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Heads up - there will be no TLDR Biotech on Monday, February 17th due to a statutory holiday up here in Canada - next edition out on Tuesday, February 18th!

THE GOOD
Approvals & Labels

Lindis Biotech and Pharmanovia's catumaxomab (targeting EpCAM, CD3) nabs EC approval for malignant ascites
Monoclonal antibody, malignant ascites - Read more

Telix Pharmaceuticals' Illuccix (targeting PSMA) lands MHRA (UK) approval for detection and localization of prostate cancer using PET scanning
Radiopharm, prostate cancer, imaging agent, PET scan - Read more

Astellas' Izervay (targeting C5) receives FDA approval for extended monthly dosing in geographic atrophy secondary to age-related macular degeneration
RNA aptamer, age-related macular degeneration (AMD), geographic atrophy (GA) - Read more

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THE GOOD
Business Development

DAAN Biotherapeutics in-licenses novel tumor-targeting antibody from LigaChem Biosciences as part of ADC development and commercialization plans
Antibody-drug conjugate, cancer - Read more

Tivic Health acquires worldwide rights to Entolimod (targeting TLR5) from Statera Biopharma
Recombinant protein, acute radiation syndrome - Read more

THE GOOD
Clinical Trials

Agios Pharmaceuticals touts positive Ph3 data for Pyrukynd (PK inhibitor) in pediatric populations
Small molecule, hemolytic anemia, thalassemia, sickle cell disease - Read more

Kelun-Biotech showcases promising Ph1/2 data for sacituzumab tirumotecan (targeting Trop-2) in advanced urothelial carcinoma
Antibody-drug conjugate, urothelial cancer - Read more

Pfizer touts positive Ph3 data for Talzenna (PARP inhibitor) plus Xtandi (androgen receptor antagonist) metastatic castration-resistant prostate cancer
Small molecule, prostate cancer, drug combo - Read more

THE GOOD
Company Launches

Newleos Therapeutics launches with $94M in funding, in-licensing four neuropsychiatry drug hopefuls from Roche
Small molecule, generalized anxiety disorder, substance use disorder, cognitive impairment - Read more

Biotech startup Latent Labs raises €47.9M ($50.3M) to develop AI models for programmable biology
Platform technology, programmable biology, drug design, generative biology, AI - Read more

THE GOOD
Earnings & Finances

Blueprint Medicines reports strong 2024 Ayvakit (targeting KIT D816V) sales of $479M, projects $2B annual revenue by 2030 and $4B peak opportunity
Small molecule, cancer, rare disease - Read more

THE GOOD
Fundraises

Allay Therapeutics $45M Series D, developing non-opioid pain meds
Small molecule, pain, non-opioid - Read more

atai Life Sciences raises $55M in public offering, funding clinical ambitions of neuropsychiatric asset pipeline
Small molecule, treatment resistant depression, social anxiety disorder, opioid use disorder, psychedelics - Read more

PulseSight Therapeutics Series A (amount not disclosed)), developing non-viral “vectorized” therapy for dry AMD and GA
Non-viral vectorized therapy, dry age-related macular degeneration (AMD), geographic atrophy (GA) - Read more

Justpoint $95M funding round, uses AI to identify harmful drugs for potential lawsuits
Harmful drugs, product-liability lawsuits - Read more

THE GOOD
Investments

Axplora investing €50M to expand French facility's peptide purification capabilities, supporting GLP-1 drug development for diabetes and obesity
CDMO, API, antibody-drug conjugate, facility expansion - Read more

THE GOOD
Partnerships

IDEAYA Biosciences, Gilead Sciences clinical development partners to evaluate IDE397 (MAT2A inhibitor) + Trodelvy (targeting Trop-2) combo treatment for MTAP-deletion NSCLC cancer patients
Small molecule, lung cancer, antibody-drug conjugate, clinical development, drug combo - Read more

Conduit Pharmaceuticals, Charles River Laboratories partner to evaluate lupus treatment hopeful AZD1656 (glucokinase activator) and derivatives in preclinical studies
Small molecule, systemic lupus erythematosus, lupus nephritis, drug development - Read more

THE GOOD
Research

University of Washington researchers develop AI model to create custom enzymes, advancing their work in molecular design following Nobel Prize success
AI, enzyme design - Read more

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THE BAD
Business Development

Idorsia is back to square one with selling Tryvio global rights as negotiations with an “undisclosed party” fall through
Small molecule, hypertension - Read more

THE BAD
Clinical Trials

Sanofi and J&J terminate Ph3 trial of E. coli vaccine due to insufficient efficacy
Vaccine, E. Coli - Read more

THE BAD
Earnings & Finances

Bristol Myers Squibb takes $1.4B impairment charge on cancer drug Augtyro (targeting ROS1, NTRK) due to lower revenue projections in commercial markets
Small molecule, lung cancer - Read more

ROVI warns that analyst 2024 profit estimates are 10-15% too high due to expected slowdown in contract manufacturing business
CDMO, forecasting - Read more

THE BAD
IPOs

Aardvark Therapeutics' IPO raised $94.2M at $16 per share, below expectations, with shares dropping 10% on first trading day
Small molecule, obesity, cardiometabolic diseases - Read more

THE BAD
Layoffs

Encoded Therapeutics cuts 29% of workforce to focus resources on Dravet syndrom gene therapy hopeful ETX101
Gene therapy, Dravet syndrome, AAV - Read more

Moderna cuts 50 digital team jobs, about 10% of digital workforce, amid cost efficiency efforts and departmental restructuring
Drug marketing, digital marketing - Read more

THE BAD
Partnerships

Amgen, Ideaya Biosciences end clinical collab in testing AMG 193 (PRMT5 inhibitor) + IDE397 (MAT2A inhibitor) as potential cancer treatment
Small molecule, cancer, solid tumor, combo therapy, clinical development - Read more

THE BAD
Politics & Policy

Senate confirms vaccine skeptic Robert F. Kennedy Jr., sworn in as HHS Secretary
Political appointee, HHS - Read more

Genentech removes diversity reports from website, evaluating impact of executive orders while preparing new annual report
DEI, executive order - Read more

THE BAD
Strategic Plans

Galapagos discontinues development of GLPG5201 (targeting CD19) CAR-T therapy for leukemia
Cell therapy, leukemia, Richter transformation, CAR-T - Read more

THE UGLY
No Ugly News Today!

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