Clinical Development

TAMPA – October 27, 2026 -- Akari Therapeutics (Nasdaq: AKTX) plans to begin Phase 1 clinical development of its lead antibody drug conjugate, AKTX-101, in mid-2027, with the compound now moving through IND-enabling toxicology and safety studies and large-scale GMP manufacturing.

CEO Abizer Gaslightwala laid out the strategy in a new CEO Corner segment. He argues that payload differentiation will matter more as ADCs move into front-line therapy and patients develop resistance to current payload classes, leaving few follow-on options.

PARIS – – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) reported that its 12-lipoxygenase inhibitor CAD-1005 reduced new or worsening thrombotic events by more than 25 percentage points versus placebo in a Phase 2 trial in heparin-induced thrombocytopenia (HIT), with 50% of treated patients affected versus more than 75% on placebo. The data were presented as one of three late-breaking abstracts at the ISTH 2026 Congress in Paris.

Trial is first randomized, blinded, placebo-controlled study in HIT

Principal Investigator Dr. Steven E. McKenzie delivered the oral presentation, which Cadrenal describes as the first randomized, blinded, placebo-controlled trial in HIT patients. CAD-1005 was formerly known as VLX-1005. The study was not sufficiently powered for statistical significance.

PONTE VEDRA, Fla. – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) reached agreement with the FDA on the primary endpoint and placebo-controlled design of its Phase 3 registration study of CAD-1005, a first-in-class 12-lipoxygenase (12-LOX) inhibitor for heparin-induced thrombocytopenia (HIT). The agreement came at a Type D meeting held July 28, 2026.

FDA accepts thrombus-extension definition of worsening HIT

The agency agreed to define worsening HIT as progression of thrombotic events through Day 14 of treatment or hospital discharge. Worsening will also include extension of an existing thrombus into a new vascular segment or bed. Cadrenal said this avoids site-to-site variability from manual size measurements.

The composite primary endpoint will measure the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events through Day 14 or hospital discharge.

Boston – October 19, 2026 -- Servier has dosed the first patients in EMBLEM-1, the pivotal Phase 2 cohort of its Phase 1/2 study of Emiltatug Ledadotin (Emi-Le) in aggressive adenoid cystic carcinoma (ACC), a cancer with no FDA-approved systemic treatment.

Emi-Le is an investigational antibody drug conjugate (ADC) directed against B7-H4. The cohort is enrolling under trial identifier NCT05377996.

EMBLEM-1 uses objective response rate per RECIST 1.1 as its primary endpoint

The trial will measure the percentage of patients who achieve a best overall response of confirmed complete response or partial response. It will also evaluate the safety of Emi-Le in ACC.

San Diego – October 19, 2026 -- The U.S. Food and Drug Administration has cleared Protego Biopharma's Investigational New Drug application for PROT-001, allowing the company to start SHIELD-AL, a global pivotal Phase 2/3 study in newly diagnosed light chain (AL) amyloidosis patients.

PROT-001 is an oral, investigational, first-in-class lambda light chain stabilizer. Protego will test it as an add-on to standard-of-care plasma cell-directed therapy, which reduces light chain production.

SHIELD-AL combines safety confirmation and pivotal efficacy testing in one randomized trial

The study is randomized, double-blind and placebo-controlled, and enrolls newly diagnosed patients with lambda AL amyloidosis. Part A is an initial safety and dose confirmation study. Part B is the pivotal safety and efficacy study.

San Diego – October 19, 2026 -- The U.S. Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) will meet on July 29, 2026, to review Capricor Therapeutics' Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD), less than four weeks before the agency's August 22, 2026 PDUFA target action date.

Panel meeting precedes the August 22 PDUFA decision date

Capricor (NASDAQ: CAPR) said its BLA remains on track against the August 22 deadline. The advisory meeting will be livestreamed. The company pointed to the Federal Register and its own website for meeting details.

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) reported that Duchenne muscular dystrophy patients who switched from placebo to Deramiocel after one year slowed their upper limb decline by 76% compared with their own prior year, according to open-label extension data from the Phase 3 HOPE-3 trial. The U.S. FDA has set a PDUFA target action date of November 22, 2026, for the therapy.

Crossover analysis shows 76% slower decline on PUL 2.0

The late-breaking poster was presented at the 31st Annual Congress of the World Muscle Society in Hiroshima, Japan. It measured upper limb function with the Performance of Upper Limb (PUL 2.0) scale. Of 106 randomized patients, 98 entered the open-label extension, 49 per arm. At Month 24, 42 patients in the placebo-origin arm and 40 in the Deramiocel arm were assessed.

Indianapolis – October 19, 2026 -- Half of pediatric ulcerative colitis (UC) patients who responded to Eli Lilly's Omvoh (mirikizumab-mrkz) were in clinical remission at Week 52, meeting the primary endpoint of the Phase 3 SHINE-2 study. Lilly (NYSE: LLY) says Omvoh is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric UC, and it plans to submit the data to global regulators for a potential label expansion.

Lilly reports 81% induction response and 50% remission at one year

In the single-arm, open-label study, 81% of patients achieved clinical response at Week 12. Among the 52 responders, ages 6 to 17, 50% reached clinical remission at Week 52. The results were presented as a late-breaking oral presentation at United European Gastroenterology (UEG) Week 2026.

Secondary outcomes at Week 52 in responders were:

North Chicago – October 19, 2026 -- AbbVie's investigational dual-targeting therapy ABBV-466 delivered endoscopic remission in 40.5% of Crohn's disease patients at Week 24, against 22.4% for risankizumab and 20.0% for trosunilimab monotherapy, according to Phase 2a TARGET-CD data (NYSE: ABBV).

ABBV-466 clears the Week 12 primary endpoint at 30.2%

At Week 12, the primary endpoint, 30.2% of ABBV-466 patients achieved endoscopic remission. Patients on anti-IL-23 p19 monotherapy (risankizumab) reached 21.3%, and those on anti-α4β7 monotherapy (trosunilimab) reached 18.0%. The gap to both monotherapy arms widened by Week 24.

ABBV-466 combines risankizumab with trosunilimab. AbbVie said its research found α4β7-driven inflammation persisting despite IL-23 p19 inhibition, which led it to add the α4β7 inhibitor to risankizumab.

Shanghai – October 19, 2026 -- Mabwell's Nectin-4-targeting antibody-drug conjugate 9MW2821 (Bulumtatug Fuvedotin, "BFv") achieved a 30.0% objective response rate in 60 efficacy-evaluable triple-negative breast cancer (TNBC) patients previously treated with a topoisomerase I (Topo I) ADC, according to Phase II data to be presented orally at the 2026 European Society for Medical Oncology (ESMO) Congress.

Phase II data show 80% disease control and 8.7-month response duration

The study (CTR20242376) evaluates 9MW2821 as monotherapy or combined with a PD-1 monoclonal antibody in locally advanced or metastatic TNBC. Data are as of October 19, 2026.