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Clearmind Expands its Clinical Trial for Alcohol Use: New Site Activated and Additional Participant Enrolled
Globenewswire· 2025-07-15 12:05
Core Viewpoint - Clearmind Medicine Inc. is expanding its Phase I/IIa clinical trial for CMND-100, a treatment for Alcohol Use Disorder (AUD), by activating a new site at Johns Hopkins University and enrolling its first participant there, indicating positive momentum in its clinical development program [1][2][3]. Group 1: Clinical Trial Details - The Phase I/IIa clinical trial aims to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100, with preliminary efficacy indicators focusing on reducing alcohol cravings and consumption [2][4]. - The trial is a multinational, multicenter study that will explore early signals of efficacy, including reductions in alcohol consumption and cravings, which could facilitate further development of this therapy [4]. Group 2: Company Strategy and Goals - The activation of new clinical sites and participant enrollment is seen as a step closer to validating CMND-100's potential to transform the treatment landscape for AUD, reflecting the scientific community's interest in the company's approach [3][5]. - Clearmind's primary objective is to research and develop psychedelic-based compounds and commercialize them as regulated medicines, foods, or supplements, addressing widespread and underserved health problems [5]. Group 3: Intellectual Property - The company currently holds an intellectual portfolio consisting of nineteen patent families, including 31 granted patents, and plans to seek additional patents for its compounds as warranted [6].
Nautilus Biotechnology to Announce Second Quarter 2025 Financial Results on July 31, 2025
Globenewswire· 2025-07-15 12:00
SEATTLE, July 15, 2025 (GLOBE NEWSWIRE) -- Nautilus Biotechnology, Inc. (NASDAQ: NAUT; or "Nautilus"), a company pioneering a single-molecule protein analysis platform for quantifying the proteome, today announced it will report financial results for the second quarter 2025 before market open on Thursday, July 31, 2025. The company's management will webcast a corresponding conference call beginning at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss its results, business developments, and outlook. ...
Relmada Therapeutics Appoints Renowned Urologic Oncologist, Yair Lotan, MD, to Chair the Clinical Advisory Board and Support Development of NDV-01
Globenewswire· 2025-07-15 12:00
Dr. Lotan's distinguished expertise in bladder cancer care and clinical development brings further scientific acumen to Relmada's NDV-01 program Yair Lotan, MD, is a urologic oncologist with over 20 years of experience caring for bladder cancer patients. Dr. Lotan graduated with high honors from the University of Texas at Austin and with honors from Baylor College of Medicine in Houston. He trained in general surgery and urology at UT Southwestern Medical Center in Dallas. Dr. Lotan heads a clinical researc ...
Polyrizon Retains Nasdaq Listing Following Hearings Panel
Globenewswire· 2025-07-15 11:55
Core Viewpoint - Polyrizon Ltd. has received approval from the Nasdaq Hearings Panel to continue its listing on the Nasdaq Capital Market, following a plan to address concerns regarding its capital structure and compliance with listing standards [1][3]. Group 1: Nasdaq Listing and Compliance - The Nasdaq Listing Qualifications Department previously issued a public interest determination under Listing Rule 5101 due to the company's issuance of securities in a private placement, particularly concerning Series A warrants [2]. - A hearing was held on June 26, 2025, where Polyrizon presented its plan to avoid complex financing instruments in future capital-raising activities [3]. - The Panel's determination on July 9, 2025, allows the company to maintain its listing, contingent upon regaining compliance with the Minimum Bid Price Rule by October 17, 2025 [3]. Group 2: Financial Position and Capital Structure - Following the private placement, the company reported a cash balance of approximately $15.68 million, and all warrants issued in the transaction have been exercised, simplifying its capital structure [4]. - The elimination of a significant source of potential dilution is expected to enhance long-term shareholder value [4]. Group 3: Internal Controls and Future Plans - The company is implementing a formal internal control framework to govern future securities issuances and ensure compliance with Nasdaq standards, including enhanced oversight and quarterly internal compliance reviews [5]. Group 4: Company Overview - Polyrizon is a development stage biotech company focused on innovative intranasal hydrogels that create a barrier against viruses and allergens in the nasal cavity [5]. - The proprietary Capture and Contain hydrogel technology is designed to function as a "biological mask," and the company is also developing the Trap and Target technology for nasal delivery of active pharmaceutical ingredients [5].
