Antibody - drug conjugates (ADCs)
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Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference
Businesswire· 2026-01-15 00:40
Core Insights - Samsung Epis Holdings is entering a significant phase in 2026, announcing six new candidates in its biosimilar pipeline, aiming for a total of 20 biosimilars by 2030 [1][4] - The company has received IND clearance for its first novel therapeutic candidate, SBE303, and plans to advance its clinical program this year [1][4] - Samsung Bioepis is expanding its portfolio beyond biosimilars, focusing on antibody-drug conjugates (ADCs) to address unmet medical needs [1][4] Biosimilar Pipeline - Samsung Bioepis currently has 11 biosimilars approved and launched in over 40 countries, covering 10 unique biological molecules [4] - The new biosimilar candidates include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab [4][6] - The company has launched several biosimilars, including adalimumab (Humira), etanercept (Enbrel), infliximab (Remicade), trastuzumab (Herceptin), and bevacizumab (Avastin) [3][5] Novel Therapeutics Development - SBE303 is Samsung Bioepis' first novel ADC targeting Nectin-4, with a Phase 1 clinical trial set to begin this year [4] - The company aims to introduce one novel therapeutic candidate into clinical studies each year [4] - Epis NexLab, a new subsidiary, is focused on developing a peptide-based drug delivery platform [4][9] Company Overview - Samsung Epis Holdings is dedicated to biopharmaceuticals and biotechnology, aiming to maximize corporate and shareholder value through R&D and strategic investments [7] - Samsung Bioepis, established in 2012, focuses on making healthcare accessible through innovative product development across various therapeutic areas [8] - Epis NexLab, established in 2025, is committed to driving innovation in next-generation biotechnology platforms [9]
GlycoMimetics(GLYC) - Prospectus
2026-01-07 22:08
As filed with the U.S. Securities and Exchange Commission on January 7, 2026. THE SECURITIES ACT OF 1933 Crescent Biopharma, Inc. (Exact name of registrant as specified in its charter) Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Cayman Islands 2834 06-1686563 (I.R.S. Employer Identification No.) 300 Fif ...
ABL Bio Receives Upfront Payment for License, Research and Collaboration Agreement for Grabody Platform and Equity Investment from Lilly
BusinessLine· 2025-12-26 08:37
Core Insights - ABL Bio has entered into a collaboration agreement with Eli Lilly, which includes a USD 40 million upfront payment and a USD 15 million equity investment [1][3] Group 1: Collaboration and Funding - ABL Bio and Eli Lilly are conducting joint research and development on multiple therapeutic candidates utilizing the Grabody platform [2] - The newly secured funding will be used to accelerate R&D on ABL Bio's core technologies, including bispecific antibodies and dual-payload ADCs [2][3] - ABL Bio aims to expand the indications of its Grabody platform into areas with high unmet needs, such as obesity and muscle disorders [3] Group 2: Clinical Development and Pipeline - ABL Bio is developing various clinical and non-clinical assets based on the Grabody platform, with 8 pipelines currently in clinical projects across multiple countries [4] - ABL301 (SAR446159) has completed Phase 1 clinical trials, with Sanofi set to conduct subsequent studies [4] - ABL001 (tovecimig) has received Fast Track designation from the FDA, and ABL111 (givastomig) has shown promising results in a Phase 1b trial [4]
Here's How AbbVie's Oncology Drugs are Aiding Top-line Growth
ZACKS· 2025-12-11 13:51
Core Insights - AbbVie is significantly expanding its oncology presence, moving from a two-drug franchise to include solid tumors, with new drugs like Epkinly, Elahere, and Emrelis contributing to over 11% of total revenues in the first nine months of 2025, reflecting a 3% year-over-year growth [1][9] Expansion Strategies - The expansion is driven by both organic and inorganic strategies, with Emrelis being AbbVie's first internally developed solid tumor drug, while Epkinly and Elahere were acquired through collaborations [2] - Sales from newer drugs and rising Venclexta sales have offset the decline in Imbruvica sales due to competition from novel therapies [2] Pipeline Development - AbbVie has a diverse pipeline