For more, let's bring in Amy Burroughs, the CEO of Turns Pharmaceuticals. Amy, great to have you with us. >> Thank you so much for having me back, Melissa.>> This was stunning for most investors, most analysts out there in terms of of the data. Three times better approximately than the standard of care right now. Can you can you sort of speak to what this means for patients and and how soon this drug can actually reach market.>> Yeah, absolutely. So chronic myo leukemia is a disease which is a chronic condi ...

Core Insights - Cellectar Biosciences is advancing its regulatory strategy for iopofosine I-131, targeting conditional marketing approval in Europe for Waldenstrom's macroglobulinemia by 2026, following guidance from the European Medicines Agency [1][5][3] - The company has initiated a Phase 1b study for CLR 125, aimed at treating triple-negative breast cancer, building on promising preclinical data [4][5] Regulatory Developments - The company received advice from the Scientific Advice Working Party (SAWP) indicating that a Conditional Marketing Approval (CMA) application for iopofosine I-131 could be acceptable for post-BTKi refractory patients with Waldenstrom macroglobulinemia [5] - Cellectar plans to submit a New Drug Application (NDA) to the FDA for accelerated approval of iopofosine I-131 once confirmatory trials are underway, contingent on sufficient funding [5] Clinical Trials and Pipeline - A Phase 3 study for iopofosine I-131 is planned, involving approximately 100 patients per arm, with full enrollment expected within 18-24 months [5] - CLR 125 has received clearance for a Phase 1b/2a dose-finding study in triple-negative breast cancer, utilizing a targeted radiotherapy approach [5][10] - CLR 225, another asset, has shown robust anti-tumor activity in pancreatic cancer models and has completed IND-enabling studies [4][10] Financial Performance - For the quarter ended September 30, 2025, the company reported a net loss of $4.4 million, or $1.41 per share, a significant reduction from a net loss of $14.7 million, or $11.18 per share, in the same period of 2024 [11][18] - Research and development expenses decreased to approximately $2.5 million from $5.5 million year-over-year, attributed to reduced clinical trial costs [11][18] - As of September 30, 2025, the company had cash and cash equivalents of $12.6 million, down from $23.3 million at the end of 2024, but believes this is sufficient to fund operations into the third quarter of 2026 [11][18] Designations and Partnerships - Cellectar has received Rare Pediatric Drug Designation for iopofosine I-131 in inoperable relapsed/refractory pediatric high-grade glioma [2][12] - The company announced a partnership with Evestia Clinical to provide CRO services for the upcoming Phase 1b study of CLR 125 [5]

Group 1 - Genmab announced its plan to acquire Merus for approximately $8 billion, significantly boosting Merus's stock price by over 37% [1][3] - Merus is developing petosemtamab, a drug that targets head-and-neck cancer and metastatic colorectal cancer, with potential peak sales estimated between $3 billion to $4 billion for head-and-neck cancer alone [2] - The acquisition is viewed positively as it enhances Genmab's portfolio with late-stage programs that could lead to substantial revenue growth in the 2030s, surpassing previous revenue peaks from Darzalex royalties [2] Group 2 - The deal values Merus at a 41% premium compared to its closing price prior to the announcement, while Genmab's stock experienced a decline of nearly 3% [3] - Analysts have noted that the acquisition is larger than expected, indicating a strategic move by Genmab to strengthen its market position [2][6]

