The analyses of progression-free survival (PFS) and overall survival (OS) remain on track for late Q1 2026 in the ongoing Phase 2/3 COMPANION-002 study of tovecimig (DLL4 x VEGF-A bispecific antibody) in patients with advanced biliary tract cancer (BTC).In the ongoing Phase 1 dose-escalation study of CTX-8371 (PD-1 x PD-L1 bispecific antibody), a previously reported third response has now been confirmed in a patient with Hodgkin Lymphoma (HL). CTX-8371 has demonstrated responses in patients with both solid ...

Acquisition Overview - Johnson & Johnson (J&J) has completed the acquisition of Halda Therapeutics for $3.05 billion in cash, enhancing J&J's oncology portfolio with Halda's Regulated Induced Proximity Targeting Chimera (RIPTAC) platform [1][2] Product Pipeline - The acquisition includes HLD-0915, a clinical-stage, once-daily oral therapy for prostate cancer, which utilizes the RIPTAC platform for precision targeting of cancer cells [2] - The deal also adds early-stage candidates for breast, lung, and other tumor types to J&J's pipeline, leveraging RIPTAC technology [2] Financial Impact - J&J anticipates earnings dilution in the fourth quarter of 2025 and into 2026, with an expected total impact on adjusted earnings per share of around $0.20, split equally between the two years [3] Strategic Vision - J&J's innovative medicine worldwide chairman emphasized the strategic importance of this acquisition in redefining cancer treatment and expressed excitement about the collaboration with Halda's team [4] - The focus will be on advancing the potential of the new pipeline and utilizing the RIPTAC platform to discover additional oncology molecules [4]

Key Takeaways PCSA surged 122.3% after a phase II update from its NGC-Cap breast cancer study.Processa Pharmaceuticals reported higher exposure to cancer-killing metabolites versus Xeloda monotherapy.PCSA said tolerability was comparable, with far lower FBAL exposure and only mild side effects.Shares of Processa Pharmaceuticals (PCSA) surged 122.3% on Wednesday after the company provided an encouraging clinical update on its ongoing mid-stage study evaluating its investigational candidate NGC-Cap in patient ...

Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) stock is skyrocketing on Wednesday, with a session volume of 2.73 million compared to the average volume of 389.09 thousand, as per data from Benzinga Pro.Processa Pharmaceuticals on Wednesday provided a clinical update on its ongoing Phase 2 study of NGC-Cap, the combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer.Data from the first 16 of 19 patients enrolled indicate that NGC-Cap significantly increases expo ...

2025 R&D Update and ASH Data Review December 11, 2025 © Genmab 2025 This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans ...

- Data reflect new insights and precision oncology advancements in portfolio and pipeline - - Cohort results from Phase 2 ILUSTRO study evaluating a zolbetuximab triplet combination regimen in first- line advanced gastric and gastroesophageal junction (GEJ) cancer featured in late-breaking oral presentation - TOKYO, Dec. 10, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced it will present data on potential treatments for pancreatic and gastr ...

Core Insights - Aprea Therapeutics, Inc. has entered into a securities purchase agreement to sell 2,623,023 shares of common stock and warrants to purchase an equal number of shares, raising approximately $3.1 million before expenses [2][3] Financing Details - The offering price for each share and accompanying warrant is set at $1.165, with warrants having an exercise price of $1.04 per share, exercisable immediately and expiring five years from the registration statement effectiveness date [2][3] - The gross proceeds from the offering are intended for general corporate purposes and research and development expenses, extending the company's cash runway into Q1 2027 [3] Company Overview - Aprea Therapeutics is focused on developing innovative cancer treatments that target specific vulnerabilities in cancer cells while minimizing harm to healthy cells, with applications across various cancer types including ovarian, endometrial, colorectal, prostate, and breast cancers [7] - The company's lead programs include APR-1051, an oral small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both in clinical development for solid tumor indications [8]

