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Neurocrine Biosciences Announces Conference Call and Webcast of Second Quarter 2025 Financial Results
Prnewswire· 2025-07-09 20:01
Group 1 - Neurocrine Biosciences has scheduled its Q2 2025 financial results conference call and webcast for July 30, 2025, at 1:30 p.m. PT [1][4] - The conference call will be accessible via the company's website, and a replay will be available approximately one hour after the event [1][4] - The company focuses on developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with a diverse portfolio of FDA-approved treatments [2] Group 2 - Neurocrine's portfolio includes treatments for tardive dyskinesia, Huntington's disease-related chorea, congenital adrenal hyperplasia, endometriosis, and uterine fibroids, with some collaborations [2] - The company has a robust pipeline with multiple compounds in mid- to late-phase clinical development across its core therapeutic areas [2]
Tonix Pharmaceuticals Announces On-line Publication of Phase 3 RESILIENT Trial Results of TNX-102 SL for Fibromyalgia in the Peer Reviewed Journal, Pain Medicine
Globenewswire· 2025-07-09 20:01
Core Insights - The RESILIENT trial data demonstrates that TNX-102 SL significantly reduces fibromyalgia pain compared to placebo, confirming previous findings from the RELIEF trial [1][2] - If approved, TNX-102 SL will be the first new drug for fibromyalgia in over 15 years, with a PDUFA target date set for August 15, 2025 [1][2] Company Overview - Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company focused on developing therapies for pain management and central nervous system disorders [8] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on two statistically significant Phase 3 studies [2][8] Study Details - The RESILIENT study was a randomized, double-blind, placebo-controlled trial involving 457 adults with fibromyalgia across 33 sites in the U.S. [2][7] - Participants received TNX-102 SL in two dosage phases: 2.8 mg for two weeks followed by 5.6 mg for twelve weeks, with a primary endpoint of pain reduction assessed over fourteen weeks [2][7] Efficacy Results - TNX-102 SL achieved a least-squares mean reduction of 1.8 points on the eleven-point daily pain numeric rating scale, compared to a 1.2-point reduction for placebo, indicating high statistical significance [2][7] - Statistically significant improvements were also noted across all six prespecified key secondary endpoints, including various patient-reported outcomes [2][3] Safety Profile - TNX-102 SL was generally well tolerated, with the most common adverse events being mild and transient, such as oral tingling/numbness and a bitter aftertaste [3] - No serious drug-related adverse events or deaths were reported, highlighting a favorable risk-benefit profile [3] Fibromyalgia Context - Fibromyalgia affects an estimated 6-12 million adults in the U.S., predominantly women, and is characterized by chronic pain, fatigue, and sleep disturbances [4] - Current treatment options are often met with dissatisfaction from both physicians and patients, indicating a significant unmet need in the market [4] Product Information - TNX-102 SL is a patented sublingual formulation of cyclobenzaprine hydrochloride designed for rapid absorption and reduced side effects [5][6] - The drug is also being explored for other indications, including acute stress reaction, Long COVID, and alcohol use disorder [5][8]
PROK Surges More Than 500% on Upbeat Data From Kidney Cell Therapy Study
ZACKS· 2025-07-09 17:31
Key Takeaways PROK surged 515% on positive Phase II data for rilparencel in diabetic chronic kidney disease patients. Group 1 showed a 78% improvement in kidney decline rate, meeting statistical and clinical benchmarks. ProKidney will seek FDA confirmation of eGFR slope as a surrogate endpoint in its ongoing Phase III trial.Shares of ProKidney Corp. (PROK) skyrocketed 515% yesterday after the company reported encouraging top-line data from the phase II REGEN-007 study evaluating its lead pipeline drug, ri ...
Connect Biopharma’s Exclusive Licensee in China, Simcere Pharmaceutical, Announced Submission of its New Drug Application for Rademikibart for the Treatment of Atopic Dermatitis in China
Globenewswire· 2025-07-09 13:00
Core Viewpoint - Connect Biopharma's collaborator, Simcere Pharmaceutical, has submitted a New Drug Application for rademikibart to treat atopic dermatitis in China, indicating significant progress in the development of this potential best-in-class therapy for inflammatory diseases [1][2]. Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory diseases, with rademikibart as its lead product candidate targeting IL-4Rα [6]. - Simcere Pharmaceutical is an R&D-driven company focusing on therapeutic areas such as neuroscience, anti-oncology, autoimmune, and anti-infection [5]. Product Development - Rademikibart is a fully human monoclonal antibody that targets IL-4Rα, blocking the Th2 inflammatory pathway, which is relevant for treating atopic dermatitis and asthma [4]. - The AD market in China presents a considerable opportunity, with an estimated 70 million patients suffering from the condition [3]. Collaboration Agreement - In 2023, Connect Biopharma and Simcere entered an exclusive license and collaboration agreement for rademikibart in Greater China, granting Simcere exclusive rights for development, manufacturing, and commercialization [2][3]. - Connect Biopharma is eligible for milestone payments totaling approximately $110 million and tiered royalties on net sales in Greater China [3].
