Workflow
Biotech
icon
Search documents
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Adverum Biotechnologies, Inc. - ADVM
GlobeNewswire News Room· 2025-04-25 17:12
Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Adverum Biotechnologies, Inc. following the company's announcement of the need to restate its financial statements due to accounting errors [1][3]. Group 1: Investigation Details - Pomerantz LLP is representing investors of Adverum and is looking into claims of securities fraud or other unlawful practices by the company and its officers or directors [1]. - Investors are encouraged to contact Pomerantz LLP for more information regarding the class action [2]. Group 2: Financial Disclosure - On March 31, 2025, Adverum disclosed that certain previously issued financial statements should no longer be relied upon due to non-cash errors related to tenant improvement allowances for an operating lease in North Carolina [3]. - The company announced it will restate its financial statements for the years ended December 31, 2022, and 2023, as well as for the quarterly periods in 2023 and 2024 [3]. - Following this announcement, Adverum's stock price dropped by $0.54 per share, a decline of 12.36%, closing at $3.83 per share on April 1, 2025 [3].
Coya Therapeutics: Treg Proof-Of-Concept Continues With Interim FTD Data Release
Seeking Alpha· 2025-04-25 15:27
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...
Cogent Biosciences Presents Four Posters at the American Association for Cancer Research Annual Meeting 2025 and Announces Two New Leaders
Globenewswire· 2025-04-25 12:08
Core Insights - Cogent Biosciences, Inc. presented preclinical data from four pipeline programs at the AACR 2025 Annual Meeting, highlighting its focus on developing precision therapies for genetically defined diseases [1][2] Pipeline Programs - The first program involves a potent KRAS (ON) inhibitor that shows selectivity for mutant KRAS over HRAS and NRAS, achieving 90% tumor growth inhibition in a mouse model with a 30 mg/kg oral dose [2][3] - The second program features CGT6297, a novel PI3Kα H1047R mutant-selective inhibitor, which demonstrates efficacy against PI3K helical mutations and broad cellular profiling across resistant cell lines [3][4] - The third program is CGT4859, a reversible and selective FGFR2/3 inhibitor that shows superior target coverage of resistance mutations and demonstrated complete tumor regressions in a model at doses greater than 2.5 mg/kg [5][6][7] - The fourth program is CGT4255, an EGFR-sparing, pan-mutant HER2 inhibitor with potential best-in-class brain penetration, showing high oral bioavailability and stability in human blood [8] Leadership Changes - Cogent announced the appointment of Ray Frost as Senior Vice President of Market Access and Adam Boyd, Ph.D., as Senior Vice President of Corporate Strategy, both bringing extensive industry experience [10][11][12] Inducement Grants - The company approved inducement equity awards for new employees, including Mr. Frost and Dr. Boyd, totaling nonqualified options to purchase 446,000 shares of common stock [13] Company Overview - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with its most advanced clinical program targeting the KIT D816V mutation associated with systemic mastocytosis and gastrointestinal stromal tumors [14]
Polyrizon Reports Successful Safety Study of a Formulation of PL-14 Allergy Blocker in Human Nasal Tissue Model
Globenewswire· 2025-04-25 11:37
Core Viewpoint - Polyrizon Ltd. has announced a successful preliminary safety study for its PL-14 Allergy Blocker, marking a significant advancement in the product's development path [1][5]. Group 1: Study Details - The safety study was conducted on fully differentiated human nasal tissue using the MucilAir™ model, demonstrating strong local tolerability [2]. - The study assessed local tolerance and tissue response after a 4-hour application of PL-14, a mucoadhesive nasal gel spray designed to act as a physical barrier against airborne allergens [3]. - Key safety indicators evaluated included tissue integrity (TEER), cytotoxicity (LDH), cilia beating frequency (CBF), mucociliary clearance (MCC), and inflammatory response (IL-8 secretion), with results showing no signs of inflammatory activation or functional impairment [4]. Group 2: Regulatory and Development Plans - The results of the study are a milestone in validating the local safety of PL-14 and support the company's clinical development plans [5]. - The data will aid in the regulatory strategy and support an upcoming FDA pre-submission meeting, with U.S. and European clinical trials expected to begin in late 2025 or early 2026 [6]. Group 3: Company Overview - Polyrizon is a development stage biotech company focused on innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens [7]. - The company is developing its proprietary Capture and Contain (C&C) hydrogel technology, which aims to enhance bioadhesion and prolonged retention for intranasal drug delivery [7].
