Pharmaceuticals & Biopharmaceuticals

Milford, Mass. – September 17, 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 17, 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 17, 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 17, 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 17, 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 17, 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 17, 2026 -- The Galien Foundation will hold the inaugural Prix Galien Japan Forum and Awards Ceremony on Thursday, September 17, 2026, 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.

Maidenhead, United Kingdom – September 17, 2026 -- CSL Seqirus has published pivotal Phase 3 results for its MF59-adjuvanted, cell-based, higher-dose quadrivalent influenza vaccine (aQIVc) in The Lancet Infectious Diseases, reporting superiority over an adjuvanted egg-based comparator across all four influenza strains and age groups tested in a 7,699-participant trial.

Trial enrolled nearly 7,700 adults aged 50 and older across eight countries

The randomised, observer-blind study recruited participants in Canada, Denmark, Estonia, Germany, Pakistan, the Philippines, the United Kingdom and the United States, comparing aQIVc against an MF59-adjuvanted egg-based quadrivalent vaccine and a recombinant quadrivalent vaccine. The vaccine met its primary objectives, showing non-inferiority versus the recombinant comparator for three of four strains in the 50-plus group and four of four strains in those aged 65 and above.

Boston – September 17, 2026 -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ) said Chief Financial Officer Tom Fitzgerald is retiring, effective immediately, and will be succeeded on an interim basis by John Tattory.

Fitzgerald exits after eight years steering TransCode through IPO and acquisitions

Fitzgerald has served as CFO since July 2018, a tenure spanning the company's initial public offering, the launch of clinical development for lead candidate TTX-MC138, the acquisition of Polynoma, and a license agreement with Oncolytics. He resigns as CFO and as a company director effective immediately but will remain to provide transition services.

Chairman and CEO Philippe P. Calais credited Fitzgerald with keeping the company funded from its early discovery-stage days. "Tom has worked tirelessly to keep us funded and on track," Calais said.

Toronto – September 17, 2026 -- Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has filed a preliminary short form base shelf prospectus in Canada and a corresponding Form F-10 registration statement with the U.S. SEC, enabling the life sciences company to raise up to US$150 million over a 25-month period.

Shelf filing permits future issuance of shares, debt and warrants

The filings, made under the U.S./Canada Multijurisdictional Disclosure System, would allow Cardiol to offer Class A common shares, debt securities, warrants, subscription receipts, units, or combinations thereof, once a final receipt is issued and the Registration Statement becomes effective. No securities are being offered under this announcement, and the Company said there is no assurance an offering will occur.

Durham – September 17, 2026 -- Seismic Pharmaceuticals has enrolled the first patient in its global Phase 3 trial testing istaroxime for heart-failure-related cardiogenic shock, a condition with no FDA-approved pharmacologic therapy. The study, RESCUE HF-CS, targets approximately 600 patients recruited at clinical sites across the United States, Europe, China and South America.

No approved drug currently exists for cardiogenic shock, a high-mortality condition

Cardiogenic shock occurs when the heart cannot pump enough blood to meet the body's needs, cutting off oxygen delivery to vital organs. Despite advances in critical care, the condition continues to carry high complication and mortality rates, and no medication has been specifically approved to treat it.

London – September 17, 2026 -- Hikma Pharmaceuticals PLC said regulators in the United States, Europe, and the UK have accepted for review its investigational epinephrine nasal spray, a needle-free treatment for anaphylaxis, with an additional filing lodged in Canada.

FDA accepts 505(b)(2) application for non-injectable anaphylaxis treatment

The US Food and Drug Administration has taken up a New Drug Application submitted under the 505(b)(2) pathway, which includes the required non-clinical and clinical data package supporting approval of the nasal spray for emergency anaphylaxis treatment.