Despite the typical year-end slowdown, the week saw a steady stream of high-impact news, highlighted by global approvals, clinical trial readouts, new product launches, and strategic buyouts.-- ARS Pharma's neffy, an emergency treatment for allergic reactions, received regulatory approval in China, while Vanda's NEREUS secured in the United States. -- FONAR Corp., the inventor of MR Scanning, is set to be taken private by its CEO-LED group. -- New analyses from InflaRx's halted phase 3 Vilobelimab trial h ...

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Clinical Trial Results of MRT-2359 - MRT-2359 combined with enzalutamide demonstrated a 100% PSA response rate in heavily pre-treated mCRPC patients with AR mutations[5, 38, 59] - Among the 4 patients with AR mutations, 2 patients showed PSA90 responses and 2 patients showed PSA50 responses[5, 38] - Two patients with AR mutations achieved RECIST partial responses (1 confirmed, 1 unconfirmed), and two had stable disease, resulting in a 100% disease control rate in the AR mutant population[5] - An overall disease control rate (DCR) of 64% was observed in 14 evaluable patients, including 5 patients without AR mutations who had stable disease[5, 59] Safety and Tolerability - The combination of MRT-2359 and enzalutamide was well-tolerated, with the most frequent adverse events (AEs) being mild or moderate manageable GI symptoms[5, 33, 59] - Treatment-related AEs occurring in >15% patients included fatigue (50%), diarrhea (45%), nausea (35%), arthralgia (30%), decreased appetite (30%), vomiting (30%), neutropenia (25%), and muscular weakness (20%)[31, 32] Future Plans - The company plans to initiate a signal-confirming 2-stage Phase 2 study (MODeFIRe-1) of MRT-2359 in combination with a 2nd generation AR inhibitor in 2026, targeting AR-mutated mCRPC[2, 56, 59] - Updated data from the Phase 1/2 study is expected to be presented at the ASCO Genitourinary Cancers Symposium in February 2026[59]

Core Insights - Orelabrutinib is the first BTK inhibitor to show significant clinical activity in a Phase 2 clinical trial for Systemic Lupus Erythematosus (SLE) [1] - Zenas BioPharma has acquired exclusive rights to develop, manufacture, and commercialize orelabrutinib for Multiple Sclerosis (MS) globally, and for non-oncology fields outside Greater China and Southeast Asia [1][5] Clinical Trial Results - In the Phase 2b study, 187 patients were randomized into three groups: orelabrutinib 75 mg once-daily, orelabrutinib 50 mg once-daily, and placebo [2] - The primary endpoint, SLE Response Index-4 (SRI-4) response rate at week 48, was met with the 75 mg group showing a response rate of 57.1% compared to 34.4% for placebo (p < 0.05) [2] - Secondary endpoints, including SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates, were also significantly higher in the 75 mg group compared to placebo (p < 0.05) [3] Safety and Tolerability - Orelabrutinib was well tolerated, exhibiting a safety profile consistent with BTK inhibition and the disease biology of SLE [3] Development Pipeline - Zenas is advancing orelabrutinib into a Phase 3 trial for Primary Progressive MS (PPMS) and plans to initiate a Phase 3 trial for Secondary Progressive MS (SPMS) in Q1 2026 [6] - Orelabrutinib is already approved for B cell malignancies in mainland China and Singapore, marketed by InnoCare [6] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [7] - The company is advancing two late-stage molecules: obexelimab and orelabrutinib, with obexelimab being a bifunctional monoclonal antibody targeting CD19 and FcγRIIb [7][8]

The only way to figure out if drugs are safe and effective is to try them in living breathing human beings and that is extraordinarily timeconuming and incredibly expensive. I wish for the day when AI is able to fully simulate an accurate human in the computer and we don't need to do clinical trials on real people. How are you actually evaluating opportunities in the US against China competition.Because, you know, if clinical trials are the major choke point and if China seems to be trying to make that proc ...

Core Insights - Novo Nordisk is cutting 9,000 jobs due to profit warnings linked to increased competition from "knock-off" weight-loss drugs and the failure of its Ozempic pill in Alzheimer's trials [2][4][5] - The company's stock has faced significant pressure, with a nearly 65% decline from its all-time high in 2024, while Eli Lilly's stock has surged, highlighting a divergence in performance [8][10] Company Performance - Novo Nordisk's revenue growth for 2024 is projected at 26%, while Eli Lilly is expected to achieve 32% growth [11] - Year-to-date revenue growth for 2025 shows Novo Nordisk at 15% compared to Eli Lilly's 46% [11] - Operating profit margins for Novo Nordisk stand at 42%, slightly higher than Eli Lilly's 39% [11] Competitive Landscape - Eli Lilly's aggressive pipeline, particularly with its oral GLP-1 pill Zepbound, provides a competitive edge over Novo Nordisk, which is also developing oral semaglutide [7] - The market for GLP-1 drugs is becoming fragmented, with increasing competition affecting Novo's market share [8][9] Valuation and Risks - Novo Nordisk's current valuation multiple is 13x TTM P/E, which is appealing compared to Eli Lilly's 49x, but reflects ongoing competitive pressures and margin contraction [11] - Supply constraints and pricing pressures are impacting Novo's margins, which have recently contracted [9] - The absence of new blockbuster candidates in its pipeline raises concerns about future growth [9][10]

