Summary of Kura Oncology Conference Call Company Overview - **Company**: Kura Oncology - **Event**: Jefferies Global Healthcare Conference 2025 - **Key Participants**: CEO Troy, Commercial Officer Brian, CMO Molly Industry Focus - **Industry**: Oncology, specifically Acute Myeloid Leukemia (AML) and Menin inhibitors Key Highlights from the Call 1. **Positive Trial Results**: Kura Oncology reported two positive trials indicating that their mechanism works in AML, suggesting that their drugs are likely approvable [4][10] 2. **Clinical Data**: - Phase 2 trial showed a 23% complete response (CR) rate and a median overall survival of 16.4 months for responders, compared to typical survival of 3 months in relapsed refractory leukemia [5] - Zifdomenib demonstrated consistent activity regardless of prior treatments or therapy lines [6] 3. **Safety Profile**: - No myelosuppression differentiation syndrome was reported, and QT prolongation was not clinically meaningful [7][8] - Once-daily oral dosing was highlighted as a convenience factor for patients and physicians [8][15] 4. **Regulatory Milestones**: - Kura has a PDUFA date set for November 30, indicating a priority review status [10][12] - The company is preparing for a significant data presentation at EHA on June 12 [9] 5. **Market Opportunity**: - Approximately 20,000 AML patients are diagnosed annually, with an estimated 10,000 potentially eligible for Menin inhibitors [52] - The potential market size for Kura's product in AML is estimated between $5 billion to $10 billion, with Kura aiming to capture around $3 billion [53] 6. **Combination Therapies**: - Kura is exploring combination therapies, including a study combining Zifdomenib with Imatinib for GIST, which could enhance treatment durability [56][59] - The company is also investigating combinations in breast cancer and other solid tumors [60][61] 7. **Pipeline and Funding**: - Kura has $703 million in cash and is eligible for an additional $375 million in near-term milestones, ensuring funding through the AML program [67] - The company is focused on advancing its pipeline, including FTI programs and diabetes treatments [67] Additional Insights - **Physician Feedback**: Physicians are excited about the introduction of Menin inhibitors, indicating a competitive landscape but also a growing acceptance of new therapies [21][22] - **Regulatory Environment**: Kura does not anticipate changes in FDA perspectives that would affect their accelerated approval pathway [33][36] - **Operational Efficiency**: Kura is combining two phase three trials under a single protocol to streamline operations and enhance patient eligibility [39][40] This summary encapsulates the critical points discussed during the conference call, highlighting Kura Oncology's advancements, market potential, and strategic direction in the oncology space.

PHILADELPHIA and VANCOUVER, British Columbia, June 04, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, announces today that the Company will be conducting two virtual investor presentations on Thursday, June 12, at 12:00 PM EDT and on Thursday, June 26, at 12:00 PM EDT, arranged by Renmark Financial Communications Inc. Briacell Therape ...

Core Insights - The Estée Lauder Companies Inc. is undergoing a leadership transition with Stéphane de La Faverie as the new CEO, who has been in the role for just over 100 days [3] - The company emphasizes the strength of its fundamentals, including strong brands and dedicated teams globally [3] Company Strategy - The "Beauty Reimagined" strategy is a key focus for the company moving forward, informed by the new CEO's experiences and learnings since taking on the role [2][3] - The company is actively engaging with various stakeholders, including teams, partners, retailers, and suppliers, to enhance its operational effectiveness [3]

SAN DIEGO, June 03, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced two oral presentations at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress, taking place June 13-16, 2025, in Glasgow, United Kingdom and virtually. The presentation details a ...

ASCO: new Sarclisa data support subcutaneous administration with on-body injector New data from two clinical studies demonstrated that Sarclisa administered subcutaneously via an investigational on-body injector shortened treatment time to minutes with similar efficacy and safety compared to intravenous infusionStudies used Enable Injections’ enFuse® on-body injector, an automated hands-free injectorData will form the basis of global regulatory submissions across all currently approved lines of treatment P ...

ASCO: new Sarclisa data support subcutaneous administration with on-body injector New data from two clinical studies demonstrated that Sarclisa administered subcutaneously via an investigational on-body injector shortened treatment time to minutes with similar efficacy and safety compared to intravenous infusionStudies used Enable Injections’ enFuse® on-body injector, an automated hands-free injectorData will form the basis of global regulatory submissions across all currently approved lines of treatment P ...

Core Insights - Tactile Systems Technology, Inc. presented new clinical data at ASCO 2025 Annual Meeting, highlighting significant benefits of Flexitouch Plus in treating head and neck cancer-related lymphedema compared to usual care [1][2] Company Overview - Tactile Medical focuses on developing at-home therapies for chronic conditions such as lymphedema, chronic venous insufficiency, and chronic pulmonary disease, aiming to improve patient quality of life and reduce healthcare costs [4] Clinical Trial Findings - The study involved 236 subjects and is the largest randomized controlled trial for head and neck cancer survivors in the U.S. [2] - Two-month data indicated that usual care and advanced pneumatic compression device (APCD) are similarly effective, but APCD showed faster initiation of therapy and better quality-of-life outcomes [3][5] - APCD participants began treatment in an average of 17.9 days, compared to 29.8 days for usual care participants [5] - 94.9% of APCD participants received therapy, versus 71% in the usual care group [5] - APCD demonstrated significant reductions in swelling and improved health-related quality-of-life scores compared to marginal improvements in usual care [5] Future Expectations - The company anticipates that the six-month results from the trial will support broader reimbursement coverage, inform clinical guidelines, and enhance awareness among patients and providers [3]

31% confirmed ORR (8 responses in 26 evaluable patients) across B7-H4 high tumors at intermediate doses 44% confirmed ORR (7 responses in 16 evaluable patients) in the subset of patients with ≤4 prior lines of therapy CAMBRIDGE, Mass., June 02, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced additional interim Pha ...

Phase 3 IFx-Hu2.0 trial as an adjunctive therapy with Keytruda® (pembrolizumab) in checkpoint inhibitor (CPI)-naïve patients with advanced or metastatic Merkel cell carcinoma (MCC) detailed in Trial in Progress Poster at ASCOPhase 3 trial of IFx-Hu2.0 to be conducted under Accelerated Approval Pathway and Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA)TAMPA, Fla., June 2, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncolog ...

DURHAM, N.C., June 02, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that its abstract on the V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for high-risk patients with end-stage renal disease was accepted for an oral presentation at the Society for Vascular Surgery Vascular Annual Meeting (VAM ...