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New IPO wave—record public funding for biotech pipelines
Parabilis Medicines surged to a blockbuster Nasdaq debut, raising about $670 million as the company drives its tumor-focused pipeline forward. The listing follows another record set by obesity...
Funding surge for ultrasound-mediated gene delivery
SonoThera raised an oversubscribed $125 million in a Series B to advance ultrasound-mediated genetic medicines into clinical development. The financing was led by Vida Ventures and includes...
First-in-human partial cell reprogramming enters glaucoma trial
Life Biosciences has dosed the first participant in a gene therapy trial testing partial cellular reprogramming for glaucoma. The approach turns on three genes intended to “partially reprogram”...
Late-stage performance in psoriasis—Takeda’s zasocitinib vs Sotyktu
Takeda reported that its oral TYK2 inhibitor zasocitinib (TAK-279) showed statistical superiority over Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a Phase 3 top-line readout for moderate...
CAR T expansion—Oricell advances GPC3-directed liver cancer into registration phase II
Oricell Therapeutics said its GPC3-targeted autologous CAR T, Ori-C101, is entering a confirmatory registration Phase 2 trial for patients with GPC3-positive advanced hepatocellular carcinoma. The...
RNA/protein delivery innovation in Duchenne—non-viral full-length mRNA in vivo
Researchers reported a systemic, non-viral strategy for delivering full-length DMD mRNA using skeletal-muscle-targeted extracellular vesicles (EVs) engineered with targeting tags. In a murine DMD...
Oncology research—engineered oncolytic VSV targets metastatic ovarian cancer
Researchers unveiled ErbB-OSV, an engineered vesicular stomatitis virus (VSV) variant designed to selectively kill metastatic ovarian cancer cells while sparing normal tissue. The study reports a...
Drug development—Cachexia biology points to GDF15 as lead target
Biocentury reported that GDF15 is emerging as the lead target in cancer-associated cachexia development, with Pfizer and CatalYm both advancing programs through Phase II/III studies. GDF15 is a...
Biopharma governance—WuXi AppTec fights Pentagon military designation
WuXi AppTec moved to challenge its inclusion on a U.S. military-linked list, filing a lawsuit that disputes the government’s characterization and argues the designation has already caused “severe...
Regulatory approval – renal cell carcinoma (adjuvant combo)
The FDA has approved an adjuvant combination of pembrolizumab and belzutifan for adults with high-risk clear cell renal cell carcinoma following surgery, according to a Dana-Farber-backed report....
M&A & pipeline – oncology big deal aftermath
GSK has acquired Nuvalent in a $10.6 billion buyout, positioning the company to deepen its oncology pipeline with a targeted strategy. The report frames the transaction around questions that...
Biotech IPO wave – record listings
Parabilis Medicines’ Nasdaq IPO landed at $670 million, extending a record-breaking run of biotech public listings and signaling that investor appetite is returning to the sector’s highest-profile...
Funding – ultrasound-mediated genetic medicine platform
SonoThera raised $125 million in an oversubscribed Series B to advance ultrasound-mediated delivery of genetic medicines into clinical development. The round was led by Vida Ventures with...
Gene therapy – first-in-human partial reprogramming trial
Life Biosciences in Boston has treated the first participant in a gene therapy trial designed to partially reprogram aged cells, a “reverse aging” approach aimed at restoring youthful cellular...
Cancer immunotherapy – engineered oncolytic virus for metastatic ovarian cancer
Researchers have unveiled ErbB-OSV, an engineered vesicular stomatitis virus (VSV) variant designed to selectively target and destroy metastatic ovarian cancer cells while sparing normal tissue....
Regulatory risk – Amgen seeks FDA review over Tavneos approval
Amgen is seeking an independent review to defend Tavneos (avacopan) as the FDA weighs potential withdrawal of the rare disease drug. The dispute is tied to FDA concerns about safety and alleged...
Clinical results – phase III psoriasis readout
Takeda’s zasocitinib (TAK-279) has shown statistical superiority over Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a phase III Latitude Atlas readout for moderate-to-severe plaque...
Deals & regulatory markets – China clears HER2 bispecific in gastric cancer
China’s National Medical Products Administration (NMPA) approved Suzhou Alphamab’s HER2 bispecific antibody anbenitamab (KN-026) through priority review for adults with locally advanced or...
Financing – Conformal peptides for hard-to-modulate targets
Parabilis Medicines closed its IPO at $770.5 million, extending the record pace for biotech capital raising and solidifying its position as a publicly traded conformationally stabilized peptide...
Regulatory approvals and label changes
FDA approval has been granted for an adjuvant pembrolizumab–belzutifan combination in high-risk, post-surgery clear cell kidney cancer, according to a Dana-Farber-backed report. The regimen pairs...