SAN DIEGO, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced its participation in the 8th Annual Evercore Healthcare Conference being held at the Loews Coral Gables Hotel in Coral Gables, FL. Management will participate in a fireside chat on Wednesday, December 3, 2025, at 10:25 am Eastern Time and will also p ...

Core Insights - Aptose Biosciences Inc. reported promising clinical results for its tuspetinib-based triple drug therapy for newly diagnosed acute myeloid leukemia (AML), demonstrating a complete response (CR) rate of 100% at higher dose levels [2][3] - The company announced a net loss of $5.1 million for Q3 2025, a decrease from $7.0 million in Q3 2024, indicating improved financial performance [8][12] - The ongoing TUSCANY trial data presented at the European School of Haematology highlighted the safety and efficacy of tuspetinib in combination with venetoclax and azacitidine [3][5] Clinical Development - Tuspetinib in combination with VEN+AZA has shown high activity and tolerability, with 100% CR/CRh responses in patients at 80 mg and 120 mg dose levels, exceeding the expected 66% response rate from VEN+AZA alone [2][3] - The TUSCANY trial data supports the use of tuspetinib across various AML populations, including those with adverse mutations [3][5] - The company is now dosing patients at the 160 mg level of tuspetinib and anticipates further updates at the upcoming ASH meeting [2][3] Financial Performance - For the three months ended September 30, 2025, total operating expenses were $4.9 million, down from $7.0 million in the same period in 2024 [8][12] - Research and development expenses decreased to $2.2 million for Q3 2025 from $4.7 million in Q3 2024, primarily due to reduced activity in the APTIVATE clinical trial [12][15] - The net loss for the nine months ended September 30, 2025, was $17.7 million, a decrease from $23.8 million in the same period in 2024 [8][12] Corporate Updates - The company’s abstract on the TUSCANY study has been accepted for poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting scheduled for December 6-9, 2025 [3][4] - As of September 30, 2025, the company had cash and cash equivalents of $1.6 million, indicating a need for financing to support ongoing operations [10][14] - The company has discontinued further development of APTO-253, focusing resources on tuspetinib and luxeptinib [15][18]

Core Insights - Prelude Therapeutics is advancing two promising drug programs targeting significant unmet needs in oncology, specifically the JAK2V617F inhibitor and KAT6A degrader programs [3][4][19] - The company expects to file Investigational New Drug (IND) applications for both programs in 2026, with the JAK2V617F program anticipated in the first quarter and the KAT6A program in mid-2026 [5][8] Pipeline Programs - **JAK2V617F Inhibitor Program**: This program targets the JAK2V617F mutation, which is prevalent in myeloproliferative neoplasms (MPNs), affecting approximately 95% of polycythemia vera patients, 60% of essential thrombocythemia patients, and 55% of myelofibrosis patients. Prelude has developed novel allosteric inhibitors that selectively target V617F+ cells, showing potential to reduce mutant allele burden and improve treatment outcomes [4][6] - **KAT6A Degrader Program**: This program focuses on KAT6A, a target in ER+ breast cancer. Prelude is developing first-in-class, highly selective oral KAT6A degraders, which may offer improved efficacy and tolerability compared to non-selective inhibitors. Preclinical data supporting this approach has been presented at relevant conferences [7][8] Financial Overview - As of September 30, 2025, Prelude had cash, cash equivalents, restricted cash, and marketable securities totaling $58.2 million. The company anticipates that this funding will support operations into 2027 [14] - Research and Development (R&D) expenses for Q3 2025 decreased to $21.7 million from $29.5 million in the prior year, while General and Administrative (G&A) expenses also saw a decline to $5.2 million from $7.7 million [15][16] - The net loss for Q3 2025 was reported at $19.7 million, or $0.26 per share, compared to a net loss of $32.3 million, or $0.43 per share, for the same period in 2024 [17][21]

Core Viewpoint - Guardant Health, Inc. has announced a proposed public offering of $250 million in common stock, with an additional option for underwriters to purchase up to $37.5 million more, subject to market conditions [1][3]. Group 1: Offering Details - The common stock offering is being managed by Goldman Sachs & Co. LLC, Jefferies, Leerink Partners, and Guggenheim Securities [2]. - The offering is part of a broader strategy that includes a concurrent offering of $300 million in Convertible Senior Notes due 2033, with an option for initial purchasers to buy an additional $45 million [4]. - The common stock offering will be made under a shelf registration statement filed with the SEC, which became effective on May 22, 2023 [5]. Group 2: Use of Proceeds - The net proceeds from the common stock offering, along with those from the convertible notes offering, are intended for general corporate purposes, which may include repurchasing a portion of the 2027 convertible senior notes, although no agreements are currently in place for such transactions [3]. - Potential uses of the proceeds may also involve acquiring complementary products, technologies, or businesses [3]. Group 3: Company Overview - Guardant Health is a leading precision oncology company focused on improving patient care and accelerating cancer therapies through advanced testing and analytics [10]. - The company aims to provide critical insights into cancer management, including early detection, monitoring, and treatment selection [10].

