NEW YORK and WALTHAM, Mass., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today announced the Company’s participation in the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York City. Marino Garcia, CEO of Dianthus Therapeutics, will participate in an analyst-led fireside chat on Thursday, February 12, 2026 at 10:00 am EST ...

Core Insights - Dianthus Therapeutics, Inc. (DNTH) shares experienced a significant increase of 9.9% to $52.76, with trading volume surpassing the average [1] - The rise in stock price is linked to positive investor sentiment regarding the company's clinical-stage pipeline candidates, claseprubart and DNTH212, aimed at treating various autoimmune conditions [2] Financial Performance - The company is projected to report a quarterly loss of $0.97 per share, reflecting a year-over-year decline of 19.8%, with expected revenues of $0.52 million, down 61% from the previous year [3] - The consensus EPS estimate for the upcoming quarter has remained unchanged over the last 30 days, indicating a lack of upward revisions in earnings estimates [4] Industry Context - Dianthus Therapeutics is part of the Zacks Medical - Biomedical and Genetics industry, where Royalty Pharma (RPRX) also operates, finishing the last trading session 1% higher at $40.11 [4] - Royalty Pharma's consensus EPS estimate for its upcoming report is $1.33, representing a year-over-year increase of 15.7%, with a Zacks Rank of 3 (Hold) [5]

Core Viewpoint - Dianthus Therapeutics is focused on developing innovative autoimmune therapeutics with a strong pipeline aimed at patient-friendly self-administration methods [3]. Group 1: Product Development - The company is advancing two clinical-stage autoimmune therapeutics, emphasizing their best-in-class potential and infrequent subcutaneous self-administration [3]. - The first program, claseprubart, is a potent classical pathway inhibitor with an 8-week half-life, targeting activated C1s, and has shown positive Phase II results in Myasthenia Gravis (MG) [4]. - Clinical proof of concept has been established for classical pathway inhibition in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) [4]. - The product is designed for convenience, utilizing a single self-administered 300-milligram 2-milliliter auto-injector, with dosing every two or four weeks [4]. Group 2: Clinical Trials - The second program, DNTH212, has recently commenced its Phase I clinical trials [5].

Dianthus Therapeutics FY Conference Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Focus**: Development of clinical-stage autoimmune therapeutics with a best-in-class pipeline targeting patient-friendly, infrequent subcutaneous self-administration [2][3] Key Products and Pipeline Clasibobart - **Description**: A potent classical pathway inhibitor with an eight-week half-life, targeting activated C1s - **Clinical Status**: Positive phase two results disclosed in September, with clinical proof of concept for classical pathway inhibition in Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [2][4] - **Administration**: 300 mg, 2 ml autoinjector dosed every two or four weeks [3][5] - **Market Potential**: Targeting over 150,000 patients in the U.S. for MG, CIDP, and Multifocal Motor Neuropathy (MMN) [5][6] - **Efficacy Data**: Impressive results with 300 mg every two weeks showing robust, statistically significant efficacy across five measures in MG [6][9] - **Phase 3 Trial**: Discussions with the FDA ongoing, aiming for a trial comparing placebo, Clasibobart every two weeks, and every four weeks [11][12] DNTH212 - **Description**: A bispecific fusion protein targeting BDCA2 and BAFF/APRIL pathways - **Clinical Status**: Currently in phase 1 trials, with plans to prioritize indications such as Systemic Lupus Erythematosus (SLE) and dermatomyositis [25][26] Market Opportunities Myasthenia Gravis (MG) - **Market Size**: Approximately 100,000 patients in the U.S. with ACHR positive MG [5] - **Competitive Advantage**: Clasibobart's mechanism may provide superior efficacy compared to existing C5 inhibitors by preventing pro-inflammatory toxins [10][11] Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - **Market Need**: High unmet need due to limitations of current treatments like IVIG and FcRns [13][14] - **Efficacy Signals**: Clasibobart showed better efficacy than IVIG in patients refractory to standard treatments [14][15] Multifocal Motor Neuropathy (MMN) - **Market Size**: Estimated 10,000-15,000 patients in the U.S. with a high potential for a blockbuster product due to lack of competition [21][33] - **Competitive Landscape**: Clasibobart is positioned against Empasibobart, with superior potency and a more convenient administration route [22][24] Financial Position - **Cash Reserves**: Approximately $514 million, providing a runway into 2028 [27] Additional Insights - **Trial Design**: Clasibobart's trial design allows for immediate switching from IVIG to Clasibobart, which may yield higher responder rates compared to traditional methods [19][20] - **Market Strategy**: Emphasis on the potential for Clasibobart to be the most convenient and patient-friendly biologic in MG and CIDP [12][13] - **Investor Considerations**: The company highlights the importance of looking at actions and trial designs rather than just statements when evaluating potential success [31][32] Conclusion Dianthus Therapeutics is positioned to make significant advancements in the treatment of autoimmune diseases with its innovative therapies, particularly Clasibobart, which shows promise in multiple indications and has a strong clinical and market strategy. The upcoming phase 3 trial and interim analyses are critical milestones to watch for potential investment opportunities.

