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Elevar Therapeutics’ Lyrfigtu has entered the FGFR2-positive cholangiocarcinoma market with a 46% response rate and a highly selective irreversible FGFR2 mechanism. Representative image.
Features & Analysis

Relay handed Lyrfigtu to Elevar for $5m upfront. FDA approval now tests the value of that unusual biotech deal

The FDA has approved Elevar Therapeutics’ Lyrfigtu for previously treated FGFR2-rearranged cholangiocarcinoma after a 46% response rate and 11.8-month median response duration. The drug enters an established targeted market, making FGFR2 selectivity, tolerability, molecular testing and eventual activity against resistance mutations more important than simply being another approved inhibitor.

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Representative image: Pulmonary function testing and lung CT imaging illustrate aTyr Pharma’s FDA-aligned Phase 3 efzofitimod program in pulmonary sarcoidosis.
Pharma & Biotech

aTyr Pharma refocuses efzofitimod Phase 3 strategy on lung function after failed steroid endpoint

aTyr Pharma gains FDA alignment for a new efzofitimod Phase 3 trial in pulmonary sarcoidosis after the earlier EFZO-FIT endpoint miss.

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Representative image: Kyverna Therapeutics’ miv-cel shows durable one-year mobility gains in stiff person syndrome as the CAR T therapy advances toward FDA review.
Pharma & Biotech

Miv-cel sustains one-year SPS benefit as Kyverna advances CAR T therapy toward FDA filing

Kyverna’s miv-cel sustains mobility gains and keeps 92% of SPS patients off chronic immunotherapy at one year as its FDA filing advances.

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AstraZeneca is expanding Trixeo Aerosphere beyond chronic obstructive pulmonary disease into uncontrolled asthma across Europe for patients aged 12 years and older. Representative image.
Pharma & Biotech

AstraZeneca turns COPD inhaler into asthma growth engine as Trixeo wins broader EU label

European regulators have approved AstraZeneca’s Trixeo Aerosphere for uncontrolled asthma from age 12 regardless of recent exacerbation history, potentially widening a respiratory franchise that generated $699 million in first-half 2026 sales.

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Representative image: Japan’s approval of IMCIVREE for acquired hypothalamic obesity expands Rhythm Pharmaceuticals’ global rare-disease footprint, strengthening the company’s growth story as setmelanotide reaches another major pharmaceutical market.
Pharma & Biotech

Viking Therapeutics stock drops after hours as $400m raise follows 36% VK2735 surge

Viking Therapeutics is seeking $400 million through stock and convertible-note offerings immediately after VK2735 obesity data sent its shares sharply higher, as the company accelerates Phase 3 development and explores monthly and every-other-week maintenance dosing.

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Celldex Therapeutics’ barzolvolimab produced deep complete responses across two Phase 3 chronic spontaneous urticaria trials while maintaining efficacy in patients refractory to omalizumab. Representative image.
Features & Analysis

Barzolvolimab can eliminate hives and itch for about half of patients. What does Celldex need to prove before launch?

Celldex Therapeutics has delivered positive results from both Phase 3 EMBARQ studies of barzolvolimab in chronic spontaneous urticaria, with roughly 42% to 46% of treated patients completely free of hives and itch by Week 12 and response rates deepening through Week 24. The clinical programme also produced substantial activity after omalizumab failure and against angioedema,

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Compass Therapeutics' tovecimig program faces a new regulatory hurdle after the FDA recommended an additional survival trial before a potential biliary tract cancer approval filing. Representative image.
Pharma & Biotech

Why Compass Therapeutics stock collapsed after FDA challenged its cancer-drug approval plan

Compass Therapeutics shares plunged to a two-year low after the FDA recommended another survival trial before a tovecimig filing, creating a high-stakes disagreement over whether strong tumor-response and progression-free survival results are enough to support an approval application in advanced biliary tract cancer.

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AbbVie is expanding Rinvoq into pediatric rheumatology after European approval for children aged two and older with active polyarticular juvenile idiopathic arthritis. Representative image.
Pharma & Biotech

AbbVie’s $2.5bn Rinvoq franchise reaches children as young as two after EU approval

The European Commission has approved Rinvoq for active polyarticular juvenile idiopathic arthritis in children aged two and older, adding another patient population to AbbVie’s rapidly growing immunology franchise and introducing a weight-based oral solution for younger patients.

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Representative image: Oruka Therapeutics reports ORKA-001 psoriasis responses deepening through Week 28, with 71.4% of patients achieving complete skin clearance without additional dosing after Week 4.
Features & Analysis

Long-acting ORKA-001 maintains deep psoriasis responses as Phase 3 planning approaches

ORKA-001 reaches 71.4% complete psoriasis clearance at Week 28 without redosing. See what the data mean for Oruka’s long-acting biologic strategy.

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Representative image: Roche sefaxersen hits Phase III IgA nephropathy endpoint as once-monthly therapy moves closer to regulatory review.
Pharma & Biotech

Roche reports positive Phase III sefaxersen results as factor B competition intensifies in IgA nephropathy

Roche’s sefaxersen hits its Phase III IgAN endpoint with significant proteinuria reduction. See what the result means for regulators and competitors.

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