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Inhibrx: Ozekibart Beyond Chondrosarcoma, With Other Targeted Indications, Too
Seeking Alpha· 2026-01-13 20:09
Core Viewpoint - The article highlights the offerings of the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1: Service Offerings - Biotech Analysis Central provides a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - The service is available for $49 per month, with a discounted annual plan at $399, representing a 33.50% savings for subscribers [1]. Group 2: Analyst Background - The author, Terry Chrisomalis, is a private investor with a background in Applied Science, focusing on generating long-term value in the healthcare sector [2]. - The service aims to assist healthcare investors in making informed decisions through comprehensive analysis and news reports [2].
12 Overlooked Stocks That Delivered Massive Gains In 2025
RTTNews· 2025-12-31 16:25
Group 1: Palvella Therapeutics Inc. (PVLA) - Palvella is a clinical-stage biopharmaceutical company focused on developing therapies for rare diseases with no FDA-approved treatments [2] - Its lead product, QTORIN rapamycin, targets microcystic lymphatic malformations and has a multi-billion-dollar market opportunity if approved [2] - The stock rose from $25 on March 10, 2025, to a 52-week high of $114.69 on December 22, 2025, before pulling back to $99.88 [3] Group 2: Cidara Therapeutics Inc. (CDTX) - Cidara is developing a preventive therapy for influenza and has agreed to be acquired by Merck for $221.50 per share, totaling approximately $9.2 billion [4] - The stock was trading at $18.98 when profiled on November 21, 2024 [4] Group 3: Celcuity Inc. (CELC) - Celcuity is focused on targeted therapies for oncology, with its lead drug candidate Gedatolisib aimed at breast and prostate cancers [5] - The stock increased from $12.60 on December 4, 2024, to an all-time high of $112.64 on December 12, 2025, before retreating to $99.16 [6] Group 4: Nanobiotix (NBTX) - Nanobiotix is a late-stage clinical biotechnology company developing physics-based therapies for cancer [7] - Its lead candidate, NBTXR3, is undergoing a phase III study for head and neck squamous cell carcinoma, with interim data expected in the first half of 2027 [8] - The stock rose from $12.23 on September 19, 2025, to a high of $30.35 on October 13, 2025, before trading around $21 [10] Group 5: Terns Pharmaceuticals Inc. (TERN) - Terns Pharma is developing small-molecule candidates for serious diseases, with TERN-701 targeting chronic myeloid leukemia [12] - Recent data showed a 75% major molecular response rate among patients receiving higher doses [13] - The stock increased from $5.98 on August 6, 2025, to an all-time high of $48.26 on December 10, 2025, before pulling back to around $40 [14] Group 6: DBV Technologies S.A. (DBVT) - DBV Technologies is developing an epicutaneous immunotherapy for food allergies, with its lead product, the VIASKIN Peanut patch, showing positive results in a phase 3 study [15] - The company aims to submit a Biologics License Application in the first half of 2026, with potential sales of $1.5 billion by 2030 if approved [15] - The stock rose from $10.64 on October 2, 2025, to a high of $26.18 on December 17, 2025, before trading around $19 [16] Group 7: Nutex Health Inc. (NUTX) - Nutex Health reported a significant turnaround from a $424 million net loss in 2022 to a $59 million net income for the nine months ended September 30, 2025 [17] - Revenue increased from $219 million in 2022 to $723.6 million in the first nine months of 2025 [17] - The stock rose from $33.56 on November 25, 2024, to a 52-week high of $193.07 before closing at $182.23 [18] Group 8: Inhibrx Biosciences Inc. (INBX) - Inhibrx is developing biologic therapies for cancer, with Ozekibart showing significant improvement in progression-free survival in chondrosarcoma [19] - The company plans to submit a biologics license application for Ozekibart in the second quarter of 2026 [20] - The stock rose from $18.35 on July 8, 2025, to an all-time high of $94.57 on December 22, 2025, before trading around $77 [21] Group 9: GRAIL Inc. (GRAL) - GRAIL focuses on early cancer detection with its Galleri test, which is not yet FDA-approved [23] - The company expects to submit a PMA for the Galleri test in Q1 2026 [23] - The stock increased from $48.50 on September 26, 2025, to a high of $115.76 on November 25, 2025, before trading around $88 [24] Group 10: Cogent Biosciences Inc. (COGT) - Cogent is developing precision therapies for genetically defined diseases, with Bezuclastinib being its lead candidate [25] - The company submitted its first NDA to the FDA for Non-AdvSM, with additional submissions planned for GIST and advanced systemic mastocytosis [26] - The stock rose from $7.25 on July 2, 2025, to a 52-week high of $43.73 on December 8, 2025, before easing back to around $35 [26] Group 11: Sol-Gel Technologies Ltd. (SLGL) - Sol-Gel has two FDA-approved products for dermatological conditions and is developing investigational products [27] - A phase III trial for SGT-610 is ongoing, with results expected in Q4 2026 [28] - The stock rose from $7.26 on May 7, 2025, to a high of $52.26 on October 6, 2025, before trading around $43 [28] Group 12: Zenas BioPharma Inc. (ZBIO) - Zenas is focused on therapies for autoimmune diseases, with Obexelimab in phase 3 trials for IgG4-RD [29] - Positive data from a phase 2 trial in multiple sclerosis showed a 95% reduction in new lesions [30] - The stock rose from $8.79 on December 17, 2024, to a high of $44.60 on December 24, 2025, before pulling back to around $35 [31]
Why Inhibrx's Recent Strength May Not Be Built to Last
Benzinga· 2025-12-24 12:33
Core Viewpoint - Inhibrx has experienced a significant stock rally of over 150% following positive topline results from its registrational trial of Ozekibart (INBRX-109), but this movement raises structural risks when analyzed through the Adhishthana framework [1][8]. Group 1: Monthly Structure Analysis - Inhibrx is currently in Phase 2 of its 18-phase Adhishthana cycle, which consists of two segments: the Sankhya period characterized by consolidation or corrective behavior, and the Buddhi period known for strong upside momentum [2]. - The stock is navigating the early Sankhya portion of Phase 2, having delivered a sharp upside move instead of the expected consolidation or correction, indicating a deviation from the anticipated structure [3][6]. - Historically, premature strength during the Sankhya phase often leads to instability later in the cycle, as seen in the case of Lamb Weston, which faced a collapse of over 60% after a similar premature rally [5]. Group 2: Investor Outlook - The current rally of Inhibrx is unfolding at an unfavorable point in the cycle, suggesting that the medium-term outlook warrants caution for investors [7]. - Investors who established positions prior to the Ozekibart announcement may continue to hold, but should be aware of the structural risks associated with the current rally, which may not be sustainable [8].
