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Immunome: Maintaining "Strong Buy" On Successful RINGSIDE Trial With Varegacestat
Seeking Alpha· 2025-12-17 19:44
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...
Immunome Announces Pricing of Public Offering of Common Stock
Businesswire· 2025-12-17 01:16
Core Viewpoint - Immunome, Inc. has announced a public offering of 18,625,000 shares of its common stock priced at $21.50 per share, with all shares being sold by the company [1] Company Summary - The public offering aims to raise gross proceeds for Immunome, which will be used for its targeted cancer therapies development [1] - The offering is underwritten, indicating that a financial institution is involved in the sale of the shares [1]
Immunome, Inc. (NASDAQ:IMNM) Targets Significant Growth with Public Offering
Financial Modeling Prep· 2025-12-16 03:07
Leerink Partners sets a price target of $40 for NASDAQ:IMNM, indicating a potential increase of approximately 76.6%.Immunome announces an underwritten public offering aiming to raise $400 million to advance cancer therapy developments.The stock price of IMNM has reached a yearly high of $25.30, with today's trading volume hitting 12.54 million shares.Immunome, Inc. (NASDAQ:IMNM) is a biotechnology company focused on developing innovative cancer therapies. On December 15, 2025, Leerink Partners set a price t ...
Why Immunome Stock Surged Today
The Motley Fool· 2025-12-15 22:43
The oncology specialist's targeted therapies could improve thousands of lives.Shares of Immunome (IMNM +15.51%) jumped over 15% on Monday after the biotech company announced positive clinical results for varegacestat, an investigational treatment for patients with progressing desmoid tumors. A destructive diseaseDesmoid tumors can be debilitating and lead to life-threatening organ damage. Each year, 1,000 to 1,650 people are diagnosed with the health condition in the U.S. alone."Desmoid tumors can have a d ...
Kyverna Therapeutics, Immunome, Almonty Industries And Other Big Stocks Moving Higher On Monday - Almonty Indus (NASDAQ:ALM), AXT (NASDAQ:AXTI)
Benzinga· 2025-12-15 15:45
U.S. stocks were lower, with the Nasdaq Composite falling more than 100 points on Monday.Shares of Kyverna Therapeutics Inc (NASDAQ:KYTX) rose sharply during Monday's session after the company announced topline data from KYSA-8.The clinical-stage biopharmaceutical company shared topline data from the KYSA-8 Phase 2 trial of mivocabtagene autoleucel (miv-cel, formerly KYV-101) in stiff person syndrome (SPS).Miv-cel is a fully human, autologous CD19-targeting CAR T-cell therapy with CD28 co-stimulation.Kyvern ...
Immunome (NasdaqCM:IMNM) Update / Briefing Transcript
2025-12-15 14:32
Summary of Immunome's Conference Call on AL102 Phase 3 Results Company and Industry Overview - **Company**: Immunome - **Industry**: Oncology, specifically focusing on desmoid tumors Key Points and Arguments 1. **Positive Phase 3 Results**: The top-line results from the AL102 Ringside phase 3 clinical trial for desmoid tumors were reported as positive, indicating the potential for AL102 to be a best-in-class treatment [4][5][6] 2. **Primary and Secondary Endpoints**: The trial met all primary and secondary endpoints, including: - Progression-Free Survival (PFS) hazard ratio of 0.16, indicating a significant reduction in disease progression risk compared to placebo [5][10] - Confirmed Objective Response Rate (ORR) of 56%, the highest reported in randomized trials for desmoid tumors [5][11] - Median tumor volume reduction of 83%, with placebo showing an 11% increase [5][12] 3. **Safety Profile**: AL102 was generally well tolerated, with a manageable safety profile consistent with the gamma secretase inhibitor (GSI) class. Common adverse events included diarrhea, fatigue, and rash, primarily grade one or two [5][13] 4. **Ovarian Toxicity**: Notably, 55.6% of women of childbearing potential experienced ovarian toxicity, which is a known side effect of GSIs. This rate is lower than the up to 75% reported in the GSI class [13][14] 5. **Regulatory Plans**: Immunome plans to meet with the FDA in early 2026 to review the trial results and aims to submit a New Drug Application (NDA) in the second quarter of 2026 [6][14] 6. **Commercial Strategy**: The company is focused on a three-pillar strategy (start, support, scale) to drive adoption of AL102 upon approval, targeting approximately 11,000 actively managed desmoid tumor patients in the U.S. [25][26] 7. **Market Dynamics**: There are about 85 specialty sarcoma centers in the U.S. that treat desmoid tumors, which will facilitate efficient engagement and rapid uptake of AL102 [26][27] 8. **Future Studies**: Additional studies are planned to explore AL102's efficacy in treating other tumors and to better understand its impact on patients with functional impairments [14][61] Other Important Insights 1. **Patient Impact**: Desmoid tumors significantly affect the quality of life, often leading to debilitating pain and loss of function, particularly in younger patients [17][18] 2. **Treatment Landscape Evolution**: The treatment approach for desmoid tumors has shifted from surgery to active surveillance and systemic therapy, with GSIs emerging as a viable option [19][20] 3. **Clinical Experience**: The call featured insights from Dr. Mrinal Gounder, an expert in desmoid tumors, who emphasized the potential of AL102 to become a standard of care based on its clinical profile [20][23] 4. **Payer Coverage**: The expectation is for over 90% payer coverage at launch, supported by the familiarity of key opinion leaders (KOLs) with AL102 [27][28] 5. **Pricing Strategy**: While specific pricing details were not disclosed, the company plans to engage with payers and doctors to determine an appropriate price for AL102 [72] This summary encapsulates the critical aspects of Immunome's conference call regarding the promising results of AL102 for desmoid tumors, highlighting its potential impact on patient care and the company's strategic plans moving forward.
