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Atopic dermatitis — Evommune and Nektar post strong Phase II signals, stocks surge
Two mid‑stage studies reported clinically meaningful, durable efficacy signals in atopic dermatitis, triggering sizable share gains. Evommune’s EVO‑301 showed statistically significant EASI...
ILiAD raises $115M to push live attenuated pertussis vaccine toward Phase III
ILiAD Biotechnologies closed an oversubscribed $115 million Series B to advance BPZE1, a live attenuated intranasal pertussis vaccine, toward Phase III development. The financing was led by RA...
Microbiotica’s oral live biotherapeutic shows remission signals in ulcerative colitis
Microbiotica reported positive Phase Ib data for MB‑310, an oral live biotherapeutic targeting ulcerative colitis. In the study, 12 of 19 treated patients achieved clinical remission versus three...
Medicare covers Personalis MRD test for lung cancer surveillance
The U.S. Centers for Medicare & Medicaid Services granted coverage for Personalis’ NeXT Personal molecular residual disease (MRD) test for surveillance of stages I–III non‑small cell lung cancer....
Thermo Fisher partners with Datavant to link trials and real‑world patient data
Thermo Fisher Scientific’s PPD clinical research arm announced a strategic partnership with Datavant to enable privacy‑preserving tokenization and linkage of de‑identified clinical trial data with...
Precision Biosciences cleared to start PBGENE‑DMD clinical trial
Precision Biosciences received FDA clearance of an IND to initiate clinical site activation for PBGENE‑DMD, a gene‑editing candidate for ambulatory Duchenne muscular dystrophy patients. The...
FDA refuses to review Moderna mRNA flu shot — internal split surfaces
The U.S. Food and Drug Administration issued a refusal-to-file (RTF) letter on Moderna’s mRNA influenza application, halting the regulator’s review and prompting a formal dispute between the...
Atopic dermatitis readouts move markets — Evommune and Nektar jump
Two separate mid-stage immunology readouts reshaped investor and competitive dynamics in atopic dermatitis. Evommune reported that EVO‑301, its IL‑18–binding fusion protein, achieved a...
Madrigal doubles down on MASH: $4.4B siRNA pact from China
Madrigal Pharmaceuticals struck an exclusive agreement to add six preclinical siRNA programs from Ribo Life Science in a deal that could pay out up to $4.4 billion. The transaction includes a...
ILiAD nets $115M to push intranasal pertussis vaccine toward pivotal studies
ILiAD Biotechnologies closed an oversubscribed $115 million Series B led by RA Capital to advance BPZE1, a live attenuated intranasal pertussis vaccine, into Phase III and pivotal human challenge...
Lilly to acquire Orna — in vivo CAR‑T bet tops $2.4bn
Eli Lilly announced a transaction to acquire Orna Therapeutics to integrate Orna’s circular RNA and lipid nanoparticle delivery platform into Lilly’s genetic medicine strategy. The deal centers on...
FDA issues CRL to Regenxbio — another gene‑therapy setback
Regenerxbio received a complete response letter (CRL) from the FDA for RGX‑121, its gene therapy candidate for mucopolysaccharidosis II (Hunter syndrome). The agency raised concerns about the...
Microbiotica’s oral live therapeutic posts robust Phase Ib remission rates
Microbiotica reported positive Phase Ib results for MB‑310, an oral live biotherapeutic for ulcerative colitis: 12 of 19 treated patients achieved clinical remission versus three of 10 on placebo....
Medicare expands coverage for Personalis MRD assay in lung cancer surveillance
The Centers for Medicare & Medicaid Services granted coverage for Personalis’s NeXT Personal molecular residual disease (MRD) test for surveillance of stages I–III non‑small cell lung cancer. CMS...
Thermo Fisher and Datavant link RWD platforms — privacy tokens at scale
Thermo Fisher Scientific’s PPD clinical research business announced a strategic partnership with Datavant to enable privacy‑preserving linkage of real‑world data (RWD) for biopharma customers. The...
Capsida confirms cerebral edema in AAV trial fatality — probe continues
Capsida Biotherapeutics reported that the autopsy of a participant in its halted SYNRGY trial confirmed cerebral edema as the cause of death after IV dosing with CAP‑002, an AAV gene therapy for...
FDA refuses to review Moderna’s mRNA flu vaccine: regulator flags trial design
The U.S. Food and Drug Administration has refused to accept Moderna’s biologics license application for its mRNA seasonal influenza candidate, citing shortcomings in the pivotal trial’s design and...
FDA issues complete response for Regenxbio gene therapy – approval pathway stalls
The FDA has issued a complete response letter to Regenxbio for its AAV-based therapy RGX-121 intended for mucopolysaccharidosis II (Hunter syndrome), leaving the program without U.S. approval and...
Capsida confirms cerebral edema in AAV trial fatality: autopsy stops short of cause
Capsida Biotherapeutics confirmed that the autopsy of a patient who died after receiving its intravenous AAV therapy showed cerebral edema but did not establish a definitive underlying cause. The...
Madrigal buys six Ribo siRNA programs – $60M upfront, $4.4B potential
Madrigal Pharmaceuticals agreed to license six preclinical siRNA programs from Ribo Life Science and Ribocure to broaden its metabolic dysfunction-associated steatohepatitis (MASH) portfolio,...