Core Insights - PMV Pharmaceuticals, Inc. released interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation [1] Efficacy - Confirmed responses were observed in patients with TP53 Y220C mutated and KRAS wild-type tumors across eight tumor types, with an overall response rate (ORR) of 33% [2] - Specific ORRs included: - Ovarian cancer: 43% ORR (19/44 patients, including one confirmed complete response and 17 confirmed partial responses) [3] - Breast cancer: 18% ORR (2/11 patients) [3] - Endometrial cancer: 60% ORR (3/5 patients, including one unconfirmed partial response) [3] - Lung cancer: 22% ORR (4/18 patients, including three unconfirmed partial responses) [3] - Other solid tumors: 21% ORR (4/19 patients) [3] - The median time to response across all cohorts was 1.4 months, with a median duration of response of 6.2 months [3] - In the ovarian cancer cohort, the median time to response was 1.3 months, and the median duration of response was 7.6 months [3] Safety - Treatment-related adverse events (TRAEs) were primarily grade 1-2, with the most frequent TRAEs (>15%) being nausea, fatigue, increased blood creatinine, and increased alanine aminotransferase [4] Regulatory Update - PMV Pharma received feedback from the U.S. Food and Drug Administration (FDA) regarding the initial New Drug Application (NDA) submission strategy for platinum-resistant/refractory ovarian cancer [5] - The company plans to enroll an additional 20-25 platinum-resistant/refractory ovarian cancer patients by the end of Q1 2026 [5] - An NDA submission for platinum-resistant/refractory ovarian cancer is planned by the end of Q1 2027 [6] Price Action - PMVP stock is down 23.30% at $1.23 as of the last check on Wednesday [6]

Core Insights - AIM ImmunoTech Inc. is focusing on advancing clinical trials of Ampligen® for pancreatic cancer treatment, aiming for drug approval [2][4] - The company reported a bolstered cash position, with funding expected to last approximately 12 months following a public equity offering that raised $8.0 million [10] - Positive mid-year data from the Phase 2 clinical study of Ampligen® in combination with AstraZeneca's Imfinzi® shows no significant toxicity and superior progression-free survival (PFS) and overall survival (OS) [2][10] Financial Highlights - AIM ImmunoTech closed a public equity offering, raising $8.0 million in gross proceeds [10] - The company has regained its listing status on the NYSE American [10] Clinical Development - The ongoing Phase 2 study (DURIPANC) evaluates Ampligen® combined with Imfinzi® for metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX [10] - The company has received U.S. and EU Orphan Drug designations for pancreatic cancer [10] Intellectual Property - AIM ImmunoTech has been granted U.S. patents covering methods of manufacturing therapeutic dsRNA, including Ampligen, and for its combination with PD-L1 drugs for cancer treatment [10] Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company focused on developing therapeutics for various cancers, immune disorders, and viral diseases, with Ampligen® as its lead product [7]

Core Viewpoint - Summit Therapeutics' stock experienced a significant decline of over 11% following a negative assessment from analyst Daina Graybosch of Leerink Partners, who initiated coverage with an underperform rating and a price target of $12 per share, nearly 40% below the recent closing price [1][2]. Group 1: Analyst's Assessment - Daina Graybosch's report highlighted concerns regarding ivonescimab, a cancer drug licensed from Akeso, indicating that despite positive results in a clinical study against Merck's Keytruda, the drug may not capture sufficient market share to justify Summit's high stock valuations [4][5]. - The analyst noted that ivonescimab is not the first drug of its kind, which could lead to increased challenges in achieving clinical success, regulatory approval, and sales [5]. Group 2: Market Dynamics - Summit's stock price volatility is closely tied to developments surrounding ivonescimab, with the potential for large addressable markets in various cancer types, suggesting that the company's prospects should not be dismissed solely based on current valuations [6].

Core Insights - Day One Biopharmaceuticals has appointed Dr. Michael Vasconcelles as Head of Research & Development, bringing over 25 years of oncology expertise to the company [2][3][4] - Dr. Vasconcelles will play a crucial role in advancing the company's pipeline and supporting the growth of its lead product, OJEMDA [3][5] Company Overview - Day One Biopharmaceuticals is focused on developing targeted therapies for life-threatening diseases, particularly in pediatric cancer, addressing a significant unmet need in therapeutic development [6][7] - The company aims to redefine cancer drug development and improve outcomes for patients of all ages from the moment of diagnosis [6] Leadership and Experience - Dr. Vasconcelles has a robust background in oncology research and development, having held leadership roles at ImmunoGen, Flatiron Health, Unum Therapeutics, and Takeda [4][5] - His previous experience includes transforming ImmunoGen into a global biotech enterprise and overseeing clinical development at Genzyme [4] Strategic Goals - The company is committed to expanding its pipeline of first- or best-in-class medicines, with a focus on delivering transformative therapies for children with cancer [3][5] - Dr. Vasconcelles' leadership is expected to enhance the company's medical and scientific strategies, driving growth and innovation [3][5]