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][3]. 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 - 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]. 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, administered at authorized treatment centers (ATCs) [3]. 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, citing slow treatment timelines and high patient drop-off as contributing factors [5]. 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 performance and operational challenges [6].

Core Viewpoint - VYNE Therapeutics Inc. is advancing its VYN202 program for treating moderate-to-severe plaque psoriasis after the FDA lifted a clinical hold for female patients on lower doses, while further data is needed for male subjects [1][2][4] VYN202 Program Update - The FDA placed a clinical hold on the Phase 1b trial due to testicular toxicity observed in dogs, but has now lifted the hold for female patients on 0.25 mg and 0.5 mg doses [2] - The 1 mg dose was excluded from the revised protocol due to a lower safety margin [2] - A 12-week non-clinical toxicology study is required to resume trials in male subjects, with the study design agreed upon with the FDA [2] Clinical Data Insights - The clinical data from the Phase 1b trial included 7 enrolled subjects, with 6 treated with VYN202 and 1 with placebo [3][5] - No serious adverse events or treatment discontinuations were reported, and all subjects treated with VYN202 showed improvement in psoriasis symptoms [7] - PASI scores improved by approximately 27% after 1 week and up to 90% by week 8 [7] - Significant reductions in serum cytokine levels were observed in subjects treated with VYN202, while no changes were noted in the placebo group [7] Future Plans and Financial Outlook - The company will not enroll new patients in the Phase 1b psoriasis study, extending its expected cash runway into Q4 2026 [4] - Further updates on the VYN202 program will follow the release of top-line results from the ongoing Phase 2b study of repibresib gel for non-segmental vitiligo [4] About VYN202 - VYN202 is an oral small molecule BET inhibitor with potential class-leading selectivity and potency for BD2, aimed at providing a non-biologic treatment option for immuno-inflammatory conditions [10] About VYNE Therapeutics Inc. - VYNE is focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions, leveraging its proprietary BET inhibitors to overcome limitations of earlier generations [11]

Core Viewpoint - The merger between Channel Therapeutics Corporation and LNHC, Inc. has been completed, leading to the formation of Pelthos Therapeutics Inc., which will focus on launching ZELSUVMI™ for treating molluscum contagiosum infections starting July 2025 [1][2]. Company Overview - Pelthos Therapeutics Inc. is a biopharmaceutical company dedicated to commercializing innovative therapeutic products for high unmet patient needs [1][7]. - The company will trade on the NYSE American exchange under the ticker symbol "PTHS" beginning July 2, 2025 [1]. Merger Details - The merger involved CHRO Merger Sub Inc., a subsidiary of Channel Therapeutics, merging with LNHC, Inc., a subsidiary of Ligand Pharmaceuticals, with LNHC continuing as a subsidiary of Channel [1]. - The merger is seen as a significant milestone for Pelthos, facilitating the launch of ZELSUVMI™ and creating shareholder value [2][5]. Financial Aspects - Concurrent with the merger, Pelthos closed a $50.1 million equity private placement from strategic investors, which includes the cancellation of approximately $18.8 million in bridge capital previously advanced to support ZELSUVMI™'s commercial launch [3][5]. - The private placement involves investments in Series A Convertible Preferred Stock and common stock [3]. Product Information - ZELSUVMI™ (berdazimer) is a topical gel approved for treating molluscum contagiosum in adults and pediatric patients aged one year and older [4][6]. - It is the first and only prescription medication for this condition that can be administered at home, making it a novel treatment option [4][6]. - The product was developed using Pelthos' proprietary nitric oxide-based technology platform, NITRICIL™ [6]. Market Opportunity - Molluscum contagiosum is a common skin infection affecting an estimated 16.7 million people in the United States, indicating a significant market opportunity for ZELSUVMI™ [4].

Core Insights - The combination treatment of mTNX-1700 with anti-PD1 antibody has shown increased survival and decreased metastases in animal models of gastric cancer compared to anti-PD1 treatment alone [1][3] - mTNX-1700 activates cancer-killing CD8+ T cells and limits neutrophil-mediated immune evasion, indicating its potential in overcoming resistance to anti-PD-1 immunotherapy [1][2] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, focusing on immunology and oncology [1][7] - The company is developing TNX-1700, a fusion protein for the treatment of gastric and colorectal cancers, under a license from Columbia University [4][5] Research Findings - The study published in Cancer Cell demonstrates that mTNX-1700 in combination with anti-PD-1 therapy shrank primary tumors, reduced liver and lung metastases, and increased survival in mouse models [2][3] - The research highlights the role of Trefoil Factor 2 (TFF2) in reducing immunosuppressive neutrophils and enhancing anti-tumoral CD8+ T cell responses [3][4] Future Development - Tonix Pharmaceuticals aims to further develop TNX-1700 to address the challenges of anti-PD-1 resistant cancers, with ongoing studies to identify potential clinical biomarkers [2][3] - The collaboration with Columbia University is expected to enhance understanding of TFF2's role in the tumor microenvironment and its impact on immunotherapy resistance [3][4]

