Core Viewpoint - Vanda Pharmaceuticals Inc. (VNDA) shares surged over 40% in after-hours trading following FDA approval of BYSANTI, a new treatment for bipolar I disorder and schizophrenia in adults [1] Group 1: Product Approval and Market Impact - The FDA has approved BYSANTI as a first-line therapy for acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults [1] - BYSANTI is expected to be commercially available in the third quarter of this year [1] - Following the approval, VNDA shares closed at $5.76, down 5.57% during regular trading, but rose to $8.30 in after-hours trading [3] Group 2: Intellectual Property and Future Developments - BYSANTI will be protected by regulatory data exclusivity and U.S. patents, with the last patent expiring in 2044, which supports long-term innovation and patient benefits [2] - This approval marks the second new drug for Vanda in less than two months, following the approval of NEREUS for motion-induced vomiting in December 2025 [3] - A phase 3 trial for BYSANTI as a once-daily adjunctive treatment for major depressive disorder (MDD) is currently underway, with results expected this year [3] Group 3: Stock Performance - VNDA has traded between $3.81 and $9.60 over the past year [3]

FirstEnergy declared quarterly dividends totaling $1.78 per share , a 5% increase from 2024, which Tierney described as consistent with a plan to provide “a solid dividend yield and an attractive total shareholder return.”Tierney said the company deployed $5.6 billion in “customer-focused” capital investments in 2025, nearly 25% higher than the prior year and about 12% above the original plan. He also said distribution reliability metrics improved 10% across the system versus 2024, including “significant” y ...

Core Viewpoint - The company received a complete response letter from the FDA regarding bitopertin, indicating that while there is evidence of its effectiveness in lowering protoporphyrin IX (PPIX), there is uncertainty about whether this reduction can predict clinical benefits [3]. Group 1: Regulatory Update - The FDA's complete response letter highlights sufficient evidence that bitopertin significantly lowers PPIX levels [3]. - However, the FDA expressed uncertainty regarding the correlation between PPIX reduction and actual clinical benefits [3].

Summary of Tango Therapeutics Conference Call Company Overview - **Company**: Tango Therapeutics (NasdaqGM:TNGX) - **New CEO**: Malte Peters, who has been a board member since 2018 and emphasizes continuity in strategy following the transition from former CEO Barbara. Key Priorities and Strategic Focus - **Regulatory Approval**: The primary focus is to achieve regulatory approval for vopimetostat, either as a monotherapy or in combination with RAS inhibitors [4][5]. - **Clinical Development**: Transitioning Tango into a late-phase drug development company is a key priority, with a pivotal trial protocol developed for second-line pancreatic cancer [4][6]. Clinical Trials and Data - **Pivotal Trial for Pancreatic Cancer**: A pivotal trial protocol for second-line pancreatic cancer has been developed, with positive feedback from the FDA regarding trial design and statistical analysis [6][11]. - **Combination Trials**: A combination trial of vopimetostat with RevMed's RAS inhibitors (daraxonrasib and zoldonrasib) has been initiated, showing early signs of clinical activity [6][16]. - **Monotherapy Study**: A 300-patient study is planned, focusing on progression-free survival (PFS) and overall survival [9][12]. - **Promising Data**: Previous monotherapy data indicated a 25% overall response rate (ORR) and approximately 7 months PFS in pancreatic cancer [12]. Market and Competitive Landscape - **Global Trial Design**: The study will be conducted globally, including the USA, Europe, and Asia Pacific, to enhance patient recruitment [11]. - **Chemo-Free Regimen**: There is significant interest in developing a chemotherapy-free regimen for pancreatic cancer, which could greatly benefit patients [37][41]. - **Comparison with Competitors**: Tango is pursuing a different strategy than competitors like BMS, focusing on non-chemotherapy combinations due to scientific and financial considerations [40][41]. Future Directions and Opportunities - **Expansion into Other Tumor Types**: The company is exploring opportunities in other tumor types with MTAP deletions, showing promising signals in head and neck cancer [45][46]. - **TNG456 Development**: The TNG456 clinical trial is in dose escalation, with plans to explore its potential in glioblastoma and non-small cell lung cancer [42][43]. - **Combination with Abemaciclib**: There are plans to pursue a combination with abemaciclib based on preclinical data suggesting potential benefits [49]. Upcoming Updates - **Data Releases**: Updates on pancreatic cancer monotherapy data, combination data with Revolution Medicines, and TNG456 dose escalation data are expected later this year [51][56]. Conclusion - **Exciting Year Ahead**: The company anticipates a year filled with significant developments and data releases, positioning itself for potential breakthroughs in cancer treatment [56].

Core Viewpoint - Paramount's CEO David Ellison is making a renewed attempt to acquire Warner Bros. Discovery (WBD) after previous offers were rejected, maintaining the bid at $30 per share while introducing new terms to enhance the offer's attractiveness to WBD shareholders [1][2]. Offer Details - Paramount's adjusted offer remains at $30 per share, but includes a "ticking fee" of $0.25 per share, amounting to approximately $650 million, payable to WBD shareholders for each quarter the deal remains unclosed until January 2027 [9]. - The total equity backing for the offer is $43.6 billion, fully supported by the Ellison family, with Larry Ellison being a significant financial figure due to his co-founding of Oracle [2]. Competitive Landscape - WBD is currently in negotiations to sell its streaming and studio assets to Netflix for $27.75 per share, which does not include its cable channels [2]. - Netflix has positioned itself as a favorable option for WBD shareholders, claiming that a merger would "create and protect jobs," and has been actively engaging in discussions regarding the regulatory process [8]. Regulatory Considerations - Ellison's offer aims to demonstrate confidence in the regulatory approval process, with the expectation that the deal will close smoothly [6]. - Former President Trump has stated he will not involve himself in the regulatory decisions regarding the Netflix-WBD deal, leaving it to the Department of Justice [7]. Market Reactions - There is speculation of a potential bidding war between Paramount and Netflix, which could increase the acquisition cost of WBD by $5 billion to $10 billion, although such a bidding war has not yet materialized [11]. - Ellison has argued that Paramount's bid is superior to Netflix's, despite not increasing the overall purchase price since the Netflix deal was announced [9][10].

