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  • Biotech & Pharma Updates | January 6 - 7, 2025

Biotech & Pharma Updates | January 6 - 7, 2025

Sana Biotechnology pushed the T1D boundary with sustained insulin delivery from implanted islet cells without immunosuppression, Avenzo Therapeutics in-licenses DualityBio's AVZO-1418/DB-1418 solid tumor-targeting bispecific, Aviceda Therapeutics $207.5M Series C fuels geographic atrophy ambitions into Ph3, Variant Bio and Novo Nordisk bet on novel drug discoveries through genetically diverse populations, Calico Life Sciences & Denali Therapeutics both face ALS clinical trial failures + 36 more stories

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⬇️ The Good News ⬇️

THE GOOD
Business Development

Avenzo Therapeutics in-licenses DualityBio's AVZO-1418/DB-1418 (targeting EFGR, HER3) solid tumor-targeting candidate for $50M upfront, with potential payments reaching $1.15B plus royalties
Bispecific antibody-drug conjugate, breast cancer, lung cancer, head and neck cancer - Read more

Candid Therapeutics buys global rights to a WuXi Biologics discovered preclinical trispecific T-cell engager in $925M deal
Trispecific T-cell engager, inflammatory disease, autoimmune - Read more

Immunome buys global rights to Hummingbird Bioscience for monoclonal antibodies targeting a “single undisclosed target“
Antibody, cancer - Read more

Kissei Pharmaceutical grants Tai Tien Pharmaceuticals Taiwan development and commercialization rights to Tavalisse (SYK inhibitor)
Small molecule, chronic idiopathic thrombocytopenic purpura - Read more

THE GOOD
Clinical Trials

Sana Biotechnology's UP421 (hypoimmune-engineered islet cells) delivers positive Ph1 data in type 1 diabetes, sustained insulin production without immunosuppression
Cell therapy, type 1 diabetes, cell transplant - Read more

Metsera's weight-loss hopefuly MET-097i delivers the Ph2a goods, with some patients losing up to 20% of their body weight
GLP-1, obesity - Read more

Immuneering's IMM-1-104 (MEK inhibitor) touts promising Ph2a trial results for pancreatic cancer when combined with gemcitabine/nab-paclitaxel
Small molecule, pancreatic cancer - Read more

Johnson & Johnson's Rybrevant (targeting EGFR, MET) plus Lazertinib (targeting EGFR) combo therapy shows survival benefit in Ph3 trial for non-small cell lung cancer
Bispecific antibody, lung cancer, small molecule - Read more

PharmaEssentia's ropeginterferon alfa-2b-njft hits Ph3 primary endpoint in essential thrombocythemia
Recombinant interferon, primary endpoint - Read more

Hoth Therapeutics' HT-001 touts “100% success” in Ph2a trial in treating skin toxicities caused by EGFR inhibitor cancer treatments
Read more
Small molecule, EGFR-linked skin toxicities, cancer - Read more

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⬇️ More Good News ⬇️

THE GOOD
Earnings & Finances

Verona Pharma's celebrates “promising” commercial start for their COPD treatment Ohtuvayre, generating $42M in 2024 sales
Small molecule, chronic obstructive pulmonary disorder - Read more

Instil Bio stock jumps 25% after Jefferies upgrades rating, citing potential of cancer drug candidate SYN-2510 (targeting PD-L1, VEGF)
Bispecific antibody, lung cancer - Read more

Major drugmakers including Bayer and Merck significantly reduce list prices for select cancer, diabetes, and respiratory medications in 2025
Drug pricing - Read more [Paywall]

Moderna stock surges 10% for an unfortunate reason; the US has its first bird flu-related death
Vaccine, bird flu, avian flu, pandemic, infectious disease - Read more

THE GOOD
Fundraises

Neumirna Therapeutics €20M ($21.8M) Series A, microRNA-based treatments for epilepsy and neurological disorders
microRNA, epilepsy, Parkinson’s disease - Read more

XyloCor Therapeutics $67.5M Series B, developing cardiac gene therapy to stimulate blood vessel growth
Gene therapy, refractory angina, cardiac disease - Read more [Paywall]

Aviceda Therapeutics $207.5M Series C, supporting current Ph2b/3 and planned pivotal Ph3 trials for nanoparticle-based geographic atrophy hopeful
Nanoparticle, geographic atropy - Read more

Alebund Pharmaceuticals RMB 550M ($76M) Series C, supporting development and commercial activities of renal disease-focused pipeline
Synthetic peptide, chronic kidney disease, IgA nephropathy - Read more

Alivexis 800M JPY ($5.1M) Series D, computational drug discovery platform expanding R&D programs and out-licensing efforts
Drug discovery, computational chemistry - Read more

