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Gold Falls 1%; ProKidney Shares Spike Higher
Benzinga· 2025-07-08 17:25
Market Overview - U.S. stocks showed mixed performance with the Dow Jones index declining by 0.35% to 44,249.09, while the NASDAQ increased by 0.07% to 20,427.63 and the S&P 500 fell by 0.03% to 6,228.39 [1] - Energy shares experienced a notable increase of 2.1%, while utilities stocks decreased by 1.9% [1] Used Vehicle Market - The US Manheim Used Vehicle Value Index rose by 1.6% month-over-month for June, following a 1.4% decline in May [2][11] Commodity Market - Oil prices increased by 0.3% to $68.14, while gold prices decreased by 1.1% to $3,306.90. Silver fell by 0.8% to $36.625, and copper dropped by 0.5% to $5.0000 [5] European Market - European shares showed positive movement with the eurozone's STOXX 600 rising by 0.40%, Spain's IBEX 35 Index up by 0.10%, London's FTSE 100 gaining 0.46%, Germany's DAX 40 increasing by 0.68%, and France's CAC 40 rising by 0.46% [6] Asian Market - Asian markets closed higher, with Japan's Nikkei gaining 0.26%, Hong Kong's Hang Seng climbing 1.09%, China's Shanghai Composite increasing by 0.70%, and India's BSE Sensex rising by 0.32% [7] Company News - ENDRA Life Sciences Inc. saw its shares surge by 134% to $8.10 after announcing a US patent for a "Radio Frequency Applicator" [9] - ProKidney Corp. shares surged by 218% to $1.95 following positive topline results from its Phase 2 REGEN-007 trial for chronic kidney disease and diabetes [9] - Humacyte, Inc. shares increased by 20% to $2.5750 after receiving Electronic Catalog Listing approval from the US Defense Logistics Agency [9] - Blue Gold Limited shares dropped by 21% to $58.75 after announcing the formation of its inaugural Advisory Board for Blockchain Evolution [9] - Sunrun Inc. shares fell by 11% to $9.84 after President Trump signed an executive order to end clean-energy tax credits [9] - Apogee Therapeutics, Inc. shares decreased by 8% to $36.24 following the release of data from its Phase 2 APEX clinical trial for atopic dermatitis [9]
INNOVENT BIOLOGICS(1801.HK):ADVANCING A BROAD PIPELINE OF NEXT-GENERATION THERAPIES
Ge Long Hui· 2025-07-08 16:35
Maintain BUY. We are positive on the global potential of Innovent's rich innovative pipelines. Innovent is on track to achieve EBITDA breakeven this year. Backed by smooth development of IBI363, we improved our possibility of success for the asset and raised our DCF-based TP to HK$102.95 from HK$94.74. 机构:招银国际 研究员:Jill WU/Andy WANG IBI363 positioned as a promising next-generation IO therapy with Ph3 trials underway. Strong survival benefits and broad potential position IBI363 (PD-1/IL-2) as a potential bloc ...
Report on Carbios’ liquidity contract with Natixis ODDO BHF
Globenewswire· 2025-07-08 16:00
Company Overview - CARBIOS is a biotech company focused on developing and industrializing biological solutions to reinvent the life cycle of plastics and textiles, aiming to reduce pollution and promote a circular economy [4]. - The company has two main technologies: biorecycling of PET and biodegradation of PLA, both of which are reaching industrial and commercial scales [4]. - CARBIOS has been recognized scientifically, including features in prestigious publications like Nature, and collaborates with major brands in various industries to enhance product recyclability [4]. Liquidity Contract and Financial Performance - As of June 30, 2025, CARBIOS reported assets on its liquidity account as part of a contract with Natixis ODDO BHF [2][3]. - The liquidity contract is in accordance with the French Financial Market Authority's regulations established in June 2021 [3]. - For the first half of 2025, the company executed 2,381 buy transactions totaling €2,121,620.77 for 324,721 shares, while sell transactions totaled €2,170,808.76 for 330,062 shares [5][11]. Future Developments - Construction of the world's first industrial biorecycling plant is expected to restart in the second half of 2025, contingent on securing additional funding [4]. - The biorecycling demonstration plant has been operational since 2021, showcasing CARBIOS's commitment to advancing its technologies [4].
