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Relay Therapeutics Stock Up 235% This Past Year as One Fund Lifts Bet to $110 Million
Yahoo Finance· 2026-02-27 16:18
On February 17, 2026, Casdin Capital disclosed a buy of 1,662,193 shares of Relay Therapeutics (NASDAQ:RLAY), an estimated $11.86 million trade based on quarterly average pricing, in its Form 13F filing. What happened According to an SEC filing dated February 17, 2026, Casdin Capital increased its holding in Relay Therapeutics by 1,662,193 shares, bringing its total to 13,003,574 shares. The estimated transaction value was $11.86 million, calculated using the quarterly average share price. The quarter-en ...
Key Opinion Leader (KOL) Panel to Discuss Acrivon’s ACR-368 Endometrial Cancer (EC) Trial during the 2026 European Society of Gynecological Oncology (ESGO) Congress
Globenewswire· 2026-02-23 13:00
Live webcast of event on February 27 at 8:00 a.m. ET will include participation of globally renowned gynecological oncology KOLs from the US and EU KOL panel to discuss maturing data from the ACR-368 registrational-intent trial, including recently disclosed promising results in serous EC, in the context of high unmet need in EC Panos Konstantinopoulos, M.D., Ph.D., Dana-Farber Cancer Institute, professor, Harvard Medical School, will deliver late-breaking oral presentation of ACR-368 interim clinical data a ...
Nuvectis Pharma, Inc. Reports 2025 Financial Results and Business Highlights
Globenewswire· 2026-02-11 12:30
Core Viewpoint - Nuvectis Pharma, Inc. has made significant progress in its NXP900 development program during 2025, with multiple potential data readouts expected in 2026, while maintaining a focus on operational execution and financial responsibility [2]. Financial Results - As of December 31, 2025, the company's cash and cash equivalents increased to $31.6 million from $18.5 million in 2024, reflecting a rise of $13.1 million due to a public offering and access to an at-the-market facility, partially offset by operating expenses [3]. - The net loss for the year ended December 31, 2025, was $26.4 million, an increase of $7.4 million compared to a net loss of $19.0 million in 2024. This loss included $6.0 million in non-cash stock-based compensation and one-time license fees of $2.4 million [4]. - Research and development expenses for 2025 were $18.2 million, up from $12.9 million in 2024, marking an increase of $5.3 million. General and administrative expenses rose to $9.4 million from $6.9 million, an increase of $2.5 million [5]. - Finance income for 2025 was $1.1 million, compared to $0.8 million in 2024, reflecting an increase of $0.3 million [6]. Company Overview - Nuvectis Pharma, Inc. is focused on developing innovative precision medicines for serious unmet medical needs in oncology, with its primary asset being NXP900, an oral small molecule inhibitor targeting SRC Family Kinases [7].
Acrivon Therapeutics Announces Late-Breaking Oral Presentation at Upcoming European Society of Gynecological Oncology (ESGO) Annual International Congress
Globenewswire· 2026-01-23 13:11
Core Insights - Acrivon Therapeutics is set to present interim clinical data for ACR-368, a treatment for endometrial cancer, at the ESGO 27 Annual Congress in February 2026, highlighting its potential in a high unmet need patient population [1][2] Company Overview - Acrivon Therapeutics is a clinical stage biotechnology company focused on precision medicine, utilizing its proprietary Generative Phosphoproteomics AP3 platform for drug discovery and development [5] - The AP3 platform enables the interpretation and quantification of drug-regulated effects in intact cells, providing actionable insights and overcoming limitations of traditional drug discovery methods [5] Clinical Development - ACR-368, also known as prexasertib, is a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a potentially registrational Phase 2 trial for endometrial cancer [6] - The FDA has granted Fast Track designation for ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in endometrial cancer patients, along with Breakthrough Device designation for the ACR-368 OncoSignature assay [6] Pipeline Programs - Acrivon is advancing ACR-2316, a selective WEE1/PKMYT1 inhibitor, which has shown promising initial clinical activity and a favorable tolerability profile in Phase 1 trials [8] - The company is also developing ACR-6840, targeting CDK11, as part of its internally discovered pipeline programs [8]
Maze Therapeutics (NasdaqGM:MAZE) FY Conference Transcript
2026-01-12 17:17
Summary of Maze Therapeutics FY Conference Call Company Overview - **Company**: Maze Therapeutics (NasdaqGM:MAZE) - **Industry**: Biotechnology, focusing on kidney disease and metabolic disorders - **CEO**: Jason Coloma - **Conference**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 12, 2026 Key Points Industry Context - **Kidney Disease Prevalence**: 37 million people in the U.S. suffer from kidney disease, which is the ninth leading cause of death globally [3][29] - **Lack of Innovation**: There are currently no approved precision medicines for kidney disease, highlighting a significant unmet medical need [3][10] Pipeline and Product Development - **MZE829**: Targeting APOL1-mediated kidney disease - **Proof-of-Concept Data**: Expected by the end of Q1 2026 [4][5] - **Patient Population**: