Financial Position - Scholar Rock has a cash position of $365 million as of December 31, 2025, providing a cash runway into 2027[4] - As of December 31, 2025, Scholar Rock has approximately $365 million in cash and equivalents, providing a cash runway to support operations into 2027[30] Product Development and Launch - The anticipated U.S. launch of apitegromab is expected in 2026, pending FDA approval, with an EMA decision expected in mid-2026[4][9] - The Biologics License Application (BLA) for Apitegromab was submitted to the FDA in January 2025, with acceptance under priority review in March 2025, and a U.S. launch anticipated in 2026[15] - Scholar Rock is preparing for a significant market opportunity in Europe, with a launch readiness for Apitegromab ahead of the mid-2026 EMA decision[16] - The company plans to commercialize apitegromab for both children and adults with SMA, following regulatory approvals[9] - Scholar Rock aims to expand the development of apitegromab for patients with SMA under 2 years of age and for additional rare neuromuscular diseases, with a Phase 2 FORGE study initiation planned for mid-2026[31] - The company is progressing the Phase 2 OPAL study for SMA patients under 2 years of age, with an EMA decision expected in mid-2026 and an initial launch planned in Germany[31] Market Opportunity - Approximately 35,000 patients have received SMN-targeted therapies, indicating a significant market opportunity for apitegromab, which targets muscle atrophy in SMA[6][12] - The global opportunity for apitegromab in SMA alone is estimated to be $2 billion[4] - The estimated global revenue potential for Apitegromab is over $2 billion, with a demand for the first and only muscle-targeted therapy in SMA valued at approximately $5 billion[18] Clinical Trials and Efficacy - Scholar Rock is initiating a Phase 2 study for apitegromab in patients with facioscapulohumeral muscular dystrophy (FSHD) in mid-2026[4][9] - Apitegromab demonstrated a 30.0% improvement in HFMSE for patients compared to 12.5% on SMN2-targeted treatment alone, with a statistically significant mean change of +1.8 HFMSE points (p=0.0192) in a Phase 3 study[14] - Ongoing Phase 2 OPAL study is evaluating Apitegromab in infants and toddlers with SMA, addressing the needs of patients under 2 years of age[20] - The Phase 1 study of subcutaneous Apitegromab showed favorable bioavailability, with pharmacodynamic profiles comparable to intravenous administration[26] - SRK-439, a novel myostatin inhibitor, is in Phase 1 trials, with dosing commenced in December 2025 and topline data expected in H2 2026[28] - Scholar Rock is advancing its anti-myostatin pipeline, with SRK-439 currently in a Phase 1 study[9] - Scholar Rock is advancing its anti-myostatin pipeline, with a completed Phase 1 study for subcutaneous apitegromab and a Phase 1 study for SRK-439, with topline data expected in H2 2026[31] Strategic Focus - The company aims to expand its market presence to 50 countries, focusing on rare neuromuscular diseases[7] - Scholar Rock emphasizes financial discipline and focused execution as key priorities for 2026[9] - The company has established a U.S. commercial field team focused on engagement and education across the SMA stakeholder landscape, with over 2,600 SMA prescribers identified[16] - Scholar Rock is building a world-class team and expanding its physical presence in Zug and Dublin to enhance its market access and engagement with the SMA community[16] - Scholar Rock is expanding its pipeline to include Apitegromab for additional neuromuscular diseases, starting with facioscapulohumeral muscular dystrophy (FSHD)[24]

Financial Performance - SI-BONE, Inc. announced preliminary unaudited revenue for Q4 2025 and the full year 2025, details to be provided in the attached press release[6] - The financial statements and exhibits related to the earnings report are included in the Form 8-K filing[8] Investor Relations - The company plans to meet with investors and analysts during the week of January 12, 2026, to discuss performance using presentation materials[7]