Inhibrx Biosciences Provides Progress Updates on the INBRX-106 Program and the Expansion Cohorts of the ozekibart (INBRX-109) Program
Prnewswire· 2025-12-16 22:00
Core Insights - Inhibrx Biosciences, Inc. announced updates on its clinical trials for INBRX-106 and ozekibart, focusing on oncology therapeutics [1] INBRX-106 Clinical Trials - The Phase 2 portion of the INBRX-106 trial has recruited 46 out of 60 patients, with expected completion of enrollment in Q1 2026 [2] - The trial targets patients with unresectable or metastatic head and neck squamous cell carcinoma (HNSCC) who have not received prior systemic therapy and have tumor PD-L1 CPS expression ≥ 20 [2] - Primary endpoint is overall response rate, with secondary endpoints including duration of response, progression-free survival, and safety [2] - Data maturity for HNSCC and NSCLC trials is anticipated in H2 2026 to assess the efficacy of INBRX-106 in combination with Keytruda [4] Ozekibart Clinical Trials - Enrollment for the Phase 1/2 trial of ozekibart in combination with FOLFIRI for advanced colorectal cancer has been completed with 44 patients [5] - Ozekibart showed good tolerability and durable responses, with progression-free survival data expected in Q2 2026 [5] - The trial for ozekibart in combination with irinotecan and temozolomide for Ewing sarcoma is expected to complete enrollment in Q2 2026, with plans to discuss accelerated approval with the FDA in H2 2026 if trends continue [6] Product Descriptions - INBRX-106 is a hexavalent sdAb-based therapeutic candidate targeting OX40, currently being investigated for HNSCC and NSCLC [7] - Ozekibart is a tetravalent DR5 agonist antibody designed to induce tumor-biased cell death, with a BLA filing expected in early Q2 2026 [8] Company Overview - Inhibrx Biosciences focuses on developing a pipeline of novel biologic therapeutic candidates using advanced protein engineering methods [9]
Inhibrx Reports Third Quarter 2025 Financial Results
Prnewswire· 2025-11-14 11:00
Core Insights - Inhibrx Biosciences, Inc. reported financial results for Q3 2025, highlighting the completion of the sale of INBRX-101 to Sanofi S.A. and the spin-off of Inhibrx as a standalone entity [1][4] - The company has two ongoing clinical programs, with positive topline results from the registrational trial of ozekibart (INBRX-109) in chondrosarcoma [2][9] - Inhibrx plans to submit a biologics license application to the U.S. FDA in Q2 2026 [6] Recent Corporate Highlights - On October 23, 2025, Inhibrx announced positive topline results from its trial of ozekibart in chondrosarcoma, demonstrating significant improvement in median progression-free survival compared to placebo [2][6] - Interim data from expansion cohorts in colorectal cancer and Ewing sarcoma show high response and disease control rates in heavily pretreated patients [6] Financial Results - As of September 30, 2025, Inhibrx had cash and cash equivalents of $153.1 million, down from $186.6 million as of June 30, 2025 [6] - Research and development expenses for Q3 2025 were $28.5 million, a decrease from $38.9 million in Q3 2024, primarily due to reduced process development and manufacturing activities [6][7] - General and administrative expenses were $5.3 million in Q3 2025, down from $7.9 million in Q3 2024, attributed to decreased legal and personnel-related expenses [6][7] - The net loss for Q3 2025 was $35.3 million, or $2.28 per share, compared to a net loss of $43.9 million, or $2.84 per share, in Q3 2024 [6][7] Summary of Financial Performance - Total revenue for Q3 2025 was $1.3 million, compared to $0.1 million in Q3 2024 [7] - Total operating expenses for Q3 2025 were $33.8 million, down from $46.8 million in Q3 2024 [7] - The company reported total liabilities of $140.6 million as of September 30, 2025, with stockholders' equity at $36.8 million [7]
Inhibrx Announces Participation in Upcoming Scientific Conferences
Prnewswire· 2025-11-04 21:01
Core Insights - Inhibrx Biosciences, Inc. is set to present clinical data on its DR5 Agonist at multiple upcoming scientific conferences, highlighting its focus on novel biologic therapeutic candidates [1][2][3] Conference Presentations - The company will present at the 21st Annual Industry/Academia Precision Oncology & Radmed Symposium on November 5, 2025, discussing DR5 Agonist clinical data in various cancers [1] - At the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting from November 12-15, 2025, Inhibrx will present results from the Phase 2 ChonDRAgon Study on ozekibart (INBRX-109) in conventional chondrosarcoma [2] - The Society for NeuroOncology (SNO) 2025 Annual Meeting from November 19-23, 2025, will feature a poster presentation on the anti-tumor activity of ozekibart in GBM models [3] Company Overview - Inhibrx Biosciences is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates, utilizing diverse protein engineering methods [4] - The company was incorporated in January 2024 and has a current clinical pipeline that includes ozekibart and INBRX-106, both employing multivalent formats for optimized agonist function [4]
