China's growing pipeline of novel drug candidates is expected to draw increased attention from global pharmaceutical companies and investors scouting for licensing opportunities, as the country's clinical trial capacity has expanded to match those in the US. That assessment was made by Shanghai-based Helen Chen, Greater China managing partner at L.E.K. Consulting, one of the most respected analysts in the mainland's life sciences industry. "There is increased interest from multinational corporations in c ...

By the end of this video, you'll know exactly what Neuralink has accomplished so far, and what the company plans to do next. We'll go over how many people are living with the implant, what they can currently do with it, how Neuralink expanded trials across multiple countries, and what new features like speech decoding and vision restoration are on the horizon. Founded by Elon Musk in 2016, Nurling set out to build the world's first scalable brain computer interface.Technology that could restore movement, sp ...

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company announced the presentation of two abstracts at ObesityWeek 2025, highlighting its drug enobosarm's potential in weight management [1][2] Company Overview - Veru Inc. is developing two late-stage novel small molecules: enobosarm and sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making fat loss more tissue-selective while preserving lean mass [3] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Studies - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when combined with semaglutide, led to greater fat loss while preserving lean mass in older patients [4] - The study involved 168 older patients (≥60 years) and showed that while weight loss was similar across treatment groups, the preservation of lean mass is expected to enhance energy expenditure [4] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients initiating GLP-1 RA treatment [5][6] - The primary efficacy endpoint for the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5][7]

Core Insights - Arcutis Biotherapeutics shares surged nearly 30% following strong third-quarter earnings and an investor day presentation that provided positive guidance exceeding analyst expectations [1] Company Growth Plans - Management aims to establish Arcutis as a leader in medical dermatology through its Zoryve (roflimilast) portfolio, which includes FDA-approved treatments for plaque psoriasis, atopic dermatitis, and seborrheic dermatitis [2] - Zoryve is a selective phosphodiesterase-4 (PDE4) inhibitor, known for its anti-inflammatory effects [2] Regulatory Developments - Zoryve has been submitted for FDA approval for plaque psoriasis in children aged 2 to 5 and is undergoing phase 2 trials for vitiligo and hidradenitis suppurativa [3] Sales Projections - Management forecasts Zoryve sales could reach between $2.6 billion and $3.5 billion over time, with near-term sales estimates for 2026 projected at $455 million to $470 million, significantly above the $438 million anticipated by analysts [4] - The high end of the sales target for Zoryve exceeds the company's market cap of less than $3 billion, indicating strong growth potential [6] Market Outlook - The company is expected to experience over 30% sales growth in the coming years, supported by less risky clinical trials currently in progress [6] - The positive medium-term sales target for the Zoryve franchise has generated excitement among investors [8]

3rd Quarter 2025 Financial Results & Investor Day October 28, 2025 Legal Disclaimers This presentation and the accompanying oral presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Forward- looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financ ...

AXPAXLI's Clinical Development and Regulatory Strategy - Ocular Therapeutix is targeting the FIRST SUPERIORITY LABEL vs anti-VEGFs for AXPAXLI [26, 29, 32, 35, 38] - AXPAXLI has SPA Agreements for SOL-1 & HELIOS-2 Trials, supporting a regulatory path for a superiority label [36] - SOL-1 is designed for success with FDA alignment through SPA, randomization of strong anti-VEGF responders, and the potential for a superiority claim on the label [133, 134, 136, 137, 140, 141, 152, 153] - SOL-R is designed for seamless, immediate adoption with methodical patient selection to exclude subjects with early persistent fluid [93, 94, 95, 96, 97, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 233, 234, 235, 236, 237] - The company plans for AXPAXLI NDA submission following SOL-R 56-Week Topline Data, with a package expected to exceed the requirements for FDA's safety database [230, 231, 232] AXPAXLI's Commercial Potential and Market Opportunity - The 2024 Global Branded Anti-VEGF Revenue is $15 Billion, indicating a significant market size [49, 52, 55] - AXPAXLI has the opportunity to significantly expand the $15B Global Retina Market by redefining the treatment attrition curve in wet AMD and establishing a standard of care in NPDR [57, 58, 59, 60, 82, 83, 84, 85, 86, 87, 88, 89, 90] - There are 18 million people with wet AMD in the U S, with 40% discontinuing treatment in the first year, presenting an opportunity for AXPAXLI to improve adherence [57, 59, 83, 86] - There are 64 million people with NPDR in the U S, with less than 1% of patients currently treated, indicating a large undertreated population [86, 89] Expansion into Diabetic Retinopathy - The company is targeting a broad indication in Diabetic Retinopathy, aiming to treat the full spectrum of diabetic retinal disease, including patients with or without DME [418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440] - The HELIOS-1 study showed a 231% 2-step DRSS improvement in the AXPAXLI arm at Week 48 compared to 0% in the sham arm [397, 398, 399]

