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  • Biotech & Pharma Updates | February 2 - 3, 2025

Biotech & Pharma Updates | February 2 - 3, 2025

United Therapeutics' gene-edited pig kidneys cleared for Ph1, Australian radiopharma AdvanCell scores a $112M Series C, NSF resumes payments after five-day freeze but uncertainty remains, epigenomic-medicine biotech Omega Therapeutics says they're weeks away from bankruptchy, Trump's new tariffs could increase generic drug prices for Americans + 35 more stories

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Johnson & Johnson's subcutaneous Rybrevant (targeting EGFR), recommended by EU panel for non-small-cell lung cancer
Bispecific antibody, lung cancer, formulation - Read more

Roche's PATHWAY test approved by FDA as companion diagnostic for Enhertu (targeting HER2) in treating metastatic breast cancer patients
Antibody-drug conjugate, breast cancer, companion diagnostic - Read more

THE GOOD
Business Development

Vanda acquires global rights to AnaptysBio's imsidolimab (targeting IL-36R) psoriasis drug for $15M upfront, plus future milestone payments and royalties
Monoclonal antibody, generalized pustular psoriasis - Read more

EQL Pharma completes DKK 120M ($16.7M) purchase of four pharmaceutical assets from Medilink
Small molecule, depression, schizophrenia, necrotic wounds, anemia (iron deficiency) - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

Pfizer showcases positive Ph3 data for Braftovi (kinase inhibitor) as part of drug combo targeting BRAF-mutated colorectal cancer
Small molecule, colorectal cancer - Read more

GH Research's inhaled mebufotenin (targeting serotonin receptors) positive Ph2 trial results good enough to “[pave] the way to…commercial success” in treatment-resistant depression
Small molecule, treatment-resistant depression, bipolar disorder, pospartum depression, psychedelic - Read more

Algiax Pharmaceuticals' touts a Ph2a win for non-opioid pain hopeful AP-325 (GABAA receptor modulator)
Small molecule, pain, pe­riph­er­al post-sur­gi­cal neu­ro­path­ic pain, non-opioid - Read more [Paywall]

Henlius Biotech publishes promising Ph2 results for serplulimab (targeting PD-1) plus bevacizumab (targeting VEGF) in hepatocellular carcinoma
Monoclonal antibody, hepatocellular carcinoma, cancer - Read more

United Therapeutics' UKidney (derived from gene-edited pig kidneys) cleared for Ph1 trial in end-stage renal disease patients, starting mid-2025
Organ transplant, renal disease, gene-edited organ - Read more

BriaCell Therapeutics showcases an “unprecedented clinical response” to their Bria-OTS immunotherapy in a Ph1/2a trial, lung metastasis resolution in metastatic breast cancer patient
Cell therapy, breast cancer, allogeneic cell therapy, personalized medicine - Read more

THE GOOD
Fundraises

Aplagon €7M ($7.21M) financing round, developing drug for peripheral arterial disease clinical trials
Modality not disclosed, peripheral arterial occlusive disease, chronic limb threatening ischemia - Read more

Enduro Genetics raises $12.4M Series A to scale biotech platform improving industrial microorganism productivity
Biomanufacturing, bioprocessing, synthetic biology - Read more

Dxcover $21.4M total funding, clinical diagnostics company expanding proprietary tech and market reach
Diagnostics, cancer screening, cancer diagnosis - Read more

AdvanCell $112M Series C, Australian radiopharmaceutical company expanding manufacturing and developing cancer treatments
Radiopharm, prostate cancer - Read more

Annovis Bio to-be-priced Public offering, developing neurodegenerative disease treatments with proceeds for clinical development
Small molecule, Alzheimer’s disease, Parkinson’s disease, neurodegenerative disease - Read more

BriaCell Therapeutics $3.05M public offering, gene-edited cell therapies targeting breast cancer
Cell therapy, breast cancer, allogeneic cell therapy, personalized medicine - Read more

Tectonic Therapeutic $185M PIPE financing, fusion proteins (relaxin receptor 1 agonists) in heart failure
Fusion protein, heart failure - Read more

Immunome $172.5M public offering, developing ADCs and radioligands against cancer
Antibody-drug conjugate, radiopharm, radioligand, cancer - Read more

89bio closes $287.5M public offering, developing therapies for liver and cardiometabolic diseases
Growth factor, metabolic dysfunction-associated steatohepatitis (MASH), hypertriglyceridemia - Read more

