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Traws Pharma Advances Antiviral Pipeline with Multiple Regulatory Submissions
Globenewswire· 2025-06-30 10:30
Phase 2 protocol submitted to HREC to evaluate tivoxavir marboxil (TXM) in a combined seasonal and bird flu study in the Southern Hemisphere Briefing documents submitted to FDA for a Type D meeting request to continue discussions on path forward for accelerated approval of TXM for bird flu Phase 2 study protocol submitted to HREC to evaluate ratutrelvir in newly diagnosed COVID patients, with extensions to measure disease rebound and development of Long COVID NEWTOWN, Pa., June 30, 2025 (GLOBE NEWSWIRE) -- ...
Edgewise Therapeutics (EWTX) Earnings Call Presentation
2025-06-26 12:37
Sevasemten Update June 26, 2025 Forward Looking Statement This presentation contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding sevasemten, statements regarding the potential marke ...
BeiGene (BGNE) Earnings Call Presentation
2025-06-26 12:16
BeOne's Innovative Pipeline Progress Investor R&D Day JUNE 26, 2025 Forward-looking Statements Certain statements contained in this presentation and in the accompanying oral presentation, other than statements of fact that are independently verifiable at the date hereof, constitute forward looking statements. Examples of such forward-looking statements include statements regarding the projected size of the oncology market and related sectors; BeOne's research, discovery, pre-clinical and early-stage clinica ...
Certara (CERT) FY Earnings Call Presentation
2025-06-25 11:12
Certara William F. Feehery, Ph.D. Chief Executive Officer William Blair 25th Annual Growth Stock Conference Wednesday, June 4th, 2025 Disclaimer Numerical figures in the presentation have been subject to rounding adjustments. Acc ordingly , numeric al f igures shown as tota ls in various tables may not be arithmetic aggregations of the figures that precede them. Trademarks and Service Marks The Certara design logo, "Certara," and our other registered or common law trademarks, service marks or trade names ap ...
EXEL Stock Rises on Positive Data From Colorectal Cancer Study
ZACKS· 2025-06-24 14:41
Key Takeaways More on EXEL's STELLAR-303 Study on Zanzalintinib Zanzalintinib is a third-generation oral tyrosine kinase inhibitor that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. The STELLAR-303 study met one of its two dual primary endpoints, demonstrating a statistically significant improvement in overall survival (OS) for the intent-to-treat (ITT) population when treated with zanzalintinib in combination with Tece ...
Idorsia’s QUVIVIQ expands into China as Simcere receives NDA approval – Idorsia and Simcere update their licensing agreement
Globenewswire· 2025-06-23 05:00
Ad hoc announcement pursuant to Art. 53 LR Idorsia to receive USD 50 million (an additional USD 30 million) approval milestone payment in return for a reduction in Simcere potential sales milestones and tiered royalty payments. Allschwil, Switzerland – June 23, 2025Idorsia Ltd. (SIX: IDIA) today announced that Simcere Pharmaceuticals Group Ltd (2096.HK, “Simcere”) has received approval for QUVIVIQ® (daridorexant) from the Chinese National Medical Products Administration for the treatment of adult patients w ...
Moleculin Announces $5.9 Million Public Offering
Globenewswire· 2025-06-20 13:20
HOUSTON, June 20, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the pricing of a public offering consisting of 16,080,000 shares of common stock (or pre-funded warrants in lieu thereof) and Series E warrants to purchase up to 48,240,000 shares of its common stock, at a combined public offering price per share of common st ...
Actuate Therapeutics Reports Positive Biomarker and Machine Learning Data from Phase 2 Elraglusib Trial in First-Line Treatment of Metastatic Pancreatic Cancer at ASCO
Globenewswire· 2025-06-20 12:45
Core Insights - Actuate Therapeutics, Inc. announced promising biomarker data from the Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel for first-line metastatic pancreatic adenocarcinoma, highlighting the potential for improved patient stratification based on pre-dose plasma biomarkers [1][2][3] Group 1: Study Findings - The analysis of 40 cytokines, chemokines, soluble cell receptors, and growth factors identified 7 significant biomarkers predicting favorable survival in the elraglusib-treated cohort, particularly highlighting CXCL2's unique survival trend [2][3] - Univariate analysis showed that elevated levels of CXCL2 and TRAIL were associated with improved overall survival, while lower levels of CCL3, IL-1α, IL-18, TGF-β, and TRAIL R3 were linked to better survival outcomes [3] - Multivariate machine learning models were developed to accurately predict patients likely to survive over one year when treated with elraglusib and GnP [3] Group 2: Company Strategy and Future Plans - The results support the use of non-invasive blood-based markers to identify patients who may benefit from elraglusib, indicating a significant advancement in the company's biomarker strategy [4] - The company plans to prospectively test the identified biomarkers in future trials and focus on optimizing patient stratification and predictive accuracy through refined machine learning models [4] - Actuate aims to apply this biomarker identification approach to guide the development of elraglusib in metastatic pancreatic cancer and other advanced cancer indications [4] Group 3: Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for difficult-to-treat cancers, with elraglusib as its lead investigational drug targeting pathways involved in tumor growth and resistance to conventional therapies [5] - Elraglusib may also enhance anti-tumor immunity by regulating immune checkpoints and immune cell functions, indicating its potential in cancer treatment [5]
Aligos Therapeutics Appoints Kieron Wesson as Vice President, Head of Chemistry Manufacturing Controls (CMC)
Globenewswire· 2025-06-18 12:00
SOUTH SAN FRANCISCO, Calif., June 18, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS) a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced the appointment of Kieron Wesson, PhD as Vice President, Head of Chemistry Manufacturing Controls (CMC), effective immediately. “I am pleased to welcome Kieron to Aligos,” said Sushmita Chanda, PhD, DABT, Executive Vice President, Chief Development ...
Biogen Initiates Phase 3 Pediatric Study of Omaveloxolone for the Treatment of Friedreich Ataxia
Globenewswire· 2025-06-18 11:30
Core Viewpoint - Biogen Inc. has initiated the BRAVE study, a global Phase 3 clinical trial to evaluate the efficacy and safety of omaveloxolone in children with Friedreich ataxia (FA) aged 2 to under 16 years, addressing a significant unmet need in the pediatric population [1][2][3]. Group 1: Study Design and Objectives - The BRAVE study will involve approximately 255 children with FA, randomized in a 2:1 ratio to receive either omaveloxolone or placebo for 52 weeks, followed by an open-label extension phase [2][4]. - The primary outcome measure is the change from baseline in the Upright Stability Score (USS), recognized as a sensitive measure of disease progression in children with FA [2][3]. - The study design has been informed by previous research and input from the FA community, with enrollment starting in the U.S. and plans to expand globally [4]. Group 2: Current Product Information - Omaveloxolone, marketed as SKYCLARYS, is currently approved for the treatment of FA in adults and adolescents aged 16 years and older in over 40 countries, including the U.S. and the European Union [1][5]. - The drug has received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the U.S. FDA, highlighting its significance in treating this rare condition [5]. Group 3: Disease Context - Friedreich ataxia is a rare, genetic, life-shortening neuromuscular disorder, with early symptoms typically appearing in childhood and leading to significant disability [7][8]. - Patients with early onset FA often experience a more aggressive disease progression, underscoring the critical need for effective treatments in the pediatric population [3][7].