Core Insights - Ziftomenib is being evaluated in combination with approved FLT3 inhibitors for frontline treatment of acute myeloid leukemia (AML) [1][2] - FLT3 mutations are prevalent in approximately 30% of newly diagnosed adult AML patients and up to 50% in those with NPM1-mutated AML, highlighting the significance of FLT3 as a target [1] - The KOMET-007 clinical trial has commenced, focusing on ziftomenib's efficacy alongside cytarabine, daunorubicin, and quizartinib for newly diagnosed AML patients [1][2] Company Overview: Kura Oncology - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting hematologic malignancies and solid tumors [4] - Ziftomenib, a menin inhibitor, is under development to address specific genetic drivers of acute myeloid leukemias [4] Company Overview: Kyowa Kirin - Kyowa Kirin is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [5] - The company is committed to developing novel medicines and treatments for high unmet medical needs, including hematological diseases and rare diseases [5]

Fort Lee, NJ, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced the appointment of Juan Sanchez, MD, to its Board of Directors. Dr. Sanchez is a seasoned biotech executive with expertise in industry, capital markets and medicine, having most recently served as Vice President of Corporate Commu ...

Core Insights - Kura Oncology, Inc. is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment [2] - The company is scheduled to participate in the UBS Virtual Oncology Day on October 1, 2025, at 2:30 p.m. ET [1] - A live audio webcast of the event will be available on Kura's website, with an archived replay following the event [1] Company Overview - Kura Oncology develops small molecule drug candidates targeting cancer signaling pathways, addressing high-need hematologic malignancies and solid tumors [2] - The company is advancing ziftomenib, a menin inhibitor aimed at specific genetic drivers of acute myeloid leukemias [2] - Kura is also pioneering advancements in menin inhibition and farnesyl transferase inhibition to combat resistance mechanisms in solid tumors [2]

Core Insights - Kura Oncology is showcasing the potential of KO-2806 (darlifarnib) in combination with various targeted therapies to enhance anti-tumor activity and address resistance mechanisms in cancer treatment [1][2][4] Group 1: KO-2806 Development and Clinical Data - KO-2806 is a next-generation farnesyl transferase inhibitor (FTI) designed for superior potency and pharmacokinetics compared to first-generation candidates [4] - Preliminary clinical data for KO-2806 will be presented at the ESMO Congress 2025 in October [1][5] - The company is conducting ongoing Phase 1 trials for KO-2806, with a focus on its combination with standard-of-care agents [4] Group 2: Mechanisms of Action and Preclinical Findings - KO-2806 has shown robust preclinical activity by suppressing mTOR signaling, enhancing the efficacy of antiangiogenic TKIs, PI3Kα inhibitors, and KRAS inhibitors [4] - The preclinical studies indicate that KO-2806 can re-sensitize tumors in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) models to KRAS inhibitors [4] - The findings suggest broad applicability across multiple cancer types, potentially impacting over 200,000 new patients annually in the U.S. [4] Group 3: Future Events and Presentations - Kura plans a second analyst/investor event on October 18, 2025, to review clinical data from the ESMO Congress presentations [5] - The company emphasizes the importance of innovative combination therapies to overcome resistance in cancer treatment [2][4]

Company Overview - Nuvectis Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative precision medicines for serious unmet medical needs in oncology [2] - The company has two clinical-stage drug candidates: NXP900 and NXP800 [2] Drug Candidates - NXP900 is an oral small molecule inhibitor targeting the SRC Family of Kinases (SFK), including SRC and YES1, with a unique mechanism that inhibits both catalytic and scaffolding functions [2] - NXP900 has completed a Phase 1a dose escalation study, and the Phase 1b program has been initiated [2] - NXP800 is an oral small molecule GCN2 activator that has shown anti-cancer activity in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer, with potential exploration in other cancer types [2] Upcoming Events - Senior management will participate in the H.C. Wainwright Global Investment Conference, with a corporate presentation available for on-demand viewing starting September 5, 2025 [1] - The conference will take place from September 8-10, 2025, where the company will also attend virtual one-on-one meetings [1]

Core Insights - Precigen is a biopharmaceutical company focused on innovative precision medicines for difficult-to-treat diseases with high unmet needs [1] - The company has received FDA approval for PAPZIMEOS, the first drug approved for treating recurrent respiratory papillomatosis in adults [2] - PAPZIMEOS is a nonreplicating adenoviral vector-based immunotherapy targeting HPV 6 and 11, which are believed to cause the disease [2] - The FDA granted full approval on August 15, ahead of the PDUFA date of August 27, and the drug is set to launch in early Q4 of this year [2]

