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ORIC® Pharmaceuticals Presents Potential Best-in-Class Profile for Enozertinib with Robust Systemic and CNS Activity in 1L and Previously Treated NSCLC Patients with EGFR Atypical Mutations at the ESMO Asia Congress 2025
Globenewswire· 2025-12-05 02:45
Core Insights - Enozertinib (ORIC-114) shows promising preliminary systemic activity with an 80% overall response rate (ORR) and a 100% intracranial ORR in first-line (1L) NSCLC patients with EGFR P-loop and alpha C-helix compressing (PACC) mutations [1][8] - The drug demonstrates a competitive safety profile with manageable on-target toxicity and no significant off-target toxicity, leading to a low discontinuation rate [1][5] - The company plans to continue enrollment and follow-up in 1L EGFR PACC patients, with the next update expected in mid-2026 ahead of a potential Phase 3 trial [1][9] Efficacy and Safety Data - In a Phase 1b trial, enozertinib was evaluated in patients with locally advanced or metastatic NSCLC with EGFR atypical mutations, allowing for patients with active untreated brain metastases [3] - As of the August 29, 2025 cutoff, 47 patients were dosed, with 36% confirmed ORR and 91% disease control rate (DCR) in previously treated patients with EGFR atypical mutations [4][7] - The most common treatment-related adverse events (TRAEs) were Grade 1 or 2, including diarrhea, paronychia, and stomatitis, with no treatment discontinuations due to TRAEs [5] Future Development Plans - The 80 mg once daily dose of enozertinib has been selected for potential Phase 3 development based on preliminary data [9] - The company will host a conference call and webcast on December 6, 2025, to discuss the findings and future plans [10] Company Overview - ORIC Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing treatments that address mechanisms of therapeutic resistance in cancer [11] - The company is also developing ORIC-944, an allosteric inhibitor for prostate cancer, alongside enozertinib for multiple genetically defined cancers [11]
Transcenta Therapeutics Presents Updated Efficacy Data from the Phase I/II Transtar102 Trial of Osemitamab plus Nivolumab and CAPOX in First-Line G/GEJ Cancer at ESMO Asia
Globenewswire· 2025-12-05 01:00
Core Insights - The updated efficacy analysis of osemitamab in combination with nivolumab and CAPOX shows promising results in patients with advanced gastric/gastroesophageal junction cancer, particularly those with higher CLDN18.2 expression [1][2][4] Efficacy Analysis - In a cohort of 26 patients with CLDN18.2 expression ≥40%, the median progression-free survival (PFS) was 16.6 months, with an overall response rate (ORR) of 68% and a median duration of response (DoR) of 18 months at a median follow-up of 25.8 months [2] - Better PFS outcomes were observed in patients with higher CLDN18.2 expression compared to lower expressors, indicating consistent treatment benefits across different PD-L1 expression subgroups [2] Safety Profile - The safety profile of the osemitamab combination regimen is consistent with previous presentations, indicating it is well tolerated [3] Expert Commentary - Clinical experts highlight the significance of the consistent benefits across PD-L1 subgroups, suggesting that the osemitamab regimen may provide meaningful improvements for a broad patient population with advanced G/GEJ cancer [4] - The ongoing strength of clinical signals reinforces the potential of osemitamab to offer effective treatment options for patients [4] Product Information - Osemitamab is a high-affinity humanized anti-CLDN18.2 monoclonal antibody that exhibits enhanced antibody-dependent cellular cytotoxicity (ADCC) and has shown potent anti-tumor activities in preclinical models [5] - It has received Orphan Drug Designation in the U.S. for treating gastric or gastroesophageal junction and pancreatic cancer [5] Company Overview - Transcenta Therapeutics is a clinical-stage biopharmaceutical company focused on antibody-based therapeutics, with integrated capabilities in discovery, research, development, and manufacturing [6][7] - The company has established a global presence with facilities in Suzhou and Hangzhou, and clinical development centers in China, the U.S., and Europe [7]
CEA Industries (Nasdaq: BNC) Responds to YZi Labs, Re-Affirms Commitment to BNB DAT Strategy, and Welcomes Shareholder Engagement
Globenewswire· 2025-12-05 00:56
Core Viewpoint - CEA Industries Inc. reaffirms its commitment to becoming the world's largest BNB treasury company amidst shareholder communications and proposals for board changes [2][3][5]. Group 1: Company Commitment and Strategy - The company holds 515,554 BNB tokens, valued at approximately $464.6 million based on a price of $901.27 per BNB as of December 4, 2025 [4]. - CEA Industries has not considered alternative tokens for its digital asset treasury strategy since the July PIPE investment [4]. - The company values its relationship with YZILabs Management Ltd. as a significant shareholder and strategic partner, and is open to constructive discussions regarding shareholder concerns [6]. Group 2: Board Composition and Changes - The current board consists of a majority of independent directors, complying with Nasdaq rules, and has recently strengthened by appointing Annemarie Tierney and Carly E. Howard as independent directors [5]. - The company is engaging in discussions with YZi to address concerns and explore potential solutions to enhance shareholder value [6]. Group 3: Shareholder Communication - Shareholders are advised that no action is required from them at this time [1][7]. - The company intends to file a consent revocation statement in response to YZi's consent solicitation [11].
