Two phase III studies of setrusumab, Orbit and Cosmic, for treating brittle bones have failed and left the developers floundering on Wall Street. Neither of Ultragenyx Pharmaceutical Inc. and Mereo Biopharma Group plc’s studies of the monoclonal antibody in treating osteogenesis imperfecta hit statistical significance in their primary endpoints, though they did achieve their secondary endpoints. The companies are still looking at the numbers to determine their next steps. Ultragenyx stock (NASDAQ:RARE) was down 43% at midday to $19.49 a share and Mereo (NASDAQ:MREO) had sagged 90% to 23 cents a share. Both stock prices are lows for the past 12 months.
J&J’s bispecific from Numab fizzles in atopic dermatitis phase II
Johnson & Johnson (J&J) has scrapped early the phase IIb Duplex-AD proof of concept study with bispecific JNJ-95475939 because the trial fell short of the efficacy bar established in atopic dermatitis. In May 2024, New Brunswick, N.J.-based J&J paid $1.25 billion to bring the product aboard by acquiring Yellow Jersey Therapeutics, a wholly owned subsidiary of Numab Therapeutics AG, of Horgen, Switzerland. Previously known as NM-26, the compound targets IL-4Ra (type I and II receptors) and IL-31. It was designed with Numab’s MATCH (Multispecific Antibody-based Therapeutics by Cognate Heterodimerization) technology platform.
China approves Innovent’s ipilimumab for colon cancer
China’s National Medical Products Administration approved Innovent Biologics Inc.’s NDA for Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient colon cancer. The win marks the second approval this month. As previously reported by BioWorld, China’s NMPA approved Innovent’s picankibart (IBI-112), branded as Pecondle, for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Tabosun is the first domestic cytotoxic lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody to be approved in China.
Top issues in South Korea’s biotechnology sector in 2025
U.S. policy, China’s strategic rise, blockbuster deals and AI dominated South Korea’s biotechnology industry this year, with U.S. tariffs and the Biosecure Act’s hitch onto 2026 legislation serving as major topics of speculation. Oh Ki-hwan, head of Korea Biotechnology Industry Organization‘s research center, told an audience in Seoul Dec. 4 that “tariffs were the first thing that came to mind” when association members talked of major issues; moreover, he forecasted that the “Biosecure Act, which died last year, is coming back to life.”
In 2025, autoimmune work notches scientific, economic successes
In October, the Nobel Committee awarded the 2025 Nobel Prize in Physiology or Medicine to Shimon Sakaguchi, Mary Brunkow and Fred Ramsdell for their discoveries in the field of autoimmunity. As has become typical for the scientific Nobel Prizes, the award-winning research is by now several decades old. The key papers identifying regulatory T cells and describing the role of the transcription factor FOXP3 in their functioning, were published between 1995 and 2003. But the discoveries were the basis for ongoing research into how to prevent autoimmunity that notched significant wins in 2025, in both basic research and in the clinic.
November phase III successes led by HIV wins from Gilead, Merck
BioWorld logged 170 clinical trial updates across phases I through III in November 2025, a decline from 252 updates in October and 230 in September, but higher than the 95 reported in August. Among the November updates, 18 phase III studies reported positive results, including those from Gilead Sciences Inc. with its bictegravir-lenacapavir combination and Merck & Co. Inc. with its doravirine and islatravir combination, both for HIV.
Holiday notice
BioWorld's offices were closed in observance of Christmas. No issues were published Thursday, Dec. 25 or Friday, Dec. 26.
2025 Year in Review
BioWorld looks back at the year's biggest news. You can find all of our 2025 Year in Review articles here.
Also in the news
Agios, Edgewise, Foresee, Gilead, Italfarmaco, JCR, Omeros, Pelthos, Repare, Sanofi, SN Bioscience, Theralase, Vor, Vyriad
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