of new therapies for blood cancers and solid tumors, including antibody-drug conjugates (ADCs), which are seen as a disruptive innovation in cancer treatment [3] - A regulatory filing for the ADC therapy pivekimab sunirine is under FDA review for treating a rare blood cancer, which could add a third ADC to AbbVie's portfolio [4] - The company is also developing Temab-A for metastatic colorectal cancer and other cancers in various stages of clinical trials [4][5] Competitive Landscape - Major competitors in the oncology space include AstraZeneca, Merck, and Pfizer, with AstraZeneca's oncology sales accounting for 43% of total revenues and growing 16% year-over-year [6] - Merck's Keytruda accounted for about 48% of its total revenues, while Pfizer's oncology revenues grew 7%, making up over 27% of its total revenues [7] Financial Performance - AbbVie shares have outperformed the industry year to date, trading at a slight discount with a P/E ratio of 15.87 compared to the industry average of 16.31 [8][11] - EPS estimates for 2025 and 2026 have declined in the past 60 days, indicating potential challenges ahead [13]
Crescent Biopharma (:) Earnings Call Presentation
2025-12-04 13:00
SEIZE THE MOMENT for a brighter future CRESCENT BIOPHARMA STRATEGIC PARTNERSHIP & PIPELINE UPDATE DECEMBER 4, 2025 NASDAQ: CBIO Disclaimers 2 Program Forward-Looking Statements Certain statements in this presentation, other than purely historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws, including for purposes of the "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, ...
Mersana Therapeutics to Host Third Quarter 2025 Conference Call on November 14, 2025
Globenewswire· 2025-11-10 13:00
Company Overview - Mersana Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing antibody-drug conjugates (ADCs) targeting cancers with high unmet medical needs [3] - The company has proprietary ADC platforms, including Dolasynthen and Immunosynthen, which have led to a pipeline of product candidates aimed at treating various cancers [3] Upcoming Financial Results - Mersana Therapeutics will provide business updates and report its financial results for the third quarter ended September 30, 2025, on November 14, 2025 [1] - A conference call and webcast will be held at 8:00 a.m. Eastern Time on the same day [1] Accessing the Conference Call - Investors can access the conference call by dialing 833-255-2826 for domestic calls or 412-317-0689 for international calls [2] - A live webcast will be available on the company's website, with a replay accessible for approximately 90 days following the call [2]
CelLBxHealth PLC Presents Proof-of-Concept Study
Accessnewswire· 2025-11-05 07:00
Core Insights - CelLBxHealth presented a proof-of-concept study utilizing Roche Tissue Diagnostics' workflow at the 16th World ADC conference, highlighting its advancements in circulating tumor cell (CTC) intelligence [1] Company Summary - CelLBxHealth is recognized as a global leader in circulating tumor cell intelligence, showcasing its innovative capabilities in cancer diagnostics [1] - The company demonstrated the compatibility of its Parsortix platform with the Roche BenchMark ULTRA automated staining system, indicating potential for enhanced diagnostic workflows [1] Industry Context - The World ADC conference is noted as the largest global event dedicated to antibody-drug conjugates (ADCs), with over 1,400 attendees focused on advancing targeted cancer therapies, underscoring the significance of the event in the oncology field [1] - The study focused on three key drug targets: HER2 (breast cancer), TROP2 (lung cancer), and PSMA (prostate cancer), which are critical areas of research in targeted cancer therapies [1]
Akari Therapeutics Announces Abstract Accepted for Oral Presentation at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting
Globenewswire· 2025-10-03 13:30
