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Clinical readouts

Phase III and pivotal trial results — positive and negative, treated alike.

391 picksRelatedSafety signalsRegulatoryOncology

Latest picks

61–80 of 391
Oct 12Mon
  1. WeChat60

    Furmonertinib Fails PFS Primary Endpoint in Global Phase III FURVENT Trial as First-Line EGFR Exon20ins Nonsquamous NSCLC Therapy

    ArriVent BioPharma, Allist Pharmaceuticals' overseas partner, announced on October 6, 2026 that the global Phase III FURVENT study of furmonertinib monotherapy as first-line treatment for EGFR exon20ins nonsquamous NSCLC did not meet its primary endpoint of BICR-assessed PFS. Allist confirmed the result in a filing the next day. The article notes a split picture among secondary endpoints and suggests the problem may not lie with the drug itself.

    Why it matters: Records the Phase III FURVENT PFS miss and the split secondary-endpoint picture, giving readers clues to judge whether the fault lies in trial design or the drug.

  2. WeChat60

    AstraZeneca ALXN1850 Fails Hypophosphatasia Trial Primary Endpoint

    AstraZeneca's ALXN1850 (efzimfotase alfa) missed the primary endpoint in a trial in hypophosphatasia. The 6MWT increased by 17.05 meters in the efzimfotase alfa group, with a p-value of 0.1675, so the difference was not statistically significant. Subgroup analysis indicated a more pronounced treatment effect in patients with childhood-onset disease.

    Why it matters: Late-stage miss for a major-company hypophosphatasia drug, with a positive childhood-onset subgroup signal.

  3. WeChat70

    Roche files for approval of IL-6 antibody vamikibart in uveitic macular edema after Phase III data

    Roche has submitted vamikibart, an IL-6 antibody for uveitic macular edema, for marketing approval after presenting 52-week data from the two Phase III trials MEERKAT and SANDCAT at AAO 2026. The results showed sustained vision improvement and reduced macular thickness. If approved, vamikibart would be the first non-steroidal targeted therapy for Uveitic macular edema, where high-dose steroids are currently the main option.

    Why it matters: Filing of what could be the first non-steroidal targeted therapy for uveitic macular edema.

  4. WeChat78

    IBI311 Hits 60.4% Proptosis Response in Phase 3 Inactive Thyroid Eye Disease Trial

    IBI311 met its primary endpoint in the Phase 3 RESTORE-3 trial in inactive thyroid eye disease, with a proptosis response rate of 60.4%. The multicenter, randomized, double-blind, placebo-controlled study enrolled 116 patients randomized about 2:1 to IBI311 or placebo. Prior clinical evidence for IBI311 came mainly from patients with active TED.

    Why it matters: Extends IBI311 evidence from active to inactive thyroid eye disease with positive Phase 3 results.

  5. 文献与产业新闻36

    Comparative efficacy of topical garlic extract and 20% podophyllin solution in the treatment of female genital warts: a triple-blind randomized clinical trial

    A triple-blind randomized clinical trial of 74 women with genital warts found that after four weeks of topical 5% garlic extract or 20% podophyllin, wart size and count decreased in both groups with no significant between-group difference (p = 0.756). Complete response rates were 51.4% and 51.4%, and complete or partial response rates were 65.7% and 67.6%. Follow-up lasted only four weeks, so durability and recurrence could not be assessed.

    Why it matters: Trial reports comparable outcomes for a low-cost topical alternative to podophyllin.

  6. WeChat73

    Merck's Remigromig Matches Anti-VEGF Vision Outcomes in DME at One Year

    Remigromig, a tetravalent trispecific agonist targeting the Wnt pathway, met the primary goal of non-inferiority to anti-VEGF therapy for vision outcomes in the pivotal Phase 2b/3 BRUNELLO study of adults with diabetic macular edema. Merck presented the one-year results at AAO 2026. Remigromig is the first biologic with a new mechanism of action to show vision non-inferiority versus anti-VEGF treatment in a pivotal DME trial, a setting where up to 40% of patients have persistent disease after six months.

    Why it matters: First non-VEGF mechanism to match anti-VEGF vision outcomes in a pivotal DME trial.

Oct 11Sun
  1. 顶刊论文（社媒热度）82

    Vasopressors or Fluids in Early Septic Shock.

    Early vasopressor therapy with restricted fluids did not improve outcomes over higher fluid volumes with later vasopressors in emergency department patients with septic shock. In 963 intention-to-treat patients, days alive and out of the hospital at day 90 were a median of 76 in both groups (difference, 0.0 days; 95% CI, -2.7 to 2.7; P = 1.00). Pulmonary edema was less frequent with the vasopressor strategy (0.6% vs. 5.0%; P<0.001).