Core Insights - The transaction indicates a complete disposition of direct equity holdings by Savitz Ryan, resulting in zero remaining directly held shares for future sales unless additional equity is acquired or more options are exercised [1][4]. Company Overview - Dianthus Therapeutics is a clinical-stage biotechnology company focused on developing monoclonal antibody therapies for severe autoimmune and inflammatory conditions, including diseases like generalized myasthenia gravis and multifocal motor neuropathy [6]. Transaction Details - On December 4, 2025, Savitz Ryan, CFO & CBO of Dianthus Therapeutics, exercised 20,000 stock options and sold the shares for a total of $903,600, at a weighted average price of $45.18 per share [4][5]. - The transaction was executed entirely through direct holdings, with no participation from indirect entities such as trusts or LLCs [2][5]. Market Context - Dianthus Therapeutics experienced significant gains after issuing 7.6 million shares at $33 per share, raising $288 million for development activities, and reported promising clinical trial results in its third-quarter earnings [9]. - The stock price has retreated from its high but remains around $38, with analysts estimating a one-year target of $63 [9].

Core Viewpoint - Dianthus Therapeutics, Inc. is actively participating in the 44th Annual J.P. Morgan Healthcare conference, highlighting its commitment to developing next-generation therapies for severe autoimmune diseases [1]. Group 1: Company Overview - Dianthus Therapeutics is a clinical-stage biotechnology company focused on transforming the treatment of severe autoimmune diseases [3]. - The company is based in New York City and Waltham, Massachusetts, and is led by an experienced team of biotech and pharmaceutical executives [3]. - Dianthus aims to deliver transformative medicines for individuals suffering from severe autoimmune and inflammatory diseases [3]. Group 2: Event Participation - CEO Marino Garcia will present a corporate overview at the J.P. Morgan Healthcare conference on January 12, 2026, at 3:00 pm PST / 6:00 pm EST [1]. - The company will also host one-on-one meetings with investors during the conference [1]. - A webcast of the presentation will be available in the "News and Events" section of the Dianthus Therapeutics website [2].