THE GOOD
IPOs

Sionna Therapeutics provides more precise figure for $150M IPO, offering shares at $16-18 per to fund cystic fibrosis ambitions
Small molecule, cystric fibrosis - Read more

THE GOOD
Partnerships

Purple Biotech, Icahn School of Medicine collaborate to study NK and T cell immunoregulation for cancer treatment
Cell therapy, cancer, research & development, T cell, Natural Killer (NK) cell - Read more

THE GOOD
Patient Access

Twelve new mpox vaccination sites open across England, expanding coverage beyond London, Brighton and Manchester
Vaccine, mpox (monkeypox), vaccine access - Read more

THE GOOD
Politics & Policy

Senators Warren and Wyden challenge RFK Jr.'s HHS nomination, citing antivaccine stance and Gardasil lawsuit conflicts of interest
Vaccine, anti-vax, conflict of interest - Read more

NSF resumes payments after five-day freeze, but researchers remain worried about funding stability and mixed messages
National Science Foundation, Research funding, research & development - Read more [Paywall]

THE GOOD
Product Launches

Helix launches registry combining genomic and health data from 15,000 GLP-1 patients to advance drug research
GLP, obesity, data registry, research & development - Read more

THE GOOD
Public Health

US confirms PEPFAR HIV aid program can continue during 90-day foreign aid pause under humanitarian assistance waiver
Humanitarian aid, human immunodeficiency virus (HIV) - Read more

THE GOOD
Strategic Plans

Biogen's research head emphasizes external partnerships and expansion beyond neurology to stay competitive
Big pharma strategy, research & development - Read more [Paywall]

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⬇️ The Bad News ⬇️

THE BAD
Business Development

Acelyrin returns autoimmune drug izokibep (targeting IL-17A) to Affibody after failed trials, ending partnership that began with $25M licensing deal in 2021
Small therapeutic protein, hidradenitis suppurativa, psoriatic arthritis, autoimmune - Read more

THE BAD
Company Shutdown

Epigenomic medicine company Omega Therapeutics announces imminent bankruptcy filing in the next few weeks
mRNA, cancer, carcinoma, solid tumor, epigenomics - Read more [Paywall]

THE BAD
Earnings & Finances

Activist investor Starboard Value urges Becton Dickinson pushes for life sciences unit spin-off after taking undisclosed stake in company
Activitist investor, divestiture - Read more

THE BAD
Layoffs

Thermo Fisher to lay off 300 more workers at Massachusetts viral vector sites, following previous cuts of 160 jobs
Cell & gene therapy, viral vector manufacturing - Read more

Charles River Laboratories closing Durham pathology facility, affecting 31 employees; work transfers to Maryland and Illinois locations.
CDMO, CRO, pathology facility - Read more [Paywall]

THE BAD
Market Reports

Despite 118 biologics losing patent protection, only 10% have biosimilars in development due to regulatory and market challenges
Drug development, commercialization, biosimilar - Read more

THE BAD
Politics & Policy

Letter supporting RFK Jr.'s HHS nomination includes discredited doctors and non-physicians among its nearly 800 signatories
HHS, political nomination - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Marketing

Novartis employee's LinkedIn likes of Cosentyx posts violated UK drug advertising rules, but company not held responsible
Drug marketing, drug advertising - Read more

THE UGLY
Politics & Policy

Trump's new tariffs on Canada, Mexico, and China could increase generic drug prices for Americans
Drug pricing, drug access, generic - Read more

Trump administration suspends Health IT Advisory Committee meetings, halting federal guidance on healthcare data and technology standards
Healthcare tech, public institution - Read more

Elon Musk claims Trump supports shutting down USAID, putting in jeopardy extensive US-backed medicines and healthcare supplies to developing nations
Humanitarian aid, global health, low- and middle-income countries - Read more

America Society for Microbiology removes diversity content from website in response to Trump's executive orders, sparking member outrage
DEI - Read more [Paywall]

CDC orders removal of gender-related terms from scientific papers following Trump executive order banning taxpayer-funded gender ideology promotion
DEI, gender issues, censorship - Read more

THE UGLY
Withdrawals & Recalls

Alvogen recalls fentanyl patches after packaging error creates overdose risk from accidentally stacked patches
Small molecule, pain, patch delivery, dosing error - Read more

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

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