THE GOOD
IPOs

NeOnc Technologies goes for a Nasdaq direct listing (again)
Small molecule, brain cancer, glioma, meningioma - Read more

THE GOOD
Marketing

Armgo Pharma rebrands as RyCarma Therapeutics, more accurately reflecting ryanodine receptor angle
Small molecule, heart failure, ryanodine receptor 1-related myopathies - Read more

THE GOOD
Market Reports

Heart failure market projected to reach $33.7bn by 2032, with US leading growth due to high prevalence and drug costs
Heart failure, industry scope - Read more

THE GOOD
Mergers & Acquisitions

Renovaro to acquire Predictive Oncology, combining AI platforms for enhanced cancer drug discovery
Drug discovery, cancer, AI - Read more

Highlander Health acquires Target RWE, advancing clinical trial data collection and analyses
Clinical trial management, clinical trial data - Read more

THE GOOD
Partnerships

Vertex Pharmaceuticals, ReNAgade (Orna Therapeutics subsidiary) team up to to develop next-gen gene therapies for blood disorders
Gene therapy, sickle cell disease, transfusion-dependent beta thalassemia, drug development - Read more

Pfizer, PostEra expand AI drug discovery partnership to include ADC development
Antibody drug-conjugate, cancer, drug discovery, AI - Read more

Variant Bio, Novo Nordisk drug discovery partnership for metabolic diseases by utilizing assessing genetics of genetically diverse populations
Drug discovery, obesity, diabetes - Read more

Sanofi, Alloy Therapeutics partner to develop blood-brain barrier-crossing genetic medicines
Antisense therapeutic, drug development, drug delivery, blood-brain barrier - Read more

AbbVie opts-in to Capsida Biotherapeutics neurodegenerative disease gene therapy program
Gene therapy, central nervous system disorder, drug delivery, AAV - Read more

Asher Biotherapeutics, AstraZeneca partner on clinical supply deal to test combined cancer therapy hopefuls etakafusp alfa (targeting CD8+ T cells) and rilvegostomig (targeting PD-1, TIGIT) in non-small cell lung cancer patients
Interleukin-2, lung cancer, bispecific antibody - Read more

THE GOOD
Product Launches

Profluent develops AI model Protein2PAM to engineer protein-DNA interactions, without wet lab screening/testing
Protein-DNA interactions, AI, drug design, research - Read more

THE GOOD
Regulatory

FDA releases draft guidance for obesity drug development, emphasizing clinical trials that demonstrate sustained year-long weight loss
Obesity, draft guidance, drug development - Read more

FDA releases draft guidance to standardize and improve safety of skin biopsy procedures in (particularly oncology) clinical trials
Draft guidance, cancer, clinical trial management, skin biopsy - Read more

THE GOOD
Strategic Plans

Generation Bio shifts focus to autoimmune diseases, using nanoparticle technology to target T cells; aiming for clinical trials by 2026
siRNA, autoimmune, nanoparticle, drug delivery -Read more

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⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

Calico Life Sciences' ALS hopeful fosigotifator (eIF2B activator) flops in Ph2/3 trial
Small molecule, amyotrophic lateral sclerosis - Read more

Denali Therapeutics' also has a bad ALS day, as DNL343 (eIF2B agonist) fails in Ph2 trial
Small molecule, amyotrophic lateral sclerosis - Read more

Acelyrin's lonigutamab (targeting IGF-1R) delivers mixed Ph1/2 results for thyroid eye disease, stock sinks
Monoclonal antibody, thyroid eye disease - Read more [Paywall]

Stoke Therapeutics faces investor backlash at “unusually lengthy duration and relatively large size” of upcoming ozorevunersen Phase III trial in Dravet syndrome
Antisense oligonucleotide, Dravet syndrome - Read more

THE BAD
Layoffs

CytomX Therapeutics cuts 40% of workforce
Antibody-drug conjugate, colorectal cancer, bispecific antibody - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Lawsuits

Aetna sues Takeda, alleging anticompetitive practices blocked generic versions of laxative Amitiza, causing millions in excess costs
Small molecule, constipation, generic, price fixing - Read more [Paywall]

THE UGLY
Adverse Events

FDA requires liver function monitoring for Agios Pharmaceuticals' Pyrukynd (targeting pyruvate kinase) after safety concerns emerged during trials for expanded use in thalassaemia patients
Small molecule, haemolytic anaemia associated with pyruvate kinase deficiency, thalassemia, liver injury - Read more

THE UGLY
Warning Letters, Form 483

FDA publishes Viatris' warning letter details, citing quality control failures and manufacturing violations at Pithampur facility
Manufacturing, quality control - Read more

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

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