Nearly six years after Ichnos Sciences Inc. launched operations, an offshoot of the company, IGI Therapeutics SA, has signed with Abbvie Inc. a global licensing partnership for trispecific antibody ISB-2001 worth $1.925 billion plus royalties. ISB-2001, which targets BCMA, CD38 and CD3, is in a phase I trial for relapsed/refractory multiple myeloma and has orphan drug and fast track status in the U.S. The Abbvie deal spans all oncology and autoimmune indications across North America, Europe, Japan and greater China in return for $700 million up front, $1.225 billion in development, regulatory and commercial milestone payments, and tiered, double-digit royalties on net sales. IGI is a wholly owned subsidiary of Ichnos Glenmark Innovation Inc., an alliance Ichnos Sciences formed in 2024 with Glenmark Pharmaceuticals Ltd., which retains rights to ISB-2001 across emerging markets.

US FDA taking the wraps off CRLs

In a step toward “radical transparency,” the U.S. FDA today made public, for the first time ever, a batch of complete response letters (CRLs) issued in response to drug and biologic sponsors seeking approval for their products over the past five years. Redacted to protect proprietary information, the CRLs reference products that have since been approved. “For far too long, drug developers have been playing a guessing game when navigating the FDA,” FDA Commissioner Marty Makary said. “Drug developers and capital markets alike want predictability.” Releasing the CRLs is intended to alleviate some of that guesswork by providing greater insight into the agency’s decision-making and the most common deficiencies cited that sponsors must address for approval. The batch of more than 200 CRLs is just the first to be made public.

More to go: Mereo and Ultragenyx wilt as phase III rolls on

Ultragenyx Pharmaceutical Inc. and Mereo Biopharma Group plc, along with investors, had hoped for an early halt to the phase III study of setrusumab in treating brittle bones. They didn’t get it, as the clinical trial’s data monitoring committee said it wants the study to roll on through its final analysis. As a result, both companies were suffering on the street at midday, as Ultragenyx stock (NASDAQ:RARE) was down 26% to $30.75 a share and Mereo (NASDAQ:MREO) had dropped 34% to $1.93 a share. The randomized, placebo-controlled Orbit study testing the fully human monoclonal antibody that inhibits sclerostinis is being conducted in pediatric and young adult patients with osteogenesis imperfecta.

Nuclidium’s radiopharma approach draws $99M in series B

Nuclidium AG is poised to circumvent the complex production and supply issues that have held back access to radiopharmaceuticals after closing a CHF79 million (US$99.3 million) series B, to advance the clinical development of its copper isotopes and extend the global manufacturing network. The new funding is on the back of initial data published in May and June 2025, showing its copper-61 imaging isotope is potentially better than approved agents for imaging neuroendocrine tumors and metastatic prostate cancer. The company also has early clinical data showing its lead therapeutic beta-emitting copper-67 radiopharmaceuticals generate strong tumor-to-background ratios in these two indications.

Biopharma financings up from a weak Q1 but fall short of past Q2 highs in 2025

Biopharma raised $16.02 billion in the second quarter (Q2) of 2025, up from Q1 but well below prior years. The first-half total of $29.13 billion lags far behind 2024’s $70.32 billion and marks the slowest H1 since 2018, signaling a continued cooldown from the pandemic-era boom.

Also in the news

Adcentrx, Atsena, Biovie, Eledon, Centivax, Cingulate, Cogent, Connect, Coregen, Daiichi Sankyo, Dimerx, Eli Lilly, Galectin, Iambic, Iaso, Jasper, Kazia, Leol, Lixte, Lupin, Maxona, Novartis, Oncozenge, Palisade, Puretech, Qanatpharma, Radiant, Revolution Medicines, Rhythm, Sernova, Simcere, Sironax, Transposon, Trethera, Zentiva, Zyversa