Core Insights - Stonegate Capital Partners has updated its coverage on Incannex Healthcare Inc. (NASDAQ: IXHL), highlighting significant clinical progress in the development of IHL-42X for obstructive sleep apnoea (OSA) [1][7] Clinical Development - In Q4 2025, Incannex reported that IHL-42X achieved statistically significant reductions in the Apnoea-Hypopnoea Index (AHI), with maximum reductions of up to 83% in the high-dose group and 79% in the low-dose group [1][7] - Exit interviews indicated that 57.6% of participants perceived an improvement in their OSA, with many describing the changes as meaningful to their daily lives, including better sleep quality and reduced fatigue [1][7] - IHL-42X was well tolerated, with no serious adverse events reported, suggesting its potential for broad use upon approval [1][7] Financial Overview - As of the quarter-end, Incannex reported cash reserves of $73.3 million, a net loss of $6.4 million, and operating expenses of $6.8 million, providing at least twelve months of financial runway [7]

Summary of United Therapeutics Conference Call Company Overview - **Company**: United Therapeutics (NasdaqGS: UTHR) - **Event**: Jefferies Linden Healthcare Conference 2025 - **Date**: November 18, 2025 Key Points Current Commercial Business - **Revenue Growth**: United Therapeutics reported significant growth in total revenue, particularly from Tyvaso and Tyvaso DPI, which are expected to be the main growth drivers moving forward [4][6] - **Tyvaso DPI**: The product has no dosing limitations, is well-received by prescribers and patients, and has a favorable product profile, including ease of use [5][6] - **Market Position**: The company believes it is well-positioned in the pulmonary space, with a strong understanding of the market dynamics [4][6] Competitive Landscape - **Utrepia Launch**: Despite the launch of Utrepia, a competing product, United Therapeutics has seen a return in referrals and start trends towards Tyvaso, indicating strong market positioning [11][12] - **Market Expansion**: The presence of more therapies in the market is expected to expand the overall patient population rather than create a zero-sum game [13][14] Litigation Concerns - **Ongoing Litigation**: The company is awaiting a ruling on litigation related to Utrepia but remains confident in its growth trajectory regardless of the outcome [15][17][18] Future Projections - **Revenue Target**: United Therapeutics aims for a quarterly revenue run rate of $1 billion by the end of 2027, primarily driven by existing commercial products [19][21] - **IPF Opportunity**: The company sees a significant market opportunity in idiopathic pulmonary fibrosis (IPF), with an estimated 100,000 patients in the U.S. and a multi-billion dollar market potential [25][34] Clinical Trials and Pipeline - **Teton Trials**: The Teton 2 trial for IPF showed promising results, and there is high conviction that these results will translate to the Teton 1 trial in the U.S. [28][31] - **Regulatory Strategy**: The company plans to meet with the FDA to discuss the approval process for Tyvaso in IPF, aiming to expedite market entry [32][33] Additional Opportunities - **PPF and Rilendipag**: The company is optimistic about the potential for Tyvaso in pulmonary fibrosis (PPF) and is conducting trials for Rilendipag, an oral therapy expected to read out in 2026 [36][38] - **Xenotransplantation**: United Therapeutics is exploring organ transplantation, having conducted its first kidney transplant in a clinical trial, with plans to expand into lung and heart transplants [43][44] Financial Position and Strategy - **Overall Strategy**: The company is confident in its commercial pipeline and long-term organ manufacturing strategy, indicating a strong financial position [46][47] Conclusion United Therapeutics is positioned for significant growth driven by its existing products, promising clinical trials, and strategic market expansion. The company remains optimistic about its future revenue targets and the potential impact of its innovative therapies in the pulmonary and transplant markets.

Research Disruption - Federally funded clinical trials experienced disruption affecting over 74,000 patients [1] - National Institutes of Health terminated billions of dollars in research grants [1] Funding Impact - Hundreds of clinical trials were disrupted due to grant terminations [1]

Core Insights - Innate Pharma S.A. is a prominent biotechnology company specializing in therapeutic antibodies for cancer and other diseases, with notable products like Lacutamab and Monalizumab, and strategic partnerships with AstraZeneca and Sanofi [1] Price Target Analysis - The average price target for Innate Pharma's stock has risen from $3.5 to $5 over the last quarter, indicating a positive sentiment among analysts [2][6] - Three months ago, the average price target was $3.5, reflecting a significant increase linked to advancements in clinical trials or new collaborations [3] - A year ago, the average price target was also $3.5, showing stability, but recent developments have led to a more optimistic outlook from some analysts [4] Analyst Perspectives - Analysts have identified a hammer chart pattern, suggesting potential support for the stock after a decline and indicating a possible trend reversal [2][6] - Despite the overall positive trend, analysts from Leerink Partners have set a more conservative price target of $2, indicating differing views on the stock's future [3][6] Future Developments - Investors are advised to monitor upcoming announcements regarding clinical trial results or new partnerships, as these could significantly influence the stock's target price and market perception [5]