Biopharmaceuticals

Shanghai – October 12, 2026 -- Shanghai Ark Biopharmaceutical (ArkBio) has received U.S. Food and Drug Administration clearance of its investigational new drug application for AK0406, allowing a phase II trial of the long-acting antiviral drug-Fc conjugate for influenza prevention in the general U.S. population.

CDC data shows 24,000 U.S. flu deaths despite vaccines

The U.S. Centers for Disease Control and Prevention reports that the 2025–2026 influenza season caused at least 32 million illnesses, 380,000 hospitalizations and 24,000 deaths in the United States. ArkBio says shifting circulating viruses and variable immune response limit vaccine protection, particularly among older adults and immunocompromised people.

Dublin – October 12, 2026 -- Keenova Therapeutics plc will present an exploratory analysis of the CONFIRM trial on October 12 at the American College of Gastroenterology Annual Meeting (October 9-14, 2026). The analysis covers TERLIVAZ (terlipressin) in hepatorenal syndrome-acute kidney injury (HRS-AKI) patients who are ineligible for liver transplant.

Ten-author analysis targets liver transplant-ineligible patients

The presentation is titled "Efficacy and Safety of Terlipressin in Patients With Hepatorenal Syndrome-Acute Kidney Injury Ineligible for Liver Transplant: An Exploratory Analysis of the CONFIRM Trial." Nancy Reau, MD, Associate Director of Solid Organ Transplantation and Section Chief of Hepatology at Rush University Medical Center, is the presenting author. Nine co-authors are listed, including Kavish Patidar, Kevin Regner and Nneka N. Ufere.

Sydney – October 12, 2026 -- The Safety Review Committee (SRC) for Racura Oncology's HARNESS-1 trial has cleared lead drug RC220 to escalate to 100 mg/m2, after finding no dose-limiting toxicities in either Cohort 1 patient. The Phase 1a/b study combines RC220 with osimertinib in patients with EGFR-mutant non-small cell lung cancer (NSCLC).

Both Cohort 1 patients received RC220 at 50 mg/m2 by intravenous infusion alongside osimertinib at 80 mg daily. The second patient has received three RC220 doses, given 21 days apart, with no dose-limiting toxicities or treatment-related safety concerns.

Riyadh – October 12, 2026 -- Bristol Myers Squibb (BMS) employees in Saudi Arabia assembled and personalized more than 70 'Small Wins' toolkits for people living with schizophrenia, in partnership with the Saudi Schizophrenia Association ('Ehtiwaa'). The project was part of the 12th edition of BMS's annual Global Patient Week.

Ehtiwaa and BMS design a four-step kit to build daily motivation

The 'Small Wins: Everyday Activity & Motivation' toolkit guides patients through four steps: pick a card, try the activity, recognize the win, and add it to a jar. Each kit contains activity cards with optional suggestions such as listening to a favorite song, spending a few minutes outside or tidying one small space. A 'Small Wins Jar' with paper slips lets users record daily moments of joy. Each kit also carries a handwritten note from a BMS volunteer.

Taipei – October 12, 2026 -- China's National Medical Products Administration (NMPA) has approved CAMCEVI® 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, for adult patients with advanced prostate cancer, Foresee Pharmaceuticals (TPEx: 6576) said. Licensing partner Changchun GeneScience Pharmaceutical (GenSci) notified Foresee of the approval of the Marketing Authorization Application and will commercialize the product in China.

GenSci holds exclusive China rights across all CAMCEVI indications

The license covers all current and pipeline indications: advanced prostate cancer, central precocious puberty (CPP) and premenopausal breast cancer. Foresee Chairman and CEO Ben Chien said GenSci's China launch will "significantly contribute" to the growth of the company's global CAMCEVI franchise.

Calgary – October 12, 2026 -- XORTX Therapeutics (NASDAQ: XRTX | TSXV: XRTX) has appointed Mika Grasso, 28, as co-CEO responsible for finance and public markets, and says it aims to advance its lead gout program, XRx-026, toward marketing approval over the next 18 months.

The company says the appointment follows a recent financing and growing investor interest. It is now restructuring its corporate and issuer status, re-initiating drug development programs and preparing regulatory filings for XRx-026. Risk disclosures in the release also refer to a voluntary delisting that may not be completed on the anticipated timeline, or at all.

Calgary – October 12, 2026 -- XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU) has appointed Depesh Narotam, a financial services executive with more than 20 years of experience, to its board as an independent director effective July 27, 2026.

Board determines Narotam meets Nasdaq and Canadian independence standards

The board determined that Narotam, 43, is independent under applicable Nasdaq listing standards and Canadian securities laws. He also joins the board's Compensation, Governance and Nominating Committee.

Narotam is a resident of British Columbia, Canada.

Calgary – October 12, 2026 -- XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX) has rescinded a US$2.5 million investor relations agreement with IR Agency LLC and recovered the full fee. The company is postponing its marketing push while it exits the TSX Venture Exchange.

XORTX terminates 90-day IR contract effective August 7, 2026

The agreement, dated May 13, 2026, ran for 90 days from May 18, 2026. It covered 10 marketing days of news distribution campaigns for an aggregate fee of US$2.5 million, payable in advance. The fee had been fully earned on receipt and was non-refundable.

Both parties agreed to rescind the arrangement, and all services under it have been discontinued. The funds were returned to XORTX in August 2026. The release cites both August 7 and August 14 as the return date.

Calgary – October 12, 2026 -- XORTX Therapeutics Inc. has re-engaged IR Agency LLC for investor relations and marketing services, following completion of its voluntary delisting from the TSX Venture Exchange.

XORTX restores IR Agency LLC consulting agreement on previously disclosed terms

The new consulting agreement carries substantially the same terms the company disclosed in news releases dated May 19, 2026 and August 28, 2026. The source gives no fee, share-based compensation or contract-length figures for the renewed engagement.

Delisting from TSX Venture Exchange precedes the renewed marketing push

The re-engagement comes after XORTX completed the delisting it had announced earlier. The company's filings reference ongoing compliance with Nasdaq listing standards, and its release states that Nasdaq has not approved or disapproved its contents.

Calgary – October 12, 2026 -- XORTX Therapeutics (NASDAQ: XRTX) plans to submit an Investigational New Drug application to the U.S. FDA in the fourth quarter of 2026 for its XRx-026 gout program, and estimates the program addresses a US$700M annual market opportunity.

XORTX targets an NDA filing in about one year, contingent on funding

The IND describes the company's clinical development plan for XORLOTM, its proprietary oxypurinol formulation, and its intention to file a New Drug Application after completing the two-part XRX-OXY-102 clinical trial. The trial is designed to characterize the pharmacokinetics and efficacy information the FDA needs to evaluate a future NDA.