Biotech Stocks Hit 52-Week Highs: MTSR, INSM, ABVX, MAZE Lead October 30 Surge
RTTNews· 2025-10-31 08:19
Core Insights - The biotech sector is experiencing significant momentum, with many clinical-stage and commercial biopharma stocks reaching new 52-week highs due to breakthrough trial data, strategic deals, and earnings surprises [1] Company Summaries - **Metsera Inc. (MTSR)**: A clinical-stage biopharmaceutical company focused on developing hormone analog peptides for obesity and related metabolic diseases. Recently, Novo Nordisk made a $9 billion unsolicited acquisition proposal, which Metsera's board considers superior to its existing agreement with Pfizer [2][3]. Metsera announced positive Phase 2b results for its GLP-1 receptor agonist MET-097i, showing up to 14.1% weight loss after 28 weeks, supporting Phase 3 initiation in late 2025 [4]. The stock rose from $32.35 to a 52-week high of $66.10, a gain of 104.3% [5]. - **Indivior Plc (INDV)**: Develops buprenorphine-based therapies for opioid dependence. The company reported Q3 net income of $42 million, up from $22 million a year ago, with adjusted earnings of $93 million, exceeding Wall Street's expectations [6][7]. The stock increased from $20.86 to a 52-week high of $30.55, reflecting a 46.5% gain [7]. - **Insmed Inc. (INSM)**: Focused on therapies for serious and rare diseases, Insmed reported a Q3 net loss of $370 million but saw net product revenue rise to $142.3 million from $93.4 million last year [8][9]. The company raised its full-year 2025 revenue guidance for ARIKAYCE to $420 million - $430 million, indicating 15% - 18% growth year-over-year [10]. The stock surged from $76.54 to a 52-week high of $194.70, marking a 154.4% gain [10]. - **Ventyx Biosciences Inc. (VTYX)**: A clinical-stage biotech company developing therapies for autoimmune and neurodegenerative diseases. Ventyx reported positive Phase 2 results for its NLRP3 inhibitor VTX3232, showing strong safety and tolerability [11][13]. The stock rose from $3.01 to a 52-week high of $8.52, a gain of over 183% [14]. - **Inhibrx Biosciences Inc. (INBX)**: Focuses on oncology and rare diseases, announcing positive topline results from its ChonDRAgon study for ozekibart in chondrosarcoma [15]. The stock increased from $18.35 to a 52-week high of $83.78, representing a gain of 356.6% [16]. - **ABIVAX Société Anonyme (ABVX)**: Developing therapies for chronic inflammatory diseases, ABIVAX presented positive Phase 3 data for obefazimod in ulcerative colitis [17]. The stock rose from $7.83 to an all-time high of $106.73, marking a significant gain of 1263% [18]. - **Arrowhead Pharmaceuticals Inc. (ARWR)**: Developing RNAi-based therapies, Arrowhead finalized a licensing agreement with Novartis for ARO-SNCA, with financial terms including a $200 million upfront payment [19][20][21]. The stock increased from $29.70 to a 52-week high of $43.33, representing a gain of over 45% [21]. - **Kodiak Sciences Inc. (KOD)**: Focused on retinal diseases, Kodiak announced positive Phase 1b data for KSI-101, showing significant vision improvements [22][23][24]. The stock climbed from $8.98 to a 52-week high of $21.17, delivering a 135.7% gain [22]. - **Arcutis Biotherapeutics Inc. (ARQT)**: Focused on dermatological treatments, Arcutis reported Q3 net income of $7.4 million, a turnaround from a net loss last year, with revenue up 122% year-over-year [25][26]. The stock rose from $14.99 to a 52-week high of $27.08, representing a gain of over 80% [27]. - **Maze Therapeutics Inc. (MAZE)**: Developing precision therapies for various diseases, Maze announced positive Phase 1 results for MZE782 and secured $150 million in a private placement [28][29]. The stock rose from $11.21 to a new 52-week high of $34.29, returning a gain of 206% [29]. - **Supernus Pharmaceuticals Inc. (SUPN)**: Focused on CNS disorders, Supernus is expected to report Q3 earnings of $0.82 per share and revenue of $180.22 million [30][31]. The stock increased from $38.21 to a 52-week high of $57.65, representing a gain of over 50% [31].
