Posted inBiotechnology
FDA rejects Zealand Pharma’s GLP-2 analog in rare bowel disease
The FDA has denied Zealand Pharma’s approval bid for glepaglutide—a possible challenger to Takeda’s Gattex—in short bowel syndrome (SBS), citing…
Posted inBiotechnology
Pyxis Oncology shelves antibody to focus on sole clinical asset, an ADC licensed from Pfizer
Pyxis Oncology is shelving a clinical-stage monoclonal antibody to focus on its lead antibody-drug conjugate (ADC) after sharing preliminary results…
Posted inBiotechnology
Oncology biotech Epitopea licenses Genevant nucleic acid delivery tech for up to $123M
To develop RNA medicines targeting a proprietary bundle of tumor antigens, Epitopea is tapping nucleic acid delivery specialist Genevant Sciences…
Posted inBiotechnology
Chutes & Ladders—FDA’s principal deputy to depart agency
Welcome to this week's Chutes & Ladders, our roundup of significant leadership hirings, firings and retirings across the industry. Please…
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Omeros antibody improves overall survival by 68% in rare condition, new analysis finds
Omeros is putting up its monoclonal antibody up for FDA approval—again. This time, the resubmission will be based on a…
Posted inBiotechnology
Merck’s HIV combo treatment meets the bar for viral suppression in pair of phase 3 studies
After hitting the mark in a phase 2 of its investigational islatravir paired with Gilead’s lenacapivir, Merck & Co.'s islatravir…
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VC firm pens $608M biobucks deal to redirect NGM’s MASH drug to rare disease
KdT Ventures has signed off on a $608 million biobucks deal for NGM Biopharmaceuticals’ phase 2-ready metabolic-dysfunction associated steatohepatitis (MASH)…
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Regeneron anticoagulant bests enoxaparin, matches Eliquis in phase 2 trial
A pair of Regeneron’s monoclonal antibodies have held their own against a commonly used anticoagulant in a phase 2 trial,…
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Vertex’s pain trial hits endpoint but sinks stock as placebo comparison spooks investors
Vertex has reported a phase 2 win that still dented confidence in its pain prospect suzetrigine. The trial linked the near-approval…
Posted inBiotechnology
Former Seagen CEO’s biotech raises $140M series A to ready PD1/VEGFR2 antibody for clinic
Two months after former Seagen CEO David Epstein unveiled his new project, the biotech has secured "over" $140 million in…