    Why it matters: It resolves equipoise over early vasopressors versus larger fluid volumes in early septic shock resuscitation.

Oct 10Sat
  1. WeChat88

    Iberdomide Combination Halves Progression Risk in EXCALIBER-RRMM Relapsed Myeloma Trial

    Median progression-free survival reached 42 months for iberdomide plus daratumumab and dexamethasone (IberDd), versus daratumumab plus bortezomib and dexamethasone, with a progression-free survival hazard ratio of 0.49. Bristol Myers Squibb reported the positive EXCALIBER-RRMM study results, which evaluated efficacy and safety in 800 multiple myeloma patients at first relapse or later.

    Why it matters: EXCALIBER-RRMM shows iberdomide combination halving progression risk in relapsed multiple myeloma.

  2. WeChat71

    Prifemilast Beats Apremilast in Phase 3 Head-to-Head Plaque Psoriasis Trial

    Prifemilast, an oral selective PDE4B inhibitor developed by cAMPfield Therapeutics and Newsoara Biopharma, was reported to beat apremilast head-to-head in a Phase 3 trial. The study randomized 607 adults with moderate-to-severe plaque psoriasis 2:1 to prifemilast 20 mg once daily or apremilast 30 mg twice daily for 16 weeks. Results were presented as two posters at the Fall Clinical Dermatology Conference in Las Vegas, with publication expected in the Dermatology Online Journal.

    Why it matters: A domestic PDE4B inhibitor claims a Phase 3 head-to-head win over apremilast in plaque psoriasis.

  3. WeChat63

    Argenx Terminates UNITY Trial of Efgartigimod in Sjögren's Syndrome on Missed Primary Endpoint

    Argenx terminated the late-stage UNITY trial of efgartigimod in Sjögren's syndrome after the independent data monitoring committee concluded the study could not meet its primary endpoint. The news, announced before a single-day share drop of 11.83% on October 9, 2026, erased more than 5 billion US dollars in market value, Argenx's largest one-day decline in nearly three years.

    Why it matters: Clinical failure of a leading autoimmune drug in Sjögren's syndrome ends a major trial and moves the market.

  4. Medical Xpress54

    Blood cancer study links blood formation and bone health

    Patients with myelodysplastic syndromes (MDS) already had lower bone density than age-matched controls and lost further bone density over three years, according to the prospective BoHemE study of 111 patients and 84 controls. Osteoporosis at baseline was linked to poorer overall survival, and a DNMT3A mutation in blood-forming cells was associated with lower bone density. The findings argue for making bone health part of routine MDS diagnosis and management.

    Why it matters: It links a common blood cancer to measurable, clinically relevant bone loss and survival in a prospective cohort.

  5. WeChat80

    Zhongsheng Ruichuang's RAY1225 Hits Primary Endpoint in Phase 3 With Every-Two-Week Dosing, 20.46% Placebo-Adjusted Weight Loss at 9mg

    Zhongsheng Ruichuang's GLP-1R/GIPR dual agonist RAY1225 met its primary endpoint in a Phase 3 trial, with the 9mg group showing a placebo-adjusted weight reduction of 20.46% from baseline. The study enrolled 641 participants across 50 centers in China, using subcutaneous injection once every two weeks for 52 weeks; the 3mg and 6mg groups achieved placebo-adjusted weight losses of 11.23% and 17.42%, respectively.

    Why it matters: Provides Phase 3 placebo-adjusted weight-loss data for a biweekly GLP-1/GIP dual agonist, useful for comparison with other long-acting agents.

  6. WeChat80

    Roche's Enicepatide 24 mg Shows 48-Week Weight Loss and Glucose Data Benchmarked Against Tirzepatide

    Roche has reported 48-week clinical data for enicepatide, its once-weekly GLP-1/GIP dual receptor agonist, at the 24 mg dose. In patients with type 2 diabetes, HbA1c fell by an average of 2.65 percentage points and weight by 15.5%. In overweight or obese patients without type 2 diabetes, mean weight loss was 22.7%, with 47.8% losing at least 20% and 26.1% at least 30%. The article discusses these results against tirzepatide, noting the two-residue difference between the molecules.

    Why it matters: The brief gives 24 mg 48-week weight and HbA1c reductions that allow comparison with tirzepatide in the same dose range.

  7. WeChat82

    RAY1225 Cuts Weight 22.24% at 52 Weeks in Phase III, Beating BGM0504's 19.2%

    RAY1225 injection, from Zhongsheng Pharmaceutical, met the primary endpoint in its Phase III weight-loss trial, with the 9 mg group losing 22.24% of baseline body weight over 52 weeks. Days earlier at EASD 2026, Borui Pharmaceutical's BGM0504 reported full Phase III data, with its 15 mg group losing 19.2% over 52 weeks. The two domestic GLP-1 candidates now post headline results exceeding the levels shown here for established comparators.

