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Corporate survival and turnaround risk after clinical setbacks
IO Biotech moved to bankruptcy after the company failed to secure an FDA path for its cancer vaccine following a pivotal phase 3 outcome. In an SEC filing, the Danish developer said it intends to...
Pipeline financing keeps oral obesity competition in motion
Ambrosia Biosciences landed $100 million in oversubscribed Series B financing to advance an oral small-molecule GLP-1 program it says is designed to compete with Novo Nordisk’s Wegovy. The company...
New oncology early-detection data lifts investor expectations
Caris Life Sciences shared finalized Achieve I results for its multi-cancer early detection test Caris Detect, driving a sharp stock reaction. The study enrolled 3,014 evaluable patients and...
Cancer immunotherapy targets the tumor microenvironment for broader reach
Memorial Sloan Kettering researchers described a new CAR T strategy aimed at uPAR-positive tumor ecosystems, seeking to expand solid-tumor targeting beyond single tumor-cell antigens. In...
Regulator timeline stretches as manufacturing data pile grows
The FDA delayed its decision on Orca Bio’s T cell therapy after the company filed additional manufacturing data, extending the agency’s review timeline by three months. The new decision deadline...
Regulatory tooling for gene- and antibody-based discovery scales in Europe
Geneus Technologies announced that its G-seq500 single-molecule nanopore sequencer and sequencing chip, G-MK02, obtained CE marking under the EU’s IVDR framework. The certification is framed by...
Reverse merger brings Alzheimer’s antibody program to public markets
Korsana Biosciences is set to go public through a reverse merger with Paragon Therapeutics’ offshoot Korsana, aiming to bring an Alzheimer’s antibody asset into the next stage with additional...
Emerging therapy access model aims to bring gene-modified HSC manufacturing to the point of care
A new collaboration seeks to develop a place-of-care manufacturing platform for autologous gene-modified hematopoietic stem cells, combining automation technology with academic and access-focused...
Big pharma M&A: Biogen expands immunology with Apellis
Biogen agreed to acquire Apellis Pharmaceuticals in a deal valued at about $5.6 billion, securing two already-commercialized immunology franchises. The acquisition includes kidney drug Empaveli...
Big pharma M&A: Lilly bets on orexin biology with Centessa
Eli Lilly agreed to acquire Centessa Pharmaceuticals for about $6.3 billion upfront, aiming to expand its neuroscience pipeline with orexin receptor 2 (OX2R) agonists. The deal follows positive...
Big pharma to AI discovery: Lilly extends Insilico Medicine pact
Eli Lilly is expanding its collaboration with Insilico Medicine, extending the company’s AI-driven drug discovery strategy into additional therapeutic areas. The multibillion-dollar expansion...
Regulation: FDA delay on Orca Bio cell therapy decision
The FDA postponed its decision on Orca Bio’s T cell therapy by three months, extending the agency’s deadline to July 6. The delay follows the filing of additional manufacturing data, pushing the...
Cell therapy at scale: ICON and Advarra link for AI-driven site operations
ICON partnered with IRB and clinical trial management technology provider Advarra to build an integrated, AI-driven site network aimed at reducing clinical trial startup delays. The agreement...
Clinical stage oncology: Oric advances PRC2 inhibitor into Phase 3 in prostate cancer
Oric Pharmaceuticals moved its prostate cancer program toward late-stage testing, planning a registrational Phase 3 program for an investigational PRC2 inhibitor after reporting results from a...
Market and funding: GenomeWeb Top 40 tracks -7% decline
The GenomeWeb Top 40 index fell about 7% in March, tracking broader weakness across omics, diagnostics, and clinical laboratory stocks. The Nasdaq Biotech Index declined roughly 3%, while most of...
Cell therapy and trials: IPF trial endpoints lift United’s Tyvaso program
United Therapeutics said its second Phase 3 idiopathic pulmonary fibrosis trial for Tyvaso (treprostinil) met endpoints, strengthening the case for regulatory momentum and a potential priority...
Diagnostics: Baebies gets FDA 510(k) and CLIA waiver for triplex respiratory test
Baebies announced FDA 510(k) clearance and a CLIA waiver for a triplex respiratory molecular test on its Finder point-of-care platform. The assay distinguishes influenza A, influenza B, and...
Biotech insolvency and regulatory outcomes: IO Biotech shuts down after FDA refusal
IO Biotech filed for bankruptcy and ceased operations after what it described as an FDA refusal that derailed its cancer vaccine Cylembio. The Danish biotech’s wind-down follows a Phase 3 miss in...
Dealmaking: big pharma moves into new neuroscience and immunology growth engines
Eli Lilly agreed to acquire Centessa Pharmaceuticals for up to $7.8 billion, paying $38 per share plus contingent value rights tied to clinical approvals, to expand its neuroscience pipeline....
FDA scrutiny of drugs after adverse events: Tavneos safety signal expands
The FDA identified eight deaths tied to Amgen’s Tavneos (avacopan) and flagged more than 70 cases of severe liver injury associated with the autoimmune therapy. The agency’s update heightens...