Workflow
Oncology
icon
Search documents
Why Is AbbVie Stock Trading Higher On Thursday?
Benzinga· 2025-07-10 18:36
Core Insights - IGI Therapeutics SA and AbbVie Inc. have entered into an exclusive licensing agreement for IGI's investigational asset ISB 2001, aimed at oncology and autoimmune diseases [1][2] - AbbVie will have exclusive rights to develop, manufacture, and commercialize ISB 2001 in North America, Europe, Japan, and Greater China [2] Financial Terms - IGI will receive an upfront payment of $700 million and is eligible for up to $1.225 billion in milestone payments, along with tiered, double-digit royalties on net sales [3] - The total potential financial benefit for IGI from this agreement could reach $1.925 billion [3] Product Details - ISB 2001 is a first-in-class trispecific T-cell engager targeting BCMA and CD38 on myeloma cells and CD3 on T cells, currently in Phase 1 for relapsed/refractory multiple myeloma [3] - Recent data from a study presented at the 2025 ASCO Annual Meeting showed a sustained overall response rate (ORR) of 79% and a complete/stringent complete response (CR/sCR) rate of 30% in heavily pretreated relapsed/refractory myeloma patients [4] Regulatory Status - The U.S. FDA granted ISB 2001 Orphan Drug Designation in July 2023 and Fast Track Designation for relapsed/refractory myeloma patients in May 2025 [5] Market Context - Other companies in the industry are also pursuing significant partnerships, such as AstraZeneca's reported talks with Summit Therapeutics for a $15 billion deal and BioNTech's agreement with Bristol Myers Squibb involving $1.5 billion upfront [5][6] - AbbVie’s stock price increased by 2.63% to $195.63 following the announcement [7]
Ichnos Glenmark Innovation (IGI) and AbbVie Announce Exclusive Global Licensing Agreement for ISB 2001, a First-in-Class CD38×BCMA×CD3 Trispecific Antibody
GlobeNewswire News Room· 2025-07-10 11:35
Core Viewpoint - IGI Therapeutics and AbbVie have entered into an exclusive licensing agreement for ISB 2001, a novel trispecific T-cell engager targeting multiple myeloma, which is currently in Phase 1 clinical trials [1][2]. Company Overview - IGI Therapeutics is a clinical-stage biotechnology company focused on developing innovative biologics in oncology, utilizing its proprietary BEAT® technology platform to create first-in-class multispecific therapies [7]. - AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines across various therapeutic areas, including oncology [8]. Product Details - ISB 2001 is designed to target BCMA and CD38 on myeloma cells and CD3 on T cells, aiming to improve safety and efficacy compared to first-generation bispecific antibodies [3]. - The drug has shown a sustained overall response rate (ORR) of 79% and a complete/stringent complete response (CR/sCR) rate of 30% in a heavily pretreated patient population [3]. Licensing Agreement - Under the agreement, AbbVie will have exclusive rights to develop, manufacture, and commercialize ISB 2001 in North America, Europe, Japan, and Greater China [2]. - IGI will receive an upfront payment of $700 million and could earn up to $1.225 billion in milestone payments, along with tiered, double-digit royalties on net sales [2]. Regulatory Designations - ISB 2001 received Orphan Drug Designation from the U.S. FDA in July 2023 and Fast Track Designation for treating relapsed/refractory myeloma patients in May 2025 [4]. BEAT® Platform - The BEAT® platform enables the development of next-generation immune cell engagers with enhanced stability and function, addressing limitations of traditional bispecific antibody production [5]. - Key features include multispecific versatility, optimized engineering for precise modulation, and robust manufacturability [5].
Will Recent Label Expansions of Opdivo Help BMY Gain Momentum?
ZACKS· 2025-07-09 14:20
Key Takeaways Opdivo led BMY's Q1 sales at $2.26B, driven by strong demand across multiple cancer indications. EC and FDA approvals expand Opdivo's use in NSCLC, HCC, and colorectal cancer treatment regimens. BMY trades at 7.37x forward earnings amid generic threats and lagging shares, down 13.9% year to date.Bristol Myers’ (BMY) growth portfolio primarily comprises Opdivo, Orencia, Yervoy, Reblozyl, Opdualag, Abecma, Zeposia, Breyanzi, Camzyos, Sotyku, Krazati and others.Among these, immuno-oncology drug ...
AstraZeneca Boasts Strong Oncology Portfolio: Can It Sustain Growth?
ZACKS· 2025-07-08 15:46
Key Takeaways AZN's oncology sales hit $5.6B in Q1 2025, up 13%, led by drugs like Tagrisso, Imfinzi, and Enhertu. Truqap and Datroway launches in HR HER2- breast cancer show early sales strength and FDA momentum. AZN eyes pipeline growth with late-stage drugs camizestrant and volrustomig across multiple cancer types.AstraZeneca (AZN) is one of the leading drugmakers in the oncology space. Oncology sales (comprising around 41% of AstraZeneca‘s total revenues) rose 13% in the first quarter of 2025, generat ...
