Pharmaceuticals & Biopharmaceuticals

TAMPA – October 29, 2026 -- Akari Therapeutics (Nasdaq: AKTX) has filed international patent application PCT/US2026/45955, adding claims on how its PH1 payload modulates alternative splicing across multiple cancer-driving genes.

The filing expands the company's intellectual property around PH1, a splicing-modulating payload derived from its proprietary Thailanstatin platform, and around PH1-based antibody drug conjugates (ADCs). Akari contrasts PH1 with conventional ADC payloads that rely on tubulin inhibition, such as vedotin, or DNA damage, such as topoisomerase I inhibitors.

Application claims PH1 shifts VEGF-A splicing to block tumor blood supply

The claims cover PH1 altering VEGF-A splicing in cancer cells. The shift moves from a pro-angiogenic isoform to the anti-angiogenic VEGF-165b isoform, which prevents blood vessel recruitment to tumors.

Tampa, FL and London – October 29, 2026 -- Akari Therapeutics (Nasdaq: AKTX) has appointed Vatnak Vat-Ho as Chief Business Officer, adding an executive who has held senior roles in oncology transactions totaling more than $25 billion in aggregate value.

Vat-Ho will run corporate strategy, partnering, licensing and investor engagement

Vat-Ho will lead corporate and business development at the oncology biotech, which is developing antibody drug conjugates (ADCs) built on a novel RNA splicing-disrupting payload called PH1. His remit covers corporate strategy, partnering and licensing, and investor engagement as the company advances its lead TROP2-targeted ADC, AKTX-101, toward the clinic.

He brings more than 20 years of experience across oncology business development, biopharmaceutical strategy, equity research and healthcare investing. His transaction record involves Pfizer, Exelixis, BioNTech, Merck KGaA, Roivant and Roche/Genentech.

LOUISVILLE – October 28, 2026 -- US WorldMeds Ventures, LLC has acquired Orbus Therapeutics, Inc., adding a late-stage eflornithine program for recurrent Grade 3 astrocytoma. In a prespecified subset of the Phase 3 STELLAR study, patients with IDH-mutant disease reached median overall survival of 34.9 months, versus 23.5 months on lomustine alone.

US WorldMeds made an undisclosed upfront payment under a definitive merger agreement. Orbus is eligible for development, regulatory and sales-based milestone payments, plus tiered royalties on U.S. net sales. It is now a wholly owned subsidiary of US WorldMeds.

STELLAR missed its primary endpoint in the full study population

The 343-patient trial compared eflornithine plus lomustine with lomustine alone in recurrent Grade 3 astrocytoma, defined under the 2016 WHO classification. It showed no overall survival difference between arms in the intent-to-treat population, which was the primary endpoint.

Kirkland, Wash. – October 28, 2026 -- EIT Pharma has appointed Dr. Joseph Toerner, a 26-year veteran of the U.S. Food and Drug Administration (FDA), as Chief Medical Officer, effective immediately, while its lead hepatitis D candidate lonafarnib is under regulatory review.

Former FDA hepatology director takes clinical lead on two programs

Toerner will provide medical and clinical leadership across EIT Pharma's development programs. That includes supporting the ongoing regulatory review of lonafarnib, a late-stage, first-in-class oral therapy for chronic hepatitis D (CHD), and peginterferon lambda, a Phase 2 treatment for severe acute viral respiratory infections.

EIT Pharma describes lonafarnib as the only oral therapeutic candidate in late-stage clinical development for CHD. The drug has not been approved by the FDA or any other regulatory authority, and its safety and efficacy have not been established.

Chanhassen – October 28, 2026 -- Every patient with investigator-assessed clinical deterioration in an exploratory 15-patient glioblastoma analysis showed sustained increases in lactate dehydrogenase (LDH) during treatment, Alpheus Medical, Inc. reported at the ESMO Congress 2026 in Madrid.

Poster 4289P tracks LDH trajectories in 15 recurrent glioblastoma patients

The clinical-stage oncology company presented the data from its first-in-human study of Porphyrin Metabolite Activation (PoMA). The cohort comprised 15 patients with MGMT-unmethylated recurrent glioblastoma. Instead of relying on a single LDH value, the analysis examined how LDH changed over time and how those trajectories related to clinical and radiographic disease status.

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).

Cambridge, Mass. – October 28, 2026 -- CREATE Medicines will present preclinical data showing complete B cell depletion in lymph nodes, spleen and bone marrow after low doses of its in vivo CAR-T therapy at the APLAR 2026 Congress in Seoul, running October 28 to November 1 at the COEX Convention & Exhibition Center.

Adam Raff presents mouse and primate data on October 31

Adam Raff, MD, PhD, SVP of Autoimmune Clinical Development, will deliver the oral abstract "In Vivo Generation of CAR-T Cells for the Treatment of B-cell Mediated Autoimmune Disease" in Abstract Session 2. The data come from mice and non-human primates. They show that low doses cleared B cells from the deep tissues where autoimmune disease takes hold.

INDIANAPOLIS – October 28, 2026 -- Carnyx Therapeutics has advanced its lead oral sleep candidate, CNYX-005, into Investigational New Drug (IND)-enabling development, bringing the preclinical asset closer to potential first-in-human studies.

Aged-rat data show 1.5 to 2 hours of added sleep

In recently reported preclinical findings, CNYX-005 increased total sleep time by roughly 1.5 to 2 hours versus controls in aged rats. The gain was driven primarily by increased non-rapid eye movement (NREM) sleep. Chief Medical Officer Chris Brearley said existing treatments are limited by safety, tolerability and long-term use concerns, which he cited as the case for additional options.

Global – October 27, 2026 -- Solid Biosciences has dosed the first participant in FALCON, a Phase 1b trial of SGT-212, its investigational gene therapy for Friedreich's ataxia (FA), and expects to release an initial data update in the second half of 2026, subject to patient enrollment.

FALCON tests a dual-route gene therapy in adults aged 18-40

FALCON is an open-label, dose-finding study designed to evaluate the safety and tolerability of SGT-212 in people aged 18-40 living with FA. Solid describes the approach as novel and first-in-class. It is the first-in-human study of SGT-212.

Intradentate nucleus infusion precedes intravenous delivery

Each participant receives an intradentate nucleus (IDN) infusion targeting the cerebellar dentate nuclei, followed by an intravenous (IV) infusion. Solid says the dual routes are intended to address the neurologic, cardiac and systemic manifestations of FA.

SHANGHAI – October 27, 2026 -- Henlius' serplulimab combined with chemotherapy delivered a median overall survival (OS) of 12.4 months versus 10.2 months for atezolizumab plus chemotherapy in the U.S. ASTRIDE study of first-line extensive-stage small cell lung cancer (ES-SCLC). The company presented the data at the European Society for Medical Oncology (ESMO) Congress 2026.

ASTRIDE shows a numerical OS edge but no formal superiority test

The hazard ratio was 0.82 (95% CI, 0.56-1.20), at a median follow-up of 14.1 months and a data cutoff of February 18, 2026. The trial was descriptive, with no formal hypothesis testing for superiority or noninferiority planned.

One-year OS rates were 52.4% for serplulimab and 41.4% for atezolizumab. Two-year OS rates were 32.2% and 17.6%, respectively. The serplulimab arm had more patients with liver metastasis (49.5% vs 40.0%).