J&J scored a major FDA approval for its once-daily psoriasis pill Icotyde, a potential megablockbuster poised to shake up the injectable-dominated market. On the dealmaking front, Sandoz expanded its biosimilar partnership with Samsung Bioepis targeting up to five next-generation assets including an Entyvio copycat. Crossbow Therapeutics raised $77M in Series B for its T cell engager platform, while Shanghai-based Excalipoint closed a $68.7M seed round for similar assets, underscoring continued investor appetite for next-generation immunotherapies.
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J&J's Icotyde Wins FDA Approval for Plaque Psoriasis, Eyes $5B+ Peak Sales
The FDA approved Johnson & Johnson's icotrokinra as Icotyde for first-line treatment of plaque psoriasis in patients 12 and older, according to Endpoints News. The once-daily oral IL-23 inhibitor stands to disrupt the injectable-filled psoriasis market, with Fierce Pharma calling it a "game-changer" and pharmaphorum reporting it's cleared for first-line use. Developed in partnership with Protagonist Therapeutics, the therapy is positioned for blockbuster-level sales with peak revenue estimates exceeding $5 billion. This signals J&J's intent to capture significant market share from established biologics with a more convenient oral formulation.
Sandoz Expands Samsung Bioepis Collaboration to Commercialize Five Next-Generation Biosimilars
Sandoz struck a licensing, development and commercialization deal with Samsung Bioepis covering up to five biosimilar candidates, with the lead asset SB36 targeting Takeda's Entyvio (vedolizumab), reported Fierce Pharma. The partnership could expand Sandoz's pipeline by up to 32 assets total, according to European Pharmaceutical Review, as the companies deepen their collaboration on next-generation biosimilars. PharmaTimes noted the deal expands Samsung Bioepis's global pipeline. Worth watching because Entyvio generated more than $5 billion in 2024 sales, making SB36 a potentially lucrative addition to Sandoz's commercial portfolio.
Crossbow Therapeutics Secures $77M Series B to Advance T Cell Engager Platform
Crossbow Therapeutics, led by drug development veteran Briggs Morrison, closed a $77 million Series B financing backed by more than a dozen investors to advance its T cell engager programs, Endpoints News and BioPharma Dive reported. The funding will support the ongoing Phase 1 trial of lead candidate CBX-250 for cancer immunotherapy, with Morrison emphasizing his "ABCs" philosophy—always be in the clinic. The move suggests continued investor confidence in T cell engagers despite increasing competition in the space.
Shanghai's Excalipoint Therapeutics Closes $68.7M Seed Round for T Cell Engager Pipeline
Excalipoint Therapeutics, founded by former I-Mab executives Lei Fang and Jielun Zhu, completed a $68.7 million seed financing round to develop T cell engager therapies, according to Endpoints News. The Shanghai-based startup emerged from a hot pot dinner conversation in fall 2024 between the co-founders, who are now building their next drug development venture focused on this crowded but potentially lucrative modality. This signals that even in a competitive landscape, experienced teams can attract substantial early-stage capital for differentiated platforms.
RBC Identifies Revolution, Xenon, Arrowhead Among Top M&A Targets
An RBC analyst identified 13 biotech companies as attractive takeover targets—including Revolution Medicines, Xenon Pharmaceuticals, and Arrowhead Pharmaceuticals—while also highlighting more than half a dozen potential buyers, BioPharma Dive reported. The analysis comes as part of a broader M&A review amid expectations for continued dealmaking activity in 2026. Worth watching because these names represent assets with clinical validation that larger pharma may pursue to fill pipeline gaps.
Premature Menopause Linked to 40% Increase in Heart Disease Risk, Study Finds
A study published in JAMA Cardiology found that premature menopause is associated with a 40% increase in heart disease risk, a condition three times more common in Black women, STAT reported. The study's authors noted that the underlying mechanisms driving this elevated cardiovascular risk are not yet fully understood. This signals a potential therapeutic opportunity for interventions targeting menopausal health disparities and cardiovascular outcomes in women.
What to Watch
- Icotyde commercial launch dynamics — J&J's pricing strategy and payer coverage decisions will determine whether this oral IL-23 inhibitor can truly displace injectable biologics in first-line psoriasis treatment.
- T cell engager differentiation — With both Crossbow and Excalipoint securing substantial funding for similar platforms, watch for clinical data demonstrating meaningful safety or efficacy advantages over existing bispecifics.
- Biosimilar SB36 development timeline — Sandoz's Entyvio biosimilar could reach market as the originator faces patent expiries, potentially capturing share in the lucrative IBD market.
- M&A activity acceleration — RBC's target list suggests analyst expectations for deal flow to pick up, particularly among clinical-stage companies with validated mechanisms.
Market Snapshot
- Oral immunology expansion: Icotyde's approval represents the latest shift toward oral alternatives in immunology, following similar moves in ulcerative colitis and rheumatoid arthritis, as pharma seeks to offer patients more convenient dosing.
- Biosimilar pipeline maturation: The Sandoz-Samsung Bioepis deal underscores how biosimilar developers are moving beyond first-generation TNF inhibitors to target newer biologics like vedolizumab, expanding addressable markets significantly.
- Cardiovascular health disparities: The JAMA Cardiology findings on premature menopause add to growing evidence of gender and racial disparities in heart disease, potentially driving policy and R&D focus on underserved populations.