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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...
Phase 3 progress risk/reward in breast cancer PI3K/mTOR
Celcuity’s gedatolisib cleared a major trial milestone in Phase 3 breast cancer testing by hitting its primary endpoint, lifting the company toward a regulatory filing for a second submission. The...
Replimune’s oncolytic therapy faces FDA rejection after breakthrough designation
The FDA rejected Replimune’s oncolytic immunotherapy RP1 twice despite the program’s breakthrough therapy designation, according to reporting. The therapy is a modified herpesvirus injected...
Gene therapy startup financing to start Huntington’s and CLN2 programs
Latus Bio raised $42 million to fund its first clinical trials, aiming to work around setbacks that have hit a more advanced competitor in the gene therapy space. The startup is moving two...
Regulatory-era impact on oncology stock after reported death in trial
Erasca’s shares slid 53% after the company disclosed a patient death during ERAS-0015 development, according to StockWatch reporting. The oral pan-RAS molecular glue reported unconfirmed overall...
Clinical dataset expands evidence for selective RET inhibitor in JCO
Rigel Pharmaceuticals published final long-term results from the Phase 1/2 ARROW study of pralsetinib (GAVRETO) in Journal of Clinical Oncology, extending follow-up by an additional 42 months. The...
Protein-enrichment platform gains Wall Street focus amid throughput push
Canaccord Genuity initiated coverage of Seer with a Buy rating and a $4 price target, citing rising adoption of the firm’s proteomics technology and ongoing product improvements. Analyst Kyle...
AI-driven synbio approach trims the amino-acid toolkit in engineered E. coli
Researchers published in Science that used AI-guided design to partially eliminate isoleucine usage in engineered Escherichia coli ribosome proteins by substituting alternatives across dozens of...
Digital twins of human lungs quantify therapeutic efficacy from EVLP data
Researchers developed computational “digital twins” of ex vivo human lungs using a large clinical ex vivo lung perfusion (EVLP) dataset, and reported that the models can assess therapeutic...