Shares of Sonnet BioTherapeutics (NASDAQ: SONN) soared in pre-market trading on Monday after the company announced a $888 million business combination to pivot into the cryptocurrency sector.Sonnet’s stock, which closed at $5.17 on Friday, traded as high as $18.68 in pre-market hours, marking a 265% jump. Year-to-date, SONN shares have already gained more than 220%. By press time, the stock was down slightly, trading about 2% lower on the day.SONN one-day stock price chart. Source: Google FinanceThe momentu ...

Core Viewpoint - Ascentage Pharma Group International Inc. is conducting an offshore placement of ordinary shares to raise funds for commercialization, clinical development, and operational strengthening [1][2]. Group 1: Offshore Placement Details - The Dajun Yang Dynasty Trust, affiliated with the CEO, will offer ordinary shares in an offshore transaction to non-U.S. persons under Regulation S of the Securities Act [1]. - The Vendor will subscribe for new ordinary shares equal to the number of Placement Shares offered, at the same price per share [1]. - The transaction is subject to customary closing conditions and will occur after the Offshore Placement [1]. Group 2: Use of Proceeds - The net proceeds from the Offshore Placement will be utilized for commercialization efforts, expanding patient access, global clinical development of core pipeline candidates, and enhancing infrastructure and working capital [2]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [5]. - The lead asset, olverembatinib, is approved in China for treating specific types of chronic myeloid leukemia (CML) and is undergoing a global Phase III trial [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global Phase III trials [7]. Group 4: Partnerships and Collaborations - Ascentage Pharma has established a portfolio of global intellectual property rights and partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer, as well as research institutions like Dana-Farber Cancer Institute and Mayo Clinic [8].

PRESS RELEASE OMass Therapeutics Presents Positive Preclinical Data For its Best-in-class MC2 Program at ENDO 2025 OMS1620 is advancing through IND-enabling studies for diseases associated with ACTH excess, including congenital adrenal hyperplasiaDesigned to resist competition from endogenous ACTH by maximizing receptor residency timeOMS1620 demonstrates best-in-class efficacy in acute and chronic preclinical models of ACTH excess Oxford, United Kingdom – 14th July 2025 – OMass Therapeutics (‘OMass’ or ‘the ...

Core Insights - CARsgen Therapeutics Holdings Limited has achieved a favorable outcome in opposition proceedings regarding its European patent EP3445407, which pertains to its GPC3-targeted CAR-T cell therapy [1][4] - A U.S.-based biotechnology company, the sole appellant among the original two opponents, has formally withdrawn its appeal against the EPO's decision to maintain the patent, making the decision final and binding [2][3] - The EPO granted the patent in 2022, and it was opposed by two parties in 2023, but the EPO upheld key claims related to the use of GPC3 CAR-T cell therapy for various cancers [3][4] Company Overview - CARsgen is a biopharmaceutical company focused on developing innovative CAR T-cell therapies to address unmet clinical needs, including hematologic malignancies, solid tumors, and autoimmune diseases [5] - The company has established comprehensive capabilities for CAR T-cell research and development, covering target discovery, preclinical research, clinical development, and commercial-scale production [5] - CARsgen aims to improve the safety profile, enhance efficacy in treating solid tumors, and reduce treatment costs, with a mission to become a global leader in providing innovative cell therapies [5]

Core Insights - Rhythm Pharmaceuticals presented new data on acquired hypothalamic obesity at the Endocrine Society's Annual Meeting (ENDO 2025), highlighting the efficacy of setmelanotide and bivamelagon in reducing body mass index (BMI) in affected patients [1][2][3]. Group 1: Clinical Data and Efficacy - The Phase 2 SIGNAL trial demonstrated that bivamelagon, a daily oral MC4R agonist, achieved statistically significant and clinically meaningful reductions in BMI over 14 weeks [2]. - The Phase 3 TRANSCEND trial showed setmelanotide resulted in a -9.3% BMI reduction in the 600mg cohort, -7.7% in the 400mg cohort, and -2.7% in the 200mg cohort, with a placebo cohort showing a 2.2% increase in BMI [4][5]. - A placebo-adjusted difference of -19.8% in BMI reduction was observed across 120 participants, with significant reductions noted in various age and sex subgroups [5][6]. Group 2: Patient Impact and Future Potential - The data from the trials suggest that both bivamelagon and setmelanotide could become transformative therapeutic options for patients with acquired hypothalamic obesity, potentially establishing a new standard of care [2][4]. - Rhythm estimates that there are between 5,000 to 10,000 individuals living with hypothalamic obesity in the U.S., indicating a significant patient population that could benefit from these treatments [11]. Group 3: Company Overview - Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, with its lead asset, setmelanotide, approved for treating obesity related to specific genetic conditions [9][12]. - The company is advancing a broad clinical development program for setmelanotide and other investigational MC4R agonists, indicating a commitment to expanding treatment options for patients with rare diseases [9].

