GERMANTOWN, Md., Jan. 5, 2026 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company advancing innovative precision medicines, today announced that Helen Sabzevari, PhD, President and Chief Executive Officer of Precigen, will present at the 44th Annual J.P. Morgan Healthcare Conference, taking place January 12–15, 2026 in San Francisco, California. Dr. Sabzevari's company presentation is scheduled for Thursday, January 15, 2026 at 7:30 AM PT. Steven M. Harasym Tel: +1 (202) 365-2563 inve ...

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]

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]

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].

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].

Core Insights - Nuvectis Pharma, Inc. is advancing its lead program NXP900, a precision medicine targeting SRC/YES1 inhibition for oncology applications, with recent positive results from Phase 1a studies [1][2][3] Clinical Development - The Phase 1a dose escalation and drug-drug interaction studies for NXP900 have shown a favorable safety profile, with common adverse events being Grade 1-2 diarrhea, fatigue, and nausea [5] - NXP900 demonstrated a robust pharmacodynamic response at doses of 150 mg/day and above, indicating its potential effectiveness [5] - The ongoing Phase 1b study is evaluating NXP900 as a monotherapy in patients with advanced solid tumors exhibiting specific genomic alterations [5] Mechanism of Action - NXP900 operates through a unique mechanism that inhibits both the catalytic and scaffolding functions of SRC kinases, leading to comprehensive shutdown of the signaling pathway [3][2] - Preclinical data presented at the conference supports the biomarker patient selection strategy for the Phase 1b program [2] Future Directions - The company is preparing to initiate the combination portion of the Phase 1b program and will provide clinical data updates as the program progresses [2] - Nuvectis is also considering next steps for NXP800, another investigational drug targeting recurrent, platinum-resistant ovarian cancer [3]

Core Insights - Aptose Biosciences Inc. is a clinical-stage precision oncology company focused on developing tuspetinib (TUS) as a frontline therapy for newly diagnosed acute myeloid leukemia (AML) [1][4] Group 1: Shareholder Meeting Outcomes - Shareholders voted to appoint Ernst & Young LLP as the independent registered public accounting firm for the Company [2] - The appointment of EY is expected to enhance the Company's growth and commitment to transparency due to their expertise in the life sciences sector [2] Group 2: Funding and Financial Updates - Aptose has received an additional US$1.5 million in funding from Hanmi Pharmaceutical Co. Ltd. as part of an US$8.5 million loan facility agreement [3] - To date, the Company has received a total of US$7.1 million under the Loan Agreement to support the clinical development of tuspetinib [3]

Core Insights - Acrivon Therapeutics is advancing two clinical-stage assets, ACR-368 and ACR-2316, both demonstrating anti-tumor activity in clinical studies [1][2] - The company utilizes its proprietary AI-driven Generative Phosphoproteomics AP3 platform to enhance drug design and development [1][10] - As of June 30, 2025, Acrivon has $147.6 million in cash and equivalents, expected to fund operations until Q2 2027 [1][9] Clinical Development - ACR-368 is in a registrational-intent Phase 2b trial for endometrial cancer, showing deep and durable responses in patients previously treated with chemotherapy and anti-PD-1 therapy [2][7] - ACR-2316, a WEE1/PKMYT1 inhibitor, is in a Phase 1 trial, with initial clinical activity observed in several solid tumor types, including confirmed partial responses in endometrial cancer [4][12] Financial Performance - For Q2 2025, Acrivon reported a net loss of $21.0 million, compared to a net loss of $18.8 million in Q2 2024 [8][17] - Research and development expenses increased to $16.2 million in Q2 2025 from $15.0 million in Q2 2024, primarily due to increased personnel for clinical trials [8][17] - General and administrative expenses remained stable at $6.5 million for Q2 2025, compared to $6.4 million in Q2 2024 [9][17] Upcoming Milestones - The company plans to provide updates on the registrational-intent trial for ACR-368 and report initial clinical data from the Phase 1 study of ACR-2316 in the second half of 2025 [14] - Acrivon is also advancing a new cell cycle drug discovery program targeting an undisclosed target towards development candidate nomination in 2025 [14]

Core Insights - Acrivon Therapeutics is advancing two clinical-stage assets, ACR-368 and ACR-2316, both demonstrating anti-tumor activity in clinical studies [1][2] - The company utilizes its proprietary AI-driven Generative Phosphoproteomics AP3 platform to enhance drug design and development [1][10] - As of June 30, 2025, Acrivon has $147.6 million in cash and equivalents, expected to fund operations until Q2 2027 [1][9] Clinical Development - ACR-368 is in a registrational-intent Phase 2b trial for endometrial cancer, showing deep and durable responses in patients previously treated with chemotherapy and anti-PD-1 therapy [2][7] - ACR-2316, a WEE1/PKMYT1 inhibitor, is in a Phase 1 trial, with initial clinical activity observed in several solid tumor types, including confirmed partial responses in endometrial cancer [4][12] Financial Performance - For Q2 2025, Acrivon reported a net loss of $21.0 million, compared to a net loss of $18.8 million in Q2 2024 [8] - Research and development expenses increased to $16.2 million in Q2 2025 from $15.0 million in Q2 2024, primarily due to increased personnel for clinical trials [8] - General and administrative expenses remained stable at $6.5 million for Q2 2025, compared to $6.4 million in Q2 2024 [9] Upcoming Milestones - The company plans to provide updates on the registrational-intent trial for ACR-368 and report initial clinical data from the Phase 1 study of ACR-2316 in the second half of 2025 [14] - Acrivon is also advancing a new cell cycle drug discovery program targeting an undisclosed target towards development candidate nomination in 2025 [14]

Core Insights - Nuvectis Pharma, Inc. has provided final clinical data from the Phase 1b study of NXP800 in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer and is progressing towards the initiation of the Phase 1b program for NXP900 [1][4] Group 1: NXP800 Clinical Data - In the Phase 1b study, 17 patients were treated with NXP800 at a target dose of 75 mg/day, with data available for 13 patients, resulting in 2 partial responses and 3 stable diseases [2][6] - Thrombocytopenia was identified as a key toxicity but was managed effectively by switching to an intermittent dosing schedule [2][6] - The company will not pursue further development of NXP800 in ovarian cancer but will explore its potential in other cancer types such as endometrial and prostate cancers [2][4] Group 2: NXP900 Development - The NXP900 DDI study has been successfully completed, supporting its potential combination with EGFR and ALK inhibitors in non-small cell lung cancer [3][6] - The Phase 1a dose-escalation study for NXP900 evaluated doses from 20 to 300 mg/day, with no dose-limiting toxicity reached, and demonstrated a robust pharmacodynamic response at doses of 150 mg/day and higher [3][6] - The initiation of the Phase 1b study for NXP900 is expected in the coming weeks, aiming to evaluate its safety and efficacy as a single agent and in combination with other anti-cancer agents [3][6] Group 3: Company Strategy and Future Outlook - The CEO of Nuvectis emphasized the decision to focus on advancing NXP900 due to the challenges and resource requirements associated with further developing NXP800 in ovarian cancer [4] - The company believes that NXP800 remains an active agent and will evaluate its feasibility in other cancer types in the coming months [4][6] - Nuvectis Pharma is positioned to leverage the therapeutic potential of NXP900 as it moves forward with its clinical programs [4][5]