NeOnc Technologies Holdings, Inc. Joins Russell Microcap® Index
Globenewswire· 2025-07-09 13:00
Core Insights - NeOnc Technologies Holdings, Inc. has been included in the Russell Microcap® Index, which is a significant recognition of the company's growth and commitment to shareholder value [1][3] - The Russell Microcap® Index includes companies with an average market capitalization of approximately $640 million, covering stocks ranging from about $30 million to $3 billion [3][4] - NeOnc is focused on advancing its Phase II clinical trials for CNS cancers and expanding into the MENA region through a proposed partnership with Quazar [3] Company Overview - NeOnc Technologies Holdings, Inc. is a clinical-stage biopharmaceutical company dedicated to developing treatments for central nervous system cancers and disorders [1][6] - The company utilizes the NEO™ drug development platform, which has produced a portfolio of novel drug candidates with patent protections extending to 2038 [6] - NeOnc's therapeutics, NEO100™ and NEO212™, are currently in Phase II human clinical trials and have received FDA Fast-Track and Investigational New Drug (IND) status [6] Industry Context - The Russell US Indexes reconstitution ranks the 4,000 largest US stocks by total market capitalization, and membership in the Russell Microcap® Index is valid for one year [2][4] - Russell indexes are widely utilized by investment managers and institutional investors, serving as benchmarks for approximately $10.6 trillion in assets as of June 2024 [4]
Palisade Bio Appoints Emil Chuang, MB BS FRACP to its Board of Directors
Globenewswire· 2025-07-09 12:45
Core Insights - Palisade Bio, Inc. has appointed Emil Chuang, MB BS FRACP to its Board of Directors, enhancing its clinical strategy in treating Fibrostenotic Crohn's Disease and Ulcerative Colitis [1][9] Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases [10] Leadership Experience - Dr. Chuang brings nearly 25 years of pharmaceutical and clinical experience, including contributions to drug development programs that led to two successful regulatory approvals: infliximab for pediatric Crohn's disease and lorcaserin for morbid obesity [3][4] - His previous roles include Chief Medical Officer at Intrinsic Medicine and leadership positions at Nestlé Health Science, Takeda, and Progenity, with over 80 peer-reviewed publications to his name [6][7] Strategic Importance - The addition of Dr. Chuang is expected to provide valuable insights into the company's clinical programs, particularly in inflammatory bowel diseases [5][6] - The company aims to leverage Dr. Chuang's expertise to advance its pipeline and address unmet medical needs in the therapeutic landscape [6]
Salarius Pharmaceuticals’ Seclidemstat Demonstrates Supporting Role in Inhibiting Validated Oncology Target LSD1 in Two Recently Published Studies
Globenewswire· 2025-07-09 12:30
Core Insights - Salarius Pharmaceuticals is advancing its Phase 1/2 clinical study of seclidemstat for myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) with updates expected later this year [1][2] - The company is progressing with its planned merger with Decoy Therapeutics, which is anticipated to create value through Decoy's innovative peptide conjugate therapeutics [2][3] Company Developments - Salarius' seclidemstat is a first-in-class, orally bioavailable LSD1 inhibitor being evaluated at MD Anderson Cancer Center [1][9] - The merger with Decoy Therapeutics is set to combine Salarius' drug candidates with Decoy's IMPACT™ platform, which focuses on developing therapeutics for respiratory viruses and cancer [3][10] - The combined company will be led by Decoy's executive team, including CEO Frederick "Rick" Pierce and CSO Barbara Hibner [4] Research Insights - Two recent animal studies highlight the importance of inhibiting LSD1 expression, supporting the potential of SP-2577 in cancer treatment [2][5] - The studies published in peer-reviewed journals provide insights into the role of KDM1A in regulating neural stem cells and oral squamous cell carcinoma progression [5] Future Plans - Decoy plans to advance its lead asset, a pan-coronavirus antiviral, towards an Investigational New Drug (IND) application with the FDA within the next 12 months [6] - The ongoing clinical trial at MDACC may yield data on MDS and CMML patients who have previously failed or relapsed after hypomethylating agent therapy [7]
Candel Therapeutics Expands Russell Index Presence with Addition to Multiple Value-Oriented Indexes in 2025 Reconstitution
Globenewswire· 2025-07-09 12:05
Core Insights - Candel Therapeutics, Inc. has been added to multiple Russell indexes as part of the 2025 Russell US Indexes annual reconstitution, effective June 30, 2025, which reflects the company's progress in clinical programs and discovery efforts in cancer immunotherapy [1][2][3] Company Overview - Candel is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to elicit systemic anti-tumor immune responses [4] - The company has established two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [4] Clinical Development - Candel's lead product candidate, CAN-2409, has completed successful phase 2a clinical trials in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [5] - A pivotal phase 3 clinical trial of CAN-2409 in localized prostate cancer is ongoing under a Special Protocol Assessment (SPA) with the FDA [5] - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including treatment-resistant PDAC and localized prostate cancer [5] Strategic Importance of Index Inclusion - Inclusion in the Russell Value indexes is expected to enhance Candel's engagement with the investment community and support its pre-commercialization efforts for CAN-2409 [3] - Russell indexes are widely utilized by investment managers and institutional investors, with approximately $10.6 trillion in assets benchmarked against them [3] Future Prospects - The company is preparing for a potential submission of a Biologics License Application for CAN-2409 and continues to advance its innovative immunotherapy platform across various solid tumors [3] - Candel's enLIGHTEN™ Discovery Platform aims to leverage human biology and advanced analytics to create new viral immunotherapies for solid tumors [6]
KALA BIO Announces Completion of Enrollment in CHASE Clinical Trial Evaluating KPI-012 for the Treatment of Persistent Corneal Epithelial Defect (PCED)
Globenewswire· 2025-07-09 12:00
-- Topline results from the CHASE trial expected by end of Q3 2025 -- -- Potential for CHASE to serve as a pivotal trial in support of a Biologics License Application (BLA) submission, contingent on positive results -- ARLINGTON, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced the completion of patient ...
Revolution Medicines and Iambic Announce Technology and Research Collaboration Using Iambic's AI Discovery Tools to Pursue New Drug Candidates
Globenewswire· 2025-07-09 12:00
REDWOOD CITY, Calif. and SAN DIEGO, July 09, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, and Iambic Therapeutics, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, today announced a technology and research collaboration to pursue novel drug candidates using Iambic's leading AI models. In this ...