Core Viewpoint - Maravai LifeSciences Holdings, Inc. is under investigation for potential claims related to a class action complaint alleging breaches of fiduciary duties by its board of directors during a specified class period [1] Financial Reporting 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] Class Action Allegations - The class action complaint alleges that Maravai's executives made materially false and misleading statements and failed to disclose adverse facts about the company's operations and financial reporting [3] - Specific allegations include inadequate internal controls over financial reporting, inaccurate revenue recognition, overstated goodwill, and misleading positive statements about the company's business prospects [3]

Core Viewpoint - Iovance Biotherapeutics Inc. is undergoing a leadership transition with the resignation of CFO Jean-Marc Bellemin amid commercial challenges and a class-action lawsuit related to its flagship drug Amtagvi [1][2][3]. Group 1: Leadership Transition - CFO Jean-Marc Bellemin will resign effective July 10, 2025, to pursue other endeavors, having held the position since November 2020 [1][2]. - The company has not yet named a successor for the CFO role, creating uncertainty during a challenging period [2]. Group 2: Commercial Challenges - Iovance's first-quarter sales for Amtagvi significantly underperformed expectations, leading to a downward revision of full-year revenue projections [3]. - The company's stock price fell over 44%, from $3.17 on May 8, 2025, to $1.75 by the close of trading on May 9, 2025, reflecting investor concerns about commercial execution [7]. Group 3: Legal Issues - Iovance is facing a class-action lawsuit alleging securities fraud related to the company's portrayal of its authorized treatment centers (ATCs) and their role in driving demand for Amtagvi [4][5]. - The lawsuit claims that ATCs experienced delays in initiating treatments and inefficiencies in patient selection, leading to higher patient drop-off rates [5][6]. - Hagens Berman is investigating the allegations to determine if the company's public statements were consistent with internal realities [8].

ProKidney (PROK 515.00%) shares closed at $3.73, rising 515% today while the S&P 500 fell 0.1% and the Dow Jones Industrial Average dropped 0.4%.The chronic kidney disease-focused biotech experienced significant volatility, trading between $0.46 and $4.86 before settling near its upper range. The gain follows ProKidney's announcement of statistically and clinically meaningful topline results from its Phase 2 REGEN-007 clinical trial evaluating is autologous cell therapy treatment, called rilparencel, in pat ...

My name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio University, Athens, OH, USA, a graduate degree in Business Management from Universidad Andina Simon Bolivar, Quito, Ecuador, and the Ph.D. degree in computer applications from the University of Alicante, Spain.Disclosure: I collaborate professionally with Edgar Torres H, who is also an author on Seeking ...

Core Viewpoint - Emergent BioSolutions Inc. has secured a contract modification to deliver Vaccinia Immune Globulin Intravenous (Human) (VIGIV) to the U.S. Department of Health and Human Services for smallpox preparedness, highlighting the company's ongoing partnership with the U.S. government [1][2]. Group 1: Contract and Partnership - The contract modification involves additional doses of VIGIV, a treatment for complications arising from smallpox vaccination, under an existing 10-year contract with the Administration for Strategic Preparedness and Response (ASPR) [1]. - This modification follows a recent contract amendment for Botulism Antitoxin Heptavalent (BAT) with ASPR, indicating a broader collaboration between Emergent and the U.S. government in public health preparedness [2]. Group 2: Product Information - VIGIV is indicated for treating complications due to vaccinia vaccination, including severe generalized vaccinia and eczema vaccinatum, but is not indicated for postvaccinial encephalitis [3][4]. - The product has specific contraindications, including isolated vaccinia keratitis and severe allergic reactions to human globulins [4]. Group 3: Safety Information - Important safety information for VIGIV includes potential interactions with glucose monitoring systems, which may lead to falsely elevated blood glucose readings [3]. - Common adverse reactions reported in clinical trials for VIGIV include headache, nausea, rigors, and dizziness, with more than 10% of patients experiencing these effects [6].

WALTHAM, Mass. and BOULDER, Colo., July 08, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that it has commenced an underwritten public offering of $150 million of its shares of common stock. In addition, Cogent intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of its shares of common stock on the same terms and conditions. All o ...

Medium and high doses improved movement quality in up to 100% of the animals in a dose-dependent manner Figure 1- SCI motor function after different doses of ExoPTEN (A) Paw use detected by the CatWalk XT camera.(B-F) CatWalk XT gait analysis demonstrates dose-dependent functional improvement following ExoPTEN treatment:B – % of hindlimbs recorded by CatWalk XT gait analysis system, recording of prints by CatWalk XT requires minimal use of leg and weight support, improvement can be seen in a dose dependen ...

RADNOR, Pa., July 8, 2025 /PRNewswire/ -- The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that a securities class action lawsuit has been filed against Sarepta Therapeutics, Inc. ("Sarepta") (NASDAQ: SRPT) on behalf of those who purchased or otherwise acquired Sarepta securities between June 22, 2023, and June 24, 2025, inclusive (the "Class Period"). The lead plaintiff deadline is August 25, 2025.CONTACT KESSLER TOPAZ MELTZER & CHECK, LLP:If you suffered Sarepta losses, ...

CARLSBAD, Calif., July 8, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today that a late-breaking abstract has been accepted for presentation at The Endocrine Society's Annual Meeting (ENDO 2025), taking place July 12-15, 2025 in San Francisco, CA.Details of the poster presentation are below: Title: "TYR ...

- SGT-501 is a novel gene therapy for rare, life-threatening, genetic arrhythmogenic disease with no approved therapies - - SGT-501 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA - - Solid expects to initiate Phase 1b clinical trial of SGT-501 in the fourth quarter of 2025 - - Expands Solid’s clinical pipeline to include first cardiac indication with urgent unmet medical need - CHARLESTOWN, Mass., July 08, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SL ...