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applied-therapeutics-ceo-steps-down-in-wake-of-fda-rejection,-warning-letter-and-investor-lawsuit
Posted inBiotechnology

Applied Therapeutics CEO steps down in wake of FDA rejection, warning letter and investor lawsuit

December 20, 2024
A turbulent month at Applied Therapeutics is being capped off with the departure of CEO and chair Shoshana Shendelman, Ph.D.,…
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sanofi-scoops-up-china-rights-to-cytokinetics’-heart-disease-med-ahead-of-approval-decision
Posted inBiotechnology

Sanofi scoops up China rights to Cytokinetics’ heart disease med ahead of approval decision

December 20, 2024
As Cytokinetics’ aficamten awaits approval decisions from regulators in the U.S. and China, Sanofi has picked up China rights to…
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apollomics,-after-giving-up-on-glycomimetics’-leukemia-therapy,-posts-drug’s-latest-phase-3-fail
Posted inBiotechnology

Apollomics, after giving up on GlycoMimetics’ leukemia therapy, posts drug’s latest phase 3 fail

December 20, 2024
The failure of a myeloid leukemia drug in a phase 3 trial in China isn’t a shock to Apollomics, which…
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novo-nordisk-stock-crashes-after-cagrisema-misses-phase-3-weight-loss-goal
Posted inBiotechnology

Novo Nordisk stock crashes after CagriSema misses phase 3 weight-loss goal

December 20, 2024
A phase 3 trial of Novo Nordisk’s next-generation obesity prospect CagriSema has failed to achieve the level of weight loss…
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idorsia’s-sale-of-tryvio-falls-behind-schedule,-but-layoffs-remain-on-track
Posted inBiotechnology

Idorsia’s sale of Tryvio falls behind schedule, but layoffs remain on track

December 20, 2024
Idorsia’s plans to sell its hypertension drug Tryvio have faced a speedbump, even as the biotech ploughs ahead with around…
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aadi-pulls-commercial-to-preclinical-pivot,-buying-adcs-and-selling-approved-drug-to-reboot-business
Posted inBiotechnology

Aadi pulls commercial-to-preclinical pivot, buying ADCs and selling approved drug to reboot business

December 20, 2024
Aadi Bioscience has rebooted its operations, transforming from a commercial business into a preclinical biotech by offloading its approved product and…
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fda-rejects-zealand-pharma’s-glp-2-analog-in-rare-bowel-disease
Posted inBiotechnology

FDA rejects Zealand Pharma’s GLP-2 analog in rare bowel disease

December 19, 2024
The FDA has denied Zealand Pharma’s approval bid for glepaglutide—a possible challenger to Takeda’s Gattex—in short bowel syndrome (SBS), citing…
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pyxis-oncology-shelves-antibody-to-focus-on-sole-clinical-asset,-an-adc-licensed-from-pfizer
Posted inBiotechnology

Pyxis Oncology shelves antibody to focus on sole clinical asset, an ADC licensed from Pfizer

December 19, 2024
Pyxis Oncology is shelving a clinical-stage monoclonal antibody to focus on its lead antibody-drug conjugate (ADC) after sharing preliminary results…
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oncology-biotech-epitopea-licenses-genevant-nucleic-acid-delivery-tech-for-up-to-$123m
Posted inBiotechnology

Oncology biotech Epitopea licenses Genevant nucleic acid delivery tech for up to $123M

December 19, 2024
To develop RNA medicines targeting a proprietary bundle of tumor antigens, Epitopea is tapping nucleic acid delivery specialist Genevant Sciences…
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chutes-&-ladders—fda’s-principal-deputy-to-depart-agency
Posted inBiotechnology

Chutes & Ladders—FDA’s principal deputy to depart agency

December 19, 2024
Welcome to this week's Chutes & Ladders, our roundup of significant leadership hirings, firings and retirings across the industry. Please…
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