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THE GOOD
Approvals & Labels

AstraZeneca’s mAb+small molecule combo (Lynparza and Imfinzi) lands EU approval
Small molecule, monoclonal antibody, endometrial cancer - Read more

Gilead’s PBC med (Livdelzi) handed FDA accelerated approval
Small molecule, primary biliary cholangitis (PBC) - Read more

Incyte, Syndax Pharmaceuticals nab FDA approval for GVHD mAb (Niktimvo)
Monoclonal antibody, graft-versus-host disease (GVHD) - Read more

Astellas’ solid tumor mAb (Vyloy) gains MHRA (UK) approval
Monoclonal antibody, stomach (gastric) or gastro-oesophageal junction cancer - Read more

UK’s NICE recommends Sumitomo Pharma’s Orgovyx (marketed by Accord Healthcare in Europe) for NHS coverage
Small molecule, prostrate cancer - Read more

THE GOOD
Clinical Trials

Acelyrin posts positive Ph3 for Izokibep in chronic inflammatory skin disorder
Small molecule, hidradenitis suppurativa - Read more

Viracta Therapeutics’ positive Ph2 data for lymphoma drug combo Nana-val in aptly named NAVAL-1 trial
Small molecule, lymphoma - Read more

Vaccinex posts additional info regarding recent positive Ph1b/2 pepinemab trial
Monoclonal antibody, Alzheimer’s disease - Read more

Verrica Pharmaceuticals’ touts positive Ph2 data for VP-315 in basal cell carcinoma (BCC), but “tenuous” cash position sinks stock
Oncolytic peptide, basal cell carcinoma (BCC), skin cancer - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Fundraises

Iceland’s Plaio €4.3M ($4.7M) raise
AI platform, pharmaceutical supply chain planning - Read more

AnaptysBio $100M equity offer
Monoclonal antibody, autoimmune, atopic dermatitis, arthritis - Read more

Avidity Biosciences upsized public offering, $300M expected raise before expenses
Antibody oligonucleotide conjugates, RNA, myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD), facioscapulohumeral muscular dystrophy (FSHD) - Read more

THE GOOD
Market Reports

J&J, Roche top S&P Global’s “pharmaceutical industry power ratings”; report - Read more

THE GOOD
Mergers & Acquisitions

Dalim BioTech acquires LysoTech via 90% shares purchase
Lysosome enhancer, degenerative disease, skin/eye health - Read more (original press release in Korean)

THE GOOD
Partnerships

XLerator Network picks 8 member cohort for NIH’s IDeA Regional Entrepreneurship Development (I-RED) program
Company incubation, drug discovery, medical device - Read more

THE GOOD
Research

Free-floating bacterial gene could upend our understanding of the gene-to-protein relationship - Read more

THE GOOD
Strategic Plans

Arrowhead Pharmaceuticals looks to get into the obesity game while also preserving muscle mass; aiming for two assets in the clinic by 2025
RNA, obesity - Read more

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THE BAD
Clinical Trals

Kezar Life Sciences drops solid tumor med as Ph1, though ongoing, doesn’t return any hits (KZR-261)
Small molecule, solid tumor - Read more

THE BAD
Company Shutdown

Avenge Bio closes doors
Cell therapy - Read more [Paywall]

After Ph3 rejection, Galera Therapeutics initiates wind down
Small molecule, severe oral mucositis, radiotherapy complication - Read more

THE BAD
Earnings & Finances

Illumina stock takes a dive after growth plans garner lackluster investor response
DNA sequencing, data analysis - Read more 

bluebird bio stock sinks after disappointing Lyfgenia sales figures, severely trailing rival Vertex Pharmaceuticals’ Casgevy
Gene therapy, sickle-cell disease - Read more

THE BAD
Layoffs

Grail restructuring claims 350 employee victims
Early cancer detection, diagnostics - Read more

Evotec to undergo restructuring, exits gene therapy entirely, layoff 7% of workforce (400 jobs)
CDMO, drug discovery and development, gene therapy - Read more

Viracta Therapeutics lays off 23% of total workforce
Small molecule, lymphoma - Read more

THE BAD
Strategic Plans

Metagenomi, spooked by Biogen and Ionis lackluster clinical results, drops ALS program; looks for new partner for program that Moderna backed out of
CRISPR, hyperoxaluria type 1, amyotrophic lateral sclerosis (ALS) - Read more

THE UGLY
Approvals & Labels

Amgen’s initial T-cell engager FDA application (since approved) allegedly involved missing/underreporting of a “large number” of adverse events
Bispecific T-cell engager, lung cancer - Read more

THE UGLY
Public Health

WHO declares mpox a public health emergency
Infectious disease outbreak, Mpox (monkeypox) - Read more

THE UGLY
Warnings Letters, Form 483

Doc involves in Takeda’s HyQvia Ph3 trial comes under FDA scrutiny for “objectionable conditions” in conducting said trial
Recombinant protein, chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), clinical trial conduct - Read more

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

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