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Phase 3 efficacy signals in oncology pipelines
Celcuity reported phase 3 results for gedatolisib, a pan-PI3K/mTOR inhibitor, in HER-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, saying the trial cleared its primary...
Oncolytics advances accelerated-approval path for oncolytic virus regimen
Oncolytics Biotech updated efficacy from the phase 1 REO 022 study of pelareorep (Reolysin) combined with bevacizumab and FOLFIRI in second-line KRAS-mutant, microsatellite-stable metastatic...
Windward Bio scales long-acting respiratory program with late-stage push
Windward Bio raised $165 million in a financing designed to carry its long-acting anti-TSLP antibody into phase 3 testing for asthma. The company’s approach targets twice-yearly dosing as a...
Gene therapy startup funding and trial initiation
Latus Bio closed a $97 million series A to advance an AAV capsid-variant platform with two lead programs: LTS-201 for Huntington’s disease and LTS-101 for late-infantile neuronal ceroid...
Applied diagnostics automation expands FDA-cleared testing workflows
Applied BioCode received expanded FDA 510(k) clearance for its multiplex respiratory pathogen panel, adding an automated extraction workflow using Thermo Fisher Scientific’s KingFisher Flex...
Regulatory and market development in contract services for life sciences
Veristat agreed to buy Certara’s regulatory and medical writing business for up to $135 million, aiming to broaden services for pharma and biotech clients. Veristat said the deal will add more...
Biotech investment in new therapeutic modalities for rare disease
In a move aimed at accelerating clinical translation, Windward Bio and other investors continue to back modality-led startups—while Latus Bio’s series A supports gene therapy candidates selected...
Novel biomarkers for oncology risk stratification
Caris Life Sciences said its ultra-deep whole-genome sequencing assay, ChromoSeq, has secured MolDx coverage for myeloid malignancies. The company positioned the test for sensitive detection of...
Regulatory: mifepristone mail access restored
The US Supreme Court restored patients’ ability to order mifepristone by mail, reversing a federal appeals court stay on Monday. The decision came after mifepristone manufacturers sought immediate...
Clinical: neonatal sepsis protocol focus on faster antibiotics
A study in the Journal of Perinatology highlights that tightening neonatal intensive care unit workflows to deliver antibiotics quickly can materially improve outcomes for infants with neonatal...
Oncology late-stage/filings momentum: Celcuity’s gedatolisib Phase 3 win
Celcuity reported that two regimens using its experimental pan–PI3K/mTOR inhibitor gedatolisib met success criteria in PIK3CA-mutant patients in a Phase 3 breast cancer trial, setting up a second...
Biotech financing: Latus Bio adds $97M Series A for AAV Huntington’s and CLN2
Latus Bio closed a $97 million Series A to advance a broad therapeutics pipeline based on novel AAV capsid variants, funding operations through milestone-driven clinical work. The company expects...
M&A: UCB to acquire Candid in $2B-plus autoimmune deal
UCB agreed to acquire Candid Therapeutics for $2 billion upfront, betting on Candid’s bispecific antibody portfolio for autoimmune diseases. The buyout includes antibody assets Candid licensed...
Clinical development: Mirum advances volixibat toward FDA filing after Phase 2 itch success
Mirum Pharmaceuticals said it mapped out an FDA path after volixibat produced a Phase 2 win by significantly reducing severe itching in patients with a rare liver disease. The report characterizes...
Clinical-stage respiratory betting: Windward Bio lands $165M for Phase 3 long-acting anti-TSLP
Windward Bio raised $165 million to push its long-acting anti-TSLP antibody into Phase 3, aiming to establish a twice-yearly dosing profile in asthma. The financing is framed as a “crossover”...
Preclinical oncology: Henlius engineered desialylation therapy targets B7-H3
Shanghai Henlius Biotech disclosed preclinical findings for E-688 (HLX-316), an engineered human sialidase enzyme fused to an anti–B7-H3 nanobody. The approach is designed to improve tumor...
Gene therapy/rare disease pipeline expansion: Dravet one-time AAV AntagoNAT preclinical efficacy
AAV9-delivered AntagoNATs showed preclinical efficacy as a one-time treatment concept for Dravet syndrome, according to a report describing results in the context of SCN1A-driven disease. The...
IPO/Capital markets: Four biotech IPOs raise $1.5B in April
Biotech IPO momentum returned in April as four newly public companies raised a combined $1.5 billion, the biggest month in five years, according to IPO research firm Renaissance Capital. The...
Late-stage move for asthma candidate backed by China-derived IP
Windward Bio has raised $165 million to advance a China-derived drug into a Phase 3 asthma trial, according to the company’s latest funding update. The Swiss biotech, which couples an external...
UCB expands autoimmune pipeline with Candid acquisition
UCB agreed to acquire Candid Therapeutics for $2 billion upfront, positioning the deal as part of a broader push into next-generation autoimmune treatments. The transaction centers on Candid’s...