Shareholder Alert: The Ademi Firm investigates whether CARGO Therapeutics, Inc. is obtaining a Fair Price for its Public Shareholders
Prnewswire· 2025-07-08 16:00
MILWAUKEE, July 8, 2025 /PRNewswire/ -- The Ademi Firm is investigating CARGO (NASDAQ: CRGX) for possible breaches of fiduciary duty and other violations of law in its transaction with Concentra Biosciences.Click here to learn how to join our investigation and obtain additional information or contact us at [email protected] or toll-free: 866-264-3995. There is no cost or obligation to you.In the transaction, shareholders of CARGO will receive $4.379 in cash per share, plus one non-transferable contingent va ...
COGT Stock Soars on Phase III Systemic Mastocytosis Study Success
ZACKS· 2025-07-08 15:56
Core Insights - Shares of Cogent Biosciences (COGT) increased by 23.4% following the positive results from a late-stage study of bezuclastinib for treating non-advanced systemic mastocytosis (SM) patients [1][7]. Study Results - The phase III SUMMIT study met all primary and key secondary endpoints, showing significant improvements in the treatment of SM patients with bezuclastinib compared to placebo [2][9]. - Bezuclastinib treatment resulted in a mean total symptom score (TSS) reduction of 24.3 points at 24 weeks, compared to a 15.4-point reduction in the placebo group, leading to a placebo-adjusted improvement of 8.91 points [8]. - 87.4% of patients treated with bezuclastinib experienced a ≥50% reduction in serum tryptase levels, a key biomarker, while no patients in the placebo group achieved this [9]. Safety and Tolerability - Bezuclastinib was reported to be well-tolerated with a favorable safety profile, indicating its potential for chronic use in this patient population [10]. Future Plans - Cogent Biosciences plans to submit a new drug application to the FDA for bezuclastinib by the end of 2025, aiming to establish it as a new standard of care for non-advanced SM [11]. - The company is also evaluating bezuclastinib for advanced SM and gastrointestinal stromal tumors in separate pivotal studies, with top-line data expected in the second half of 2025 [12]. Market Performance - Year-to-date, Cogent Biosciences shares have increased by 19.9%, outperforming the industry, which saw a decline of 1.9% [4].
Bayer Begins Phase I/II Study on Cell Therapy for Eye Disease
ZACKS· 2025-07-08 15:36
Core Insights - Bayer's subsidiary, BlueRock Therapeutics, has initiated the first patient treatment in the phase I/IIa CLARICO study with OpCT-001, an investigational iPSC-derived cell therapy for primary photoreceptor diseases [1][9] - OpCT-001 is the first iPSC-derived cell therapy tested in humans for inherited eye diseases, including retinitis pigmentosa and cone-rod dystrophy, which can cause vision loss [2][9] - The CLARICO study aims to evaluate the safety, tolerability, and clinical outcomes of OpCT-001, with a focus on safety in the phase I portion and additional safety and visual function data in the phase II part [4][9] Bayer's Stock Performance - Year-to-date, Bayer's shares have increased by 56.6%, contrasting with a 0.7% decline in the industry [7] Pipeline Developments - Bayer has expanded its pipeline to include cell therapy through the acquisition of BlueRock and gene therapy through AskBio, targeting various diseases including retinal disorders and Parkinson's disease [10] - The FDA has granted Fast Track designation to OpCT-001 for treating primary photoreceptor diseases, indicating potential for significant therapeutic advancements [11] Other Developments - Bayer is also developing bemdaneprocel (BRT-DA01) in a phase III study for Parkinson's disease, which has received Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA [12]
RCKT INVESTOR ALERT: Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In RCKT To Contact Him Directly To Discuss Their Options
Prnewswire· 2025-07-08 15:20
Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In Rocket Pharmaceuticals To Contact Him Directly To Discuss Their OptionsIf you suffered losses exceeding $50,000 in Rocket Pharmaceuticals between February 27, 2025 and May 26, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310).[You may also click here for additional information]NEW YOR ...
