Core Viewpoint - Zenas BioPharma's shares dropped over 50% following the Phase 3 results for obexelimab in patients with immunoglobulin G4-related disease, as efficacy metrics did not meet market expectations, leading to a significant stock repricing [1][2]. Group 1: Trial Results and Market Reaction - The Phase 3 trial showed a meaningful reduction in flare risk, but the overall efficacy metrics fell short of what the market anticipated, resulting in a sharp decline in stock price [1][2]. - The stock's cyclical positioning indicated elevated risk prior to the trial results, which explains the aggressive selloff [2]. Group 2: Adhishthana Framework Analysis - Zenas BioPharma is currently in Phase 2 of its 18-phase Adhishthana cycle, which is characterized by two segments: the Sankhya period (consolidation and volatility) and the Buddhi period (sustained upside moves) [3]. - The stock's initial rally during the Sankhya period was atypical, as premature rallies in this phase are often unstable and corrected quickly [4][6]. Group 3: Future Outlook and Investment Strategy - Despite the significant decline, caution is advised as Zenas remains in the Sankhya period, with high volatility expected until a transition to the Buddhi phase occurs [7][12]. - Deviations during Phase 2 can impair the quality of any subsequent Buddhi move, suggesting that anticipated rallies may not materialize, supporting a wait-and-watch approach [8][9]. - The recent downgrade from Morgan Stanley aligns with the deteriorating risk profile of the stock, indicating latent structural risks not immediately visible through fundamentals [9][10].

Core Viewpoint - The article highlights the offerings of the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1: Service Offerings - Biotech Analysis Central provides a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - The service is available for $49 per month, with a discounted annual plan at $399, representing a 33.50% savings for subscribers [1]. Group 2: Analyst Background - The author, Terry Chrisomalis, is a private investor with a background in Applied Science, focusing on generating long-term value in the healthcare sector [2]. - The service aims to assist healthcare investors in making informed decisions through comprehensive analysis and news reports [2].

Core Insights - The analysis highlights significant price declines among three companies, emphasizing the volatility in the biotech and technology sectors [1][4][5] Company Summaries Zenas BioPharma Inc. (NASDAQ:ZBIO) - Experienced a -57.30% drop in stock price, falling to $14.73, following the Phase 3 INDIGO trial results for obexelimab despite positive outcomes [1][5] - The market's negative reaction indicates the unpredictable nature of biotech investments [5] Signing Day Sports, Inc. (SGN) - Stock price decreased to $0.51, reflecting a -46.30% change [2] - The company announced an opportunity in AI and HPC infrastructure with BlockchAIn Digital Infrastructure, but competitive pressures and operational challenges may have contributed to the decline [2] Shineco, Inc. (SISI) - Experienced a -37.16% drop, with stock price falling to $0.18 [3] - The company saw a 6.8% decline during mid-day trading, despite a 99% reduction in trading volume, suggesting market competition and regulatory challenges in China's sectors may be impacting its performance [3] Market Trends - The significant price movements among these companies underscore the stock market's volatility, particularly in the biotech and technology sectors [4] - Investors must consider clinical trial outcomes, regulatory decisions, and competitive pressures when making informed decisions in this rapidly changing landscape [4]

Market Performance - U.S. stocks experienced gains, with the Dow Jones index increasing by 1.66% to 49,183.51, the NASDAQ rising by 0.80% to 23,420.85, and the S&P 500 up by 0.81% to 6,913.76 [1] - European shares also saw positive movement, with the eurozone's STOXX 600 gaining 0.94%, Spain's IBEX 35 Index rising by 0.70%, London's FTSE 100 up by 0.54%, Germany's DAX increasing by 1.34%, and France's CAC 40 climbing by 0.20% [5] - Asian markets closed mostly higher, highlighted by Japan's Nikkei 225 gaining 2.97% and China's Shanghai Composite surging 1.38%, while India's BSE Sensex fell by 0.38% [6] Commodity Prices - In commodity trading, oil prices increased by 1.7% to $58.30, gold rose by 2.9% to $4,454.40, silver surged by 7.3% to $76.230, and copper climbed by 5.1% to $5.9815 [4] Company Developments - Momentus Inc (NASDAQ:MNTS) shares surged by 57% to $8.98 following the announcement of an additive-manufactured fuel tank for flight testing [8] - GH Research PLC (NASDAQ:GHRS) shares increased by 17% to $15.43 after the FDA lifted the clinical hold on its Investigational New Drug Application for GH001 [8] - VerifyMe Inc (NASDAQ:VRME) shares rose by 66% to $1.12 due to a strategic merger letter of intent with Open World [8] - Zenas Biopharma Inc (NASDAQ:ZBIO) shares dropped by 57% to $14.94 after announcing results from the Phase 3 INDIGO trial [8] - Palisade Bio Inc (NASDAQ:PALI) shares fell by 16% to $2.10, and Palvella Therapeutics Inc (NASDAQ:PVLA) decreased by 14% to $86.16 [8] Economic Indicators - The ISM manufacturing PMI declined for the third consecutive month to 47.9 in December, marking the lowest reading since October 2024, down from 48.2 in November and below market estimates of 48.3 [2][7]