    Why it matters: Two Chinese obesity drug candidates report competing Phase III weight-loss results within one week.

  8. 文献与产业新闻51

    Testing peripheral and central therapies for provoked vestibulodynia: results from the UPDATe trial

    The multicenter 2×2 factorial randomized UPDATe trial enrolled 209 women aged 18-50. Topical 5% lidocaine/0.05% estradiol cream, oral nortriptyline, and the combination did not significantly reduce cotton swab-test-provoked vulvar pain versus placebo at 16 weeks. In the primary model, baseline pain was the strongest predictor of Week 16 pain (β=0.68, p<0.001), with no difference between VBD-peripheral and VBD-central subgroups. The trial, registered as NCT03844412, was conducted at two academic medical centers.

    Why it matters: This 2×2 factorial randomized trial in 209 participants showed neither peripheral nor central drugs outperformed placebo, providing negative RCT evidence for commonly prescribed but unverified treatments.

  9. Reddit70

    Some good news for celiacs today

    argenx's investigational antibody FB102 (anti-CD122) met its primary endpoint in the phase 2 trial FB102-301 (NCT06982963), and the company plans to advance it into phase 3 development. The trial enrolled 126 adults in Australia; after an 8-week oral gluten challenge, the villus height-to-crypt depth ratio (Vh:Cd) at Day 78 was significantly better than placebo (p=0.0176).

    Why it matters: The brief provides the Vh:Cd p-value and the 126-participant sample size, letting readers compare FB102 with a gluten-free diet in reducing gluten-induced intestinal injury.

Oct 9Fri
  1. WeChat68

    Oral GLP-1 Agonist Safiglipron Improves Glycemic Control in Phase 3 OUTSTAND-1 Trial

    The oral small-molecule GLP-1 receptor agonist safiglipron (HRS-7535), developed by Hengrui Pharmaceuticals and taken once daily without fasting or dietary restrictions, significantly improved glycemic control as monotherapy in patients with early type 2 diabetes in the phase 3 OUTSTAND-1 trial. Higher doses also produced weight benefits, and improvements were observed in islet function and multiple cardiometabolic and cardiorenal metabolic markers. The results were published in Nature Medicine.

    Why it matters: Phase 3 data on a once-daily oral GLP-1 receptor agonist offer an injection-free option for type 2 diabetes.

  2. The Lancet75

    Oral deucrictibant for on-demand treatment of hereditary angioedema attacks: a phase 3, multicentre, randomised, double-blind, placebo-controlled crossover trial.

    A 20 mg oral deucrictibant capsule gave faster onset of symptom relief than placebo in hereditary angioedema attacks, with median relief times of under one and a half hours for deucrictibant and beyond twelve hours for placebo, a statistically significant difference. In the phase 3 RAPIDe-3 crossover trial, 113 participants treated 201 attacks, and no severe, serious or treatment-related discontinuation events occurred. Deucrictibant could become the first orally administered bradykinin B2 receptor antagonist for treating attacks of bradykinin-mediated angioedema.

    Why it matters: Phase 3 data show an oral capsule can relieve hereditary angioedema attacks far faster than placebo.

  3. WeChat68

    Kodiak Sciences' Zenkuda and Tabirafusp-ted Hit Primary Endpoint in Phase III DAYBREAK Trial

    Kodiak Sciences reported on September 28, 2026 that its two ophthalmology drug candidates, Zenkuda and tabirafusp-ted, both met the primary endpoint in the pivotal Phase III DAYBREAK study, which compared the ABC fusion candidates against aflibercept. The company plans to submit Zenkuda for market approval in the fourth quarter of 2026. The results position the lead candidate for regulatory filing.

    Why it matters: Phase III success for both candidates sets up a near-term filing against aflibercept.

  4. Medical Xpress75

    Cervical cancer trial finds similar early recovery results after robot-assisted versus open surgery

    Robot-assisted radical hysterectomy for early-stage cervical cancer produced fewer intraoperative complications than open surgery (5.7% vs 10.0%), but the difference mainly involved less serious events. In the randomized RACC study of 900 patients across European hospitals, complications within 30 days were nearly identical (33.4% vs 34.8%), and overall early recovery and most quality-of-life measures were similar. Recurrence-free survival, the primary outcome, is still being followed.

    Why it matters: First large randomized perioperative comparison of robot-assisted versus open radical hysterectomy in early cervical cancer.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org