Approximately 250,000 individuals in the U.S. could benefit, with 60% not having diabetes [6][10] - **Mechanism**: Aims to block harmful cellular processes caused by APOL1 overexpression [12][13] - **Phase 2B/3 Study**: Planning to initiate if proof-of-concept data is positive, focusing on a 30% reduction in UACR (urine albumin-to-creatinine ratio) [18][42] - **MZE782**: For phenylketonuria (PKU) and chronic kidney disease (CKD) - **PKU Patient Population**: Approximately 60,000 individuals in key geographies, with many unable to benefit from existing therapies [21][22] - **Mechanism**: Aims to reduce toxic accumulation of phenylalanine without relying on enzyme presence, potentially benefiting all PKU patients [22][23] - **Phase 2 Study**: Expected to start by mid-2026 for PKU, with CKD studies planned for the second half of 2026 [28][29] Financial Position - **Capital Position**: Strong, with operating capital secured until 2028, allowing for the support of near-term milestones and studies [5][39] - **Funding Milestones**: Includes reporting data from the Horizon study, initiating PKU proof-of-concept, and advancing CKD programs [51] Market Dynamics - **Current Treatments**: Existing therapies for kidney disease, such as SGLT2 inhibitors, have high discontinuation rates (over 40%) due to side effects [30][29] - **Strategic Positioning**: MZE782 may complement or replace SGLT2 inhibitors, providing a new treatment option for patients who do not respond well to current therapies [30][38] Future Outlook - **Vision**: To build a next-generation precision medicines company focused on kidney and metabolic diseases, leveraging genetic insights to develop best-in-class therapies [38][39] - **Upcoming Data**: Anticipated updates on MZE829 and MZE782 will be crucial for investor confidence and future development plans [40][51] Additional Insights - **Patient Impact**: The goal is to significantly improve the quality of life for patients suffering from kidney diseases and metabolic disorders through innovative therapies [19][38] - **Regulatory Path**: Clear registrational paths for both MZE829 and MZE782 are being established, with a focus on clinically meaningful endpoints [48][49] This summary encapsulates the critical aspects of Maze Therapeutics' conference call, highlighting the company's strategic focus, product pipeline, financial health, and the broader context of kidney disease treatment.
Precigen to Present at the 44th Annual J.P. Morgan Healthcare Conference
Prnewswire· 2026-01-05 21:05
Core Insights - Precigen, Inc. is set to present at the 44th Annual J.P. Morgan Healthcare Conference from January 12–15, 2026, with CEO Helen Sabzevari scheduled to speak on January 15, 2026, at 7:30 AM PT [1] - Dr. Sabzevari will also participate in a fireside chat hosted by Eversana on January 12, 2026, at 10:30 AM PT during the Biotech Showcase [2] - Precigen focuses on developing innovative precision medicines for difficult-to-treat diseases, with a strong pipeline in immuno-oncology, autoimmune disorders, and infectious diseases [3] Company Overview - Precigen, Inc. specializes in advancing precision medicines aimed at addressing high unmet patient needs [3] - The company is committed to moving scientific breakthroughs from proof-of-concept to commercialization [3] - Precigen is developing a robust pipeline of differentiated therapies across its core therapeutic areas [3]
UPDATE -- Acrivon Therapeutics to Announce Clinical Update on its Ongoing Phase 2b Studies and Planned Confirmatory Phase 3 Trial for ACR-368, Initial Clinical Data on ACR-2316, and Other AP3 Pipeline Updates via Webcast
Globenewswire· 2025-12-17 14:34
Core Insights - Acrivon Therapeutics is a clinical stage biotechnology company focused on precision medicine through its proprietary Generative Phosphoproteomics AP3 platform, which enables the interpretation and quantification of drug-regulated effects in intact cells [2][3] Company Overview - Acrivon Therapeutics utilizes its Generative Phosphoproteomics AP3 platform to develop precision medicines, providing rapid and actionable insights from terabytes of proprietary data [2] - The platform includes tools such as the AP3 Data Portal, AP3 Kinase Substrate Relationship Predictor, and AP3 Interactome, allowing for advanced drug discovery beyond traditional methods [2] Clinical Programs - The lead program, ACR-368 (prexasertib), is a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a Phase 2b trial for endometrial cancer, with Fast Track designation from the FDA [3] - ACR-2316, a second clinical stage asset, is a potent WEE1/PKMYT1 inhibitor showing promising early clinical activity and safety in a Phase 1 trial, with initial tumor shrinkage observed [4][6] Upcoming Updates - Acrivon plans to provide updates on ACR-368 and ACR-2316 clinical data via a conference call and webcast in January 2026, including interim data from ongoing trials and new preclinical candidates [1][6]
Kura Oncology and Kyowa Kirin Announce FDA Approval of KOMZIFTI™ (ziftomenib), the First and Only Once-Daily Targeted Therapy for Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia
Globenewswire· 2025-11-13 15:51
