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Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer's disease
GlobeNewswire News Room· 2025-07-23 05:10
Elecsys pTau181 is the first In Vitro Diagnostic Regulation (IVDR) certified test to rule out Alzheimer’s associated amyloid pathology.The minimally invasive, blood-based test can serve as a rule out for Alzheimer’s pathology, reducing the need for confirmatory testing with a negative result.Data from clinical study supports use in primary care for people with varying signs of cognitive decline. Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE Mark for its Elecsys® ...
European Commission approves Roche’s Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation
Globenewswire· 2025-07-23 05:00
Approval based on INAVO120 data showing the Itovebi™ (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone1 Up to 40% of ER-positive breast cancers have a PIK3CA mutation and are associated with poor prognosis; this approval helps address an urgent unmet need2-4Itovebi is the first PI3K-targeted therapy to significantly extend survival, reinforcing the need for biomarker testing at diagnosis5 Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: R ...
Chimeric Therapeutics (CHM) 2025 Earnings Call Presentation
2025-07-23 01:00
20 25 CHI MERIC THE RAPEUTICS For personal use only CHIMERIC PIONEERS IN CELL THERAPY CHM ASX: DISCLAIMER Certain statements contained in this presentation, including, without limitation, statements containing the words "believes," "plans," "expects," "anticipates," and words of similar import, constitute "forward-looking statements." Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Chimeric (co ...
MARAVAI INVESTIGATION ALERT: Bragar Eagel & Squire, P.C. Continues Investigation into Maravai LifeSciences Holdings, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-07-22 23:27
Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Maravai LifeSciences Holdings, Inc. due to a class action complaint alleging breaches of fiduciary duties by the board of directors during a specified class period [1][3]. Group 1: Company Financial Issues - On February 25, 2025, Maravai announced a postponement of its fiscal 2024 earnings release and the filing of its annual report due to an error in revenue recognition, which resulted in approximately $3.9 million being incorrectly recorded [2]. - The company identified a material weakness in its internal controls over revenue recognition and required additional time to assess a potential non-cash impairment charge related to goodwill from its acquisition of Alphazyme LLC [2]. - Following this announcement, Maravai's share price fell by $0.87, or 21.70%, closing at $3.14 per share on February 25, 2025, amid unusually heavy trading volume [2]. Group 2: Class Action Allegations - The class action complaint alleges that Maravai's management made materially false and misleading statements and failed to disclose adverse facts about the company's operations and prospects [3]. - Specific allegations include inadequate internal controls over financial reporting related to revenue recognition, inaccurate revenue recognition during fiscal 2024, and overstated goodwill [3]. - The complaint asserts that the positive statements made by the defendants regarding the company's business lacked a reasonable basis due to these undisclosed issues [3].
ALTO CLASS ACTION ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against Alto Neuroscience, Inc. (ANRO) and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-07-22 22:49
Core Viewpoint - A class action lawsuit has been filed against Alto Neuroscience, Inc. for allegedly misleading investors regarding the effectiveness of its drug ALTO-100 during the class period from February 2, 2024, to October 22, 2024 [2][3]. Group 1: Lawsuit Details - The lawsuit is on behalf of all individuals and entities who purchased Alto securities during the specified class period [2]. - Investors have until September 19, 2025, to apply to the Court to be appointed as lead plaintiff in the lawsuit [2]. - The complaint alleges that the Offering Documents for the IPO were negligently prepared and that key information about ALTO-100's effectiveness was not disclosed [3]. Group 2: Impact on Stock Price - On October 22, 2024, Alto announced that ALTO-100 did not meet its primary endpoint in a Phase 2b trial for treating Major Depressive Disorder (MDD), leading to a significant stock price drop [4]. - Following the announcement, Alto's stock price fell by $10.17 per share, or 69.99%, closing at $4.36 per share on October 23, 2024 [4]. Group 3: Contact Information - Investors who suffered losses or have questions regarding the lawsuit can contact Bragar Eagel & Squire, P.C. for more information [5][8].
IQVIA: Q2 Earnings Exceeded My Expectations
Seeking Alpha· 2025-07-22 21:40
Group 1 - The article discusses IQVIA Holdings Inc.'s recent performance, highlighting a revenue of $3.83 billion in Q1, which was driven by growth in the Technology & Analytics Solutions (TAS) segment [1] - The author emphasizes the importance of innovative companies in the biotech and pharmaceutical sectors, particularly those developing breakthrough therapies with potential acquisition catalysts [1] Group 2 - The article is part of a subscription marketplace service called Compounding Healthcare, which offers model healthcare portfolios, a weekly newsletter, and a daily watchlist for investors [1]
X @Bloomberg
Bloomberg· 2025-07-22 21:33
Roche paused all shipments of the controversial gene therapy Elevidys following a similar action by the embattled US biotechnology company that developed the treatment https://t.co/cO5yNWlLjM ...
ABIVAX (ABVX) Update / Briefing Transcript
2025-07-22 21:30
ABIVAX (ABVX) Update / Briefing July 22, 2025 04:30 PM ET Speaker0Hello, and welcome to the Abtech Results Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, Please be advised that today's conference is being recorded. It is now my pleasure to introduce Senior Vice President, Investor Relations, Pat Molloy.Speaker1Great. Thank you, operator, and good afternoon and good e ...
Eupraxia Pharmaceuticals Invited to Present at Upcoming Investor Conferences
Globenewswire· 2025-07-22 21:17
Core Viewpoint - Eupraxia Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on optimizing local, controlled drug delivery through its proprietary DiffuSphere™ technology, addressing significant unmet medical needs in various therapeutic areas [1][3]. Company Overview - Eupraxia is developing locally delivered, extended-release products aimed at therapeutic areas with high unmet medical need, utilizing its DiffuSphere™ technology for targeted drug delivery [3]. - The technology is designed to enhance the safety, tolerability, efficacy, and duration of effect of existing FDA-approved drugs, with potential applications extending beyond pain and inflammatory gastrointestinal diseases to oncology and infectious diseases [3]. Clinical Trials and Pipeline - Eupraxia's EP-104GI is currently in a Phase 1b/2 trial (RESOLVE trial) for treating eosinophilic esophagitis (EoE), utilizing a unique injection method for local drug delivery [4]. - The company recently completed a Phase 2b clinical trial (SPRINGBOARD) for EP-104IAR, targeting pain from knee osteoarthritis, achieving its primary endpoint and three of four secondary endpoints [4]. - Eupraxia is also developing a pipeline of long-acting formulations for other inflammatory joint conditions and oncology, aimed at improving the activity and tolerability of currently approved drugs [4]. Upcoming Investor Conferences - Eupraxia's management will present at several upcoming investor conferences, including: - Canaccord Growth 45th Annual Growth Conference on August 13, 2025, in Boston, MA [2]. - Citi Biopharma Back to School Conference on September 2-3, 2025, in Boston, MA [2]. - Cantor Global Healthcare Conference on September 5, 2025, in New York, NY [2]. - H.C. Wainwright 27th Annual Global Investment Conference on September 8-10, 2025, in New York, NY [2].
DBV Technologies Announces Appointment of James Briggs as Chief Human Resources Officer
Globenewswire· 2025-07-22 20:30
Châtillon, France, July 22, 2025 DBV Technologies Announces Appointment of James Briggs as Chief Human Resources Officer DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Market: DBVT), a clinical-stage biopharmaceutical company, today announced the appointment of James Briggs as its Chief Human Resources Officer, succeeding Caroline Daniere. An experienced human capital executive, James will lead key initiatives as DBV transitions from a development-stage biotechnology company to a potential c ...