Patients suffering in the long-stagnant therapeutic landscape of ulcerative colitis and Crohn’s disease gained encouragement with positive mid-stage results from Prometheus Biosciences Inc., which tested its tumor necrosis factor-like cytokine 1A-targeting PRA-023 against both forms of inflammatory bowel disease. San Diego-based Prometheus closed at $95.80, up $59.74, or 165.7% after the company made known data from the phase II study called Artemis-UC and the Apollo-CD phase IIa experiment. Prometheus intends to advance PRA-023 into phase III testing next year. Read More
Replimune Group Inc. has found consistent treatment efficacy in its pivotal phase II Ignyte melanoma study. The interim data strongly bolstered the stock (NASDAQ:REPL), which ended Dec. 7 with a 22% increase to $23.09. The new results for the combination treatment show what Replimune called clinically meaningful durable activity across the range of anti-PD1 failed cutaneous melanoma presentations, including in patients with moderate to high tumor burden, with 85% of responses ongoing. Read More
Shares of Oncopeptides AB dropped 35% Dec. 7 on the U.S. FDA’s request to withdraw marketing authorization of Pepaxto (melflufen), a drug that had gained accelerated approval in early 2021 for use in relapsed/refractory multiple myeloma. The move followed a negative advisory committee vote in September 2022 and is based on the outcome of the confirmatory phase III Ocean study. Read More
Apogee Therapeutics Inc. emerged from stealth with $169 million in financing and a pipeline of four preclinical antibody development programs that take aim at major immunological and inflammatory disorders. Read More
The positively charged nanoparticle polyamidoamine generation 3 (P-G3) can be specifically targeted to either visceral or subcutaneous fat, and affects both types of fat in different ways, researchers from Columbia University reported in two papers recently published. The studies, published online in Nature Nanotechnology on Dec. 1, 2022, and in Biomaterials on Nov. 28, 2022, are both “a conceptual advance” and “quite amenable to translation,” co-corresponding author Kam Leong told BioWorld. Read More
We wrapped up 2022 and are preparing for 2023 on this BioWorld Insider podcast. Staff writer Lee Landenberger talked to four CEOs, visionaries of companies producing new science and drug development. The CEOs offered their insights into what happened this year and looked at the challenges and opportunities for next year. Read More
New and updated clinical data presented by biopharma firms at the ESMO Immuno-Oncology Congress 2022, including: Achilles, Compugen, Poseida, SQZ. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzheon, Biovie, Cassava, Celldex, Dragonfly, Editas, Gossamer, Imaginab, Kinarus, Leo, Medicinova, Mirati. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Altavant, Clear Creek, Enzyvant, Equillium, Essential, Everson, Explorna, Hotspot, Intrinsic, Kyowa, MEI, Metrion, Nykode, Omnispirant, Ono, Pfizer, Replimune, Roche, Tris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altrubio, Biocardia, Biogen, Curadev, Ocuphire, Sage, SQZ, Vistagen. Read More
