Core Insights - Biotech shares experienced significant movements in after-hours trading, with Sarepta Therapeutics leading due to anticipated trial data and other companies benefiting from recent clinical and regulatory updates [1] Company Summaries - Sarepta Therapeutics Inc. (SRPT) saw a surge of 9.65% to $23.17, driven by anticipation for a webcast on January 26, 2026, where three-year topline results from its Phase 3 trial of ELEVIDYS for Duchenne muscular dystrophy will be presented, potentially pivotal for its gene therapy program [2] - Fractyl Health, Inc. (GUTS) increased by 7.66% to $2.25, indicating speculative interest despite no new company news, suggesting momentum-driven trading [3] - Greenwich LifeSciences, Inc. (GLSI) advanced 2.08% to $26.00 following FDA approval of the first commercial lot of GP2 vials for the FLAMINGO-01 trial, marking a significant step in its commercialization efforts with the potential to prepare approximately 200,000 doses [4] - Anebulo Pharmaceuticals, Inc. (ANEB) rose 8.41% to $1.16, attracting buyers despite no new updates, reflecting investor interest [5] - OmniAb, Inc. (OABI) gained 4.59% to $2.05, similar to Anebulo, indicating broader investor interest in the biotech sector without fresh news [6] - Trevi Therapeutics, Inc. (TRVI) added 3.40% to $10.33 after publishing results from its Phase 2b CORAL trial in a peer-reviewed journal, enhancing credibility and investor enthusiasm [7] - AEON Biopharma, Inc. (AEON) edged up 1.80% to $1.13, confirming a meeting with the FDA and securing shareholder approval for financing transactions, simplifying its capital structure ahead of a second PIPE financing closing expected around January 27, 2026 [8]

Patient-reported outcome measure of cough frequency was consistent with reduction observed with objective cough monitoring NEW HAVEN, Conn., Jan. 22, 2026 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy oral nalbuphine ER for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced that the ...

Core Insights - Trevi Therapeutics is advancing its investigational therapy Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [1][4][5] Company Updates - The company has scheduled an End-of-Phase 2 meeting with the FDA in the first quarter of 2026 to discuss the clinical development and regulatory pathway for Haduvio [1][7] - A Phase 2b trial for RCC is planned to initiate in the first half of 2026 [1][7] - David Hastings, the new Chief Financial Officer, will attend the LifeSci Partners Corporate Access Event alongside senior management [7] Product Information - Haduvio (oral nalbuphine ER) is the first investigational therapy to show a statistically significant reduction in cough frequency in clinical trials for both IPF chronic cough and RCC [4] - The therapy acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in chronic cough control [4] Market Need - There are approximately 150,000 U.S. patients with IPF, with two-thirds experiencing uncontrolled chronic cough [5] - About 228,000 U.S. patients have non-IPF ILD, with 50-60% suffering from uncontrolled chronic cough [5] - RCC affects an estimated 2-3 million U.S. patients and is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions [6]

Leadership Change - Trevi Therapeutics, Inc. appointed David Hastings as Chief Financial Officer, effective January 6, 2026, marking a significant leadership change as the company transitions into a more advanced development stage [2] - Hastings brings 25 years of financial leadership experience in public life sciences companies and has helped raise $2 billion in equity and debt financing, aligning with Trevi's growth strategy [2] Clinical Development - Trevi is preparing to request an End-of-Phase 2 meeting with the FDA in Q4 2025 for its lead program targeting chronic cough associated with idiopathic pulmonary fibrosis (IPF), having completed key Phase 2 work [3] - The company expects to initiate a Phase 3 program in the first half of 2026, reinforcing its transition into this critical phase of development [3] Safety and Efficacy Studies - The ongoing Phase 1 TIDAL study in IPF patients has shown no safety signals, and a completed drug-drug interaction study confirmed that nalbuphine ER can be safely co-administered with standard antifibrotic therapies [4] - Trevi has presented topline Phase 2b CORAL data, enhancing clinical and investor visibility [4] Financial Position - As of the end of Q3 2025, Trevi Therapeutics reported a cash balance of $194.9 million, positioning the company well to capitalize on its clinical momentum [5] - The company is focused on developing Haduvio, an oral extended-release therapy for chronic cough across IPF, Non-IPF ILD, and refractory chronic cough [5]

