Scott Garland, a seasoned biopharma executive with a strong track record of leading successful companies and drug launches, joins Enliven's Board of Directors Building on positive data reported in 2025, Enliven continues to prepare for Phase 3 trial initiation in 2026 and the commercialization of ELVN-001 BOULDER, Colo., Jan. 7, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of smal ...

SAN DIEGO, Jan. 06, 2026 (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 44th Annual J.P. Morgan Healthcare Conference being held at the Westin St. Francis in San Francisco, California. Management will present on Tuesday, January 13, 2026, at 1:30 pm Pacific Time and will also participate in one-o ...

Core Viewpoint - Burning Rock Biotech Limited successfully passed all shareholder resolutions at its 2025 annual general meeting, indicating strong support for the company's strategic direction and governance [1][2]. Company Overview - Burning Rock Biotech Limited focuses on next generation sequencing (NGS) technology in precision oncology, with a mission to guard life via science [1]. - The company's business includes NGS-based therapy selection testing for late-stage cancer patients and cancer early detection, which has progressed to the clinical validation stage [1]. Shareholder Resolutions - The appointment of Ernst & Young Hua Ming LLP as the auditor for the fiscal year ending December 31, 2025, was ratified, with the directors authorized to determine the auditor's remuneration [2]. - Feng Deng and Licen Lisa Xu were re-elected as directors of the company [2]. - Each director was authorized to take necessary actions to effectuate the resolutions as deemed fit [2].

Core Viewpoint - Burning Rock Biotech Limited will hold its annual general meeting (AGM) on December 23, 2025, to discuss key proposals supported by the board of directors [1][2][4]. Group 1: AGM Details - The AGM is scheduled for December 23, 2025, at 10:30 a.m. local time in Shanghai [1]. - The record date for determining shareholders entitled to attend the AGM is December 1, 2025 [3]. - Shareholders holding Class A and Class B ordinary shares are eligible to attend the AGM [3]. Group 2: Proposals for Vote - The proposals include the ratification of Ernst & Young Hua Ming LLP as the auditor for the fiscal year ending December 31, 2025 [8]. - The re-election of directors Feng Deng and Licen Lisa Xu is also on the agenda [8]. - Directors are authorized to take necessary actions to effectuate the proposed resolutions [8]. Group 3: Company Overview - Burning Rock focuses on next generation sequencing (NGS) technology in precision oncology, including therapy selection testing and cancer early detection [6]. - The company has moved its cancer early detection efforts beyond proof-of-concept R&D into clinical validation [6]. Group 4: Financial Reporting - The company has filed its annual report on Form 20-F with complete audited financial statements for the year ended December 31, 2024 [5].

Core Insights - Apis Capital Advisors has initiated a new position in Celcuity Inc., acquiring 776,000 shares valued at $38.33 million as of September 30, representing 8.5% of the fund's total U.S. equity assets of $452.7 million [2][7] - Celcuity's stock has surged 669% over the past year, significantly outperforming the S&P 500's 13% gain during the same period [3] - The company specializes in precision oncology solutions, focusing on personalized treatment for advanced or metastatic breast and ovarian cancer [5] Company Overview - Celcuity Inc. has a market capitalization of $4.6 billion and a share price of $100.35 as of the latest market close [4] - The company reported no revenue and a net income loss of $162.7 million for the trailing twelve months [4] - Celcuity's lead candidate, Gedatolisib, and the CELsignia diagnostic platform are central to its strategy of targeting abnormal cellular signaling in cancer [5] Recent Developments - Following positive phase 3 results for Gedatolisib, Celcuity submitted a new drug application to the FDA on November 17 [8] - The company's momentum is attributed to rapid clinical and platform progress, aiming to address complex cancer treatment challenges [8] - Investors view Celcuity as one of the most promising stories in precision oncology for the year, reflecting growing confidence in its scientific approach [6]

Core Insights - Erasca, Inc. is a clinical-stage precision oncology company focused on therapies for RAS/MAPK pathway-driven cancers [1][3] - The company will participate in the 8th Annual Evercore Healthcare Conference on December 3, 2025, including a fireside chat and one-on-one investor meetings [1] Company Overview - Erasca aims to "erase cancer" by discovering, developing, and commercializing therapies specifically targeting RAS/MAPK pathway-driven cancers [3] - The company was co-founded by pioneers in precision oncology and RAS targeting, emphasizing the development of novel therapies and combination regimens [3] - Erasca's scientific advisory board includes leading experts in the RAS/MAPK pathway, enhancing its capability to achieve its mission [3]

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]