WVE-007, an INHBE GalNAc-siRNA for obesity designed to drive fat loss while preserving muscle mass, achieved dose-dependent, mean reductions of Activin E of up to 85% in INLIGHT clinical trial, exceeding levels that led to weight loss and prevention of rebound weight gain following cessation of GLP-1 in preclinical models Activin E reduction in lowest single dose cohort of INLIGHT was sustained through six months, supporting once or twice a year dosing Achieved key AATD treatment goals to recapitulate the ...

BRISBANE, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that the Company’s management team will present at the TD Cowen Immunology & Inflammation Summit, which is taking place virtually from November 12-13, 2025. The management team will also participate in one-on-one investor meetings. Presentati ...

Core Insights - Apogee Therapeutics announced positive interim Phase 1 results for APG333, demonstrating a half-life of approximately 55 days and suppression of key biomarkers for 6 months after a single dose, supporting potential 3- and 6-month dosing regimens [1][2][5] - APG333 was well tolerated across all cohorts with doses up to 1,000 mg, with the most common treatment-emergent adverse events being headache and upper respiratory tract infection [5][6] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing optimized, novel biologics for inflammatory and immunology (I&I) markets, including treatments for Atopic Dermatitis, asthma, and Chronic Obstructive Pulmonary Disease [5][6] - The company aims to achieve best-in-class profiles through its antibody programs by targeting established mechanisms of action and utilizing advanced antibody engineering [6] Clinical Trial Details - The Phase 1 clinical trial for APG333 was a double-blind, placebo-controlled study involving 32 healthy adults across four cohorts, evaluating safety, tolerability, and pharmacokinetics [2][3] - Results indicate that APG333's pharmacokinetic profile supports potential dosing two to four times a year, which is a significant improvement over current standard treatments [3][5] Future Development - The positive results from APG333 support the development of a co-formulation with APG777, potentially allowing for quarterly or less frequent dosing to address respiratory diseases more effectively [1][2][3] - The combination of APG777 and APG333 is expected to suppress complementary pathways involved in obstructive airway disease, expanding treatment options for patients [3][5]

Core Insights - Tenaya Therapeutics announced significant advancements in its gene therapy programs, TN-201 and TN-401, aimed at treating serious genetic cardiomyopathies, with positive recommendations from Data Safety Monitoring Boards for both products [2][3]. Business and Program Updates - TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), showed robust transduction and durable expression, with a dose-dependent increase in MyBP-C protein. Cohort 1 patients exhibited decreases in circulating biomarkers and reductions in left ventricular hypertrophy over time [3]. - The MyPEAK-1 trial for TN-201 is currently on clinical hold, with the company working with the FDA to resolve the issue and resume dosing [4]. - TN-401, targeting PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), has completed dosing in Cohort 2 of the RIDGE-1 trial, with initial safety and biopsy data expected to be shared by year-end 2025 [5][6]. Research and Development Updates - A seroprevalence study indicated that nearly 95% of MYBPC3-associated HCM patients had low pre-existing immunity to AAV9, suggesting a favorable patient eligibility for the MyPEAK-1 trial [7]. - The MyClimb study, focusing on pediatric patients with MYBPC3-associated HCM, revealed that 93% of participants had the nonobstructive HCM phenotype, highlighting the need for treatment options [7]. - Tenaya presented new preclinical data on cardiac function improvement in a pig model of ischemic heart failure, achieved through a proprietary in vivo reprogramming cocktail [7]. Financial Highlights - As of September 30, 2025, Tenaya reported cash, cash equivalents, and marketable securities totaling $56.3 million, sufficient to support operations into the second half of 2026 [12]. - Research and Development (R&D) expenses for Q3 2025 were $15.4 million, down from $20.4 million in Q3 2024. General and Administrative (G&A) expenses also decreased to $5.6 million from $6.4 million in the same period [12][16]. - The net loss for Q3 2025 was $20.3 million, or $0.12 per share, compared to a net loss of $25.6 million, or $0.30 per share, in Q3 2024 [12][16].

Core Insights - Septerna, Inc. has selected SEP-479 as its next-generation oral PTH1R agonist development candidate for hypoparathyroidism and is currently conducting a Phase 1 clinical trial for SEP-631 targeting MRGPRX2 for mast cell-driven diseases [2][3] - The company reported a robust financial position with cash, cash equivalents, and marketable securities totaling $561.6 million, expected to support operations at least into 2029 [1][13] Business Updates - SEP-479 demonstrated robust, dose-dependent increases in serum calcium and decreases in endogenous parathyroid hormone levels in a seven-day study in healthy cynomolgus monkeys, with plans to initiate a Phase 1 clinical trial in the first half of 2026 [7][3] - The ongoing Phase 1 clinical trial for SEP-631 is evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics, with initial data expected in the first half of 2026 [4][2] - Septerna is advancing its TSHR NAM program aimed at developing a potential oral treatment for Graves' disease and thyroid eye disease [8] Financial Performance - Revenue for the quarter ended September 30, 2025, was $21.5 million, a significant increase from $0.2 million in the same quarter of 2024, driven by the amortization of the $195 million upfront payment from Novo Nordisk [13] - Research and development expenses were $24.3 million for the quarter, compared to $17.8 million in the same quarter of 2024, while general and administrative expenses rose to $7.1 million from $4.9 million [13] - The company reported a net income of $8.2 million for the quarter, a turnaround from a net loss of $20.5 million in the same quarter of 2024 [13]

Core Viewpoint - A lawsuit has been filed against MoonLake Immunotherapeutics and its senior executives for potential violations of federal securities laws, following disappointing results from its Phase 3 VELA trials for sonelokimab, which led to a significant drop in stock price [1][3][7]. Group 1: Company Overview - MoonLake Immunotherapeutics is a clinical-stage biotechnology company focused on developing therapies for inflammatory diseases [4]. - The company conducted Phase 3 VELA trials for sonelokimab, an investigational therapeutic aimed at treating moderate to severe hidradenitis suppurativa [4]. Group 2: Allegations and Claims - The lawsuit asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in MoonLake common stock [3]. - Allegations include that MoonLake misled investors regarding the clinical data and the Nanobody structure of sonelokimab, which purportedly did not provide a superior clinical benefit compared to competitors [5][6]. Group 3: Stock Performance and Impact - Following the announcement of disappointing results from the VELA trials on September 28, 2025, MoonLake's stock price plummeted by $55.75 per share, nearly 90%, from $61.99 on September 26, 2025, to $6.24 on September 29, 2025 [7].

