Biotechs with drugs on the market were eager to share their fourth quarter revenue with investors as the J.P. Morgan 2026 Healthcare Conference kicked off today with some even brave enough to give revenue guidance for the year ahead. BioWorld takes a look at announcements and presentations from Alnylam, Incyte, Bridge Bio, Krystal, Soleno, Esperion, Axsome, and more.
Abbvie snags PD-1/VEGF bispecific in potential $5B Remegen deal
As rumors swirl regarding a couple of potential mega-mergers, the week of the J.P. Morgan Healthcare Conference kicked off with the official disclosure of some billion-dollar collaborations, leading with Abbvie Inc.’s exclusive licensing deal with Remegen Co. Ltd. for PD-1/VEGF-targeted bispecific antibody RC-148. Under the terms, Abbvie gains rights to RC-148 outside of greater China in exchange for an up-front payment of $650 million, with milestones that could reach up to $4.95 billion, plus tiered, double-digit royalties. Other deals announced include Novartis AG’s agreement to gain rights to Scineuro Pharmaceuticals Inc.’s amyloid beta-targeted antibody program for Alzheimer’s disease, and Haisco Pharmaceutical Group Co. Ltd.’s deal granting Airnexis Inc. rights to HSK-39004, a PDE3/4 dual inhibitor in development for chronic obstructive pulmonary disease.
Stoke updates phase III timeline for Dravet candidate
Stoke Therapeutics Inc. provided an update on zorevunersen, the antisense oligonucleotide in development with Biogen Inc. as a first-in-class potential disease-modifying treatment for Dravet syndrome. Accelerated timelines were disclosed for the completion of enrollment and a phase III data readout from the Emperor study. Signups of 150 patients are expected in the second quarter of the year, which puts the study on track for a readout in mid-2027. Beford, Mass.-based Stoke plans to submit a rolling NDA in the first half of 2027. Shares (NASDAQ:STOK) were trading at $26.66, down $6.19, or 18%.
FDA takes flexibility, modernization steps in Rx development
Moving away from a one-size-fits-all or a case-by-case approach, the US FDA's CBER released details today about how it is leveraging its growing experience with cell and gene therapies to exercise greater regulatory flexibility in chemical, manufacturing and control requirements for the products. In another effort to streamline the development of innovative drugs and biologics, the agency issued a draft guidance on modernizing statistical methods used in clinical trials. The guidance is intended to facilitate the use of Bayesian methodologies to help sponsors make better use of the data, conduct more efficient trials, and deliver safe and effective treatments to patients sooner, the FDA said.
Atara, Pierre Fabre: FDA flipflops on Ebvallo’s rare disease BLA
A second complete response letter (CRL) issued by the U.S. FDA for Atara Biotherapeutics Inc.’s Ebvallo (tabelecleucel) for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) is “a complete reversal of position” by the agency, which had previously confirmed the single arm Allele trial was enough to support a BLA under the accelerated approval pathway, the company said. Atara’s shares (NASDAQ:ATRA) plunged 53% to $6.40 in early trading Jan. 12. Partner Pierre Fabre Pharmaceuticals Inc., which took over the BLA in November 2025, said patients with EBV+ PTLD “have no FDA-approved treatment options and a life expectancy often measured in weeks to months.” Another delay blocks patient access and “may have far-reaching consequences for the development of rare disease treatments … ,” the company said. Atara received the first CRL almost exactly a year ago.
Newco Rage Bio enters clinic with inhaled oligonucleotide in COPD
After raising AU$29 million (US$19.44 million) in a series A round, Rage Biotech Pty Ltd. is beginning phase I trials of its lead candidate, RB-042, an inhaled splice-switching oligonucleotide for treating chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. The funding round was led by IP Group Australia and Hostplus with continued participation from existing investors including Monash Ventures. The funds will support the advancement of Rage Bio’s lead program into first-in-human clinical trials, Rage Bio CEO Siro Perez told BioWorld. Clinical trials will begin in Perth, with recruiting beginning in January and dosing expected to begin in mid-February.
Top and slop: 2026 is shaping up as another big year for AI
Depending on who you ask, AI will take over the world and save it; or ruin it. Certainly, it is changing it. Science magazine dedicated its first editorial of 2026 to AI. Despite its title – “Resisting AI slop“ – editor-in-chief Holden Thorp gave the sort of nuanced review that is typical of him. “Like many tools, AI will allow the scientific community to do more if it picks the right ways to use it,” he wrote. “The community needs to be careful and not be swept up by the hype surrounding every AI product.”
Also in the news
Acepodia, Acousia, Airnexis, Alessa, Anaptys, Aquestive, Ashvattha, Aurora, Avista, Biocytogen, Clarametyx, Clene, Cytoreason, Dewpoint, Eli Lilly, Enhanced Genomics, Enodia, Enyo, Find, GC, GSK, Ibio, Iktos, Innovent, Kezar, Krystal, Link Cell Therapies, Madrigal, Medilink, Medipost, Monte Rosa, Nona, Octave, Orca, PDS, Pfizer, Pierre, Praxis, Pulse, Ray, Ribo, Roche, Sanofi, Septerna, Sonothera, Tesaro, Uniqure, Zyus
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