相关临床试验
68
35 进行中
药物批准
4
批准总数
监管机构
1
监管机构数
成立时间
2008
进行中（未招募）
34
50.0%
已完成
21
30.9%
尚未招募
1
1.5%
招募中
7
10.3%
终止
2
2.9%
Unknown
1
1.5%
撤回
2
2.9%
- Biogen has extended its felzartamab program with an open-label long-term extension study in kidney transplant patients who developed antibody-mediated rejection or microvascular inflammation in the TRANSCEND or TRANSPIRE trials. - Felzartamab is administered as a slow intravenous infusion every eight weeks and is designed to calm immune attacks on transplanted kidneys, with safety as the study's primary goal. - Biogen executives describe antibody-mediated rejection as the foundational opportunity for felzartamab, noting there are no approved therapies and roughly 11,000 U.S. patients experience secondary kidney transplant rejection. - The company also plans to evaluate felzartamab in IgA nephropathy and membranous nephropathy, supported by nephrology infrastructure gained through its Apellis acquisition.
- Biogen reported Q2 2026 adjusted earnings of $3.60 per share on revenue of $2.74 billion, surpassing analyst estimates of $2.95 and $2.46 billion respectively. - The company raised its full-year 2026 revenue guidance to mid-single-digit growth from a prior forecast of mid-single-digit decline, citing rare disease portfolio strength. - Global sales of Alzheimer's drug Leqembi rose 15% year-over-year to approximately $184 million, with a new subcutaneous formulation expected to boost uptake. - Biogen cut its 2026 adjusted EPS guidance to $12–$13 from $14.25–$15.25, reflecting a $3.85 per share impact from the $5.6 billion Apellis Pharmaceuticals acquisition.
- At ASRS 2026 in Montreal, durable treatment strategies for wet AMD dominated research, with gene therapy, intravitreal implant and optogenetic data presented across four days. - Ocular Therapeutix reported phase 3 SOL-1 results showing a single AXPAXLI injection maintained BCVA in 74.1% of patients at Week 36 versus 55.8% with monthly aflibercept. - Nanoscope Therapeutics presented 3-year REMAIN data showing durable BCVA gains of about 3 ETDRS lines with MCO-010 in retinitis pigmentosa, alongside a rolling BLA submission. - Belite Bio's phase 3 DRAGON trial of oral tinlarebant met its primary endpoint with a 36% reduction in retinal lesion growth versus placebo in Stargardt disease.
- Inflammasome Therapeutics' dual inflammasome inhibitor K8 reduced geographic atrophy lesion growth by 54% versus control over six months in a Phase 2 trial (p=0.016). - A prespecified extrafoveal analysis showed a 4.0-letter mean BCVA advantage for K8-treated eyes versus controls (p=0.004), a functional endpoint neither approved GA therapy has met. - K8 is delivered as a bioerodible sustained-release intravitreal implant dosed once every three months, potentially reducing treatment burden compared to monthly approved therapies. - No drug-related serious adverse events, endophthalmitis, intraocular inflammation, or neovascular AMD were reported through six months in the 30-patient, 60-eye multicenter trial.
- The Dry Age-Related Macular Degeneration market across the 7MM is projected to grow at a 19.2% CAGR through 2036, driven by novel therapies and rising disease prevalence exceeding 72 million AMD cases in 2025. - Emerging oral therapies like Tinlarebant and Gildeuretinol acetate target vitamin A–driven retinal toxicity, offering alternatives to chronic intravitreal injections required by approved complement inhibitors IZERVAY and SYFOVRE. - Ocugen reported a statistically significant 31% reduction in GA lesion growth in its Phase II ArMaDa trial for gene therapy OCU410, with Phase III initiation planned for Q3 2026. - Gene therapies and regenerative medicine candidates, including Eyestem's recently approved Phase II cell therapy Eyecyte-RPE, are attracting substantial industry interest for their potential one-time administration benefit.
- Biogen announced the acquisition of Apellis Pharmaceuticals for $41 per share in cash, representing approximately $5.6 billion in upfront equity consideration, with additional contingent payments up to $4 per share based on SYFOVRE sales milestones. - The acquisition brings two FDA-approved complement-targeting therapies to Biogen's portfolio: EMPAVELI for rare kidney diseases and paroxysmal nocturnal hemoglobinuria, and SYFOVRE for geographic atrophy secondary to age-related macular degeneration. - Combined 2025 net product revenue for both drugs reached $689 million, with expected growth rates in the mid-to-high teens through at least 2028, strengthening Biogen's expansion into nephrology and immunology markets. - The transaction is expected to be increasingly accretive to Biogen's non-GAAP earnings per share starting in 2027 and meaningfully increase the company's earnings growth rate through the end of the decade.
- NovelMed Therapeutics reported positive Phase II results for Ruxoprubart in treatment-naïve PNH patients, achieving 100% transfusion independence and hemoglobin improvements of 1.5-2.7 g/dL during weekly dosing. - The company received regulatory clearance to initiate Phase II trials for subcutaneous administration, enabling weekly self-injection at home and reducing patient burden from IV infusions. - Ruxoprubart's precision targeting of activated Bb fragment provides selective alternative pathway inhibition while preserving classical pathway function for infection protection. - The drug holds FDA Orphan Drug Designation and demonstrated excellent safety with no drug-related adverse events, positioning it as a potential first-in-class monotherapy for PNH.
- Novartis announced encouraging results from the Phase III APPEAR-C3G trial showing Fabhalta (iptacopan) provided sustained improvements for patients with C3 glomerulopathy over 12 months when used alongside supportive care. - C3 glomerulopathy is a serious kidney disorder that frequently progresses to kidney failure within a decade of diagnosis, representing a significant unmet medical need. - The APPEAR-C3G study represents the first Phase III trial for an oral Factor B inhibitor targeting the alternative complement pathway in this rare disease. - The complement 3 glomerulopathy pipeline includes 3+ key companies developing therapies, with emerging treatments like NM8074, Pegcetacoplan, and LNP023 expected to impact the market significantly.
- The FDA approved multiple breakthrough therapies in 2025, including semaglutide for chronic kidney disease, atrasentan for IgA nephropathy, and pegcetacoplan for C3 glomerulopathy, marking a shift toward precision-driven nephrology care. - IgA nephropathy emerged as a major therapeutic focus with accelerated approval of atrasentan and positive phase 3 results for telitacicept and sibeprenlimab, demonstrating the transition from supportive care to targeted, disease-modifying strategies. - The CONFIDENCE trial showed that simultaneous initiation of finerenone and SGLT2 inhibitors was safe and effective in chronic kidney disease with type 2 diabetes, supporting proactive combination therapy over stepwise treatment escalation. - The FDA cleared the first xenotransplant trial for gene-edited kidneys, representing a translational step toward addressing organ shortages for patients with end-stage kidney disease.
- The dry age-related macular degeneration market is expected to experience substantial growth through 2034, driven by the uptake of recently approved therapies and the anticipated launch of emerging treatments. - Multiple innovative therapies are advancing through clinical trials, including Gildeuretinol from Alkeus Pharmaceuticals, which demonstrated a 0.25 sq mm per year reduction in geographic atrophy lesion growth compared to placebo in its Phase II/III SAGA trial. - The United States represents the largest market opportunity with approximately 21 million prevalent cases in 2024, while dry AMD accounts for nearly 90% of all AMD cases, representing a vast untapped therapeutic opportunity.
