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GRAIL’s Galleri Test Heads to FDA Panel After Staff Review
GRAIL Inc. (Nasdaq: GRAL) is scheduled to bring its Galleri multi-cancer blood test before a U.S. Food and Drug Administration advisory panel on September 23, 2026, following the release of agency briefing materials that identified no outstanding panel questions in several core review areas. The FDA’s Molecular and Clinical Genetics Panel will discuss and vote…
OS Therapies Reports FDA Alignment on OST-HER2 Phase 3 Design
OS Therapies Inc. (NYSE American: OSTX) announced on September 21, 2026, that it completed a Type C Statistical Methods Meeting with the U.S. Food and Drug Administration regarding OST-HER2, its investigational immunotherapy for recurrent osteosarcoma. According to the company, the FDA aligned with the updated adaptive design of a planned confirmatory Phase 3 study. OS…
TML-6 Enters a Field Where Rival Drugs Are Already Approved
Merry Life Biomedical, a privately held Taiwan biotechnology company, announced Sept. 21 that its investigational Alzheimer’s pill TML-6 is advancing in a global Phase 2 study now spanning 20 clinical sites in Taiwan, Sweden, and the United States. The trial will enroll about 210 people with early Alzheimer’s disease, testing whether a drug built around…
Telix to Buy Radioisotope Giant ITM for $1.65 Billion
Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) said Sunday it has signed a definitive agreement to acquire ITM Isotope Technologies Munich SE, a privately held German company that makes the radioactive isotopes used in a growing class of cancer drugs called radiopharmaceuticals, or radioligand therapies. These drugs attach a radioactive isotope to a molecule that…
Longeveron Phase 2b Heart Trial Misses Primary Endpoint
Longeveron Inc. (Nasdaq: LGVN) has reported that its Phase 2b ELPIS II trial of laromestrocel in infants with hypoplastic left heart syndrome did not meet its primary efficacy endpoint. The randomized, double-blind trial enrolled 40 infants and evaluated laromestrocel as an addition to Stage 2 palliative heart surgery. Participants received either a single dose of…
Ultragenyx Wins FDA Approval for Fayuvi in Sanfilippo Syndrome
Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE) has received standard full approval from the U.S. Food and Drug Administration for Fayuvi, making it the first approved treatment for children with Sanfilippo syndrome type A. The approval covers Fayuvi, formerly known as UX111, for treating the neurological manifestations of mucopolysaccharidosis type IIIA in pediatric patients with preserved neurodevelopmental…
Skyhawk’s SKY-0515 Holds Up at 15 Months in HD Trial
Skyhawk Therapeutics, a privately held biotech based in Waltham, Massachusetts, announced final 15-month results Monday from its Phase 1/2 trial of SKY-0515, an experimental once-daily pill for Huntington’s disease. Patients who took the drug held steady or slightly improved on a standard measure of disease severity through 15 months. A comparison group of untreated patients,…
Optimi Health Plans Phase 3 MDMA Trial for PTSD
Optimi Health Corp. (Nasdaq: OPTH; CSE: OPTI) plans to begin a Health Canada-authorized Phase 3 clinical trial evaluating MDMA-assisted therapy for post-traumatic stress disorder in 2027. According to the company’s September 16 announcement, the multicenter Canadian study is expected to enroll up to 100 veterans and current or former frontline workers. Eligible groups will include…
Telo Genomics Reports Higher MRD Detection in Myeloma Study
Telo Genomics Corp. (TSXV: TELO; OTCQB: TDSGF) has reported clinical research results showing that its experimental blood-based TELO-MRD assay detected residual multiple myeloma cells in a higher proportion of matched samples than a bone-marrow test. The September 15 announcement covered 42 samples matched by patient and collection date. TELO-MRD detected circulating myeloma cells in 39…
Inside the Federal Review That Could Reshape Lab AI
Federal regulators are reconsidering how a set of lab-testing rules written in 1992 should handle artificial intelligence, and the group representing the country’s clinical lab professionals just weighed in. The outcome could matter for investors well beyond any one company: the two largest publicly traded U.S. commercial labs, plus at least one AI-native diagnostics company,…