重组蛋白概念下跌1.56%,5股主力资金净流出超千万元
Market Performance - The recombinant protein sector declined by 1.56%, ranking among the top losers in concept sectors as of April 25 [1][2] - Notable stocks within the sector that hit the daily limit down include Jiangsu Wuzhong and Weiming Pharmaceutical, while stocks like HJ Bio, Wanfang Development, and Aladdin saw significant declines [1] Top Gainers and Losers - Among the top gainers in the recombinant protein sector, Borui Pharmaceutical, BeiDa Pharmaceutical, and Tonghua Dongbao increased by 4.39%, 2.42%, and 2.31% respectively [1] - The sector experienced a net outflow of 158 million yuan, with 22 stocks seeing net outflows, and five stocks exceeding 10 million yuan in outflows [2] Capital Flow Analysis - The stock with the highest net outflow was Xilong Science, with a net outflow of 190 million yuan, followed by Furida and Dezhan Health with outflows of 19.41 million yuan and 19.18 million yuan respectively [2][3] - Conversely, the stocks with the highest net inflows included Zhongyuan Qihua, Zhifei Biological, and Chengdu Xian Dao, with inflows of 26.63 million yuan, 25.06 million yuan, and 17.51 million yuan respectively [2][3]
Why NovoCure Stock Leaped 4% Higher Today
The Motley Fool· 2025-04-24 23:03
Thursday morning NovoCure (NVCR 4.28%) published its first set of quarterly results for 2025, and they pleased more than a few investors. With that tailwind, the biotech's stock price rose in excess of 4%, easily topping the slightly over 2% increase of the S&P 500 index.A double beat for the inaugural quarterFor the first quarter, NovoCure recorded net revenue that was just shy of $155 million. That was a nearly 12% improvement over the same period of 2024. Compounding that, the biotech managed to narrow i ...
Tenaya Therapeutics Presents Interim Data from RIDGE™ Natural History and Seroprevalence Study of Adults with PKP2-associated ARVC at Heart Rhythm 2025
Globenewswire· 2025-04-24 18:07
RIDGE is Largest Natural History Study Conducted with More Than 175 Participants Enrolled to Date with Arrhythmogenic Right Ventricular Cardiomyopathy Due to Mutations in the PKP2 Gene Patients Experience High Burden of Arrhythmias and Severe Disease Progression Despite Standard-of-Care Treatments Large Majority of PKP2-associated ARVC Patients Appear Eligible for TN-401 Gene Therapy Based on Low Rates of Preexisting Immunity to AAV9 Antibodies SAN DIEGO, April 24, 2025 (GLOBE NEWSWIRE) -- Tenaya Therapeuti ...
Pasithea Therapeutics to Present Updated Data from Ongoing Phase 1 Trial of PAS-004 in Advanced Cancer Patients at the 2025 ASCO Annual Meeting
GlobeNewswire News Room· 2025-04-24 11:02
Core Viewpoint - Pasithea Therapeutics Corp. announced the acceptance of an abstract for a poster presentation at the ASCO Annual Meeting, highlighting the ongoing Phase 1 clinical trial of PAS-004, a macrocyclic MEK inhibitor for treating neurofibromatosis type 1 and other MAPK pathway-driven conditions [1][2]. Group 1: Clinical Trial Details - The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway-driven advanced solid tumors [5]. - Updated interim clinical data from cohorts 4A and 4B of the trial has shown clinical activity, target engagement, and a favorable safety profile [3]. Group 2: Presentation Information - The poster presentation will take place on June 2, 2025, from 1:30 PM to 4:30 PM CDT, under the title "Phase 1 dose-escalation study of the safety and pharmacokinetics of PAS-004" [4]. - The full abstract will be available on the ASCO website on May 22, 2025, at 5:00 PM ET [4]. Group 3: Company Overview - Pasithea Therapeutics is focused on the discovery, research, and development of innovative treatments for central nervous system disorders, RASopathies, and MAPK pathway-driven diseases [6].
Cardiff Oncology Announces a Second Patent for the Treatment of mCRC for Bev-Naïve Patients
Globenewswire· 2025-04-23 20:05
Core Viewpoint - Cardiff Oncology has received a patent for the use of onvansertib in combination with bevacizumab for treating all bev-naïve metastatic colorectal cancer (mCRC) patients, which is expected to enhance its market opportunities and growth potential [1][2]. Group 1: Patent and Treatment Scope - The newly issued patent covers the combination treatment of onvansertib and bevacizumab for all bev-naïve mCRC patients, including those with RAS mutations and RAS wild type, across all lines of therapy until at least 2043 [1]. - This patent expands the applicability of onvansertib beyond the current focus on first-line RAS-mutated patient populations, potentially redefining the standard of care for mCRC [2]. Group 2: Clinical Development - Onvansertib is currently being evaluated in a Phase 2 clinical trial (CRDF-004) in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab for RAS-mutated mCRC patients [2]. - Initial data from the ongoing CRDF-004 trial was announced in December 2024, with additional clinical data expected in the first half of 2025 [2]. Group 3: Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing therapies leveraging PLK1 inhibition for various cancers, with onvansertib as its lead asset [3]. - The company is targeting treatment-resistant tumors and aims to deliver superior clinical benefits compared to standard of care in indications such as mCRC, metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple-negative breast cancer [3].
BriaCell Announces Four Clinical Data Presentations at ASCO 2025
Newsfilter· 2025-04-23 11:30
PHILADELPHIA and VANCOUVER, British Columbia, April 23, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ:BCTX, BCTXW)) (TSX:BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce three clinical data poster presentations and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL. The details ...