Top Story Today
J&J's New Psoriasis Pill Might Make Needles Obsolete
The FDA approved ICOTYDE, the first oral peptide for moderate-to-severe plaque psoriasis, and the clinical data is genuinely striking: approximately 70% of patients achieved clear or almost clear skin at 16 weeks. In head-to-head trials, ICOTYDE beat BMS's Sotyktu at both checkpoints. The safety profile looked essentially identical to placebo. J&J is already running Phase 3 trials in psoriatic arthritis and a Phase 2b trial in ulcerative colitis, positioning this as a multi-indication franchise drug in a $34 billion global market.
Why it matters: An oral drug matching injectable biologic efficacy could fundamentally rewire how dermatologists treat psoriasis, pulling millions of needle-averse patients into the most effective treatment tier and reshuffling competitive dynamics across the entire inflammatory disease landscape.
Read more →Regulatory Roulette
The Eye Drug That Can't Take a Hint
The FDA rejected Aldeyra's dry eye drug reproxalap for the third time, citing inconsistent efficacy data that "raises serious concerns about the reliability" of positive findings. The stock cratered over 70%, and H.C. Wainwright downgraded the company with a $2 price target. Aldeyra has $70 million in cash and plans to request a meeting with regulators, but AbbVie's $100 million approval milestone is looking more like a fantasy than a paycheck.
Read more →4,000 Staffers Gone: The FDA One Year Into Trump's Second Term
The FDA lost roughly 20% of its workforce and burned through five CDER directors in a single year. Novel drug approvals slipped to 46 (down from 55 in 2023), and 11% of scheduled reviews were delayed in Q3 2025, nearly triple the historical average. Biotech companies are increasingly routing clinical trials overseas to avoid the bottleneck.
Read more →Pipeline Shake-Ups
Bicycle Therapeutics Deprioritized Its Lead Drug and Cut 30% of Staff
Bicycle deprioritized lead cancer drug zelenectide after the FDA signaled its pivotal trial wouldn't support accelerated approval, and early combo data looked uncompetitive against Pfizer's Padcev. The company cut 86 employees (its second major layoff), plans to halve operating costs, and is betting its remaining $628 million in cash on backup candidate BT5528 and a pivot to radioconjugates.
Read more →A Senator Says GSK Pulled a Vanishing Act With America's Most Common Asthma Inhaler
Senator Hassan accused GSK of discontinuing branded Flovent and replacing it with an authorized generic to dodge Medicaid rebate penalties, leaving many kids navigating insurance chaos. The good news: the FDA just approved the first true independent generic from Glenmark. The bigger fight is over closing the structural loophole that made GSK's strategy legal in the first place.
Read more →Deals & Discovery
J&J Keeps Closing Its Startup Incubators. Four Down, Three to Go.
J&J shuttered its New York JLABS site, the fourth closure in a year, leaving just three U.S. locations. The company spent $32 billion on R&D and acquisitions in 2025, signaling a clear preference for buying winners over growing them. The uncomfortable question: if every pharma giant adopts this approach, who builds the startups they want to acquire?
Read more →A Japanese Biotech and an AI Startup Team Up to Crack 'Undruggable' Targets
PRISM BioLab's molecular mimicry platform (which builds pill-sized molecules shaped like protein handshakes) is pairing with Receptor.AI's computational screening engine to go after protein-protein interactions that traditional drugs can't reach. First target: obesity and metabolic disease. Eli Lilly already invested in PRISM's platform, and the partners plan to jointly court pharma licensees.
Read more →