DNLI's BLA for Hunter Syndrome Drug Gets FDA's Priority Review
ZACKS· 2025-07-08 15:01
Core Insights - Denali Therapeutics, Inc. (DNLI) has received FDA acceptance for its biologics license application (BLA) for tividenofusp alfa, aimed at treating Hunter syndrome, with a target action date set for January 5, 2026 [1][7] - The acceptance of the BLA marks a significant step for DNLI towards becoming a commercial-stage biotech company, especially as its shares have declined by 30.1% year to date [2] Drug Development and Clinical Trials - Tividenofusp alfa has received Breakthrough Therapy Designation from the FDA for Hunter syndrome, a rare genetic disorder caused by a deficiency in the iduronate 2-sulfatase (IDS) enzyme [3] - The drug is designed to cross the blood-brain barrier, addressing both cognitive and physical symptoms of MPS II, unlike traditional enzyme replacement therapies [4] - The BLA submission is supported by data from a phase I/II study involving 47 participants, and an ongoing phase II/III COMPASS study is expected to provide pivotal data for global regulatory filings [5] Pipeline and Collaborations - Denali is also evaluating DNL126 for Sanfilippo syndrome type A and has engaged in discussions with the FDA for an accelerated development path [9] - Another candidate, DNL593, is being co-developed with Takeda for frontotemporal dementia, with an ongoing phase I/II study [10] - Denali and Biogen are jointly developing a LRRK2 inhibitor for Parkinson's disease, with a global phase IIb study fully enrolled and results expected in 2026 [11] - Denali is also conducting a phase IIa study for LRRK2-associated Parkinson's disease and evaluating DNL343 for amyotrophic lateral sclerosis (ALS), although a primary endpoint was not met in a recent trial [12] - The company has multiple early-stage clinical and preclinical programs and maintains a sound cash position to fund ongoing initiatives [13]
SRPT Investors Have the Opportunity to Lead the Sarepta Securities Fraud Lawsuit with Faruqi & Faruqi, LLP
Prnewswire· 2025-07-08 13:50
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Sarepta Therapeutics, Inc. due to significant losses suffered by investors related to the company's product ELEVIDYS, with a deadline for lead plaintiff applications set for August 25, 2025 [2][4]. Group 1: Legal Investigation and Claims - The law firm is encouraging investors who experienced losses exceeding $100,000 in Sarepta between June 22, 2023, and June 24, 2025, to discuss their legal options [1]. - A federal securities class action has been filed against Sarepta, alleging violations of federal securities laws, including making false or misleading statements regarding the safety and efficacy of ELEVIDYS [4][9]. - The firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [3]. Group 2: Product Safety Issues - The complaint alleges that ELEVIDYS posed significant safety risks, including severe side effects that were not adequately detected during clinical trials [4]. - Following a safety update on March 18, 2025, Sarepta's stock price fell by $27.81 per share, or 27.44%, after a patient died post-treatment with ELEVIDYS [5]. - On April 4, 2025, Sarepta disclosed that regulatory authorities requested a review of the death, leading to a further stock price decline of $4.18 per share, or 7.13% [6]. - A second patient death due to acute liver failure was reported on June 15, 2025, resulting in a significant stock price drop of $15.24 per share, or 42.12% [7][8]. - The FDA issued a Safety Communication on June 24, 2025, regarding the investigation into the risk of acute liver failure associated with ELEVIDYS, causing an additional stock price decline of $1.52 per share, or 8.01% [8][9].
Longeveron® Announces U.S. FDA Approval of IND Application for a Phase 2 Pivotal Registration Study Evaluating Laromestrocel as a Treatment of Pediatric Dilated Cardiomyopathy (DCM)
Globenewswire· 2025-07-08 13:15
Core Insights - Longeveron Inc. has received FDA approval for its IND application for laromestrocel, a stem cell therapy aimed at treating pediatric dilated cardiomyopathy (DCM) [2][4] - The approval allows the company to proceed directly to a Phase 2 pivotal registration clinical trial, anticipated to begin in the first half of 2026 [8] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with laromestrocel being its lead investigational product [6] - Laromestrocel is derived from mesenchymal stem cells (MSCs) and has multiple potential mechanisms of action, including anti-inflammatory and pro-vascular regenerative responses [3][6] Disease Context - DCM is the most common form of cardiomyopathy in children, with 50-60% of pediatric cardiomyopathy cases diagnosed as dilated [5] - Nearly 40% of children diagnosed with DCM may require a heart transplant or may die within two years of diagnosis, highlighting the urgent need for effective treatments [3][8] Clinical Development - The IND approval marks a significant milestone in pediatric cardiovascular treatment, as current therapies primarily manage symptoms rather than address underlying causes [4] - The development program for laromestrocel reinforces Longeveron's commitment to innovative stem cell therapies for rare diseases, particularly in the cardiovascular space [3][4] Market Potential - Pediatric cardiomyopathies affect at least 100,000 children globally, indicating a substantial market opportunity for effective treatment options [8] - The innovative approach of using stem cells to repair damaged heart tissue could represent a groundbreaking development in treating cardiovascular diseases in children [4]