Miata Metals Announces Filing of Final Short Form Prospectus – Accessible on SEDAR+
Globenewswire· 2025-12-05 00:19
Core Points - Miata Metals Corp. has filed a final short form prospectus for a public offering of common shares at $0.48 per share, aiming for gross proceeds of up to $10,000,080 [1] - The offering is being managed by a syndicate of agents led by Cormark Securities Inc., with an option to sell an additional 3,125,000 shares, potentially raising total gross proceeds to $11,500,080 if fully exercised [2] - The closing of the offering is expected around December 8, 2025, pending regulatory approval [4] Company Overview - Miata Metals Corp. is a Canadian mineral exploration company listed on the Canadian Securities Exchange, OTCQB, and Frankfurt Exchanges, focusing on the acquisition, exploration, and development of mineral properties [6] - The company holds a 70% interest in the Sela Creek Gold Project and a 70% beneficial interest in the Nassau Gold Project, both located in Suriname's greenstone belt [6]
Ascentage Pharma Announces Global Registrational Phase III Study of Olverembatinib in First-Line Treatment of Ph+ ALL Cleared by US FDA and EMA
Globenewswire· 2025-12-05 00:00
Core Viewpoint - Ascentage Pharma has received regulatory clearance from the US FDA and EMA to conduct a global Phase III study of olverembatinib for treating newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), marking a significant advancement in its clinical development efforts [1][3]. Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer, with a strong pipeline that includes third-generation kinase inhibitors and Bcl-2 inhibitors [6][7]. Clinical Development - The POLARIS-1 trial is a global, multicenter, randomized controlled Phase III study aimed at evaluating the efficacy and safety of olverembatinib in combination with chemotherapy for newly diagnosed Ph+ ALL patients [2][3]. - The trial is designed to accelerate the registration process for olverembatinib, particularly in the US and European markets, with simultaneous patient enrollment across multiple countries [1][2]. Efficacy and Safety Data - Preliminary data from the POLARIS-1 study indicates that approximately 65% of treatment-naïve Ph+ ALL patients achieved minimal residual disease (MRD) negativity and molecular MRD-negative complete response (CR) after three treatment cycles, significantly outperforming other drugs in the same class [3]. - The combination therapy demonstrated a favorable safety profile, with a low incidence of manageable adverse events [3]. Market Context - Ph+ ALL accounts for 20%-30% of all adult acute lymphoblastic leukemia cases and is associated with high relapse rates and poor prognosis, particularly in elderly patients [3]. - Prior to the introduction of tyrosine kinase inhibitors (TKIs), the five-year overall survival rate for Ph+ ALL was less than 20%, highlighting the need for improved treatment options [3]. Strategic Partnerships - Ascentage Pharma has signed an exclusive option agreement with Takeda for olverembatinib, which could lead to Takeda licensing global rights for the drug outside of certain regions, enhancing its commercial potential [4].