Core Viewpoint - The proposed merger between Rio Tinto and Glencore may necessitate asset divestitures to obtain regulatory approval from China, which has ongoing concerns regarding resource security [1] Group 1: Regulatory Concerns - China, as a major commodity buyer, has expressed longstanding worries about resource security, which could impact the merger's approval process [1]

Core Viewpoint - MoonLake Immunotherapeutics (NASDAQ: MLTX) is experiencing mixed market reactions following a downgrade from Goldman Sachs, yet positive developments regarding FDA feedback may enhance its prospects in the biopharmaceutical sector [1][6]. Group 1: Company Overview - MoonLake Immunotherapeutics focuses on developing innovative therapies for inflammatory diseases [1]. - The company has a market capitalization of approximately $1.1 billion [5]. Group 2: Stock Performance - MLTX shares surged by 9.6%, closing at $15.72, up from a previous close of $14.34, despite a downgrade to Sell by Goldman Sachs [2][6]. - The stock has fluctuated between $17.02 and $17.91 recently, with a high of $62.75 and a low of $5.95 over the past year [5]. Group 3: Analyst Ratings - HC Wainwright reaffirmed a Buy rating and raised its price target to $32, indicating strong confidence in the stock's potential [4]. - Needham also maintained a Buy rating with a price target of $20, further supporting a positive outlook for the company [4]. Group 4: Regulatory Developments - Favorable feedback from the FDA suggests that MoonLake may file for skin drug approval without new clinical trials, potentially expediting the Biologics License Application process [3][6].

Core Insights - Lexicon Pharmaceuticals is advancing its pipeline with multiple potential catalysts expected in 2026, including the completion of the SONATA-HCM study and the resubmission of the NDA for Zynquista [2][3][4] Business and Pipeline Highlights - The SONATA-HCM pivotal Phase 3 study for sotagliflozin is on track, targeting enrollment of 500 patients, with completion expected in mid-2026 and topline results anticipated in Q1 2027 [3] - Zynquista (sotagliflozin) for Type 1 Diabetes is set for NDA resubmission in 2026, contingent on FDA feedback and additional clinical data from the STENO1 study [4][5] - Lexicon is pursuing international expansion for sotagliflozin, with regulatory approval already received in the UAE and applications submitted in other markets including Canada and Australia [4][6] Financial Updates - A $10 million milestone payment was triggered from a licensing agreement with Novo Nordisk for LX9851, with potential for an additional $20 million in milestone payments in 2026 [11] - Lexicon ended 2025 with cash, investments, and restricted cash totaling $125.2 million, which is sufficient to support operations into 2027 [11]

Industry Overview - The drug and biotech sector regained momentum in the latter part of 2025 after a weak first half, setting the stage for a strong year for select stocks [1] - Improved policy clarity following drug pricing agreements with the Trump administration reduced uncertainty, while a rebound in mergers and acquisitions revived investor appetite for risk [1] - Innovation accelerated across high-growth areas such as obesity, gene therapy, inflammation, and neuroscience, with the FDA approving 43 novel therapies as of December 22, 2025 [2] Company Highlights Ionis Pharmaceuticals - Ionis Pharmaceuticals' shares surged 127.6% in 2025, significantly outperforming the industry growth of 5% [5][6] - The company advanced its wholly-owned portfolio, highlighted by the FDA approval of Tryngolza for familial chylomicronemia syndrome, generating $57.4 million in sales in the first nine months of 2025 [9] - Ionis is evaluating Tryngolza in late-stage studies for severe hypertriglyceridemia, with plans to file for FDA label expansion soon [10] - The FDA approved Ionis' second drug, Dawnzera, for hereditary angioedema, with a regulatory filing in the EU expected in early 2026 [11] Structure Therapeutics - Structure Therapeutics' shares surged 127.2% in the past year, compared to the industry's 15.6% growth [13] - The stock rally was driven by positive data from the ACCESS clinical program for aleniglipron, showing up to 15.3% placebo-adjusted weight loss [15][16] - The company plans to initiate phase III development for aleniglipron in mid-2026 and is also developing other candidates for obesity treatment [18] Monopar Therapeutics - Monopar Therapeutics' shares rallied 185.9% in the past year, significantly outperforming the industry [20] - The stock price increase was fueled by positive expectations regarding its lead candidate ALXN-1840 for Wilson disease, following a licensing agreement with AstraZeneca [22] - Monopar plans to submit a regulatory filing with the FDA in early 2026 based on favorable long-term data for ALXN-1840 [26] Kodiak Sciences - Kodiak Sciences' shares rallied 181.1% in the past year, contrasting with the industry's 15.7% decline [27] - The stock's performance reflects growing investor confidence in its late-stage pipeline assets, particularly tarcocimab and KSI-501 [29] - Kodiak plans to submit a regulatory filing for tarcocimab for multiple indications, with top-line data from pivotal studies expected in 2026 [31][33]

As filed with the U.S. Securities and Exchange Commission on December 18, 2025. Registration No. 333- (State or other jurisdiction of incorporation or organization) FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Primary Standard Industrial Classification Code Number) Delaware 3842 86-1369123 (IRS Employer Identification Number) 4875 White Bear ...