Core Insights - After-hours trading in the biotech and therapeutics sector saw significant price movements, particularly among small- and mid-cap companies, driven by clinical updates and strategic announcements [1] Company Summaries - **Cyclerion Therapeutics, Inc. (CYCN)**: Shares surged 48.01% to $4.47 after announcing a strategic relaunch focused on neuropsychiatric therapies, including a licensing agreement with MIT for its treatment-resistant depression program. The stock had closed at $3.02, down 0.66% during regular trading. A Phase 2 trial for the TRD program is expected to start in 2026, with initial data anticipated in 2027 [2][3] - **Clearside Biomedical Inc. (CLSD)**: The stock rose 6.82% to $4.23 after a regular session close of $3.96, despite a 9.79% decline during the day. The increase followed presentations at the EURETINA Congress regarding its Phase 2b ODYSSEY trial for wet age-related macular degeneration. The next key catalyst is the initiation of the Phase 3 trial, incorporating FDA feedback [3][4] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares increased by 11.50% to $0.32 after closing at $0.287, following a 6.61% decline during regular trading. The price action comes ahead of the company's participation in the Lytham Partners Fall 2025 Investor Conference [4][5] - **Acumen Pharmaceuticals, Inc. (ABOS)**: The stock advanced 5.69% to $1.30 after a regular session close of $1.23, despite a 3.91% decline during the day. The company reported that topline data from its Phase 2 ALTITUDE-AD trial is on track for late 2026 and plans to decide on advancing a preclinical candidate in early 2026 [5][6] - **PepGen Inc. (PEPG)**: Shares rose 5.13% to $2.05 after closing at $1.95, following an 8.02% decline during the day. The company completed patient dosing in its Phase 1 FREEDOM-DM1 trial and is on track to report topline data in early Q4 2025 [6][7] - **Corcept Therapeutics Inc. (CORT)**: The stock gained 4.54% to $87.10 after a regular session close of $83.32. The company announced it will present late-breaking data from its Phase 3 ROSELLA trial at the 2025 ESMO Annual Meeting. Two upcoming PDUFA dates were confirmed for relacorilant in hypercortisolism and platinum-resistant ovarian cancer [7][8][9]

Acquisition of Metsera - Pfizer plans to acquire Metsera, Inc, with the transaction expected to close in 4Q 2025 and drive growth from the late 2020s and beyond[16] - The acquisition will be funded primarily with available cash and proceeds from new debt and is not expected to impact Pfizer's credit rating[19] - The enterprise value is based on Metsera's June 30 reported cash balance of approximately $500 million[19] Pipeline and Clinical Trials - Pfizer and Roche have a global collaboration for the p40 x TL1A bispecific antibody (PF-07261271)[23] - Pivotal trials are ongoing or initiation is planned before or during 1H 2026 for several drug candidates[22] - MET-097i is a fully biased ultra-long-acting next-generation GLP-1 receptor agonist[33] MET-097i Clinical Data - In a Phase 2a trial, a monthly dose of MET-097i after 12 weekly doses was well tolerated with continued weight loss observed[38] - Phase 1 data demonstrate robust efficacy and placebo-like tolerability at potential starting doses for MET-233i[41] - Placebo-adjusted weight change in adherence to treatment subgroup was -14.2% with 1.2 mg → 4.8 mg of MET-097i[40] Market Opportunity - Obesity and associated conditions are on track to become among the largest pharmaceutical opportunities[27] - The acquisition aligns with Internal Medicine R&D strategy and expertise, leveraging significant primary care commercial infrastructure and field force[27] - The deal structure is risk-managed using a Contingent Value Right (CVR), sharing risk and upside with Metsera shareholders[28] - The acquisition has the potential for attractive returns for Pfizer shareholders[28] - The acquisition targets a market impacting over 1 billion lives globally[48]

香港特区施政报告：吸引更多药企落户香港，进行罕见病药、高端肿瘤药及先进疗法制品等临床试验和治疗。成立“AI效能提升组”统筹和指导各政府部门有效应用AI，並研究重组不合时宜的工作流程。 ...

Core Insights - United Therapeutics Corporation will present clinical data from its commercial and development portfolio at the European Respiratory Society Congress in Amsterdam from September 27 to October 1, 2025 [1][2] Group 1: Clinical Studies and Presentations - The successful phase 3 TETON-2 study results of inhaled treprostinil for idiopathic pulmonary fibrosis will be highlighted in an oral presentation [1][2] - Additional analyses from the TETON-2 study and interim data from the ADVANCE EXTENSION study evaluating ralinepag for pulmonary arterial hypertension will also be presented [2] - The PHINDER study's interim findings, aimed at improving pulmonary hypertension detection in patients with interstitial lung disease, will be discussed [2] Group 2: Presentation Details - An oral presentation on the TETON Phase 3 Clinical Trials of inhaled treprostinil will take place on September 28, 2025, from 11:00 a.m. to 12:15 p.m. CET [3][4] - Poster sessions will include interim results from the PHINDER study and high-resolution computed tomography findings related to pulmonary hypertension [5][6][7] Group 3: Company Overview - United Therapeutics operates as a public benefit corporation, focusing on innovative pharmaceutical therapies and technologies to address unmet medical needs [8]