Core Viewpoint - The investment thesis for Puma Biotechnology (PBYI) remains optimistic despite potential concerns, with a focus on the scientific aspects of the business and the importance of due diligence in biotech investments [1]. Group 1 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies, which informs the positive outlook on Puma Biotechnology [1]. - There is a commitment to educating investors about the science behind biotech businesses to help them avoid investment pitfalls [1].

Core Insights - The article emphasizes the potential of investing in smaller, lesser-known biotech companies alongside established market leaders, highlighting Viking Therapeutics and Axsome Therapeutics as promising candidates for growth in the biotech sector [1][2]. Viking Therapeutics - The weight loss market is projected to grow from $15 billion last year to $150 billion by 2035, driven by breakthroughs and increasing demand for obesity-related treatments [3]. - Viking Therapeutics is developing VK2735, a dual GLP-1/GIP agonist, currently in phase 3 trials for subcutaneous use, with promising efficacy observed in mid-stage trials for an oral formulation [4]. - The company is also working on another weight-loss candidate in preclinical studies and plans to initiate human clinical trials next year, alongside VK2809, which has completed phase 2 studies for metabolic dysfunction-associated steatohepatitis [7]. Axsome Therapeutics - Axsome Therapeutics has achieved significant clinical and regulatory advancements, with third-quarter revenue reaching $171 million, a 63% year-over-year increase, primarily due to its depression medication, Auvelity [9]. - Auvelity, launched in 2022, is expected to achieve blockbuster status in treating depression and is awaiting approval for use in Alzheimer's disease agitation, with potential peak sales estimated between $1.5 billion to $3 billion [10][11]. - The company has a robust pipeline with other approved products and ongoing late-stage trials, including AXS-12 for narcolepsy and AXS-14 for fibromyalgia, which are expected to enhance financial performance [12][13].

Group 1: US Government Shutdown and Market Reactions - The Senate has advanced a bill to end the US government shutdown and fund federal agencies through January, with a potential vote in the House soon [2][8] - Global equities are gaining on signs that the deadlock may be ending, with US and European futures pointing higher [2] - The market has shown resilience, rallying despite concerns over the shutdown, indicating that other factors, such as AI valuation concerns, are more influential on market movements [5][6][22] Group 2: NASDAQ and Corporate Developments - The NASDAQ is looking to rebound after its worst week since April, with a notable rally off its lows on Friday [3][10] - Novo Nordisk lost a bidding war for Metsera, with Pfizer closing a $10 billion deal for the US biotech company, prompting Novo Nordisk to explore other acquisition options [3] - The market is differentiating between companies based on their AI capital expenditure, with significant volatility observed in tech stocks [20][24] Group 3: Economic Indicators and Consumer Confidence - Recent consumer confidence data has been disappointing, suggesting a potential weakening of the US consumer, which could impact economic growth [36][38] - The ongoing government shutdown has raised concerns about its impact on travel and economic activity, particularly during the Thanksgiving season [7][18] - Despite challenges, the labor market remains relatively stable, with low unemployment rates and ongoing capital expenditure driving economic growth [38][40] Group 4: Financial Sector Insights - The financial sector has seen a rerating, with European banks achieving significant earnings revisions and trading above one times price to book for the first time in 15 years [44] - There are expectations of deregulation and asset price inflation supporting investment banking activities, which could benefit banks in both the US and Europe [45] - The tech sector is experiencing strong earnings growth, with financials also showing robust performance, indicating a broader trend of recovery in these sectors [43][47]

Market Trends - The Santa Claus Rally is anticipated as a familiar market trend, historically resulting in stock increases 80% of the time during this period since 1972 [1] - This year's rally is expected to be accompanied by volatility due to factors such as AI speculation, a weakening labor market, and record-low consumer sentiment [2] Labor Market and Layoffs - October saw over 150,000 layoffs, the highest figure in 20 years, impacting companies including Amazon, which laid off 14,000 corporate employees [2] Stock Market Performance - The tech-heavy Nasdaq Index fell 5% recently, indicating cracks in the bull market, with Amazon shares dropping 6% [3] Investment Opportunities - Utz Brands Inc. (UTZ) is highlighted as an attractive investment, trading at 13 times forward earnings, significantly lower than its long-term average, with a profit outlook of 5% growth this year and 15% next year [12] - Greenwich LifeSciences Inc. (GLSI) is noted for its potential in cancer immunotherapy, with recent insider buying and FDA Fast Track designation, despite a 33% decline in shares due to short selling [15][19] - Matador Resources Co. (MTDR) is recognized for its strong insider buying activity and attractive cost structure, trading at a low valuation compared to peers, with a 4% dividend yield [22][25][26] Insider Buying as a Bullish Signal - Insider buying is considered a strong bullish signal, with examples of significant gains following such activity in companies like Longeveron Inc. and Nuvation Bio Inc. [14][27] Upcoming Events - A Profit Surge Event is scheduled, where insights on market volatility and trading opportunities will be shared [7][28]