Core Insights - Rhythm Pharmaceuticals presented new data on acquired hypothalamic obesity at the Endocrine Society's Annual Meeting (ENDO 2025), highlighting the efficacy of setmelanotide and bivamelagon in reducing body mass index (BMI) in affected patients [1][2][3] Group 1: Clinical Data and Efficacy - The Phase 3 TRANSCEND trial demonstrated significant BMI reductions with setmelanotide, showing a -9.3% reduction in the 600mg cohort, -7.7% in the 400mg cohort, and -2.7% in the 200mg cohort, while the placebo cohort experienced a 2.2% increase [4][5] - A placebo-adjusted difference of -19.8% in BMI reduction was observed across 120 participants, with significant reductions noted in various age and sex subgroups [5][6] - Bivamelagon, a daily oral MC4R agonist, also showed statistically significant BMI reductions in a Phase 2 trial, indicating its potential as a transformative treatment option for patients with acquired hypothalamic obesity [2][3] Group 2: Patient Population and Market Potential - Acquired hypothalamic obesity is a rare condition affecting an estimated 5,000 to 10,000 individuals in the U.S., with similar prevalence in Japan and the E.U. [11][10] - The condition is characterized by rapid weight gain and hyperphagia due to damage to the hypothalamic region of the brain, often following brain tumors or their treatment [10][11] - The presentations at ENDO 2025 underscore the potential for MC4R-targeted therapies to become the standard of care for this patient community if approved [2][3]

Core Viewpoint - A lawsuit has been filed against Iovance Biotherapeutics, Inc. and certain senior executives for potential violations of federal securities laws, with claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 [1][2]. Group 1: Company Overview - Iovance Biotherapeutics is a commercial-stage biopharmaceutical company focused on developing treatments for melanoma and other solid tumor cancers [3]. - The company launched its key melanoma treatment, Amtagvi, in February 2024, which is administered at authorized treatment centers (ATCs) [3]. Group 2: Allegations and Issues - The lawsuit alleges that Iovance misrepresented the effectiveness of its ATCs as a driver of demand for Amtagvi, while in reality, these centers faced long timelines for patient treatment and high patient drop-off rates due to ineffective patient identification and selection [4]. - Following disappointing financial results for Q1 2025, Iovance revised its full-year 2025 revenue guidance, attributing the poor performance to slow treatment timelines and high patient drop-off rates [5]. Group 3: Stock Performance - On May 8, 2025, Iovance's stock price fell over 44%, dropping from $3.17 per share to $1.75 per share the following day, in response to the negative news regarding its financial results and operational challenges [6].

Core Viewpoint - A lawsuit has been filed against Organon & Co. and its senior executives for potential violations of federal securities laws, particularly related to misleading statements about the company's dividend policy following a significant acquisition [1][2]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the District of New Jersey, titled Hauser v. Organon & Co., et al., No. 25-cv-05322, and investors have until July 22, 2025, to seek lead plaintiff status [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Organon securities [2]. Group 2: Company Background and Acquisition - Organon is a global healthcare company focused on women's health, known for rewarding shareholders with dividends [3]. - In October 2024, Organon completed a $1.2 billion acquisition of Dermavant, a biopharmaceutical company, which increased the company's debt [3]. Group 3: Dividend Policy and Stock Performance - Following the acquisition, Organon assured investors it would maintain its dividend, claiming it was the "1 capital allocation priority," but later shifted focus to debt reduction, leading to a significant dividend cut [3]. - On May 1, 2025, Organon announced a reduction in its dividend payout from $0.28 per share to $0.02 per share, resulting in a stock price decline of approximately 27%, from $12.93 to $9.45 per share [4].

Core Viewpoint - The FDA issued a Complete Response Letter (CRL) for Ultragenyx's Biologics License Application (BLA) for UX111, a gene therapy for Sanfilippo syndrome type A, citing specific chemistry, manufacturing, and controls (CMC) observations that are resolvable [1][2] Group 1: Company Overview - Ultragenyx Pharmaceutical Inc. is focused on developing therapies for rare and ultra-rare genetic diseases, with a diverse portfolio aimed at addressing high unmet medical needs [6] - The company is led by a management team experienced in rare disease therapeutics, emphasizing time- and cost-efficient drug development [7] Group 2: Product Information - UX111 is an in vivo gene therapy in Phase 1/2/3 development for Sanfilippo syndrome type A (MPS IIIA), a rare fatal lysosomal storage disease with no approved treatment [4] - The therapy targets the SGSH enzyme deficiency, which leads to the accumulation of heparan sulfate in the brain, causing neurodegeneration [4] - UX111 is administered via a one-time intravenous infusion using a self-complementary AAV9 vector to deliver a functional copy of the SGSH gene [4] Group 3: Regulatory Status - The FDA's CRL did not raise any issues regarding the clinical data package or clinical inspections, acknowledging the robustness of the neurodevelopmental outcome data and supportive biomarker data [3] - The company plans to address the CMC observations and resubmit the BLA, anticipating a review period of up to 6 months post-resubmission [2][3] Group 4: Disease Context - Sanfilippo syndrome type A (MPS IIIA) affects approximately 3,000 to 5,000 patients in commercially accessible areas, characterized by rapid neurodegeneration and a median life expectancy of 15 years [5] - The disease is caused by biallelic pathogenic variants in the SGSH gene, leading to a deficiency in the sulfamidase enzyme [5]

JENA, Germany, July 11, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it has received a written notice (the “Notice”), dated July 11, 2025, from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty (30) consecutive business days, the bid price for the Company’s common shares had closed below the minimum $1.00 pe ...