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ORIC® Pharmaceuticals Presents Enozertinib Data in NSCLC Patients with HER2 Exon 20 Mutations at the ESMO Asia Congress 2025
Globenewswire· 2025-12-05 06:00
Core Insights - ORIC Pharmaceuticals announced data from a Phase 1b trial of enozertinib (ORIC-114) for treating NSCLC patients with HER2 exon 20 mutations, showing a 35% overall response rate (ORR) and 100% disease control rate (DCR) in the 80 mg cohort [1][8] - The trial included patients with active brain metastases, and the safety profile was manageable with a low discontinuation rate due to treatment-related adverse events (TRAEs) [1][4] - Enrollment for the HER2 exon 20 patient population has been completed, with no further development planned, while the 80 mg dose has been selected for potential Phase 3 development based on preliminary data [6][8] Trial Design and Patient Demographics - The Phase 1b trial evaluated enozertinib in patients with locally advanced or metastatic NSCLC with HER2 exon 20 mutations, allowing for patients with untreated brain metastases [2] - As of the cutoff date, 49 patients were dosed, with 80% having received prior chemotherapy and 35% having undergone HER2 targeted therapy [3] Safety and Efficacy Analysis - Enozertinib was well tolerated, with most TRAEs being Grade 1 or 2, and only 2 patients discontinued treatment due to TRAEs [4] - Tumor responses were noted in both dosing cohorts, with deeper regressions observed in the 80 mg cohort, potentially due to fewer dose reductions [5] Next Steps and Future Development - The company plans to continue enrollment and follow-up in 1L NSCLC patients with EGFR exon 20 and other mutations, with updates expected in mid-2026 [6] - The 80 mg QD oral enozertinib has been selected for potential Phase 3 development based on the trial results [6] Conference Call and Webcast - ORIC will host a conference call and webcast on December 6, 2025, to discuss the trial results and future plans [7]
Tallinna Sadam financial calendar 2026
Globenewswire· 2025-12-05 06:00
Core Points - AS Tallinna Sadam plans to disclose its financial results and hold its annual general meeting according to a specific schedule in 2026 [1] - The company is one of the largest cargo and passenger port complexes in the Baltic Sea region, providing various services including ferry operations and shipping [2] Schedule of Financial Disclosures - The unaudited interim report for 2025 will be released on February 26, 2026 [1] - The audited annual report for 2025 and dividend proposal will be disclosed on April 2, 2026 [1] - The annual general meeting of shareholders is scheduled for April 28, 2026 [1] - Additional interim reports for Q1, Q2, and Q3 of 2026 will be published throughout the year [1] Company Operations - Tallinna Sadam operates ferry services between the Estonian mainland and its largest islands through its subsidiary OÜ TS Laevad [2] - The company also engages in shipping activities via its subsidiary OÜ TS Shipping, which charters the multifunctional vessel Botnica for icebreaking and offshore services [2] - Tallinna Sadam is a shareholder in AS Green Marine, which provides waste management services [2]
Bigben Interactive announces the initiation of discussions with the holders of senior conditionally secured bonds exchangeable into Nacon company shares, maturing on February 19, 2026
Globenewswire· 2025-12-05 06:00
Core Viewpoint - Bigben Interactive is initiating discussions with holders of senior conditionally secured bonds exchangeable into Nacon company shares, maturing on February 19, 2026, to renegotiate the terms of the bonds to maintain operational and financial flexibility [1][6]. Group 1: Bond Details - The company established a bond loan amounting to €87.3 million on February 12, 2021, with a maturity date of February 19, 2026 [2]. - As of the press release date, the outstanding amount of the bonds totals €57.4 million, which is repayable at maturity at 103%, equating to €59.1 million [3]. - After a partial refinancing agreement of €43 million secured on November 24, 2025, the residual unrefinanced balance of the bonds is approximately €16 million [4][5]. Group 2: Strategic Intentions - The company aims to propose a renegotiation of the bond terms to avoid premature cash mobilization that could limit development prospects [6]. - Following discussions, all bondholders may be convened to vote on any amendments to the bond terms in accordance with legal and regulatory provisions [7]. Group 3: Company Overview - Bigben Interactive is a European player in video game publishing and the design and distribution of mobile and gaming accessories, as well as audio-video products, with a goal to be a leader in its markets [8]. - The company is listed on Euronext Paris and has over 1,300 employees [8].
Ipsen provides update on legacy of Henri Beaufour
Globenewswire· 2025-12-05 05:58
Core Viewpoint - Ipsen is undergoing a transfer of shares from Beech Tree to the Alasol Foundation, following the wishes of the late Mr. Henri Beaufour, a board member and representative of the founding family [1][2]. Group 1: Share Transfer Details - Beech Tree is the holding company that owns Mr. Beaufour's stake in Ipsen [2]. - The Alasol Foundation, created by Mr. Beaufour, focuses on promoting education and vocational training for disadvantaged children and young adults [2]. - The share transfer is expected to occur in early 2026, pending regulatory approvals [1]. Group 2: Company Overview - Ipsen is a global biopharmaceutical company specializing in transformative medicines across three therapeutic areas: Oncology, Rare Disease, and Neuroscience [3]. - The company has nearly 100 years of development experience and operates global hubs in the U.S., France, and the U.K., with teams in over 40 countries [3]. - Ipsen's medicines reach patients in more than 100 countries, supported by both internal and external innovation [3]. Group 3: Stock Information - Ipsen is listed on Euronext Paris under the ticker IPN and has a Sponsored Level I American Depositary Receipt program in the U.S. under the ticker IPSEY [4].
Symbotic Announces Pricing of Primary and Secondary Offering of Class A Common Stock
Globenewswire· 2025-12-05 03:05
Core Points - Symbotic Inc. has announced a public offering of 10,000,000 shares of its Class A common stock at a price of $55.00 per share, with 6,500,000 shares sold by the company and 3,500,000 shares sold by SoftBank's affiliate [1] - The offering is expected to close on December 8, 2025, subject to customary closing conditions [2] - The net proceeds from the offering will be used for general corporate purposes, while the selling securityholder will receive all net proceeds from their shares sold [2] Company Overview - Symbotic is a leader in automation technology, focusing on A.I.-powered robotics and software for supply chain management [7] - The company aims to transform warehouses into strategic assets for major retail, wholesale, and food & beverage companies, enhancing speed, agility, accuracy, and efficiency in goods movement [7]
Protara Announces Pricing of $75 Million Public Offering
Globenewswire· 2025-12-05 03:03
Core Viewpoint - Protara Therapeutics, Inc. has announced a public offering of 13,043,479 shares of common stock priced at $5.75 per share, aiming to raise approximately $75 million for clinical development and other corporate purposes [1]. Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 1,956,521 shares at the public offering price [1]. - The offering is expected to close on December 8, 2025, pending customary closing conditions [1]. - Protara intends to use the net proceeds for the clinical development of TARA-002 and other clinical programs, as well as for working capital and general corporate purposes [1]. Group 2: Underwriters and Management - J.P. Morgan, TD Cowen, and Piper Sandler are acting as joint book-running managers for the offering [2]. - LifeSci Capital is serving as the lead manager, while H.C. Wainwright & Co. is acting as a manager of the offering [2]. Group 3: Regulatory Information - The shares will be issued under an effective shelf registration statement on Form S-3, declared effective on November 14, 2023, by the U.S. Securities and Exchange Commission [3]. - A final prospectus supplement will be filed with the SEC and will be available on their website [3].
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]