Core Insights - Precigen, Inc. announced participation in two virtual fireside chats to discuss the recent FDA approval of a therapy for recurrent respiratory papillomatosis [1][2] Group 1: Company Overview - Precigen is a biopharmaceutical company focused on innovative precision medicines aimed at treating difficult diseases with high unmet needs [3] - The company is committed to advancing scientific breakthroughs from proof-of-concept to commercialization [3] - Precigen is developing a diverse pipeline of therapies in immuno-oncology, autoimmune disorders, and infectious diseases [3] Group 2: Upcoming Events - The first virtual fireside chat will be hosted by Jennifer Kim from Cantor on August 27, 2025, featuring CEO Helen Sabzevari and CCO Phil Tennant [2] - The second chat will be moderated by Swayampakula Ramakanth from H.C. Wainwright on September 2, 2025, also featuring CEO Helen Sabzevari and CCO Phil Tennant [2] - Live webcasts of these events will be accessible through Precigen's website [2]

Core Viewpoint - Nuvectis Pharma, Inc. is positioned for growth following significant advancements in its clinical programs and a strengthened financial position, with a focus on innovative precision medicines for oncology [2][8]. Financial Performance - As of June 30, 2025, cash and cash equivalents increased to $26.8 million from $18.5 million at the end of 2024, primarily due to a public offering in February 2025 [3]. - The net loss for the second quarter of 2025 was $6.3 million, an increase from $4.4 million in the same period of 2024, attributed mainly to the completion of the NXP900 drug-drug interaction study [4]. - Research and development expenses rose to $3.6 million in Q2 2025 from $2.9 million in Q2 2024, while general and administrative expenses increased to $3.0 million from $1.7 million in the same period [5]. Clinical Development - NXP900 has successfully completed its Phase 1a dose escalation study and a drug-drug interaction study, paving the way for the imminent initiation of the Phase 1b program [2][8]. - The company plans to explore NXP800 in additional cancer types, including endometrial and prostate cancers, over the coming months [2]. Cash Position - Following a share acquisition by a healthcare-focused institutional investor, the proforma cash position as of June 30, 2025, is approximately $39 million, expected to fund operations into the second half of 2027 [2][8].

Core Viewpoint - Kura Oncology is set to report its second quarter 2025 financial results on August 7, 2025, and will provide a corporate update during a conference call [1] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment [3] - The company's pipeline includes small molecule drug candidates targeting cancer signaling pathways [3] Key Developments - Ziftomenib, an oral menin inhibitor, is the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for relapsed or refractory NPM1-mutant acute myeloid leukemia [3] - A global strategic collaboration with Kyowa Kirin was established in November 2024 to develop and commercialize ziftomenib for AML and other hematologic malignancies [3] - Enrollment in the Phase 2 trial (KOMET-001) for ziftomenib in R/R NPM1-m AML has been completed, with the FDA accepting a New Drug Application and setting a target action date of November 30, 2025 [3] Ongoing Trials - Kura and Kyowa Kirin are conducting clinical trials for ziftomenib in combination with current standards of care for newly diagnosed and R/R NPM1-m and KMT2A-rearranged AML [3] - Ziftomenib is also being evaluated in a Phase 1 trial (KOMET-015) in combination with imatinib for advanced gastrointestinal stromal tumors [3] - KO-2806, a next-generation farnesyl transferase inhibitor, is in a Phase 1 trial (FIT-001) as monotherapy and in combination with targeted therapies for various solid tumors [3] - Tipifarnib is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for PIK3CA-dependent head and neck squamous cell carcinoma [3]

Core Insights - Nuvectis Pharma, Inc. has provided updates on the Phase 1a dose-escalation study of NXP900, indicating robust pharmacodynamic responses and an acceptable safety profile with no dose limiting toxicity identified up to 250 mg/day [1][5][6] - The company is preparing to initiate the Phase 1b program, focusing on biomarker-selected cancers and evaluating NXP900 in combination with leading therapies for resistant non-small cell lung cancer (NSCLC) [4][5] Group 1: Clinical Study Highlights - NXP900 demonstrated systemic exposure that increased with dosage, achieving clinically relevant concentrations starting at 150 mg/day, with over 90% SRC inhibition observed in patient samples after a single dose [6] - The study included 29 patients with advanced cancers, with a median age of 62 years, where common treatment-emergent adverse events were mostly Grade 1-2 [6] Group 2: Preclinical Data and Rationale - Preclinical data supports NXP900's potential as a single agent and in combination with existing therapies to overcome resistance in NSCLC, particularly targeting YES1 gene amplifications and Hippo pathway alterations [1][3][4] - The addition of NXP900 to market-leading EGFR and ALK inhibitors reversed resistance, highlighting its potential in addressing unmet clinical needs in NSCLC [6] Group 3: Company Overview - Nuvectis Pharma, Inc. is focused on developing innovative precision medicines for oncology, with NXP900 being an oral small molecule inhibitor of the SRC Family of Kinases [7] - The company is also developing another candidate, NXP800, for different cancer indications, showcasing a diverse pipeline in oncology [7]