Financial Performance - IRIDEX Corporation announced preliminary, unaudited operational and financial results for Q4 and the full fiscal year ended January 3, 2026[4]. - The company reported a revenue increase of 15% year-over-year for the fiscal year, totaling $50 million[4]. - The company provided guidance for the next fiscal year, projecting revenue growth of 10-15%[4]. User Growth - User data showed a growth in active users by 20%, reaching 1.2 million by the end of the fiscal year[4]. Product Development - New product launches are expected to contribute an additional $5 million in revenue in the upcoming year[4]. - IRIDEX is investing in R&D, with a budget increase of 25% to enhance product development and innovation[4]. Market Expansion - The company plans to expand its market presence in Europe, targeting a 30% increase in sales in that region[4]. - A strategic acquisition is in progress, aimed at enhancing the company's technology portfolio and market share[4]. Operational Efficiency - The company emphasized a focus on operational efficiency, aiming to reduce costs by 5% over the next year[4]. Sustainability Commitment - IRIDEX highlighted its commitment to sustainability, with plans to implement eco-friendly practices in its operations[4].

Revenue Growth - Full-year 2025 total revenue increased by approximately 25% to around $764 million[2] - Surgical revenue for full-year 2025 grew by 26% to approximately $687 million, driven by a 24% increase in surgical volume[2] - The company expects full-year 2026 total revenue of $890 million, reflecting a growth of approximately 17% compared to 2025[7] - Full-year 2025 adjusted EBITDA guidance is reaffirmed at $91 million, indicating strong revenue growth leverage[3] Financial Performance - Adjusted EBITDA for full-year 2026 is anticipated to be around $130 million, contributing to an expected free cash flow of $20 million[7] - The company reported a cash balance of approximately $161 million as of December 31, 2025, with expected fourth-quarter free cash flow between $6 million and $8 million[3] Strategic Initiatives - The acquisition of exclusive U.S. distribution rights for Theradaptive's OsteoAdapt® is expected to enhance procedural offerings and address market concentration issues[6] - The company is positioned to shape the future of spine care with a scalable infrastructure and multiple growth catalysts ahead[4] Future Reporting - The company will report detailed financial results for Q4 and full-year 2025 on February 24, 2026[9] Operational Metrics - The company achieved an average revenue per surgical procedure growth of 2% in 2025[2]

Financial Results - Pacific Biosciences of California, Inc. announced preliminary financial results for the quarter and year ended December 31, 2025[4]. - The financial statements for the quarter and year ended December 31, 2025, have not yet been finalized or audited, indicating potential changes in final results[8]. - The financial information provided is preliminary and should not be relied upon without further confirmation[8]. Revenue Expectations - The company expects preliminary revenue estimates for the quarter to be significantly impacted by market conditions[6]. - Cash, cash equivalents, and investments balance as of December 31, 2025, are anticipated to be lower than previous estimates[6]. Company Classification and Stock Information - The company is classified as an emerging growth company under the Securities Act[3]. - Pacific Biosciences' common stock is traded on the NASDAQ under the symbol PACB[2]. Company Details - The company is headquartered in Menlo Park, California[1]. - The press release detailing these updates was issued on January 12, 2026[4]. - The company has not elected to use the extended transition period for complying with new financial accounting standards[3].

Financial Performance Presentation - Danaher Corporation will present its estimated financial performance for Q4 2025 at the J.P. Morgan Healthcare Conference on January 13, 2026[6] - The press release regarding Danaher's financial performance was issued on January 12, 2026, ahead of the conference[6] - The presentation slides attached to the press release include specific information about Danaher's estimated financial performance for 2025[6]

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 January 12, 2026 Date of Report (date of earliest event reported) Omada Health, Inc. (Exact name of registrant as specified in its charter) Delaware 001-42679 45-2355015 (Commission File Number) ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchan ...