Summary of Key Points from Biotechnology Equity Research Conference Call Industry Overview - The report focuses on the biotechnology sector, specifically highlighting companies with significant potential for growth and upcoming catalysts in 2026. Key Companies and Their Outlook 1. **Dianthus Therapeutics, Inc. (DNTH)** - Market Cap: $1.82 billion - Price Target: $66 - Key catalysts include: - CIDP Phase III interim analysis in Q2 2026 - Initiation of gMG Phase III study in mid-2026 - Phase II MMN topline data in 2H26 - Potential for significant upside based on peak revenue estimates of ~$2 billion across neuromuscular diseases [19][20][24] 2. **Taysha Gene Therapies, Inc. (TSHA)** - Market Cap: $1.50 billion - Price Target: $11 - Focus on pivotal study for TSHA-102 in Rett syndrome with potential for a 6-month interim readout by YE26/1Q27 [26][27] 3. **Tyra Biosciences (TYRA)** - Market Cap: $1.36 billion - Price Target: $32 - Major catalysts include: - Phase III data for achondroplasia in early 2026 - Initial data for IR-NMIBC in 1H26 - Potential to disrupt the market with oral FGFR3 inhibitors [31][35] 4. **Tango Therapeutics, Inc. (TNGX)** - Market Cap: $1.15 billion - Price Target: $14 - Expected to show de-risking data for vopimetostat in combination with RVMD's RAS inhibitors in 2026 [37][40] 5. **ORIC Pharmaceuticals (ORIC)** - Market Cap: $783 million - Price Target: $23 - Key catalysts include dose-optimization data for prostate cancer and validating data from PFE's MEVPRO-1 trial [42][48] 6. **Solid Biosciences (SLDB)** - Market Cap: $463 million - Price Target: $15 - Focus on DMD program with key regulatory feedback expected in 1H26 [49][53] Major Catalysts and Events - **Upcoming Catalysts:** - RARE and MREO Phase III ORBIT final analysis expected in Dec'25/Jan'26 with potential stock movements of +100%/-30% [2] - ALNY, CRSP, and others expected to provide revenue guidance and business plans early in 2026 [1] - Regulatory events including FDA's Rare Disease Day on 2/23/26 [12] - **Drug Launches:** - Expected launches in 2026 include drugs from ALNY, ARWR, KALV, and others targeting various conditions [3] Financial Updates - **Price Target Changes:** - ARWR raised from $67 to $90 - KOD raised from $24 to $39 [6][10] Market Dynamics - **Pricing Stability:** - 2026 net pricing expected to remain stable with current Medicare contracts influencing high gross-to-net (GTN) guidance [12] - **Strategic Interest:** - Potential for M&A activity as companies like ORIC attract interest due to their prostate cancer programs [43] Conclusion - The biotechnology sector is poised for significant developments in 2026, with multiple companies presenting strong investment opportunities based on upcoming catalysts, drug launches, and strategic positioning in the market.

Core Insights - Jefferies has released a report on the outlook for the U.S. biotech industry in 2026, highlighting key clinical trial data disclosures, new drug approvals, and policy dynamics that could lead to value re-evaluation for companies in the sector [1] Six Preferred Stocks - Jefferies identified six companies as core recommendations for 2026 based on market catalysts and valuation potential: - Dianthus Therapeutics (DNTH.US), target price $66: Focused on claseprubart for various neuromuscular diseases, with peak revenue estimated at $2 billion [2] - Taysha Gene Therapies (TSHA.US), target price $11: TSHA-102 for Rett syndrome, with peak revenue potential of $2 billion and a key trial data disclosure expected by the end of 2026 [2] - Tyra Biosciences (TYRA.US), target price $32: Dabogratinib for bladder cancer and achondroplasia, with critical data expected next year [3] - Tango Therapeutics (TNGX.US), target price $14: Collaboration with Revolution Medicines for a pancreatic cancer treatment, with data expected in mid-2026 [3] - ORIC Pharmaceuticals (ORIC.US), target price $23: Two potential assets targeting prostate cancer and lung cancer, with key data expected next year [4] - Solid Biosciences (SLDB.US), target price $15: Focused on gene therapy for Duchenne muscular dystrophy, with critical meetings with the FDA planned for 2026 [4] Seven Undervalued Companies - The report also highlighted seven undervalued companies with significant catalysts: - Ultragenyx Pharmaceutical (RARE.US), target price $114: Expected key catalysts in 2026, including data for treatments for osteogenesis imperfecta and Angelman syndrome [5] - Beam Therapeutics (BEAM.US), target price $41: Updates on AATD therapy and SCD therapy expected in 2026, showcasing strong potential [5] - Aurinia Pharmaceuticals (AUPH.US), target price $21: Steady growth in lupus nephritis treatment, with new drug development paths expected to expand growth [6] - Kodiak Sciences (KOD.US), target price $39: Anticipated data from three pivotal trials in 2026, with significant potential for stock volatility [7] - Intellia Therapeutics (NTLA.US), target price $45: Key data for hereditary angioedema therapy expected in mid-2026, with sufficient cash reserves to support operations [7] - Compass Therapeutics (CMPX.US), target price $8: Data for cholangiocarcinoma therapy expected in early 2026, with a significant market opportunity [8] - KalVista Pharmaceuticals (KALV.US), target price $38: First oral treatment for hereditary angioedema expected to see rapid growth in 2026 [8] Five Potential Acquisition Targets - Jefferies identified five companies that may become acquisition targets in 2026 due to their unique assets or market positions: - Arrowhead Pharmaceuticals (ARWR.US): Strong RNAi product line for cardiovascular and metabolic diseases [9] - Celcuity (CELC.US): Unique efficacy of gedatolisib in breast cancer [9] - ORIC Pharmaceuticals: High-value prostate and lung cancer projects [9] - Travere Therapeutics (TVTX.US): Potential for significant market expansion in rare kidney diseases [9] - KalVista Pharmaceuticals: First-mover advantage in oral HAE treatment [9]