Core Insights - The FDA has granted full approval for KOMZIFTI (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, marking it as the first once-daily oral menin inhibitor approved for this indication [1][11] - The approval is based on the KOMET-001 trial, which demonstrated a complete remission rate of 21.4% and a median duration of response of 5.0 months in patients with R/R NPM1-m AML [5][6] - KOMZIFTI is positioned to address a significant unmet need in a patient population with historically poor outcomes and limited treatment options [1][4] Company Overview - Kura Oncology, in collaboration with Kyowa Kirin, is committed to advancing the development of KOMZIFTI across the treatment continuum for AML, aiming to improve patient outcomes [2][8] - The companies have established a global strategic collaboration for the development and commercialization of KOMZIFTI, with Kura leading efforts in the U.S. [8] Clinical Data - In the pivotal KOMET-001 trial, 112 patients were evaluated, with 88% of those achieving complete remission or complete remission with partial hematologic recovery within 6 months of treatment initiation [5][6] - The trial also reported a median time to first response of 2.7 months, indicating a rapid onset of efficacy [5] Safety Profile - KOMZIFTI has a favorable safety profile, with no Boxed Warning related to QTc prolongation or Torsades de Pointes, which is significant for patients on multiple concurrent medications [6][7] - The most common adverse reactions included increased liver enzymes and infections, with serious adverse reactions reported in 79% of patients [21][23] Market Potential - The approval of KOMZIFTI represents a major advancement in targeted therapies for AML, particularly for patients who are older and unable to tolerate intensive chemotherapy [6][8] - The drug's once-daily oral administration and compatibility with other medications enhance its potential to become the preferred treatment option in its approved indication [2][6] Access and Support - Kura has established a support program, Kura RxKonnect, to facilitate access and reimbursement for patients prescribed KOMZIFTI [9]
Nuvectis Pharma, Inc. Reports Third Quarter 2025 Financial Results and Business Highlights
Globenewswire· 2025-11-04 12:30
Core Viewpoint - Nuvectis Pharma, Inc. is advancing its clinical-stage biopharmaceutical efforts, particularly focusing on the NXP900 program, which aims to address unmet medical needs in oncology through innovative precision medicines [1][2]. Financial Results - As of September 30, 2025, the company reported cash and cash equivalents of $35.4 million, an increase of $16.9 million from $18.5 million at the end of 2024, primarily due to a public offering and the use of an At-the-Market facility [3]. - The net loss for the third quarter of 2025 was $7.5 million, compared to $4.2 million for the same period in 2024, marking an increase of $3.4 million, largely due to a one-time milestone expense of $2.0 million for NXP900 and $0.7 million for a clinical study [4]. - Research and development expenses were $5.8 million for the third quarter of 2025, up from $2.8 million in the same quarter of 2024, reflecting an increase of $3.0 million [5]. - General and administrative expenses rose to $2.0 million in the third quarter of 2025 from $1.5 million in the same quarter of 2024, an increase of $0.5 million [5]. - Interest income for the third quarter of 2025 was $0.3 million, compared to $0.2 million in the same period of 2024 [6]. Business Progress - The Phase 1b program for NXP900 has been initiated, with the single-agent study currently underway, aiming to provide preliminary evidence of clinical efficacy in advanced cancers [8]. - The Phase 1a dose escalation study for NXP900 has been successfully completed, demonstrating robust pharmacodynamic responses at clinically relevant doses [8]. - A clinical drug-drug interaction study in healthy volunteers has also been successfully completed, supporting the strategy for combination therapy [8]. - The company expects its cash runway to support operations into the third quarter of 2027 [8]. Company Overview - Nuvectis Pharma, Inc. focuses on developing innovative precision medicines for serious oncology conditions, with its lead program NXP900 being an oral small molecule inhibitor targeting SRC Family of Kinases [9].
Kura Oncology Receives Second $30 Million Development Milestone Payment in AML Menin Inhibitor Program With Kyowa Kirin
Globenewswire· 2025-11-03 21:02
Core Insights - Kura Oncology has received a $30 million milestone payment from Kyowa Kirin for the dosing of the first patient in the second Phase 3 trial of ziftomenib, bringing total milestone payments received to $105 million, with expectations of up to $315 million in additional near-term milestones [1][2]. Group 1: Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting cancer signaling pathways and addressing hematologic malignancies and solid tumors [3]. - The company is developing ziftomenib, a menin inhibitor aimed at specific genetic drivers of acute myeloid leukemia (AML), and is pioneering advancements in menin inhibition for both acute leukemias and solid tumors [3]. Group 2: Clinical Trials - The KOMET-017 trial consists of two independent, global, randomized double-blind, placebo-controlled Phase 3 trials evaluating ziftomenib in combination with intensive and non-intensive chemotherapy regimens for patients with newly diagnosed NPM1-mutated or KMT2A-rearranged AML [2]. - Kura believes that KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings [2].