Immunome's experimental drug meets main goal in late-stage study
Reuters· 2025-12-15 12:16
Core Insights - Immunome's experimental drug successfully met the primary endpoint in a late-stage study targeting patients with a rare type of tumor [1] Company Summary - The company is advancing its drug development efforts in the oncology sector, focusing on rare tumor types [1]
Immunome to Announce Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors
Businesswire· 2025-12-14 21:00
Core Insights - Immunome, Inc. is set to host a conference call and webcast on December 15, 2025, to disclose topline results from the Phase 3 RINGSIDE trial of varegacestat, a gamma secretase inhibitor for desmoid tumors [1][2] Company Overview - Immunome is a clinical-stage targeted oncology company focused on developing first-in-class and best-in-class targeted cancer therapies [3] - The company has a portfolio that includes varegacestat, a late-clinical stage gamma secretase inhibitor, IM-1021, a clinical-stage ROR1 antibody-drug conjugate (ADC), and IM-3050, a FAP-targeted radiotherapy that has received IND clearance [3] - Immunome is also advancing a range of early-stage ADCs targeting undisclosed solid tumor indications [3]
Immunome (NasdaqCM:IMNM) FY Conference Transcript
2025-12-03 15:12
Immunome FY Conference Summary Company Overview - **Company**: Immunome (NasdaqCM:IMNM) - **Date of Conference**: December 03, 2025 Key Accomplishments in 2025 - Immunome focused on executing its clinical trials and IND-enabling work for ADCs, particularly AL102 and IM1021, with top-line data expected by the end of 2025 [3][4] - The company filed an IND for IM1021 at the end of 2024 and is preparing for a potential NDA submission and commercial launch [4] Product Differentiation and Clinical Data - **AL102**: Expected to show a higher objective response rate compared to Ogsiveo (41% response rate) with a phase 2 data showing a 64% response rate [5][6] - Tumor volume reduction for AL102 was reported at a median of 88%, significantly higher than Ogsiveo's 59% [6][7] - The company emphasizes the importance of secondary endpoints like tumor volume reduction and T2-weighted imaging, which may not be as well-known but are crucial for understanding treatment benefits [8][9] Market Opportunity - The desmoid tumor market is still developing, with approximately 1,600 new diagnoses annually, but patients often live with the disease for many years, indicating a larger prevalence pool [14] - Ogsiveo has treated around 1,000 patients, suggesting significant room for growth and market displacement, particularly for patients currently under active surveillance [15] ADC Platform and Innovation - Immunome's ADC platform utilizes a topo I inhibitor (HC-74) with a broader therapeutic index compared to competitors [16][17] - The platform aims to overcome resistance seen in other ADCs, particularly in patients with high expression of efflux transporters [17][18] - The lead ADC, IM-1021, targets ROR1 and is differentiated from Merck's ROR1 asset by a better safety profile, allowing for higher dosing [19][20] Future Developments - Multiple additional INDs are expected throughout 2026, including IM-1617, IM-1340, and IM-1335, all targeting solid tumors [21][22] - A successful outcome for IM1021 could validate the platform's capabilities, influencing the perception of other assets [22] Conclusion - Immunome is positioned for significant advancements in the desmoid tumor market and ADC development, with a focus on clinical efficacy and safety. The upcoming data releases and IND filings will be critical for the company's growth trajectory and market positioning.
Immunome (NasdaqCM:IMNM) FY Conference Transcript
2025-12-03 15:02
Immunome (NasdaqCM:IMNM) FY Conference December 03, 2025 09:00 AM ET Company ParticipantsClay Siegall - CEOConference Call ParticipantsBiren Amin - Senior Research AnalystBiren AminGreat. Welcome, everyone, to the Piper Sandler Healthcare Conference. My name is Biren Amin. I'd like to welcome our next company. We have Immunome and their CEO, Clay Siegall. Welcome, Clay. Maybe if you could, we could start off with just the company's focus on Varegacestat, as well as the ADC platform. If you could just maybe ...