Core Viewpoint - Zenas BioPharma Inc. stock is experiencing a decline despite positive results from the Phase 3 INDIGO trial of obexelimab for Immunoglobulin G4-Related Disease (IgG4-RD) [1][4]. Group 1: Trial Results - Obexelimab achieved the primary endpoint with a statistically significant 56% reduction in the risk of IgG4-RD flare compared to placebo over a 52-week period [2]. - The drug also met all four key secondary endpoints, showing significant activity in reducing investigator-assessed IgG4-RD flare, the number of flares requiring rescue therapy, the proportion of patients achieving complete remission, and the cumulative use of rescue therapy [3]. Group 2: Safety and Future Plans - Rates of infections, including Grade 3, were lower in the obexelimab group compared to placebo, with similar incidence of injection site reactions across both groups [4]. - Zenas plans to submit a Biologics License Application (BLA) for obexelimab to the FDA in Q2 2026 and a Marketing Authorization Application (MAA) to the EMA in the second half of 2026 [7]. - The company expects to report topline results from the Phase 2 SunStone trial in SLE in Q4 2026 [8]. Group 3: Competitive Landscape - Amgen's Uplizna, the first approved treatment for IgG4-RD, demonstrated an 87% reduction in flare risk compared to placebo, with 10.3% of participants experiencing a flare versus 59.7% in the placebo group [5]. - Amgen acquired Uplizna through a $27.8 billion acquisition of Horizon Therapeutics [6].

Market Overview - U.S. stocks traded higher, with the Dow Jones index gaining over 250 points, up 0.54% to 48,641.58, NASDAQ up 0.65% to 23,386.57, and S&P 500 up 0.63% to 6,901.52 [1] - Energy shares increased by 2.9% on Monday [1] Sector Performance - Consumer staples stocks dipped by 0.4% [2] Commodity Prices - Oil traded up 1.4% to $58.12, gold up 2.4% to $4,433.50, silver up 7.5% to $76.320, and copper rose 4.1% to $5.9260 [5] European Market Performance - Eurozone's STOXX 600 gained 0.5%, Spain's IBEX 35 Index rose 0.3%, London's FTSE 100 up 0.4%, Germany's DAX gained 0.2%, and France's CAC 40 climbed 0.1% [6] Asian Market Performance - Asian markets closed mostly higher, with Japan's Nikkei 225 gaining 2.97%, Hong Kong's Hang Seng Index up 0.03%, China's Shanghai Composite surging 1.38%, while India's BSE Sensex fell 0.38% [7] Company News - The FDA lifted the clinical hold on GH Research Plc's Investigational New Drug Application for GH001 [3] - Momentus Inc shares surged 94% to $11.14 after announcing the development of an additive-manufactured fuel tank [9] - TMD Energy Ltd shares increased by 76% to $0.78 [9] - VerifyMe Inc shares rose 40% to $0.94 following a strategic merger announcement [9] - Zenas Biopharma Inc shares dropped 55% to $15.54 after Phase 3 trial results [9] - Signing Day Sports Inc shares fell 37% to $0.60, and Lavoro Ltd shares decreased by 26% to $0.82 [9]

