Pharmaceuticals & Biopharmaceuticals

HANGZHOU – November 04, 2026 -- TJ Biopharma's GM-CSF antibody plonmarlimab achieved an 83.3% overall response rate at Week 8 in the Phase 2 PRIME-1 study of macrophage activation syndrome (MAS), according to results now published in the Journal of Hematology & Oncology.

PRIME-1 enrolled 18 patients who had failed high-dose glucocorticoids

The open-label, single-arm, multi-center study treated patients who were refractory to, or had relapsed after, high-dose glucocorticoid therapy. Fifteen of 18 patients achieved a complete or partial response. Median time to response was 2.1 weeks, with the earliest response recorded on Day 5.

SOUTH SAN FRANCISCO – November 04, 2026 -- IDEAYA Biosciences (NASDAQ: IDYA) will hold an Investor R&D Day in London on Nov. 16, 2026, at 5:00 PM GMT, presenting Phase 1 dose-escalation data for its PRMT5 inhibitor IDE892 and outlining targeted 2027 clinical milestones.

The oncology company will also appear at two sell-side conferences in London that week. CEO Yujiro S. Hata will join a fireside chat at the UBS Global Biopharma Conference on Nov. 16 at 10:40 AM GMT, hosted by Michael Yee. On Nov. 17 at 1:00 PM GMT, Hata, R&D President Michael White and CFO Joshua Bleharski will appear at the Jefferies Global Healthcare Conference, hosted by analyst Maury Raycroft.

New York – November 04, 2026 -- Morning email sends delivered a 13% higher weighted composite engagement score than afternoon sends in a biopharma campaign, contradicting existing predictive models, according to GrowthLoop and EVERSANA, which are expanding their Composable AI Decisioning solution into biopharmaceutical marketing.

The solution builds on GrowthLoop's composable customer data platform (CDP) and AI Studio. It uses continuous experimentation to identify which marketing actions lift healthcare professional (HCP) engagement, then feeds those findings into AI decisioning for subsequent interactions.

Austin – November 04, 2026 -- Genprex, Inc. (NASDAQ: GNPX) reported that low TROP2 expression was consistently associated with primary resistance to its lead gene therapy Reqorsa (quaratusugene ozeplasmid) across multiple preclinical non-small cell lung cancer (NSCLC) models. The company says the finding could guide patient selection in future trials.

About half of tested NSCLC models showed primary resistance

Approximately 50% of 10 NSCLC cell lines and 50% of 12 patient-derived organoid models showed primary resistance to TUSC2 gene delivery. Protein-expression analyses identified low TROP2 expression as a marker associated with that resistance.

Patient biopsies from a TUSC2 trial back the association

Analysis of pretreatment tumor biopsies from patients enrolled in a TUSC2 gene therapy clinical trial supported the link between TROP2 expression and treatment response. The company did not disclose patient numbers or effect sizes.

Newton, Mass. – November 04, 2026 -- Karyopharm Therapeutics (Nasdaq: KPTI) will present Week 48 data from its Phase 3 SENTRY trial and early monotherapy data from its Phase 2 SENTRY-2 trial in two oral sessions at ASH 2026, giving selinexor two oral slots in myelofibrosis. A third abstract, from the STOMP trial in multiple myeloma, was selected for a poster.

SENTRY Week 48 data go on stage December 13

The SENTRY presentation (publication number 526) is scheduled for December 13, 2026, from 10:15 a.m. to 10:30 a.m. CT. It will cover updated results for selinexor plus ruxolitinib in JAK inhibitor-naïve myelofibrosis. Chief Medical Officer Reshma Rangwala said the data show ongoing benefit through week 48.

BOULDER, Colo. – November 04, 2026 -- Edgewise Therapeutics (Nasdaq: EWTX) reported third-quarter 2026 net income of $1,166.2 million, or $9.65 per diluted share, driven by a $1.348 billion gain on the sale of its sevasemten program and muscular dystrophy business to Servier. In the same period of 2025, the company posted a net loss of $40.7 million, or $0.39 per share.

Servier sale delivers $1.396 billion in upfront cash

The transaction closed in July 2026. Edgewise received $1.396 billion in upfront cash at closing. The reported gain includes consideration recognized at closing, among it amounts tied to the general indemnification arrangement. It is stated net of the carrying value of transferred assets, transaction costs and consideration allocated to transition services. Income tax expense associated with the transaction partly offset the gain in net income.

PHILADELPHIA – – November 04, 2026 -- Verismo Therapeutics' CD19-targeted KIR-CAR T therapy SynKIR-310 produced an 80% objective response rate (4 of 5 evaluable patients) in relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL), with no cytokine release syndrome (CRS) or neurotoxicity (ICANS) of any grade. The data come from the first two dose cohorts of the Phase 1 CELESTIAL-301 trial (NCT06544265). The company will present updated results as an oral presentation at the 68th American Society of Hematology (ASH) Annual Meeting.

SynKIR-310 delivers 60% complete response rate and no dose-limiting toxicities in early cohorts

Across dose cohorts 1 and 2, the complete response rate was 60%. Median duration of response in complete responders has not been reached, and one patient remained in complete response at the 12-month assessment.

CRANFORD, N.J. – November 05, 2026 -- Citius Oncology (Nasdaq: CTOR) reported that 13 of 41 heavily pretreated cutaneous T-cell lymphoma (CTCL) patients with significant itch (32%; 95% CI, 18.1–48.1) achieved a clinically meaningful itch reduction on LYMPHIR (denileukin diftitox-cxdl) in the pivotal Study 302. The health-related quality of life (HRQoL) data were presented orally by Christiane Querfeld, MD, PhD, of City of Hope at the EORTC-CLTG 2026 Annual Meeting in Berlin, held October 8–10, 2026.

Responders show Skindex-29 improvement of up to 13.69 points

Among 25 responders in the primary analysis set (Stage I–III, n=69), the mean change from baseline in Skindex-29 Total Score ranged from −5.38 to −13.69 points across assessments. Lower scores indicate better quality of life. Non-responders showed slightly positive to near-zero changes.

Houston – November 05, 2026 -- ImmunoGenesis will present IND-enabling data for IMGS-203, its novel STING agonist for recurrent glioblastoma (GBM), at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting, running November 4-8 at the Phoenix Convention Center in Arizona.

ImmunoGenesis targets recurrent glioblastoma with IMGS-203 as its first clinical indication

The company plans to advance IMGS-203 into clinical development first for recurrent GBM, which it describes as an aggressive brain cancer with limited therapeutic options and significant unmet medical need. IMGS-203 is a Stimulator of Interferon Genes (STING) agonist designed to stimulate antitumor immune responses. The presentations will cover both the IND-enabling activities and the therapeutic potential of the candidate, in poster and oral formats.

HONG KONG – – November 05, 2026 -- China's National Medical Products Administration (NMPA) has granted Priority Review to Akeso's ivonescimab plus chemotherapy for first-line locally advanced or metastatic biliary tract cancer (BTC), a designation expected to accelerate the subsequent regulatory review in China.

HARMONi-GI1 Phase III trial beats durvalumab regimen on overall survival

In the randomized, double-blind, multicenter HARMONi-GI1 study (AK112-309), ivonescimab plus chemotherapy was compared with durvalumab plus chemotherapy, the current global first-line standard in BTC. A prespecified interim analysis reviewed by the Independent Data Monitoring Committee showed the trial met its primary endpoint of overall survival (OS). The improvement over the control arm was statistically significant and clinically meaningful. The study also met all key secondary endpoints, including progression-free survival and objective response rate.