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Apogee Therapeutics: Funding Supports Best-In-Class Ambitions In Atopic Dermatitis
Seeking Alpha· 2025-07-08 20:50
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 ...
Emergent BioSolutions Secures $51.9 Million Contract Modification Award for CNJ-016® [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV) as part of U.S. Biodefense Preparedness Efforts
Globenewswire· 2025-07-08 20:45
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].
Cogent Biosciences Announces Proposed $150 Million Public Offering of Common Stock
Globenewswire· 2025-07-08 20:26
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 ...
New ExoPTEN Preclinical Study Indicates Significant Improvement in Walking Quality in Spinal Cord Injury Model
Globenewswire· 2025-07-08 20:24
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 ...
Class Action Announcement for Sarepta Therapeutics, Inc. (SRPT): Kessler Topaz Meltzer & Check, LLP Announces that a Securities Class Action Lawsuit Has Been Filed Against Sarepta Therapeutics, Inc.
Prnewswire· 2025-07-08 20:12
Core Viewpoint - A securities class action lawsuit has been filed against Sarepta Therapeutics, Inc. for allegedly misleading investors regarding the safety and efficacy of its gene therapy treatment, ELEVIDYS, during the specified Class Period from June 22, 2023, to June 24, 2025 [1][2]. Group 1: Allegations Against Sarepta - The lawsuit claims that Sarepta made false or misleading statements about the safety risks associated with its gene therapy treatment, ELEVIDYS [2]. - It is alleged that the trial protocols for ELEVIDYS failed to identify severe side effects, which could lead to regulatory scrutiny and halt recruitment and dosing in ongoing trials [2]. - The severity of adverse events from ELEVIDYS treatment is said to have been downplayed, resulting in materially misleading statements from the company [2]. Group 2: Lead Plaintiff Process - Investors in Sarepta have until August 25, 2025, to apply to be appointed as lead plaintiffs, representing the interests of the class in the litigation [3]. - The lead plaintiff is typically the investor or small group of investors with the largest financial stake in the case [3]. - Participation as a lead plaintiff does not affect the ability of other investors to share in any potential recovery from the lawsuit [3]. Group 3: Firm Information - Kessler Topaz Meltzer & Check, LLP is the law firm handling the class action and has a reputation for prosecuting class actions and recovering significant amounts for victims of corporate misconduct [4]. - The firm encourages affected investors to reach out for more information regarding the lawsuit [4].
Tyra Biosciences Announces Late-Breaking Poster Presentation on TYRA-300 Preclinical Results at ENDO 2025
Prnewswire· 2025-07-08 20:05
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 ...
Solid Biosciences Announces FDA IND and Health Canada CTA Approval for First-in-Class Cardiac Gene Therapy to Treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Globenewswire· 2025-07-08 20:05
Core Insights - Solid Biosciences has announced the approval of its Investigational New Drug (IND) application for SGT-501, a novel gene therapy for catecholaminergic polymorphic ventricular tachycardia (CPVT), a rare and life-threatening cardiac condition [1][2][3] - SGT-501 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA, indicating its potential as a first-in-class therapy [1][3] - The company plans to initiate a Phase 1b clinical trial for SGT-501 in the fourth quarter of 2025, expanding its clinical pipeline to address urgent unmet medical needs in cardiac diseases [1][2] Company Overview - Solid Biosciences is focused on developing precision genetic medicines for neuromuscular and cardiac diseases, including Duchenne muscular dystrophy and CPVT [10] - The company aims to improve the lives of patients with rare diseases through innovative gene therapy approaches [10] Scientific Background - SGT-501 is designed to deliver a functional copy of the human cardiac calsequestrin (CASQ2) gene to heart muscle cells, which may stabilize the ryanodine receptor (RYR2) and reduce the risk of ventricular tachycardia [3][4] - The therapy is based on research conducted by Dr. Silvia Priori and the IRCCS ICS Maugeri lab, which demonstrated the therapeutic potential of calsequestrin overexpression in CPVT models [4][5] Disease Context - CPVT is characterized by abnormal heart rhythms triggered by stress or physical activity, leading to severe outcomes such as fainting, seizures, and sudden death [5][6] - It is estimated to affect approximately 1 in 10,000 individuals globally, often misdiagnosed, and currently lacks approved treatments that address its underlying mechanisms [5][6]