FormFactor Announces Participation in 14th Annual NYC Summit
Globenewswire· 2025-12-05 00:00
Core Points - FormFactor, Inc. will participate in the 14th Annual NYC Summit investor conference on December 16, 2025, at Mastro's Steakhouse in New York [1] - The NYC Summit features a "round-robin" format allowing investors and analysts to engage with management teams from 15 participating companies [2][3] - Attendance is by invitation only, limited to accredited investors and publishing research analysts, with a registration deadline of December 10, 2025 [4] Company Overview - FormFactor, Inc. is a leading provider of test and measurement technologies throughout the integrated circuit (IC) life cycle, supporting semiconductor companies in optimizing device performance and yield knowledge [5]
North American Niobium and Critical Minerals Corp. Announces Private Placement of Flow-Through Shares
Globenewswire· 2025-12-04 23:49
Core Viewpoint - North America Niobium and Critical Minerals Corp. is initiating a non-brokered private placement to raise up to $1,000,000 through the issuance of flow-through common shares at a price of $1.45 per share, aimed at advancing exploration programs in Quebec [1][5]. Group 1: Offering Details - The company plans to issue up to 689,655 flow-through common shares at $1.45 each, with gross proceeds expected to reach $1,000,000 [1]. - Finders' fees of up to 7.0% of the gross proceeds will be paid to eligible finders, along with non-transferable finders' warrants equivalent to 7.0% of the FT Shares sold [2]. - The proceeds will be allocated to eligible Canadian exploration expenses in Quebec, specifically for flow-through critical mineral mining expenditures, with a commitment to incur these expenses by December 31, 2026 [3]. Group 2: Regulatory and Closing Conditions - The closing of the offering is contingent upon receiving necessary corporate and regulatory approvals, including from the Canadian Securities Exchange (CSE) [4]. - All securities issued will be subject to a statutory hold period of four months plus a day from the issuance date [4]. Group 3: Company Overview - North American Niobium and Critical Minerals Corp. focuses on the acquisition and development of precious, base, and critical mineral assets, with properties in British Columbia and Quebec [6]. - The Quebec properties enhance the company's exposure to rare earth elements, niobium, and nickel-copper occurrences, which are vital for energy and defense applications [6].
Mawson Shareholders Approve Arrangement with First Nordic Metals Corp.
Globenewswire· 2025-12-04 23:18
Core Viewpoint - Mawson Finland Limited has received overwhelming shareholder approval for its business combination with First Nordic Metals Corp, which involves the acquisition of all common shares of Mawson by First Nordic through a statutory plan of arrangement [1][2]. Group 1: Shareholder Approval - A total of 11,568,435 common shares were voted at the special meeting, representing 52.09% of the issued and outstanding shares, with 100% voting in favor of the arrangement [2]. Group 2: Arrangement Details - The arrangement will exchange all issued and outstanding common shares of Mawson for 1.7884 First Nordic common shares after a 4:1 consolidation of First Nordic's shares, or 7.1534 on a pre-consolidation basis for each Mawson share [4]. - Following the completion of the arrangement, Mawson will become a wholly-owned subsidiary of First Nordic [4]. Group 3: Next Steps - The arrangement is subject to final approval by the Ontario Superior Court of Justice, with a hearing scheduled for December 8, 2025, and the closing is expected around December 16, 2025 [3]. Group 4: Company Background - Mawson Finland Limited is focused on the acquisition and exploration of precious and base metal properties in Finland, primarily gold and cobalt, holding a 100% interest in the Rajapalot Gold-Cobalt Project [6].
Grupo Aeroportuario del Pacifico Reports a Passenger Traffic Decrease in November 2025 of 2.0% Compared to 2024
Globenewswire· 2025-12-04 23:15
GUADALAJARA, Mexico, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Grupo Aeroportuario del Pacífico, S.A.B. de C.V., (NYSE: PAC; BMV: GAP) (“the Company” or “GAP”) announces preliminary terminal passenger traffic figures for November 2025, compared with November 2024. During this period, the total number of terminal passengers at GAP’s 12 Mexican airports increased by 3.5%, compared to November 2024. Guadalajara and Puerto Vallarta airports presented an increase in passenger traffic of 6.7% and 4.5%, respectively, whil ...
Optiva Receives Final Order Approving Arrangement with Qvantel
Globenewswire· 2025-12-04 23:05
TORONTO, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Optiva Inc. (TSX: OPT) ("Optiva") today announced the receipt of the final order of the Ontario Superior Court of Justice (Commercial List) dated December 2, 2025, (the "Final Order") with respect to the previously-announced plan of arrangement transaction (the "Arrangement") involving Qvantel Oy (the "Purchaser"). The Final Order was the final substantive court approval required prior to closing of the Arrangement, which is anticipated to occur before the end of t ...