OSR Holdings Appoints Dr. Andreas Niethammer as Chief Medical Officer of Vaximm AG, an OSR Company
Prnewswire· 2025-07-15 11:30
BASEL, Switzerland and SEOUL, South Korea, July 15, 2025 /PRNewswire/ -- OSR Holdings, Inc. (NASDAQ: OSRH), a global healthcare company dedicated to advancing healthcare outcomes and improving the quality of life for people and their families, today announced the appointment of Dr Andreas Niethammer, M.D., Ph.D., as Chief Medical Officer of Vaximm AG, an OSR Company developing a platform of orally administered target-specific T-cell activators, including VXM01, a clinical stage anti-VEGFR-2. . OSR Holdi ...
BriaCell Adds Mayo Clinic to Phase 3 Study in Metastatic Breast Cancer
GlobeNewswire News Room· 2025-07-15 11:30
Core Insights - BriaCell Therapeutics Corp. has added Mayo Clinic as a key clinical site for its ongoing pivotal Phase 3 clinical study in metastatic breast cancer [1][2] - The Phase 3 study now includes 69 active clinical sites across 15 states, enhancing the reach and potential patient enrollment for the trial [2] - The study evaluates BriaCell's lead candidate, Bria-IMT™, in combination with an immune checkpoint inhibitor against physician's choice in advanced metastatic breast cancer [3][4] Study Details - The primary endpoint of the study is overall survival (OS), with interim data analysis planned after 144 patient events (deaths) occur [4] - BriaCell has previously announced positive Phase 2 survival data for a similar patient population treated with the Bria-IMT combination regimen [4] - The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential significance in cancer treatment [4] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [6]
Iovance Biotherapeutics Appoints Corleen Roche as Chief Financial Officer
Globenewswire· 2025-07-15 11:30
Core Insights - Iovance Biotherapeutics, Inc. has appointed Corleen Roche as Chief Financial Officer, effective August 6, 2025, to support its first commercial launch and revenue growth [1][2][3] Company Overview - Iovance Biotherapeutics focuses on developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for cancer patients, aiming to be a global leader in this field [1][3] - The company has achieved FDA approval for its T cell therapy, Amtagvi, which is the first of its kind for a solid tumor indication [3] Leadership Experience - Corleen Roche brings over 30 years of experience in the biotech and life sciences industry, having held executive financial leadership roles in several publicly traded companies [2] - Roche's previous positions include CFO of CG Oncology, Immunome, and Biogen, where she successfully prepared for multiple product launches [2] Strategic Focus - The company aims to grow revenue, manage its balance sheet, and advance its mission of developing innovative therapies for solid tumors under Roche's financial leadership [2][3] - Roche expressed commitment to focusing pipeline investments on high-value opportunities while achieving financial goals to build a profitable biotechnology company [3]
ProKidney Announces Alignment with the FDA on the Accelerated Approval Pathway for Rilparencel
Globenewswire· 2025-07-15 11:30
FDA confirmed that eGFR slope is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with CKD and type 2 diabetesFDA also confirmed that the ongoing Phase 3 PROACT 1 study can be used for both accelerated approval and for full approvalNearly half of the patients required for the accelerated approval analysis using eGFR slope have been enrolledTopline data to support an application for accelerated approval is anticipated in Q2 2027 WINSTON-SALEM, N.C., July 15, 2025 (GLOBE NE ...
Emergent BioSolutions to Report Second Quarter 2025 Financial Results on August 6, 2025
Globenewswire· 2025-07-15 11:30
Core Points - Emergent BioSolutions Inc. will host a conference call on August 6, 2025, at 5:00 pm eastern time to discuss its financial results for the second quarter of 2025 [1] - Participants can access the conference call via webcast or telephone, with advance registration required for telephone participation [2] - A replay of the conference call will be available on the Investors page of Emergent's website [3] Company Overview - Emergent BioSolutions has been dedicated to protecting and saving lives for over 25 years, focusing on public health preparedness [4] - The company provides life-saving solutions for various health threats, including smallpox, mpox, botulism, Ebola, anthrax, and opioid overdose emergencies [4]
X @Bloomberg
Bloomberg· 2025-07-15 09:15
China was once notorious for knockoff drugs, but the country’s biotech companies are advancing ferociously, eclipsing the EU and catching up to the US.@AmberTongPW looks at how Chinese drugmakers are challenging Western dominance on innovation https://t.co/0N3s5ude99 https://t.co/hibHYj5scH ...