3 Top Earnings Acceleration Stocks to Buy for 2H25
ZACKS· 2025-07-08 20:01
Core Insights - The focus on steady earnings growth is essential for assessing a company's profitability, but rapid earnings growth can significantly drive stock prices higher [1] - Research indicates that stocks with accelerating earnings often see their prices increase subsequently [1] Earnings Acceleration - Earnings acceleration refers to the incremental growth in a company's earnings per share (EPS), characterized by an increase in quarter-over-quarter earnings growth rates [3] - This metric helps identify stocks that have not yet attracted investor attention, potentially leading to a price rally once recognized [4] Screening Parameters - The screening process involves identifying stocks where the last two quarter-over-quarter EPS growth rates exceed previous periods' growth rates, with projected EPS growth rates for the upcoming quarter expected to surpass prior periods [6][7][8] - Additional criteria include a current price of at least $5 and an average 20-day trading volume of 50,000 or more to ensure adequate liquidity [8] Identified Stocks - The screening narrowed down to three stocks: Yext, Agenus, and NCR Voyix, all showing strong earnings acceleration [9] - NCR Voyix leads with an expected EPS growth rate of 152.7%, followed by Agenus at 114.7% and Yext at 37.1% for the current year [9] Company Profiles - **Yext**: Provides a platform for consumer inquiries globally, with an expected earnings growth rate of 37.1% [10] - **Agenus**: A biotechnology firm focused on developing immune therapies for cancer and infections, with an expected earnings growth rate of 114.7% [11] - **NCR Voyix**: Offers digital commerce solutions for retail and dining, with an expected earnings growth rate of 152.7% [12]
Levi & Korsinsky Notifies Shareholders of Rocket Pharmaceuticals, Inc.(RCKT) of a Class Action Lawsuit and an Upcoming Deadline
GlobeNewswire News Room· 2025-07-08 19:49
Core Viewpoint - Rocket Pharmaceuticals, Inc. is facing a class action securities lawsuit due to alleged securities fraud related to the safety and clinical trial protocol of its RP-A501 treatment, which resulted in a significant stock price decline after the FDA placed a clinical hold on the study [1][2]. Group 1: Lawsuit Details - The lawsuit seeks to recover losses for investors affected by alleged securities fraud between February 27, 2025, and May 26, 2025 [1]. - Defendants allegedly provided misleading statements about the safety of RP-A501 while concealing serious adverse events, including participant deaths during the clinical trial [2]. - Following the announcement of the FDA's clinical hold on May 27, 2025, Rocket's stock price plummeted from $6.27 to $2.33 per share, a decline of approximately 37% in one trading day [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the relevant time frame have until August 11, 2025, to request appointment as lead plaintiff, although participation does not require this role [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years [4]. - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as a leading securities litigation firm in the United States [4].
Artelo Biosciences Analyst See It As An Emerging Biotech
Benzinga· 2025-07-08 19:06
Core Viewpoint - Artelo Biosciences, Inc. has been upgraded from Hold to Buy by D. Boral Capital, with a price target of $20, highlighting its focus on Cachexia and chemotherapy-induced peripheral neuropathy (CIN) [1] Group 1: Drug Development and Pipeline - ART27.13, a Phase 2 asset, is a selective benzimadazole agonist acquired from AstraZeneca, showing potential to stimulate appetite and promote weight gain, which could improve the quality of life for cancer patients [1][2] - ART26.12, another asset licensed from the University of Stonybrook, appears to protect nerves from damage without compromising chemotherapy efficacy, with favorable results from its first-in-human study affirming its safety and pharmacokinetic profile [3] - New preclinical data on ART12.11, a Cannabidiol and Tetramethylpyrazine cocrystal drug candidate, was presented, indicating its potential for treating depression and anxiety, particularly in patients with cognitive dysfunction [4][6] Group 2: Efficacy and Market Position - ART12.11 demonstrated significant behavioral improvements in male rats under chronic stress, showing efficacy comparable to sertraline (Zoloft), a leading SSRI, while also reversing stress-induced memory deficits [6][7] - Artelo Biosciences stock increased by 14.66% to $16.42 following these developments, reflecting positive market sentiment [6]