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  • Biotech & Pharma Updates | December 9 - 10, 2024

Biotech & Pharma Updates | December 9 - 10, 2024

uniQure stock skyrockets on clear(er) path to accelerated approval, BioNTech's breast cancer bispecific dreams of dethroning Keytruda, Tasca Therapeutics launches with $52M to discover novel lipid-bound protein pockets, GSK and Relation partner on fibrotic disease and osteoarthritis drug discovery + 33 more stories

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

uniQure’s FDA alignment on route to AMT-130 accelerated approval launches stock +100%
Gene therapy, Huntington’s disease - Read more

CellTrion’s Omlyclo (targeting IgE; omalizumab biosimilar, Novartis & Genentech) lands Health Canada approval
Monoclonal antibody, chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps - Read more

Chimerix’s stock explodes +220% on FDA filing of dordaviprone (targeting DR5, Akt/ERK, Foxo3a) in glioma
Small molecule, glioma, brain cancer - Read more

Santhera Pharmaceuticals’ DMD therapy Agamree (targeting glucocorticoid and mineralocorticoid receptors) recommended by UK’s NICE
Small molecule, Duchenne muscular dystrophy - Read more

THE GOOD
Clinical Trials

BioNTech touts Ph1b/2 data for BNT327 (targeting PD-(L)1, VEGF) bispecific in breast cancer, continuing their offensive on Merck & Co.’s “King Keytruda”
Bispecific antibody, breast cancer - Read more

Johnson & Johnson, Legend Biotech strengthen case for Carvykti in multiple myeloma with new Ph3 data
Cell therapy, multiple myeloma, cancer, autologous T-cell - Read more

Eli Lilly touts Ph3 results for Jaypirca (BTK inhibitor) in lymphocytic leukemia and small lymphocytic lymphoma
Small molecule, leukemia, lymphoma, cancer - Read more

TNF Pharmaceuticals touts “statistically significant” Ph2a data for MYMD-1 (pro-inflammatory cytokine modulator) in sarcopenia
Small molecule, sarcopenia - Read more

Olema Oncology unveils interim Ph1b/2 data for palazestrant (selective oestrogen receptor degrader) + Novartis’ Kisqali (CDK4/6 blocker) in breast cancer
Small molecule, breast cancer - Read more

NewAmsterdam Pharma touts “unexpected” heart protection results from Ph3 obicetrapib (CETP inhibitor) in cardiovascular disease
Small molecule, heterozygous familial hypercholesterolemia, atherosclerotic cardiovascular disease - Read more

Halia Therapeutics positive topline Ph2 data for HT-6184 (targeting NEK7) in myelodysplastic syndromes
Small molecule, myelodysplastic syndromes - Read more

Cardiff Oncology touts positive initial Ph2 data for onvansertib (PLK1 inhibitor) in metastatic colorectal cancer
Small molecule, colorectal cancer - Read more

BeiGene touts 5-year follow-up data for Brukinsa (Bruton tyrosine kinase inhibitor) in chronic lymphocytic leukemia and small lymphocytic lymphoma
Small molecule, lymphocytic leukemia, lymphocytic lymphoma - Read more [Paywall]

BeiGene showcases Ph1 preliminary efficacy and safety data for BGB-16673 (Bruton tyrosine kinase degrader) in chronic lymphocytic leukemia and small lymphocytic lymphoma
Small molecule, lymphocytic leukemia, lymphocytic lymphoma - Read more

Arvinas, Pfizer tout initial Ph1 data for vepdegestrant (PROTAC protein degrader) in combo with abemaciclib (targeting CDK4, CDK6) in breast cancer
Small molecule, breast cancer - Read more

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⬇️ More Good News ⬇️

THE GOOD
Company Launches

Tasca Therapeutics launches with $52M from Regeneron, novel medicines targeting protein pockets on proteins that undergo auto-palmitoylation
Small molecule, cancer - Read more

THE GOOD
Earnings & Finances

Eli Lilly to deploy part of its ocean of cash for a $15B stock buyback
Stock buyback - Read more 

THE GOOD
Fundraises

Eikonzio Therapeutics equity investment from Novo Nordisk
Small molecule, cardiorenal disease, neurodegenerative disease - Read more

AQEMIA $38M equity raise, gen AI for drug discovery
Drug discovery, generative AI - Read more

Orthogon Therapeutics $5.2M financing, BK virus reactivation management in transplant patients
Small molecule, BK virus (polyomavirus) reactivation, antiviral - Read more

Biomemory $18M Series A, DNA-based storage device
DNA-based data storage - Read more

Qnovia $16M Series B, proprietary inhalation device
Drug delivery, medical device, nebulizer, asthma, chronic obstructive pulmonary disease - Read more

DeepLife $10M Series A, AI-powered drug simulation on “digital twins” of cells
Drug simulation, digital twin, AI, indication discovery - Read more [Paywall]

Cardiff Oncology $40M direct offering, small molecules for solid tumors
Small molecule, colorectal cancer, pancreatic ductal adenocarcinoma, lung cancer, breast cancer - Read more

THE GOOD
Investments

BioMarin expands Irish manufacturing site with €60M ($63M) investment
Manufacturing, site expansion - Read more

THE GOOD
Partnerships

GSK, Relation “computation and experimentation”-driven drug discovery partnership focused on fibrotic diseases and osteoarthritis
Drug discovery, computational, fibrotic disease, osteoarthritis - Read more

Cimeio Therapeutics, Kyowa Kirin cell therapy drug discovery and development partnership
Cell therapy, drug discovery, drug development, cancer, autoimmune - Read more

Nona Biosciences, Kodiak Sciences partner on next-gen antibodies for ophthalmic diseases
Antibody, drug discovery, ophthalmic disease - Read more

Orion Corporation, Evariste AI and mathematics-powered small molecule preclinical research agreement
Small molecule, drug discovery, drug design, AI, cancer - Read more

Ahn-Gook Pharmaceutical, APITBIO joint research collab to to develop innovative antibody-based drugs
Antibody, drug development - Read more [Press Release in Korean]

THE GOOD
Research

GLP-1 usage my have unintended blood clot risk-reducing benefit
GLP-1, obesity, diabetes, venous thromboembolism - Read more

Capsida Biotherapeutics’ CAP-002 gene therapy delivers positive data in severe form of epilepsy; mice studies
Gene therapy, epilepsy, developmental and epileptic encephalopathy, AAV - Read more

Incyte uses open-source machine learning algorithm to optimize clinical trial dosing of INCB057643 (BET inhibitor)
Small molecule, myelofibrosis, AI, drug dosing - Read more

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⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

Cervomed’s neflamapimod (targeting p38 MAPK) flops in Ph2b, stock craters
Small molecule, Lewy body dementia - Read more

Recursion’s REC-617 (CDK7 inhibitor) Ph1 data isn’t “encouraging” enough to investors as stock slips 10%
Small molecule, ovarian cancer - Read more

Lava Therapeutics’ LAVA-1207 (targeting Vδ2, PSMA) Ph1 performance doesn’t meet “internal benchmarks”, discontinued
Bispecific antibody, prostate cancer - Read more

Ahead of pediatric RSV vaccine adcom, FDA releases data that provides context for Moderna’s decision to discontinue their pediatric RSV vaccine ambitions
mRNA vaccine, respiratory syncytial virus - Read more

⬇️ The Ugly News ⬇️

THE UGLY
No Ugly Stories today!

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

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