Clinical Development

Shanghai – October 31, 2026 -- Shanghai Zhimeng Biopharma has completed enrollment of 255 patients in the pivotal Phase 2/3 trial of CB03-154 for amyotrophic lateral sclerosis (ALS), moving the potassium channel opener toward topline data and a possible new drug application in China.

Trial runs at 15 Chinese centers with a Week 39 primary endpoint

The study is led by Professor Fan Dongsheng of the 3rd Affiliated Hospital of Peking University and spans 15 clinical research centers in Mainland China. Its primary efficacy endpoint is the change from baseline in ALSFRS-R score at Week 39. China's Center for Drug Evaluation (CDE) cleared the Phase 2/3 study in July 2025. The U.S. FDA granted CB03-154 Orphan Drug Designation in October 2023.

Shelton – October 30, 2026 -- Intensity Therapeutics (Nasdaq: INTS) will report third-quarter 2026 financial results before the market opens on November 5, 2026, with management hosting a live webcast and conference call at 8:00 a.m. Eastern time to review the numbers and give a corporate update.

The quarter covers the period ended September 30, 2026. An archived webcast will be available for replay shortly after the call ends.

Phase 3 sarcoma trial is the late-stage anchor of the pipeline

The late-stage clinical biotech develops intratumoral cancer therapies. Its lead candidate, INT230-6, combines cisplatin and vinblastine sulfate with a penetration enhancer molecule called SHAO, which the company says disperses the drugs throughout tumors. The drug is injected directly into the tumor.

BOSTON – October 29, 2026 -- TransCode Therapeutics (Nasdaq: RNAZ) has opened a formal strategic process that could end in a sale or licensing of its oncology assets, a partnership or a business combination, with lead candidate TTX-MC138 now in Phase 2a development.

Tungsten Advisors to run the process as exclusive financial advisor

The Board of Directors initiated the review to maximize the value of the company and its oncology portfolio. Options include licensing or selling individual assets, development and commercialization partnerships, portfolio transactions and business combinations. TransCode has engaged Tungsten Advisors as exclusive strategic financial advisor.

CEO and Chairman Philippe P. Calais said the process is meant to support continued development of TTX-MC138 while seeking to maximize value for stockholders.

HONG KONG – October 29, 2026 -- Ascletis Pharma (HKEX: 1672) reported that its oral small molecule GLP-1 receptor agonist ASC30 cut HbA1c by a placebo-adjusted 1.7% at the 40 mg dose, 1.6% at 60 mg and 1.7% at 80 mg in a U.S. Phase II study in type 2 diabetes. The 13-week trial (NCT07321678) met its primary endpoint and all secondary endpoints, the company said.

ASC30 delivers placebo-adjusted weight loss of up to 4.4% with no plateau

Placebo-adjusted body weight reductions at 13 weeks were 4.4% (40 mg, n=20), 3.8% (60 mg, n=29) and 4.0% (80 mg, n=28). No weight plateau was observed. Baseline average body weight was 93.7 kg. The weight results were statistically significant versus placebo (p = 0.001 to 0.003).

STOCKHOLM – October 29, 2026 -- Sobi's investigational gout drug pozdeutinurad (AR882) met the primary endpoint of the Phase 3 REDUCE-2 study, with 69.2% of patients on the 75 mg dose reaching serum urate (SU) below 6 mg/dL at month 6, against 8.1% on placebo. The company is presenting the late-breaking data at ACR Convergence 2026.

Both pozdeutinurad doses beat placebo on the primary endpoint at month 6

REDUCE-2 randomised 811 gout patients to pozdeutinurad 75 mg, pozdeutinurad 50 mg or placebo. In the 50 mg arm, 56.6% of patients achieved SU below 6 mg/dL at month 6. Both doses were significant versus placebo (p<0.0001).

Pozdeutinurad is a once-daily oral, highly selective URAT1 inhibitor. Sobi is developing it for uncontrolled gout, defined as SU above 6 mg/dL with persistent flares and/or tophi despite oral urate-lowering therapy.

PONTE VEDRA – October 29, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) has launched a structured partnering process for three cardiovascular assets while holding about $4.2 million in cash, enough to fund operations only through the first quarter of 2027.

