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Nektar’s rezpeg... Mid‑stage win sparks comeback and $460M raise
Nektar Therapeutics released positive maintenance data from the 52‑week Phase IIb REZOLVE‑AD study of rezpegaldesleukin (rezpeg) in moderate‑to‑severe atopic dermatitis. The drug hit high rates of...
FDA rejects Disc’s bitopertin—voucher program faces first failure
The FDA issued a Complete Response Letter for Disc Medicine’s bitopertin in erythropoietic protoporphyria (EPP), questioning whether the surrogate biomarker (PPIX reduction) reasonably predicts...
Lex Diagnostics gets FDA greenlight for Velo PCR: 510(k) and CLIA waiver
Lex Diagnostics secured 510(k) clearance and a CLIA waiver for its Velo point‑of‑care molecular diagnostic system and a multiplex respiratory cartridge for influenza A/B and SARS‑CoV‑2. The system...
Zelluna hires Medpace to run Phase I of off‑the‑shelf TCR‑NK therapy
Norwegian cell‑therapy developer Zelluna selected Medpace as CRO for its first‑in‑human Phase I trial of ZI‑MA4‑1 (ZIMA‑101), an allogeneic TCR‑NK product targeting MAGE‑A4 across solid tumors....
ArgenTag and PacBio partner to enable long‑read single‑cell isoform sequencing
ArgenTag announced a co‑marketing and compatibility agreement with Pacific Biosciences, confirming ArgenTag’s single‑cell long‑read RNA library kit works with PacBio’s Kinnex RNA kits and HiFi...
Systematic molecular‑glue discovery... New high‑throughput ligand diversification method
Two complementary reports described scalable approaches to discover molecular glues—small molecules that induce proximity between a target protein and ubiquitin ligases to trigger degradation. One...
Compass nails second Phase 3: psilocybin meets endpoint in treatment‑resistant depression
Compass Pathways reported a second positive pivotal trial for its synthetic psilocybin candidate COMP‑360 and is advancing toward regulatory filing. The company said both Phase 3 studies met their...
Ocular’s Axpaxli shows superiority at week 36 – trial beats low‑dose Eylea
Ocular Therapeutix reported that its intravitreal hydrogel Axpaxli (OTX‑TKI) met the superiority primary endpoint versus a low‑dose aflibercept (Eylea) in the Sol‑1 Phase 3 trial for wet...
Federal judge narrows Moderna’s defenses in long mRNA patent fight with Arbutus
A federal judge rejected portions of Moderna’s defenses in its protracted patent dispute with Arbutus, advancing Arbutus’s claims in litigation tied to mRNA technology. Court rulings limited...
Velo cleared in US; Ella platform wins EU mark — point‑of‑care and benchtop diagnostics advance
Two regulatory moves broaden the toolkit for decentralized testing and translational research. Lex Diagnostics secured FDA 510(k) clearance and a CLIA waiver for its Velo point‑of‑care molecular...
FDA rejects Disc Medicine’s bitopertin: agency questions surrogate endpoint
The FDA declined approval for Disc Medicine’s bitopertin for erythropoietic protoporphyria (EPP), marking a setback for a drug that had previously been selected for an accelerated regulatory...
NIAID told to drop 'pandemic preparedness' language — institute refocuses mission
Staff at the National Institute of Allergy and Infectious Diseases were directed to remove references to 'biodefense' and 'pandemic preparedness' from web pages as NIAID undergoes a strategic...
Zelluna hires Medpace to run Phase I of off‑the‑shelf TCR‑NK solid tumor program
Zelluna selected CRO Medpace to manage its first‑in‑human Phase I trial of ZI‑MA4‑1 (ZIMA‑101), an off‑the‑shelf TCR‑NK cell therapy targeting MAGE‑A4 in advanced solid tumors. The scope covers...
Gilead buys Genhouse MAT2A asset: $80M upfront, billion‑dollar milestones for synthetic‑lethal cancer drug
Gilead paid $80 million upfront to acquire global rights to Genhouse Bio’s MAT2A‑targeting synthetic‑lethal oncology candidate GH31, with up to $1.45 billion in milestones and tiered double‑digit...
Fujifilm opens UK mega‑CDMO: single‑use capacity and innovation hub go live
Fujifilm Biotechnologies inaugurated its expanded Teesside site—the UK’s largest single‑use CDMO—bringing new 2,000 L and 5,000 L single‑use bioreactor capacity and a combined 19,000 L total to...
Public cash backs early biotech: Germany funds DNAzyme platform, Sweden’s CubaseBio raises €5.9M
European public and venture funding flowed to two early biotech platforms this week. German research teams won €3.2 million from the federal Go‑Bio Next program to develop a DNAzyme cancer therapy...
FDA says no to Disc’s bitopertin: voucher program faces its first major test
The FDA has declined to approve Disc Medicine’s bitopertin for erythropoietic protoporphyria (EPP), issuing a complete response that questioned whether the drug’s surrogate biomarker reliably...
Compass posts second pivotal win – psilocybin approval push intensifies
Compass Pathways reported a second successful Phase 3 study for its COMP360 psilocybin formulation in treatment‑resistant depression, prompting management to pursue regulatory filings. The company...
Axpaxli edges out low‑dose Eylea – wet‑AMD durability data draw close scrutiny
Ocular Therapeutix reported Phase 3 results showing its Axpaxli formulation maintained vision longer than a low‑dose regimen of Regeneron’s Eylea, meeting the trial’s primary durability and...
FDA clears Lex’s Velo POC PCR and grants CLIA waiver – multiplex respiratory test cleared
Lex Diagnostics received 510(k) clearance and a CLIA waiver for its Velo point‑of‑care molecular system and an influenza A/B plus COVID‑19 assay. The cartridge‑based system delivers multiplex...