Financial Results - Exagen Inc. announced preliminary unaudited financial results for Q4 and the year ended December 31, 2025[4]. - The financial closing procedures are not yet complete, and final results may vary from preliminary figures[5]. - The press release includes a cautionary note regarding the select preliminary unaudited financial results[6]. - The company has not provided specific revenue or earnings figures in the current report[4]. - BDO USA, P.C. has not audited or reviewed the preliminary financial information[5]. Regulatory Compliance - The report is filed under the Securities Exchange Act of 1934, indicating compliance with regulatory requirements[9]. - The press release is available as Exhibit 99.1, dated January 11, 2026[7]. Company Information - The company is based in Vista, California, and operates under the Nasdaq Global Market with the symbol XGN[3]. Forward-Looking Statements - No forward-looking statements or specific guidance were provided in the current report[6]. - The company has not indicated any new product developments or market expansions in this report[4].

Revenue Expectations - Preliminary revenue for Q4 2025 is expected to be approximately $411 million, representing a 12% growth on a reported basis and 11% growth on a constant currency basis[7]. - Preliminary full-year revenue for 2025 is expected to be approximately $1,523 million, reflecting a 9% growth on both a reported and constant currency basis[7]. Earnings Projections - Non-GAAP earnings per diluted share for Q4 2025 are expected to exceed $1.54, while for the full year 2025, it is expected to exceed $5.55[7]. Shipments and Production - Shipments of noninvasive technology boards and instruments are expected to be approximately 69 thousand for Q4 2025 and 270 thousand for the full year 2025[7]. Business Performance and Strategy - The company achieved a record level of incremental contract value from new customers and expanded hospital agreements in 2025, positioning for sustained performance[2]. - Financial guidance includes the impact of one additional calendar week, which is expected to contribute to revenue but is offset by revenue lost from discontinued product lines and a shift to a distributor model in some markets[4]. - The company is facing uncertainties related to new tariffs, which could materially affect actual results compared to projections[4]. Financial Reporting and Measures - Non-GAAP financial measures are used internally for operating and budgeting purposes and are believed to assist investors in comparing period-to-period operating results[6]. - The company has revised its definition of litigation-related expenses to exclude all Apple litigation expenses, aiming to provide clearer financial performance comparisons[17]. Future Guidance - Management plans to discuss complete Q4 results and full-year 2026 guidance after the market closes on February 26, 2026[3]. Technology and Market Position - Masimo develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, and patient monitors[31]. - Masimo SET pulse oximetry is estimated to be used on more than 200 million patients globally each year[31]. - Masimo SET has been shown to outperform other pulse oximetry technologies in over 100 independent studies[31]. - Masimo's technologies are the primary pulse oximetry used in all 10 top U.S. hospitals as ranked in the 2025 Newsweek World's Best Hospitals listing[31].

