69 per barrel handle. After two consecutive weeks of large builds, API Petroleum inventories data saw its largest weekly draw of 2025, signifying increase in demand. Check out this evening’s top movers from around Wall Street, compiled by The Fly. HIGHER AFTER EARNINGS – SurgePays (SURG) up 95.7% GameStop (GME) up 7.4% Paysign (PAYS) up 4.0% Kolibri Global Energy (KGEI) up 3.6% ALSO HIGHER – Immunome (IMNM) up 6.2% on insider buy Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on SURG: Disclaimer & DisclosureReport an Issue SurgePays sees FY25 revenue $200M, consensus $95.11M SURG Earnings this Week: How Will it Perform?

Net loss: US$293.0m (loss widened by 174% from FY 2023). US$5.00 loss per share. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 3.9%. Earnings per share (EPS) also missed analyst estimates by 14%. Looking ahead, revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 3.0% from a week ago. Before you take the next step you should know about the 2 warning signs for Immunome (1 is potentially serious!) that we have uncovered. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Topline data for Phase 3 RINGSIDE study of varegacestat in progressing desmoid tumors expected in second half of 2025. First patient dosed in Phase 1 clinical trial evaluating IM-1021, a ROR1-targeted ADC. IND submitted in March 2025 for IM-3050, a FAP-targeted radioligand therapy. Projected cash runway extends into 2027 BOTHELL, Wash., March 19, 2025--(BUSINESS WIRE)--Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the full year ended December 31, 2024 and provided a business update. "Immunome’s efficient execution in 2024 laid the foundation for a productive 2025," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "We are pleased with the progress of our pipeline and, with multiple programs now in clinical development, we expect that our recent financing will support multiple clinical milestones. We particularly look forward to topline data in the second half of 2025 for the RINGSIDE trial of varegacestat, which we believe will demonstrate significant benefits for patients with desmoid tumors. "Our highly capable team is achieving our vision of a broad, differentiated portfolio of ADCs. We recently dosed the first patient in the Phase 1 clinical trial of IM-1021, our ROR1-targeted ADC. Three additional novel ADCs, IM-1617, IM-1335 and IM-1340, are in IND-enabling manufacturing, with additional discovery-stage programs under evaluation. We recently submitted the IND for IM-3050, our FAP radiotherapy, and anticipate initiating a Phase 1 clinical trial for that program later this year." Pipeline Highlights Varegacestat: Full enrollment for the Phase 3 RINGSIDE Part B study of varegacestat for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing the manufacturing and pharmacology work required to support a new drug application filing for varegacestat. IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with the first patient dosed in February 2025. The Phase 1 trial is an open-label, multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid tumors. IM-3050: Immunome recently submitted an IND for...