港股异动 | 创胜集团-B(06628)现涨超4% ozekibart明年中前将提交美国适应症...
Xin Lang Cai Jing· 2025-10-31 06:27
Core Viewpoint - Chuangsheng Group-B (06628) experienced a significant stock price increase following positive clinical trial results for its partner Inhibrx Biosciences, Inc.'s (INBX.US) DR5-targeting antibody, ozekibart, in treating advanced or metastatic, unresectable sarcoma patients [1] Company Summary - Chuangsheng Group's stock rose nearly 10% during trading, closing up 4.75% at HKD 3.09, with a trading volume of HKD 4.006 million [1] - The company holds exclusive development and commercialization rights for ozekibart in China, Hong Kong, Macau, and Taiwan [1] Industry Summary - Inhibrx Biosciences announced positive primary results from a registrational clinical study evaluating the efficacy of ozekibart compared to placebo in patients with advanced or metastatic, unresectable soft tissue sarcoma [1] - Inhibrx plans to submit a marketing application for ozekibart for soft tissue sarcoma indications to U.S. regulatory authorities by the end of June 2026 [1]
港股异动 | 创胜集团-B(06628)现涨超4% ozekibart明年中前将提交美国适应症上市许可申请
智通财经网· 2025-10-31 06:08
Core Viewpoint - Chuangsheng Group-B (06628) experienced a significant stock price increase following positive clinical trial results for its partner Inhibrx Biosciences, Inc.'s drug ozekibart, which is aimed at treating advanced or metastatic, unresectable soft tissue sarcoma [1] Group 1: Stock Performance - Chuangsheng Group-B's stock rose nearly 10% during trading, closing up 4.75% at HKD 3.09, with a trading volume of HKD 4.006 million [1] Group 2: Clinical Research Results - Inhibrx Biosciences, Inc. announced positive primary results from a registrational clinical study of ozekibart, a DR5 agonistic antibody, comparing its efficacy against a placebo in patients with advanced or metastatic, unresectable soft tissue sarcoma [1] - Based on these results, Inhibrx plans to submit a marketing application for the soft tissue sarcoma indication to U.S. regulatory authorities by the end of June 2026 [1] Group 3: Development Rights - Chuangsheng Group holds exclusive development and commercialization rights for ozekibart in China, Hong Kong, Macau, and Taiwan [1]
创胜集团-B(06628.HK):合作伙伴Inhibrx公布ozekibart治疗软骨肉瘤的II期临床试验积极结果
Xin Lang Cai Jing· 2025-10-30 23:16
Core Viewpoint - Inhibrx Biosciences, Inc. announced positive primary results from the ChonDRAgon clinical study, evaluating the efficacy of ozekibart (INBRX-109) in patients with advanced or metastatic, unresectable chondrosarcoma compared to placebo [1] Group 1: Clinical Study Results - The ChonDRAgon study involved 206 participants and demonstrated significant improvement in progression-free survival (PFS) for chondrosarcoma patients treated with ozekibart [1] - Ozekibart is the first investigational drug to show a significant improvement in PFS in a randomized controlled trial for this patient population [1] Group 2: Regulatory and Market Implications - Inhibrx plans to submit a New Drug Application (NDA) to the U.S. regulatory authorities for ozekibart's chondrosarcoma indication by the end of June 2026 [1] - The company holds exclusive development and commercialization rights for ozekibart in mainland China, Hong Kong, Macau, and Taiwan through its wholly-owned subsidiary, HJB [1] Group 3: Market Context - Currently, there are no approved systemic treatment options for chondrosarcoma, highlighting the potential market value of ozekibart for global patients and in the regions where the company has exclusive rights [1]