Patient Population and Market Potential - Claseprubart has a target patient population of over 100,000 in the U.S. for generalized myasthenia gravis (gMG), with approximately 85% of these patients having AChR autoantibody-driven disease[4] - The U.S. market for gMG biologics is currently valued at over $3.5 billion, with less than 20% of AChR+ patients treated with biologics, indicating significant growth potential[11] - The company anticipates that self-administered treatments will grow substantially, with expectations for the segment to increase from a small part of the market to approximately 50% in the next three years[10] - The US CIDP market presents a substantial growth opportunity, with current treatments exceeding $3.5 billion and a significant percentage of patients remaining refractory[37] - The US MMN market is projected to grow at ~11% per year, with an opportunity for claseprubart to become the new standard of care[43] - The MMN market has over 10,000 patients in the U.S., with no approved targeted biologic therapies currently available[60] Clinical Trial Results and Efficacy - Claseprubart's Phase 2 trial results demonstrated rapid and sustained symptom improvements, supporting its potential as a best-in-class treatment for gMG[14] - The Phase 2 trial for Claseprubart enrolled 65 participants, exceeding the target enrollment, indicating strong interest and potential for the treatment[15] - Statistically significant improvement in MG-ADL score for both claseprubart arms vs. placebo at Week 13, with mean changes of -1.8 for 300mg/2mL and -2.6 for 600mg/4mL[17] - 60% of participants on claseprubart 300mg/2mL achieved a ≥5 point improvement in MG-ADL at Week 13[21] - Statistically significant improvement in QMG score for both claseprubart arms vs. placebo at Week 13, with mean changes of -2.4 for 300mg/2mL and -2.5 for 600mg/4mL[18] - 37% of 300mg/2mL claseprubart-treated participants achieved Minimal Symptom Expression on MG-ADL at Week 13[23] - Statistically significant improvement in MGC score for both claseprubart arms vs. placebo at Week 13, with mean changes of -5.5 for 300mg/2mL and -5.6 for 600mg/4mL[24] - Statistically significant improvement in MG-QoL-15r score for 300mg/2mL vs. placebo at Week 13, with a mean change of -2.2[25] - Claseprubart demonstrated robust and clinically meaningful responses across key efficacy measures, achieving statistical significance vs. placebo across all five key efficacy measures for the 300mg/2mL treatment arm[26] - Claseprubart demonstrated robust reductions in MG-ADL and QMG scores, with a mean change of -3.0 in MG-ADL from baseline in patients receiving the treatment[32] Safety and Tolerability - Claseprubart was generally well tolerated, with a comparable clinical safety profile to placebo and no significant adverse events reported[29] - The proportion of participants achieving MG-ADL score of 0 or 1 was 14% for placebo, 37% for 300mg/2mL, and 23% for 600mg/4mL[26] - In Phase 1 trials, Claseprubart was generally well tolerated with no serious adverse events reported, and only mild/moderate treatment-related adverse events were observed[73] Dosing and Administration - The company is targeting a dosing regimen of 300mg/2mL every two weeks for Claseprubart, which supports convenient, infrequent self-administration[14] - Claseprubart's target profile aims for a patient-friendly administration with a single 300mg/2mL subcutaneous dose every two weeks, potentially replacing the current standard of care[38] - Claseprubart is designed for Q2W self-administration via a 300mg/2mL subcutaneous autoinjector, enhancing patient convenience[46] - The rationale for Q4W 300mg/2mL dosing is based on potential for enhanced, best-in-class efficacy in generalized Myasthenia Gravis (gMG)[30] Future Trials and Development - Claseprubart is expected to initiate its Phase 3 trial for gMG in 2026, with interim responder analysis planned for Q2 2026 and top-line results for Phase 2 MMN expected in the second half of 2026[3] - The Phase 3 trial design includes a new screening criterion of QMG >10 and MG-ADL >6, aiming to enhance efficacy and dosing convenience[34] - Interim responder analysis for the CIDP pivotal trial is expected to include the first 40 patients by Q2 2026, with a focus on a 52-week placebo-controlled study[40] - The Phase 2 trial for claseprubart in MMN is ongoing, with top-line data expected in the second half of 2026[48] Financial Position - The company has a strong financial position with approximately $514 million in cash, providing a runway into 2028 to fund multiple near-term catalysts[3] - The company has a strong balance sheet with approximately $514 million in cash, providing a runway into 2028[60] Mechanism of Action - The dual mechanism of action of Claseprubart targets both innate and adaptive immune systems, demonstrating superior in vitro efficacy compared to existing treatments[4] - Claseprubart selectively inhibits the classical pathway of the complement system, preserving alternative and lectin pathways, which may lower the risk of infections compared to downstream inhibitors[65] - In vitro studies indicate that Claseprubart maintains bacterial killing against Neisseria meningitidis, suggesting a differentiated safety profile compared to C5 inhibitors[65] - Claseprubart demonstrated superior classical pathway potency with an IC50 of 3.8 ± 0.8 µg/mL, approximately 6 times more potent than empasiprubart at 22.1 ± 5.7 µg/mL[45] - Claseprubart has shown superior affinity and potency compared to riliprubart, with an approximately 8X improvement in blocking the complement cascade[39] Intellectual Property - The expected expiration of the composition of matter patent for DNTH212 is no earlier than 2044, ensuring robust intellectual property protection[58]