Market Overview - The article discusses the potential for strong market momentum to continue into 2026, with a focus on identifying the next wave of multibagger stocks [1][2] - Chris Toomey from Morgan Stanley expects a solid year for markets in 2026, driven by secular tailwinds, improving earnings visibility, supportive fiscal and monetary policies, and a revival of market enthusiasm due to deregulation and increased M&A activity [3][4] Investment Strategy - Toomey emphasizes the importance of market leadership broadening, suggesting that previously overlooked sectors may present new investment opportunities, moving beyond the dominance of mega-cap technology stocks [5] - The methodology for selecting the best multibagger stocks includes filtering for stocks with a market capitalization over $500 million, at least 150% returns over the past year, and a minimum of 50% upside potential [7] Company Highlights CytomX Therapeutics, Inc. (NASDAQ:CTMX) - Market Cap: $696.38 million, with a 1-year price return of 263.72% and an upside potential of 58.20% [9] - 90% of analysts are bullish on CTMX, with a median price target of $6.50, indicating a healthy upside potential [10] - H.C. Wainwright has reiterated a "Buy" rating with a $10.00 price target, anticipating critical data for the CX-2051 therapy in colorectal cancer [11] - The firm outlines performance benchmarks for CX-2051, categorizing potential outcomes into "slam dunk," "bull," and "bear" scenarios based on expected response rates and survival metrics [12] - The company is progressing with its CX-2051 program, with enrollment nearing 100 patients ahead of a planned Phase 1 update in Q1 2026 [13][14] Trevi Therapeutics, Inc. (NASDAQ:TRVI) - Market Cap: $1.59 billion, with a 1-year price return of 169.11% and an upside potential of 73.40% [15] - The appointment of David Hastings as CFO is seen as a strategic move to support the company's transition into advanced development stages [16] - Trevi is preparing for a Phase 3 program for Haduvio in chronic cough associated with idiopathic pulmonary fibrosis (IPF), with an End-of-Phase 2 meeting with the FDA expected in Q4 2025 [17] - Ongoing studies have shown no safety signals, and the company has a cash balance of $194.9 million as of Q3 2025, positioning it well for future clinical developments [18][19]

Core Insights - CFOs are increasingly using terms like "uncertainty" and "unprecedented" to describe the current economic landscape, reflecting a sense of fatigue with ongoing unpredictability [1] - The focus for CFOs is on taking actionable steps to build resilience in the face of uncertainty, rather than succumbing to inaction [1][2] - There is a significant shift in resource allocation towards technology functions within companies, although uncertainty remains regarding AI's full impact on financial performance [3][4] Financial Strategies - Key questions for CFOs include improving liquidity, operational efficiency, and determining essential versus non-essential investments [2] - Despite uncertainty, it is crucial for companies to review long-standing strategies and seize competitive opportunities, particularly in AI investments [2] - The recommended focus for AI efforts is 80% on productivity for growth and 20% on productivity for efficiency, emphasizing better time utilization rather than headcount reduction [5] Future Outlook - McKinsey's research suggests that by 2030, profound changes in work processes will necessitate a reorganization of value creation and activities [4] - Managing uncertainty effectively involves planning for both positive and negative scenarios, highlighting the importance of a cross-functional approach within the C-suite [6] - The global economic outlook indicates that AI-driven investments are supporting better-than-expected growth, despite underlying demand remaining soft [9]

Core Insights - Trevi Therapeutics, Inc. has appointed David Hastings as the new Chief Financial Officer effective January 6, 2026, to lead financial strategy and support the company's growth phase [1][2][3] Company Overview - Trevi Therapeutics is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for treating chronic cough associated with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC) [1][4] - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF chronic cough and RCC patients [4] Market Need - There are approximately 150,000 patients with IPF in the U.S., with two-thirds experiencing uncontrolled chronic cough, and around 228,000 patients with non-IPF ILD, with 50-60% also suffering from uncontrolled chronic cough [5] - RCC affects an estimated 2-3 million patients in the U.S. and is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions [6] Leadership Experience - David Hastings brings over 25 years of financial leadership in life sciences and biopharmaceuticals, having raised over $2 billion in equity and debt financing throughout his career [2] - His previous roles include CFO at Arbutus and Incyte, where he managed financial operations during significant transitions and commercialization phases [2][3] Strategic Importance - Hastings' experience is deemed critical as Trevi transitions into Phase 3 development for Haduvio, with a focus on advancing the treatment for chronic cough [3] - The company is positioned with statistically significant data across target indications, limited competition, and a strong cash position, which are expected to enhance long-term value for patients and shareholders [3]

Core Viewpoint - Trevi Therapeutics (TRVI) is being initiated with a "Buy" rating due to its advancement in getting its lead program into phase 3 testing [2]. Company Overview - Trevi Therapeutics is positioned favorably in the biotech sector, with its lead program already progressing to phase 3 testing, indicating a strong potential for future growth and value creation [2]. Analyst Background - The analysis is provided by Terry Chrisomalis, who has extensive experience in the biotech sector and runs the Biotech Analysis Central service, which offers in-depth analysis and a model portfolio of biotech stocks [2].

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. This article is intended to provide informational content and should not be viewed as an exhaustive an ...

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]