Core Insights - Pelthos Therapeutics Inc. is set to launch ZELSUVMI™ for treating Molluscum contagiosum infections in July 2025, following the completion of a merger with Channel Therapeutics Corporation [1][2] - Ligand Pharmaceuticals has invested $18 million in Pelthos and will receive a 13% royalty on worldwide sales of ZELSUVMI [1][2] - Pelthos will begin trading on the NYSE American exchange under the ticker symbol "PTHS" on July 2, 2025 [1] Company Developments - The merger between Ligand's subsidiary LNHC, Inc. and Channel Merger Sub Inc. has been completed, forming Pelthos Therapeutics Inc. [1][2] - Pelthos raised $50.1 million in equity capital, with $32 million from a group of strategic investors and $18 million from Ligand [2] - The capital raised will support the commercial launch of ZELSUVMI and includes the cancellation of approximately $18.8 million in bridge capital previously advanced to Pelthos [2] Product Information - ZELSUVMI (berdazimer) is a topical gel approved for treating Molluscum contagiosum, a common skin infection affecting an estimated 16.7 million people in the U.S. [3] - It is the first and only prescription medication for this condition that can be administered at home by patients or caregivers [3] - Pelthos is also evaluating the development of Channel's existing NaV 1.7 programs for various types of chronic pain and post-surgical nerve blocks [3]

Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics [2] - The company aims to deliver sustainable growth through its Rare Disease business, Generics business, and Brands business [2] Recent Developments - Nikhil Lalwani, President and CEO of ANI Pharmaceuticals, will host 1x1 meetings at the Leerink Partners Therapeutics Forum: I&I and Metabolism on July 8, 2025, in Boston, MA [1]

Core Insights - Instil Bio, Inc. has received FDA clearance for the Investigational New Drug (IND) application for AXN-2510, a bispecific antibody targeting PD-L1 and VEGF, aimed at treating multiple solid tumors [1][3] - The company plans to initiate a phase 1 trial of AXN-2510 as a monotherapy for patients with relapsed/refractory solid tumors before the end of 2025 [2] - Initial safety and efficacy results from a phase 2 trial of AXN-2510 in combination with chemotherapy for first-line non-small cell lung cancer (NSCLC) in China are expected to be shared in the second half of 2025 [1][2] Company Overview - Instil Bio is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies [3] - The lead asset, AXN-2510, is positioned as a differentiated treatment option for various solid tumors [3]

SAN DIEGO, July 1, 2025 /PRNewswire/ -- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Sarepta Therapeutics, Inc. (NASDAQ; SRPT) securities between June 22, 2023 and June 24, 2025, both dates inclusive (the "Class Period"), have until August 25, 2025 to seek appointment as lead plaintiff of the Sarepta class action lawsuit.  Captioned Dolgicer v. Sarepta Therapeutics, Inc., No. 25-cv-05317 (S.D.N.Y.), the Sarepta class action lawsuit charges Sarepta as well as certain of Sarepta' ...

Core Insights - Cue Biopharma, Inc. has reported promising results from its Phase 1 trial of CUE-101, showing an overall response rate (ORR) of 50% in treatment-naïve patients with recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) [3] - The 12-month overall survival (OS) rate is 88%, indicating a significant reduction in the risk of death compared to historical data [3] - The median overall survival (mOS) is currently estimated at 32 months [3] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics aimed at selectively engaging and modulating disease-specific T cells for treating autoimmune diseases and cancer [2][7] - The company's proprietary platform, Immuno-STAT™, is designed to harness the body's immune system without the adverse effects associated with broad systemic immune modulation [7] Product Details - CUE-101 is the most advanced clinical stage drug candidate from the CUE-100 series, designed to activate and expand HPV16 tumor-specific T cells [6] - The mechanism of action involves presenting two signals to T cells: one from the HPV E7 protein and another from an engineered IL-2 variant [6] - The CUE-100 series consists of Fc-fusion biologics that selectively target and activate tumor-specific T cells while minimizing systemic activation and potential toxicities [5] Clinical Trial Insights - The Phase 1 trial of CUE-101 is fully enrolled and evaluates the drug as a monotherapy and in combination with pembrolizumab (KEYTRUDA) for HPV16+ driven recurrent/metastatic HNSCC [6] - The trial results indicate that CUE-101 may represent a breakthrough therapeutic approach for patients battling HNSCC, as stated by the company's chief medical officer [4]