FDA & Clinical Trials
Ribo Seeks EU Nod for First Human Trial of INHBE Obesity Drug
Suzhou Ribo Life Science (HKEX: 6938) wants to start testing an experimental obesity drug in people. The siRNA developer and its Swedish subsidiary, Ribocure Pharmaceuticals AB, said on October 7 that they have submitted a Phase 1 clinical trial application (CTA) in the European Union for RBD3133, a drug that targets a gene called INHBE.…
Marvel Biosciences Signs Novatech LOI for First MB-204 Trial
Marvel Biosciences Corp. (TSXV: MRVL; OTCQB: MBCOF) has signed a letter of intent with clinical research organization Novatech for a planned first-in-human Phase 1 trial of MB-204, its experimental treatment for autism spectrum disorder and other neurodevelopmental conditions. The company announced on October 6, 2026, that the study is expected to begin in Australia during…
Ractigen’s RNA Activation Drug Shows Early Duchenne Signal
Three boys. One dose level. About six months of follow-up. That is the full dataset behind Ractigen Therapeutics’ first look at its Duchenne drug RAG-18 in people, and it should frame everything that follows. The privately held Chinese biotech presented the Phase 1 results on October 3 at the World Muscle Society’s 31st Annual Congress…
Surrozen Receives FDA Clearance to Begin SZN-8141 Eye Trial
Surrozen Inc. (Nasdaq: SRZN) announced on October 2, 2026, that its Investigational New Drug application for SZN-8141 has become effective, allowing the company to begin clinical development of the experimental treatment for diabetic macular edema. The FDA milestone permits Surrozen to initiate DUET, a Phase 1b/2a clinical trial expected to dose its first patient during…
Foundayo Passes Heart-Safety Test in Type 2 Diabetes Trial
Eli Lilly’s weight-loss pill just passed the test it needed for a second, bigger market. In the Phase 3 ACHIEVE-4 trial, Foundayo (orforglipron) showed no increase in the risk of major heart events compared with insulin glargine in adults with type 2 diabetes and obesity or overweight at elevated cardiovascular risk. Eli Lilly and Company…
Ascletis Psoriasis Pill ASC50 Shows Early Signal in Phase 1
Ascletis Pharma wants to put one of psoriasis medicine’s most proven targets into a pill. Early data suggest it might work. Emphasis on early. The Hong Kong-listed drugmaker (HKEX: 1672) said in a September 28 press release that its experimental drug ASC50 cut psoriasis severity by 48.9% more than placebo after 28 days of once-daily…
Cartesian Reports Durable Responses After Descartes-08 Retreatment
Cartesian Therapeutics Inc. (Nasdaq: RNAC) reported additional Phase 2 retreatment data for Descartes-08 on September 29, 2026, showing sustained reductions in myasthenia gravis symptoms among five patients followed for 12 months after receiving a second treatment course. Descartes-08 is an investigational autologous CAR-T therapy targeting B-cell maturation antigen, or BCMA. Unlike conventional DNA-based CAR-T therapies,…
Akeso’s China-Approved Bispecific Heads Into a Global Phase 3
Akeso, Inc. (HKEX: 9926) has enrolled the first patient in COMPASSION-37, a global Phase 3 trial testing its cancer drug cadonilimab against today’s first-line standard of care for advanced stomach cancer. The Hong Kong-listed drugmaker announced the milestone in a press release dated Sunday, September 27, 2026. There are no results yet. The trial just…
Sobi Brings Four Gamifant Posters to HS2026 in Rotterdam
Sobi (Nasdaq Stockholm: SOBI) will present four posters on its antibody Gamifant (emapalumab) at the Histiocyte Society’s 2026 annual meeting in Rotterdam, which runs September 26 to 29. The company announced the lineup in a September 24 press release. What it did not announce was a single result. That gap matters for investors. Gamifant is…
Oruka Reports Deeper Psoriasis Responses in ORKA-001 Phase 2 Trial
Oruka Therapeutics Inc. (Nasdaq: ORKA) reported deeper clinical responses at Week 28 in its Phase 2a EVERLAST-A trial of ORKA-001, an investigational monoclonal antibody for moderate-to-severe plaque psoriasis. According to the September 23 announcement, 71.4% of the 63 patients initially assigned to ORKA-001 achieved PASI 100 at Week 28, indicating complete skin clearance. The PASI…