Summary of Zenas BioPharma Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Focus**: Development of obexelimab for the treatment of immunoglobulin G4-related disease (IgG4-RD) Key Industry Insights - **Disease Prevalence**: Estimated diagnosed prevalence of IgG4-RD in the U.S. is around 20,000 patients, with total prevalence (including undiagnosed) potentially reaching 40,000. Similar global prevalence is suggested [doc id='9'] - **Market Opportunity**: The market opportunity for IgG4-RD treatment is approximately $3 billion in the U.S. and $2 billion in Europe, with over half of diagnosed patients experiencing frequent flares [doc id='17'] Core Findings from INDIGO Trial - **Trial Results**: The INDIGO trial met its primary endpoint, showing a 56% reduction in the risk of IgG4-RD flare compared to placebo, with a hazard ratio of 0.443 and a p-value of 0.0005 [doc id='12'] - **Secondary Endpoints**: All four key secondary endpoints were met, including time to first flare and the proportion of patients achieving complete remission [doc id='13'] - **Safety Profile**: Obexelimab demonstrated a compelling safety and tolerability profile, with lower incidences of serious adverse events and infections compared to placebo [doc id='15] Treatment Advantages - **Mechanism of Action**: Obexelimab's unique inhibitory mechanism targets B-cells without depleting them, which may provide advantages over existing therapies like Uplizna [doc id='16'] - **Administration**: The drug is administered subcutaneously at home, aligning with patient preferences and reducing the need for infusion center visits [doc id='16'] - **Cost-Effectiveness**: The at-home administration model may lead to lower out-of-pocket costs for patients compared to high-priced infused therapies [doc id='17'] Future Plans - **Regulatory Submissions**: Plans to submit a Biologics License Application (BLA) to the U.S. FDA in Q2 and a marketing authorization application to the European Medicines Agency in the second half of the year [doc id='6'] - **Pipeline Expansion**: Zenas is advancing multiple candidates, including orelabrutinib and ZBO21, into clinical trials, aiming to establish a strong portfolio in autoimmune diseases [doc id='19'] Market Dynamics - **Underdiagnosis**: IgG4-RD is currently underdiagnosed, and the approval of obexelimab could enhance disease recognition and treatment [doc id='18'] - **Competitive Landscape**: The efficacy and safety profile of obexelimab positions it as a potential first-line therapy, especially for older patients who may not tolerate B-cell depletion [doc id='24'] Additional Insights - **KOL Feedback**: Key opinion leaders expressed enthusiasm for obexelimab's efficacy and safety, viewing it as a strong candidate for first-line treatment [doc id='23'] - **Payer Discussions**: Preliminary conversations with payers indicate a favorable view of obexelimab's risk-benefit profile, especially in comparison to existing therapies [doc id='49'] Conclusion - **Transformational Year**: 2025 was highlighted as a transformational year for Zenas, with the INDIGO results expected to drive momentum into 2026 and beyond [doc id='18']

Core Viewpoint - Zenas BioPharma's experimental drug has demonstrated effectiveness in reducing the risk of disease flare-ups in patients with a rare immune system-related condition in a late-stage study [1] Group 1 - The drug targets a condition that can lead to organ damage over time [1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 5, 2026 ZENAS BIOPHARMA, INC. Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): ¨ Written communications pursuant to Rule 425 un ...

Core Insights - Zenas BioPharma announced positive results from the Phase 3 INDIGO trial of obexelimab, showing a 56% reduction in the risk of IgG4-RD flare compared to placebo, with a Hazard Ratio of 0.44 and p=0.0005 [1][2] - Obexelimab demonstrated statistically significant activity on all four key secondary efficacy endpoints, including reduction in flares requiring rescue therapy and the proportion of patients achieving complete remission [1][2] - The company plans to submit a Biologics License Application (BLA) to the FDA in Q2 2026 and a Marketing Authorization Application (MAA) to the EMA in H2 2026 [1][2] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing therapies for autoimmune diseases [15] - The company is advancing two late-stage product candidates: obexelimab and orelabrutinib, with obexelimab being the lead candidate targeting IgG4-RD [15] - Zenas aims to address the unmet medical needs of patients with autoimmune diseases through innovative therapies [15] Clinical Trial Details - The Phase 3 INDIGO trial enrolled 194 patients and was designed to evaluate the safety and efficacy of obexelimab over a 52-week period [10] - The primary endpoint was the time to first IgG4-RD flare requiring rescue therapy, with key secondary endpoints including the number of flares and the cumulative use of rescue therapy [11][12] - Obexelimab was well tolerated, with lower rates of infections and similar incidence of injection site reactions compared to placebo [1][2] Future Developments - Zenas expects to report topline results from the Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) in Q4 2026 [4] - The company is also studying orelabrutinib in a global Phase 3 trial for Primary Progressive Multiple Sclerosis (PPMS) and plans to initiate a trial for non-active Secondary Progressive Multiple Sclerosis (naSPMS) in Q1 2026 [4] - Zenas is preparing to initiate Phase 1 clinical development for two additional product candidates, ZB021 and ZB022, in 2026 [4]