Core Insights - HUTCHMED has introduced its innovative Antibody-Targeted Therapy Conjugate (ATTC) platform, which aims to redefine precision oncology through a dual-mechanism of action [1][2] - The lead candidate HMPL-A251, a selective PI3K/PIKK inhibitor, has shown promising preclinical efficacy and safety, positioning HUTCHMED's late-stage pipeline for further development [1][4] - The company is making significant progress in global and China trials, including studies for fruquintinib, surufatinib, and fanregratinib, enhancing its late-stage pipeline [1][9] ATTC Platform and Lead Candidate - The ATTC platform integrates monoclonal antibodies with small-molecule inhibitor payloads, providing synergistic anti-tumor activity and improved safety profiles compared to traditional antibody-drug conjugates [2][3] - HMPL-A251 is designed to target the PAM signaling pathway, which is often associated with poor prognosis in various cancers, and aims to enhance targeted delivery while minimizing systemic exposure [3][4] - Preclinical data indicates that HMPL-A251 exhibits strong anti-tumor activity, particularly in HER2-positive tumors, and shows potential for improved efficacy compared to existing therapies like trastuzumab deruxtecan [4][5] Clinical Development Plans - HUTCHMED plans to advance HMPL-A251 into clinical development in late 2025, focusing on various cancer types with different HER2 and PAM alteration statuses [5] - The company aims to explore a broader range of antibody selections and payload options to enhance treatment outcomes and overcome resistance [6] Late-stage Program Updates - The company reported significant progress in late-stage programs, including the FRUSICA-2 study for fruquintinib, which demonstrated a progression-free survival of 22.2 months compared to 6.9 months with standard treatments [9] - Recruitment for the SANOVO study in first-line EGFR-mutated non-small cell lung cancer has been completed, with further studies for surufatinib and fanregratinib also advancing [9]

Core Insights - Guardant Health, Inc. is set to present data on the importance of blood-based testing in enhancing cancer screening adherence at the ACG 2025 Annual Meeting [1] Company Overview - Guardant Health is recognized as a leading precision oncology company [1] Event Details - The presentation will take place during the American College of Gastroenterology (ACG) 2025 Annual Meeting in Phoenix, Arizona, from October 24 to October 29, 2025 [1]

Core Insights - Prelude Therapeutics has appointed Katina Dorton to its Board of Directors, effective October 17, 2025, bringing over 30 years of experience in healthcare and life sciences [1][2] - Ms. Dorton will also take over as Audit Committee Chair, succeeding Mardi C. Dier, who has served on the board since August 2020 [3] - Prelude Therapeutics is focused on advancing its precision oncology drug candidates and aims to create significant shareholder value [2][3] Company Overview - Prelude Therapeutics is a clinical-stage precision oncology company developing innovative medicines for cancer patients with high unmet needs [4] - The company's pipeline includes several novel drug candidates, such as first-in-class SMARCA2 and KAT6A degraders, and it is also researching next-generation degrader antibody conjugates [4] - Prelude's mission is to extend the promise of precision medicine to every cancer patient in need [4]

Core Insights - Aptose Biosciences is presenting promising data from the TUSCANY trial, which evaluates the safety and efficacy of the tuspetinib-based triplet therapy (TUS+VEN+AZA) for newly diagnosed AML patients ineligible for induction chemotherapy [1][2][3] Group 1: Clinical Trial Data - The TUSCANY trial has shown that the addition of tuspetinib to the standard treatment of venetoclax and azacitidine has resulted in complete remission (CR) or complete remission with incomplete hematologic recovery (CRh) in 100% of patients treated at higher doses of 80 mg and 120 mg [5][6] - Overall, 90% of patients in the trial have achieved CR/CRh responses, with 88% of FLT3 wildtype AML patients responding positively [6][8] - The therapy has demonstrated activity across diverse genetic subtypes, including those with unmutated FLT3, FLT3-ITD, NPM1c, biallelic TP53, RAS, and myelodysplasia-related mutations [3][14] Group 2: Safety Profile - The TUS+VEN+AZA combination has been well tolerated, with no significant safety concerns or dose-limiting toxicities reported, including no prolonged myelosuppression, differentiation syndrome, QTc prolongation, or treatment-related deaths [2][6] - Dosing has commenced at the 160 mg level, indicating ongoing escalation in the trial [5][14] Group 3: Trial Design and Objectives - The TUSCANY trial is a Phase 1/2 study being conducted at 10 leading U.S. clinical sites, aiming to establish a safe and effective frontline therapy for a broad range of newly diagnosed AML patients [9][11] - The trial is designed to test various doses and schedules of tuspetinib in combination with standard dosing of azacitidine and venetoclax, with an anticipated enrollment of 18-24 patients by the end of 2025 [9][10]

Group 1 - Guardant Health, Inc. and Quest Diagnostics have announced a strategic collaboration to provide Guardant's Shield blood-based screening test to physicians and patients in the United States [1] - Shield is the first and only blood test to receive full FDA approval as a primary screening option for colorectal cancer [1]

Company Overview - Erasca, Inc. is a clinical-stage precision oncology company focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers [3] - The company aims to "erase cancer" by creating novel therapies and combination regimens that comprehensively target the RAS/MAPK pathway [3] Recent Events - Erasca announced its participation in the Morgan Stanley 23rd Annual Global Healthcare Conference, scheduled for September 9, 2025, at 3:20 pm Eastern Time [1] - The company will also engage in one-on-one investor meetings during the conference [1] Accessibility of Information - A live audio webcast of the conference presentation will be available on Erasca's website, with an archived replay accessible for 30 days post-event [2]