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Insilico splits NLRP3 rights: $66M deal and China license accelerate ISM‑8969
Insilico Medicine agreed to a transaction that delivers a $10 million upfront and a broader $66 million‑value arrangement to carve up rights for its brain‑penetrant NLRP3 inhibitor, enabling a...
Beam…biomarkers for approval: FDA agrees biomarker‑based path in AATD
Beam Therapeutics said the FDA accepted a biomarker‑based accelerated‑approval approach for BEAM‑302, its base‑editing therapy for alpha‑1 antitrypsin deficiency (AATD). Regulators agreed that...
Engineered CHO cells cut feeds and wastes: Self‑sufficient amino‑acid producers
Danish researchers at DTU reported engineered Chinese hamster ovary (CHO) cell lines that synthesize threonine and histidine internally and exhibit reduced lactate and ammonia production....
GSK buys Rapt for $2.2B — Adds long‑acting anti‑IgE
GSK agreed to acquire Rapt Therapeutics for $2.2 billion to add ozureprubart, a long‑acting anti‑IgE antibody in Phase IIb, to its allergy and immunology pipeline. The deal gives GSK global rights...
FDA opens path: MRD negativity could back myeloma accelerated approvals
The U.S. Food and Drug Administration released draft guidance clarifying how measurable residual disease (MRD) negativity and complete response rates can support accelerated approval pathways for...
Erasca prices upsized offering — $225M gross proceeds
Erasca priced an upsized public offering of 22.5 million shares at $10.00 per share, generating expected gross proceeds of about $225 million and granting underwriters a 30‑day option on...
Corvus pill soars — ITK inhibitor posts strong Phase I eczema results
Corvus Pharmaceuticals reported positive Phase I results for soquelitinib, an oral ITK (IL‑2‑inducible T‑cell kinase) inhibitor, prompting a dramatic stock rally as clinicians and investors parsed...
Illumina wins CMS reimbursement — TruSight Oncology Comprehensive covered
The Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive (TSO) at $2,989.55 per test under PLA code 0543U, effective Jan. 1, 2026. The...
Valneva pulls chikungunya from U.S. after FDA safety probe
Valneva voluntarily withdrew its U.S. chikungunya vaccine application and halted related post‑marketing study activities after learning the FDA placed a clinical hold following a newly reported...
Beam wins biomarker path: FDA allows MRD‑style route for BEAM‑302
Beam Therapeutics said it agreed with FDA reviewers that validated biomarkers assessed over a year could support an accelerated approval pathway for BEAM‑302, its in vivo base‑editing candidate...
Merck, Guardant pair up — Companion diagnostics tied to global trials
Merck and Guardant Health announced a multi‑year collaboration to develop and commercialize companion diagnostics using Guardant’s liquid and tissue biopsy assays to help enroll patients in...
Appropriations bill would ease Medicare coverage for FDA‑approved MCED tests
Congressional negotiators included a provision in the current appropriations package that would create a streamlined pathway for Medicare coverage of FDA‑approved multi‑cancer early detection...
Insilico splits NLRP3 rights — China deals and licensing cash
AI‑driven drug developer Insilico Medicine struck commercial agreements splitting rights to its preclinical, brain‑penetrant NLRP3 inhibitor, generating upfront payments and structured milestones...
GSK to buy Rapt for $2.2B — adds long‑acting anti‑IgE
GSK agreed to acquire Rapt Therapeutics for $2.2 billion to obtain ozureprubart, a long‑acting anti‑IgE monoclonal antibody currently in a Phase IIb prophylactic trial for food allergy. The...
Corvus’ atopic dermatitis pill... shares surge on phase I readout
Corvus Pharmaceuticals reported early clinical data showing robust activity for oral ITK inhibitor soquelitinib in atopic dermatitis, prompting a sharp market rally. The company said the latest...
Merck‑Moderna cancer vaccine sustains 49% risk cut at five years
Long‑term follow‑up shows Merck and Moderna’s personalized cancer vaccine continued to reduce the risk of recurrence or death by 49% at five years when added to Keytruda in melanoma patients, the...
Erasca upsized offering at $10 — raises $225M for RAS/MAPK programs
Erasca priced an upsized public offering of 22,500,000 shares at $10.00 per share, expected to generate about $225 million in gross proceeds to fund its clinical‑stage RAS/MAPK oncology programs....
CMS backs Illumina's TruSight test — $2,989.55 reimbursement set
The U.S. Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989.55 per test, effective Jan. 1, 2026, under PLA code 0543U....
Congress drafts Medicare pathway for MCED tests — coverage starts 2029
A provision in the current appropriations bill would create a Medicare coverage pathway for FDA‑approved multi‑cancer early detection (MCED) tests, with reimbursement modeled on the multi‑target...
Biomakers raises $8M — AI oncology platform to scale into Latin America
Biomakers raised $8 million from strategic and venture investors, including Labcorp Venture Fund and Oncology Ventures, to scale its AI‑enabled precision oncology platform and expand molecular...