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  • Biotech & Pharma Updates | November 4 - 5, 2024

Biotech & Pharma Updates | November 4 - 5, 2024

Zealand Pharma Ph1 obesity data with less nausea, AstraZeneca plans Ph2b trials for Eccogene licensed obesity hopeful, Vertex beats Q3 analyst expectations, PrognomiQ $34M Series D for early lung cancer detection, Cerebral agrees to $3.7M settlement over unauthorized ADHD/controlled substance prescriptions, Nxera Pharma & Antiverse collab on AI-powered antibody therapeutic design, Merus & Organon both face FDA approval decision delays, Beam Therapeutics first set of sickle cell base editing data includes a patient death (likely due to conditioning regimen), Verrica Pharmaceuticals stock plummets after Q3 results, Sana Biotechnology pivot results in layoffs, AstraZeneca shares take a big hit after speculative reports released on China employee investigations

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Both Merus and Organon are facing delayed FDA approval decisions. | Gif: xponentialdesign on Giphy

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⬇️ The Good News ⬇️

THE GOOD
Business Development

Syndax Pharmaceuticals, Royalty Pharma agree on $350M royalty agreement for Niktimvo for GVHD
Monoclonal antibody, chronic graft-versus-host disease - Read more

THE GOOD
Clinical Trials

Biomed Industries touts positive topline Ph1 data for obesity hopeful NA-931
Small molecule, obesity, weight management - Read more

Atossa Therapeutics’ positive Ph2 data for (Z)-endoxifen in reducing mammographic breast density
Small molecule, breast cancer, premenopausal women with mammographic breast density - Read more

Intra-Cellular Therapies showcases positive Ph3 data for lumateperone in schizophrenia
Small molecule, schizophrenia - Read more

MannKind posts positive Ph1 data for nintedanib DPI in pulmonary fibrotic diseases
Small molecule, idiopathic pulmonary fibrosis - Read more

Sanofi’s Principia Biopharma acquisition inches closer to paying off, as rilzabrutinib Ph3 data showcases raised and sustained platelet levels
Small molecule, immune thrombocytopenia - Read more

Zealand Pharma continues jockeying for obesity supremacy, touts new Ph1 petrelinde data that demonstrates lower nausea instances compared to existing GLP-1s
Peptide, obesity - Read more

Johnson & Johnson multiple myeloma med Darzalex hits primary endpoint in Ph3
Monoclonal antibody, multiple myeloma, cancer - Read more [Paywall]

Novo Nordisk plans Ph3 for Forma Therapeutics acquired sickle cell med etavopivat
Small molecule, sickle cell disease - Read more

Abbott touts additional positive data for dissolving stent in severe peripheral artery disease
Medical device, chronic limb-threatening ischemia, severe peripheral artery disease - Read more

AstraZeneca plans pair of Ph2b trials for Eccogene licensed obesity hopeful AZD5004
GLP-1, obesity - Read more

BioCity Biopharma’s SC0062 delivers Ph2 positive data in pair of chronic kidney diseases
Small molecule, IgA nephropathy, diabetic kidney disease - Read more

Response Pharmaceuticals’ RDX-002 may contribute to reduced antipsychotic drug-induced weight gain, 20 person pilot study
Small molecule, antipsychotic-induced weight gain - Read more

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⬇️ More Good News ⬇️

THE GOOD
Earnings & Finances

Vertex Pharmaceuticals exceeds analyst expectations in Q3 (driven by Trikafta) and reports first commercial Casgevy dose administered
Small molecule, cystic fibrosis, gene therapy, sickle cell disease, thalassemia - Read more

Supernus Pharmaceuticals posts solid YoY improvements in Q3 earnings
Small molecule, CNS disorder - Read more

THE GOOD
Fundraises

Accord Healthcare £50M ($65 million) from UK government, expanding manufacturing sites
Drug manufacturing, small molecule, injectables, public funding - Read more

PrognomiQ $34M Series D, early lung cancer detection test development
Disease detection, lung cancer, blood test, diagnostics - Read more

Inquis Medical $40M Series B, blood clot removal system
Medical device, blood clot removal, venous thromboembolism - Read more

THE GOOD
Lawsuits

Cerebral agrees to $3.7M settlement over encouraging unauthorized prescribing of Adderal and other controlled substances
Small molecule, attention deficit hyperactivity disorder - Read more [Paywall]

THE GOOD
Mergers & Acquisitions

StarFish Medical acquires Omnica, medical device design & engineering
Medical device, product design, product development - Read more

THE GOOD
Partnerships

858 Therapeutics, OpenBench enter machine learning-powered small molecule drug discovery collab
Small molecule, drug discovery, machine learning - Read more

Nxera Pharma, Antiverse collab on antibody therapeutic design for G-protein coupled receptors
Antibody, drug design, drug discovery, AI - Read more

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⬇️ The Bad News ⬇️

THE BAD
Approvals & Labels

Merus’ zenocutuzumab approval decision delayed by FDA, citing requiring “sufficient time” to review CMC information
Bispecific antibody, lung cancer, pancreatic ductal adenocarcinoma - Read more

Organon’s extended approval request for Vtama also faces FDA decision delay, citing ask of final dataset and long-term extension study data
Small molecule, atopic dermatitis - Read more

THE BAD
Clinical Trials

Beam Therapeutics’ first set of sickle cell disease clinical data using its “base editing” technology includes a patient death (likely due to conditioning regimen)
Base editing, sickle cell disease - Read more

Gilead, Arcellx reports three patient deaths as part of Ph2 of anito-cel in multiple myeloma
Cell therapy, multiple myeloma, cancer, CAR-T - Read more 

THE BAD
Earnings & Finances

Catalent misses expected fiscal Q1 revenue target
CDMO, contract manufacturing - Read more

Verrica Pharmaceuticals stock nearly half after Q3 results and leadership changes
Small molecule, dermatological disorders - Read more

THE BAD
Layoffs

Sana Biotechnology announces layoffs and pivots clinical focus to diabetes, lupus
Cell therapy, diabetes, lupus - Read more

THE BAD
Strategic Plans

Cellectis drops one CAR-T (UCART123) clinical asset to focus on the other two in pipeline
Cell therapy, leukemia, lymphoma, cancer, CAR-T - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Criminal Acts

AstraZeneca shares take a beating as alleged details emerge on spate of China-based employee criminal investigations
Insurance fraud - Read more

You’re all caught up on the latest Pharma & Biotech News!

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