The company is exploring development, licensing and commercialization deals for CAD-1005, frunexian and tecarfarin. It is pursuing out-licensing, portfolio monetization and commercial co-development rather than funding large late-stage trials on its own. Cadrenal said it will not start a clinical trial unless funding to complete that trial is in place.

Second-quarter net loss narrows to $3.3 million on lower R&D spending

Research and development expenses fell to $0.7 million in the quarter ended June 30, 2026, from $1.1 million a year earlier. General and administrative expenses were $2.6 million, against $2.7 million in the prior-year period.

Hangzhou – October 29, 2026 -- Lynk Pharmaceuticals reported that its oral JAK1 inhibitor zemprocitinib sustained a 91.8% ACR20 response rate at Week 76 in rheumatoid arthritis patients who had failed or could not tolerate biologic therapy, with no new safety signals in the pivotal Phase III trial.

Trial met primary endpoint at Week 24 before long-term extension

The double-blind, placebo-controlled study randomized 430 patients with moderate-to-severe active RA and prior bDMARD inadequate response or intolerance; 429 received at least one dose. Patients received zemprocitinib 12 mg twice daily or placebo for 24 weeks. The trial met its primary ACR20 endpoint and key secondary endpoints versus placebo (p<0.0001). Patients then continued or switched to active treatment, with efficacy and safety tracked through Week 76 and a 4-week safety follow-up.

Thousand Oaks – October 29, 2026 -- Amgen's dazodalibep reduced systemic disease activity in Sjögren's disease patients by 5.6 points on the ESSDAI scale at Week 48 in the Phase 3 OASIZ-301 trial, against 3.8 points for placebo. The company will present the late-breaking data at the American College of Rheumatology (ACR) Convergence 2026.

Both dazodalibep regimens beat placebo on the primary endpoint

Patients entered OASIZ-301 with an average ESSDAI score of 10.2. The trial enrolled approximately 621 adults with moderate-to-severe systemic disease activity (ESSDAI of at least 5).

The 1,500 mg every-four-weeks regimen cut scores by a least-squares mean of 5.6 points, 1.8 points better than placebo (adjusted p<0.001). The 3,000 mg every-12-weeks regimen cut scores by 5.2 points, 1.4 points better than placebo (adjusted p=0.010). Treatment effects appeared as early as four weeks.

New York – October 29, 2026 -- ProJenX will present long-term Phase 1b data at the 2026 NEALS Annual Meeting showing that its ALS candidate prosetin reached target therapeutic exposures and kept a favorable safety profile over extended dosing. The meeting runs Oct. 27-30 in Clearwater, Florida, and online.

PRO-101 data show target engagement tracking with prosetin exposure

Prosetin is an oral, CNS-penetrant MAP4K inhibitor being tested in people with ALS in the Phase 1b PRO-101 study. The trial is evaluating safety, tolerability, pharmacokinetics and pharmacodynamics. According to CEO Stan Abel, target engagement in PRO-101 tracked with exposure.

Abel said the results show for the first time that CNS-penetrant MAP4K inhibition is "a viable clinical strategy." The company has not disclosed participant numbers, dosing levels or efficacy endpoints in this announcement.

WASHINGTON – October 28, 2026 -- Vanda Pharmaceuticals (Nasdaq: VNDA) reported that NEREUS (tradipitant) cut the incidence of semaglutide-induced vomiting by 27% in a Phase III trial. Vomiting occurred in 43.0% of treated participants (61/142) versus 58.5% on placebo (96/164), with a p-value of 0.006.

The company plans to discuss the data with the U.S. Food and Drug Administration (FDA). It intends to file a supplemental New Drug Application (sNDA) for preventing vomiting associated with GLP-1 receptor agonist therapy.

NEREUS lowers combined vomiting and severe nausea by 35% in key secondary endpoint

The key secondary endpoint combined any vomiting with worst nausea of 3 or higher. It occurred in 33.1% of participants on NEREUS (47/142) versus 50.6% on placebo (83/164), a 35% relative reduction (p=0.002).