Core Insights - LBL-047 (DNTH212) is a bifunctional fusion protein targeting plasmacytoid dendritic cells to reduce Type 1 interferon production and inhibit B cell function, with top-line results expected in the second half of 2026 [1][4] - The drug has the potential to be a first-line biologic for multiple autoimmune disorders, offering patient-friendly subcutaneous self-administration and dosing every four weeks or less [1][3] Company Overview - Leads Biolabs is a clinical-stage biotechnology company focused on developing innovative therapies for oncology, autoimmune, and severe diseases, with a pipeline of 14 drug candidates, including six in clinical stages [10][11] - Dianthus Therapeutics is also a clinical-stage biotechnology company dedicated to next-generation therapies for severe autoimmune diseases, with a team of experienced biotech and pharma executives [9] Clinical Trial Details - The Phase 1 trial of LBL-047 (DNTH212) is a two-part, double-blind, randomized, placebo-controlled study designed to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers and patients with systemic lupus erythematosus [2] - The trial is being conducted in collaboration with leading medical professionals in Shanghai, with the healthy volunteer part led by Professor Meng Xianmin and the SLE part by Professors Ye Shuang and Chen Sheng [2] Partnership and Development - Leads Biolabs entered an exclusive global partnership with Dianthus, with a total potential deal value of up to $1 billion, allowing Dianthus to develop and commercialize LBL-047 outside Greater China [4] - Dianthus plans to provide updates on prioritized indications for DNTH212 in the first half of 2026 [4]

Dianthus Therapeutics FY Conference Summary Company Overview - Dianthus Therapeutics is perceived as a significantly de-risked company following the presentation of positive Phase 2 data for its neuromuscular conditions treatment, specifically with a dosing regimen of 300 milligrams every two weeks [3][4] - The company is preparing for two important catalysts in 2026: an interim responder analysis for CIDP in Q2 and Phase 2 top-line data from the MMN trial in the second half of 2026 [4] Key Points on CIDP Trial - The accelerated timeline for the CIDP trial is attributed to faster recruitment following the MG data presentation, which reassured investigators about the safety and efficacy of the treatment [7][8] - The trial design is modeled after the ADHERE trial from argenx, featuring an open-label part A that allows patients to receive active treatment before randomization [10][11] - The trial is designed to be more attractive for participants compared to competitors, with less frequent dosing (every two weeks) versus weekly for other treatments [10][12] - The company emphasizes the importance of confirming CIDP diagnoses through an independent review board, ensuring a dual authentication system for patient eligibility [17][18] Efficacy Expectations - The company aims to achieve a responder rate in the range of 40%-50%, which would indicate a competitive drug compared to riliprubart [40] - There is a focus on achieving significant inhibition of the classical pathway with a lower dose and fewer injections compared to competitors [41][42] - The interim analysis may not disclose specific responder rates due to FDA guidelines, but the expectation is to demonstrate at least similar efficacy to riliprubart [24][33] MMN Trial Insights - The MMN trial is modeled after argenx's Phase 2 trial, with expectations to report top-line results in the second half of next year [54] - The primary endpoint for the Phase 3 trial is still under discussion with the FDA, with grip strength being a likely candidate based on ongoing conversations [59] New Asset Introduction - Dianthus has licensed a new bispecific fusion protein, NTH 212, from China, which is expected to be a first-in-class and best-in-class potential treatment [4][60] - The timing for the indication selection disclosure for NTH 212 is planned before the Phase 1 data release in the second half of next year [62] Additional Considerations - The company is considering removing certain burdensome tests, such as ANA titers, from the trial protocols, similar to actions taken by competitors [43][44] - The overall sentiment is optimistic, with a strong belief in the efficacy of classical pathway inhibition in CIDP and a commitment to patient-friendly dosing regimens [24][41]