Biopharmaceuticals

Seoul – September 12, 2026 -- SystImmune, Inc. announced that new global Phase 1 data support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose for iza-bren (izalontamab brengitecan), a bispecific EGFRxHER3 antibody drug conjugate, in previously treated EGFR-mutated metastatic non-small cell lung cancer (NSCLC).

Randomized Phase 1 cohort confirms higher efficacy at the 2.5 mg/kg dose level

The abstract, presented in an oral session at the IASLC 2026 World Conference on Lung Cancer (WCLC) in Seoul, South Korea, evaluated iza-bren across three dose levels in a randomized dose-expansion cohort. Patients enrolled had EGFR-mutated metastatic NSCLC and had previously received a third-generation EGFR inhibitor. Results showed promising antitumor activity with a manageable safety profile, with the highest efficacy observed at the 2.5 mg/kg dose.

Quebec – September 16, 2026 -- Devonian Health Group Inc. (TSXV: GSD) (OTCQB: DVHGF) expects its common shares and warrants to begin trading on NYSE American LLC as early as September 16, 2026, under the ticker symbols "DHGR" and "DHGR WS."

Devonian pursues dual listing tied to underwritten public offering

The proposed NYSE American listing is connected to an underwritten public offering of Devonian's common shares and warrants. The company will retain its existing listing on the TSX Venture Exchange and has reserved the symbol "DHGR" there, with plans to later change its TSXV ticker from "GSD" to "DHGR."

Listing remains contingent on NYSE American's final authorization

Trading commencement on NYSE American depends on market conditions and final approval of Devonian's listing application, as well as the company's continued compliance with exchange rules.

Delft, Netherlands – September 15, 2026 -- AdJane Biosciences has published a technical white paper detailing a strategy to add a proprietary mucosal-immunity booster to established intramuscular respiratory vaccine franchises, using its clinically validated Nm-nOMV platform derived from Neisseria meningitidis outer membrane vesicles.

The paper, titled 'Boosting mRNA: Mucosal Immunity and a Platform Beyond It,' outlines a heterologous prime-boost regimen: existing intramuscular vaccines would prime systemic immunity, while an intranasal Nm-nOMV dose would generate complementary IgA responses at the respiratory mucosa, the initial entry point for pathogens.

Plymouth, Mich. – – September 16, 2026 -- Esperovax, Inc. has secured a Notice of Allowance from the United States Patent and Trademark Office for U.S. Patent Application No. 18/038,673, covering its engineered yeast platform for producing therapeutic proteins directly inside the body.

USPTO clears patent covering in vivo yeast-based protein expression

The allowed application, titled "Yeast-Based Expression of Therapeutic Proteins In Vivo," protects technology that uses engineered yeast administered to patients to manufacture biologic proteins within the body itself, rather than requiring external production and repeated dosing of purified biologics.

Indianapolis – September 16, 2026 -- Eli Lilly and Company (NYSE: LLY) has completed its acquisition of AtaiBeckley Inc., a clinical-stage biopharmaceutical company developing rapid-acting neuroplastogens for mental health conditions.

Deal adds BPL-003 to Lilly's neuroscience pipeline for treatment-resistant depression

The acquisition brings Lilly control of AtaiBeckley's lead investigational program, BPL-003, targeting patients with treatment-resistant depression who have not responded to multiple prior therapies. AtaiBeckley shareholders approved the transaction at a special meeting held ahead of closing.

Milford, Mass. – September 16, 2026 -- Waters Corporation (NYSE: WAT) will have President and CEO Udit Batra, Ph.D., participate in a fireside chat at the J.P. Morgan U.S. All Stars Conference on Wednesday, September 23, 2026.

Batra to address investors at 7:00 AM Eastern Time session

The fireside chat is scheduled for 12:00 PM BST (GMT+1), equivalent to 7:00 AM Eastern Time, on September 23, 2026.

Live webcast will run through Waters Investor Relations site

Waters will stream the session live via the 'Events & Presentations' section of its Investor Relations website. A replay will remain accessible for 90 days following the event.

Arlington, Mass. – – September 16, 2026 -- Eloxx Pharmaceuticals, Inc. (Nasdaq: ELOX) has dosed the first two patients in the EXACT Study, a Phase 2b trial evaluating its investigational drug exaluren in patients with nonsense mutation Alport syndrome (NMAS), a rare kidney disease with no FDA-approved therapy targeting its genetic cause.

Trial targets 24 patients with a 16-week placebo-controlled start

The global, randomized, delayed-start Phase 2b trial will enroll 24 patients carrying nonsense mutations in the COL4A3, COL4A4, or COL4A5 genes. The initial 16-week placebo-controlled portion measures the drug's effect on structural podocyte changes via foot process effacement, assessed through kidney biopsies in non-U.S. pediatric patients and all adult participants.

Valby, Denmark – – September 16, 2026 -- The U.S. Food and Drug Administration has granted Orphan Drug Designation to asedebart (Lu AG13909), Lundbeck's investigational anti-ACTH monoclonal antibody, for the treatment of endogenous Cushing's syndrome.

FDA designation adds U.S. market exclusivity potential for Lundbeck's rare disease pipeline

The designation covers drugs and biologics intended for rare diseases and can provide tax credits for qualified clinical testing, exemption from certain FDA application fees, and up to seven years of market exclusivity if the drug is approved for the designated indication.

Seoul -- September 9, 2026 -- MegazoneCloud has begun system development on 'Hanmi Q-Agent,' an AI agent designed to cut Hanmi Pharmaceutical's quality assurance document workload by more than 40%, with build work starting September 7.

MegazoneCloud deploys RAG-based agent across 4,000 quality documents

The Seoul-based AI and cloud company will build a search-based AI agent covering roughly 4,000 quality documents accumulated by Hanmi Pharmaceutical, using its enterprise AI OS 'AIR Studio.' The retrieval-augmented generation (RAG) system will retrieve and summarize documents, then compare them against the latest pharmaceutical regulations to flag non-conforming items.

Tokyo – September 16, 2026 -- The Galien Foundation will hold the inaugural Prix Galien Japan Forum and Awards Ceremony on Thursday, February 25, 2027, at the Hotel New Otani in Tokyo, marking the first time the life sciences prize has been presented in Japan.

Six award categories will honor pharmaceutical, biotech and digital health innovators

The ceremony will present awards across six categories: Best Pharmaceutical Product, Best Biotechnology Product, Best Product for Rare/Orphan Diseases, Best Medical Technology, Best Digital Health Solution, and Best Startup. Winners will be selected by the Prix Galien Japan Awards Committees, made up of biomedical scientists and industry executives from Japan and abroad.