SNAPSHOT

Lynk’s oral JAK1 hits Phase 3 win in China’s atopic dermatitis race

Lynk Pharmaceuticals reported positive phase 3 results in China for its oral JAK1 inhibitor zemprocitinib in moderate-to-severe atopic dermatitis (AD), showing significant skin clearance and a competitive safety profile.

Why it matters: The win strengthens Lynk’s case that its next-generation JAK1-selective drug can compete in a crowded market while potentially avoiding the safety concerns that have plagued earlier JAK inhibitors.

Backstory: JAK inhibitors such as AbbVie’s Rinvoq, Pfizer’s Cibinqo and Incyte’s Opzelura are already approved for atopic dermatitis but carry FDA boxed warnings due to risks including infections and cardiovascular events. Lynk has positioned zemprocitinib as more selective for JAK1, aiming to preserve efficacy while reducing off-target side effects. The company also reported a phase 3 win in rheumatoid arthritis (RA) in January.

Big picture: With multiple JAK inhibitors on the market, differentiation on safety could be key. Positive late-stage data in both eczema and RA bolsters zemprocitinib’s value as a core pipeline asset and supports Lynk’s broader growth and commercialization ambitions in and beyond China.

Zoom in: In a 356-patient study, the 12-mg dose improved eczema severity scores (EASI-75) by 38.1% over placebo; the 24-mg dose improved scores by 46.4%. On a global AD assessment, the 12-mg and 24-mg doses showed 30% and 31% improvements over placebo, respectively.

What else: The drug also met secondary endpoints across itch, skin clearance and quality-of-life measures with no serious adverse events related to decreases in hemoglobin, neutrophils or lymphocytes. Not even concerns with liver enzyme safety emerged.

What’s next: Lynk plans to file for approval for atopic dermatitis in China in the first half of 2026 and for rheumatoid arthritis in the second half. While Simcere holds commercialization rights in greater China for RA, Lynk retains global rights outside China and recently struck a separate, $600 million-plus deal with Formation Bio for an allosteric TYK2 inhibitor, signaling broader ambitions in immunology.

SNIPPETS

What’s happening in biotech today?

📉 Shares plunge: UniQure’s shares fell more than 40% after the FDA rejected its plan to seek accelerated approval for its Huntington’s disease gene therapy, AMT-130, based on Phase 1/2 data compared with an external control, instead recommending a prospective, randomized, sham surgery-controlled Phase 3 trial. The decision delays potential approval by years despite earlier FDA feedback that appeared supportive and data showing a 75% reduction in disease progression versus natural history controls. The agency cited insufficient treatment effects versus sham at 12 months, while uniQure argued longer follow-up is needed in early-stage patients and questioned the ethics of sham surgery. The setback adds to broader concerns about stricter FDA standards for rare disease therapies.

⚠️ Liver worries: Roche announced that its oral BTK inhibitor fenebrutinib met the primary endpoint in a second Phase 3 trial in relapsing multiple sclerosis, reducing annual relapse rates by 51% compared with Sanofi’s Aubagio, consistent with results from a prior study and a separate success in primary progressive disease. However, safety concerns may cloud its approval prospects: one case of severe liver enzyme elevation meeting “Hy’s law” criteria (used to identify drugs capable of causing severe drug-induced liver injury) occurred in each treatment arm, and eight deaths were reported among fenebrutinib recipients across two trials versus one with Aubagio. Analysts note that prior FDA scrutiny of similar liver risks in competing BTK inhibitors could complicate regulatory review despite strong efficacy data.

🏆 Phase 3 win: United Therapeutics reported a phase 3 victory for its once-daily oral pulmonary arterial hypertension (PAH) candidate ralinepag, showing a 55% reduction in risk of first clinical worsening versus placebo when added to standard therapy in a 687-patient trial. Clinical worsening occurred in 18.3% of ralinepag patients compared with 35.9% on placebo, with the benefit driven mainly by less disease progression, fewer starts of inhaled/infused prostacyclin, and fewer unsatisfactory long-term responses, while death and PAH hospitalization rates were similar between arms. United also cited significant secondary-endpoint gains (including six-minute walk distance and a cardiac biomarker) and a 47% higher odds of clinical improvement by Week 28, saying effects were consistent across subgroups. The company plans an FDA filing in the second half of 2026 and argues ralinepag’s durability and once-daily dosing could challenge J&J’s twice-daily Uptravi.

 🟢 EMA greenlight: The European Medicines Agency (EMA) has recommended approval of Moderna’s combination flu and COVID-19 vaccine, mCombriax, for adults aged 50 and older, marking a significant milestone for the company after regulatory challenges in the United States. While the FDA has required additional data and raised concerns about study comparators, delaying and complicating Moderna’s U.S. approval efforts, the EMA concluded that the vaccine generates adequate immune responses against both viruses and that supporting flu data demonstrate effectiveness. The recommendation, pending European Commission ratification, offers Moderna a potential new revenue source amid declining COVID-19 vaccine sales and reflects a smoother regulatory path in Europe compared to the U.S.

⏸️ Trial pause: Aardvark Therapeutics has voluntarily paused its Phase 3 “HERO” trial of ARD-101 for Prader-Willi syndrome after detecting reversible cardiac abnormalities in healthy volunteers receiving higher-than-therapeutic doses, triggering a more than 50% drop in its share price. The findings, observed on EKG tests and resolved after treatment stopped, prompted the company to halt dosing and enrollment while it reviews the data, delaying an anticipated readout later this year. Although no such issues have appeared at Phase 3 dose levels, analysts warn the drug’s safety margin may be narrower than expected, raising regulatory uncertainty in a field already challenged by safety concerns despite the recent approval of Soleno’s competing therapy.

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