Core Viewpoint - Ascentage Pharma presented four-year follow-up data for Olverembatinib, demonstrating its long-term efficacy and safety in treating TKI-resistant/intolerant chronic-phase chronic myeloid leukemia (CML-CP) at the 67th ASH Annual Meeting [1][2][3] Group 1: Efficacy Results - Olverembatinib showed a median event-free survival (EFS) of 21.2 months compared to 2.9 months for the best available therapy (BAT) in patients with TKI-resistant/intolerant CML-CP [3][12] - For patients without the T315I mutation, Olverembatinib achieved an EFS of 11.9 months versus 3.1 months for BAT [3][12] - The complete hematologic response (CHR) rates were 85% for Olverembatinib compared to 35% for BAT, while complete cytogenetic response (CCyR) rates were 38% versus 19% [12] Group 2: Safety Profile - The safety profile of Olverembatinib was favorable, with a vascular occlusion incidence of 7% among patients [3][11] - No new safety signals were reported, and the study included patients with and without the T315I mutation [11] Group 3: Regulatory and Commercialization Status - Olverembatinib is the first third-generation BCR-ABL1 inhibitor approved in China for specific CML indications, and it is included in the China National Reimbursement Drug List (NRDL) [4][15] - Ascentage Pharma is conducting three global registrational Phase III studies for Olverembatinib in various indications, including newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and gastrointestinal stromal tumors (GIST) [4][15] Group 4: Clinical Significance - The data presented at ASH 2025 reinforces Olverembatinib's role in clinical practice for long-term treatment of CML-CP, providing confidence to physicians and patients [5][11] - The study's findings highlight the need for effective treatment options for patients resistant to or intolerant of first- and second-generation TKIs [8][12]

Core Viewpoint - Ascentage Pharma has presented promising updated data on Olverembatinib, a novel drug for second-line treatment of chronic myeloid leukemia (CML) at the 67th American Society of Hematology (ASH) Annual Meeting, indicating its potential as a safe and effective treatment option for patients resistant to prior therapies [1][3][5]. Group 1: Efficacy and Safety Data - Olverembatinib demonstrated a complete cytogenetic response (CCyR) rate of 71.8% and a major molecular response (MMR) rate of 43.6% in patients with CML resistant/intolerant to one prior line of tyrosine kinase inhibitors (TKIs) without the T315I mutation [3][12]. - In patients who failed first-line treatment with second-generation TKIs, the CCyR rate was 76.7% and the MMR rate was 43.3% [3][12]. - The safety profile of Olverembatinib was consistent with previous reports, with no new safety signals identified [3][10]. Group 2: Clinical Study Details - The study was an open-label, single-arm, multicenter clinical trial evaluating Olverembatinib at 40 mg every other day in Chinese patients with CP-CML resistant/intolerant to one prior line of TKIs [8]. - As of July 24, 2025, 47 patients were enrolled, with 39 patients receiving at least one efficacy evaluation [8][12]. - The median treatment duration was 16.0 cycles, with 89.4% of patients experiencing treatment-related adverse events [10]. Group 3: Regulatory and Commercialization Aspects - Olverembatinib is the first third-generation BCR-ABL inhibitor approved in China, currently commercialized in partnership with Innovent Biologics [4][14]. - The drug is approved for adult patients with TKI-resistant CML-CP or accelerated-phase CML harboring the T315I mutation, and is included in the China National Reimbursement Drug List [4][14]. - Ascentage Pharma is conducting three global registrational Phase III studies for Olverembatinib in multiple indications, including CML-CP and newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia [4][14].

REDWOOD CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Coherus Oncology, Inc. (NASDAQ: CHRS) today announced compelling six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI® (toripalimab-tpzi) plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). The findings reveal a striking and durable survival advantage that underscores the urgent clinical need to incorporate LOQTORZI with chemotherapy as first-line treatment. In this explorato ...