Gilead Sciences Rallies 27.2% in Six Months: Buy or Sell the Stock?
ZACKS· 2025-07-08 14:56
Key Takeaways GILD stock has surged 27.2% in six months, outpacing its industry, sector, and the S&P 500 index. FDA approval of Yeztugo, the first twice-yearly PrEP, strengthens GILD's HIV portfolio and market edge. New liver drug Livdelzi and rising earnings estimates support GILD's growth and dividend sustainability.Shares of Gilead Sciences, Inc. (GILD) have gained 27.2% in the past six months against the industry’s decline of 2.2%. The stock has also outperformed the sector and the S&P 500 index in th ...
Crescent Biopharma Appoints Jan Pinkas, Ph.D., as Chief Scientific Officer
Globenewswire· 2025-07-08 11:30
Seasoned Leader Brings Deep Experience in Oncology Drug Development as Company Advances Portfolio of Next Generation Therapeutics for Solid Tumors WALTHAM, Mass., July 08, 2025 (GLOBE NEWSWIRE) -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced the appointment of Jan Pinkas, Ph.D., as chief scientific officer. Dr. Pinkas brings more than two decades of experience in o ...
Arcus Biosciences(RCUS) - 2024 Q4 - Earnings Call Presentation
2025-07-08 05:48
COMBINING TO CURE ® Forward-Looking Statements/Safe Harbor Arcus is at the forefront of designing combination therapies, with best-in-class potential, in the relentless pursuit of cures for cancer. Forward Looking Statements Safe Harbor: This presentation contains forward-looking statements about Arcus Biosciences, Inc. ("we," "Arcus" or the "Company") made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements regarding events or results to occur in t ...
Exelixis Surges 35.2% in Three Months: Buy or Sell the Stock?
ZACKS· 2025-07-07 14:26
Key Takeaways EXEL rose on positive STELLAR-303 results, showing OS benefit for zanzalintinib plus Tecentriq in CRC. Cabometyx sales should gain from label expansions and strong demand in RCC. EXEL raised 2024 revenue guidance by $100M, backed by Cabometyx momentum and pipeline progress.Exelixis (EXEL) has put up a stellar performance so far this year. Shares of the biotech company have rallied 35.2% in the past three months compared with the industry’s growth of 11.8%. The stock has also outperformed the ...
GT Biopharma (GTBP) Earnings Call Presentation
2025-07-07 08:30
TriKE® Technology and Pipeline - GT Biopharma's TriKE® platform utilizes camelid nanobodies to target NK cells to tumor cells, activating them via CD16A and IL-15 [5, 13] - The company has 6+ pipeline assets in preclinical development, targeting both solid tumors and hematological malignancies [5] - GTB-3650, a 2nd generation TriKE® targeting CD33, has an IND accepted in June 2024, with the first patient dosed on January 21, 2025 [5, 7] - GTB-7550 TriKE® is in development for the treatment of lupus and other autoimmune disorders [5, 37] - GTB-3550, the first generation TriKE® targeting CD33, showed proof of concept in Phase 1 in AML patients, reducing CD33+ bone marrow blast levels by 333%-636% in some patients [5, 26] Financial Status - As of March 31, 2025, GT Biopharma had $25 million in cash and short-term investments, with a debt-free balance sheet [5] - An additional $54 million in cash was raised on May 12, 2025 [5]
Akari Therapeutics (AKTX) Earnings Call Presentation
2025-07-07 08:27
Akari Therapeutics Overview - Akari Therapeutics focuses on innovating antibody-drug conjugates (ADCs) as immuno-oncology therapies [3] - The company's lead payload, PH1, is a spliceosome inhibitor that causes cell death and activates the immune system [10] - Akari is developing novel target ADCs with the PH1 payload applicable to colon, lung, breast, and prostate cancers [12] PH1 Payload Mechanism and Advantages - PH1's mechanism of action generates mis-spliced transcripts leading to immunogenic neoantigens, 9 times greater than DM4 [23, 25] - PH1 overcomes resistance mechanisms and has reduced off-target toxicity due to its linker being engineered for intracellular release [17] - Preclinical data shows synergy between PH1 payload ADCs and checkpoint inhibitors [16] ADC Pipeline and Development - Akari's proprietary PH1 payload can build an entire ADC pipeline, with the ability to design several uniquely targeted ADCs in parallel [33] - AKTX-101 (Trop2 target) is ready for GMP manufacturing/GLP tox studies [36] - AKTX-102 is being developed against a novel target with potential in lung, colon, and breast cancers [36] Market Opportunity and Deal Flow - There is a strong need for ADCs with new payload mechanisms beyond current ADC therapies, especially in lung cancer [13] - Early-stage ADC deal flow shows continued momentum, with deals ranging from $20 million to $400 million upfront and total deal highlights reaching up to $1.34 billion [8] - One licensing deal for EO-1022 (HER3) reached $368 million in upfront and clinical, regulatory, and commercial milestone payments [8]