Core Insights - Akari Therapeutics, Plc is an oncology biotechnology company focused on developing novel payload antibody drug conjugates (ADCs) [1][2] - The company’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and utilizes a proprietary linker to deliver a novel spliceosome modulator payload, PH1, designed to disrupt RNA splicing [2] - AKTX-101 has shown significant preclinical activity, inducing cancer cell death and activating immune cells, with potential synergy with checkpoint inhibitors [2] Presentation Details - Akari Therapeutics will present an abstract at the 40th Annual SITC Meeting, scheduled for November 5-9, 2025 [1] - The presentation titled "A Novel Splicing-Targeted ADC Payload Drives Immune Activation, Synergy with Checkpoint Inhibitors, and Enhanced Therapeutic Potential beyond Cytotoxicity" will be delivered by Dr. Satyajit Mitra [1] - The oral presentation is set for November 9, 2025, at 11:05 AM ET, with a poster presentation on November 7, 2025 [1]
IDEAYA Biosciences Announces First-Patient-In for Phase 1/2 Combination Trial of IDE397, A Potential First-in-Class MAT2A Inhibitor, and Trodelvy® in MTAP-Deletion Non-Small Cell Lung Cancer
Prnewswire· 2025-09-04 10:00
Core Insights - IDEAYA Biosciences has enrolled its first patient with non-small cell lung cancer (NSCLC) in a Phase 1/2 combination trial of IDE397 and Trodelvy, focusing on patients with methylthioadenosine phosphorylase (MTAP)-deletion solid tumors [1][2] - The collaboration with Gilead Sciences aims to explore the potential of this combination therapy across multiple solid tumors with MTAP-deletion, an area currently lacking approved targeted therapies [3][4] Company Overview - IDEAYA is a precision medicine oncology company dedicated to developing transformative cancer therapies, utilizing expertise in small-molecule drug discovery and bioinformatics to create targeted therapies aligned with genetic disease drivers [7] - The company has a robust pipeline focused on synthetic lethality and antibody-drug conjugates (ADCs) for molecularly defined solid tumor indications, aiming to improve clinical outcomes for cancer patients [7] Product Information - Trodelvy is currently approved in over 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 40 countries for certain pre-treated HR+/HER2-metastatic breast cancer patients [5] - The use of Trodelvy in MTAP-deletion NSCLC and urothelial cancer (UC) is investigational, with safety and efficacy yet to be established [6]
ABBV's Improving Oncology Sales Poise It Well for Long-Term Growth
ZACKS· 2025-08-22 13:46
Core Insights - AbbVie has a strong immunology franchise with blockbuster drugs and has also developed a substantial oncology franchise with key products like Imbruvica and Venclexta [1] Oncology Franchise Development - AbbVie and Genmab's Epkinly was approved for relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma, while Emrelis was approved for non-squamous non-small cell lung cancer [2] - The acquisition of Immunogen added Elahere to AbbVie's oncology portfolio, contributing to double-digit revenue growth for Elahere and Epkinly in the first half of 2025 [2] - AbbVie's oncology segment generated $3.3 billion in revenue in the first half of 2025, a 4.2% increase year over year, driven by Venclexta and new drugs [3] Innovation in Oncology - AbbVie is enhancing its oncology portfolio with antibody-drug conjugates (ADCs), which are seen as a disruptive innovation in cancer treatment [4] - The company has two ADCs in its commercial portfolio and two additional next-generation ADCs in late-stage development, along with others in early-stage development [4] Pipeline and Growth Potential - A key candidate in AbbVie's oncology pipeline is etentamig/ABBV-383, targeting relapsed/refractory multiple myeloma [5] - Despite competitive pressure on Imbruvica, AbbVie's oncology business is well-positioned for growth in the coming years [5] Competitive Landscape - Major competitors in the oncology space include AstraZeneca, Merck, Bristol-Myers, and Pfizer, with AstraZeneca's oncology sales comprising around 43% of total revenues and growing 16% in the first half of 2025 [6] - Merck's Keytruda accounts for about 50% of its pharmaceutical sales, with a 6.6% sales increase to $15.1 billion in the first half of 2025 [7] - Pfizer's oncology revenues grew 9% in the first half of 2025, driven by various drugs, while AbbVie's oncology revenues rose 4.2% to $3.3 billion [8] Financial Performance and Valuation - AbbVie's stock has increased by 21.2% this year, outperforming the industry [10] - The company's shares trade at a price/earnings ratio of 15.54, higher than the industry average of 14.64 [13] - The Zacks Consensus Estimate for 2025 earnings has slightly decreased to $12.02 per share, while the estimate for 2026 has increased to $14.31 per share [16]