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INDUSTRY REPORT by TLDR Biotech
Cell & Gene Therapy: A Field at a Crossroads

Compiled from 43 industry interviews at Meeting on the Mesa 2024, this report covers both industry sentiment and the big threats and opportunities facing the cell & gene therapy industry.

Get access for free here.

THE GOOD
Approvals & Labels

PTC Therapeutics’ rare genetic disorder gene therapy Kebilidi nabs FDA approval
Gene therapy, aromatic L-amino acid decarboxylase (AADC) deficiency, AAV - Read more

Caris Life Sciences scores FDA approval for cancer companion diagnostic
Companion diagnostic, cancer, precision medicine, sequencing - Read more

Sanofi makes some headway with UK’s NICE as agency agrees to Sarclisa reassessment
Monoclonal antibody, multiple myeloma, cancer - Read more

THE GOOD
Business Development

MycoMedica Life Sciences buys rights to Enveric Biosciences’ EB-002 psilocin prodrug
Small molecule, depression, neuropsychiatric disorders, psychedelic - Read more

THE GOOD
Clinical Trials

Adaptimmune Therapeutics touts positive Ph2 data for lete-cel in rare sarcomas
Cell therapy, synovial sarcoma, myxoid/round cell liposarcoma, cancer, T-cell receptor (TCR) - Read more

X4 Pharmaceuticals touts positive Ph2 results for mavorixafor in chronic neutropenia
Small molecule, chronic neutropenia - Read more

Microbion’s positive topline Ph2 data for topical pravibismane in diabetic foot ulcers
Small molecule, diabetic foot ulcers - Read more

Gilead Sciences showcases full Ph3 data for lenacapavir in HIV infection prevention
Small molecule, human immunodeficiency virus infection - Read more

Gubra isn’t SAD about Ph1 results for obesity hopeful GUBamy
Peptide, obesity - Read more

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⬇️ More Good News ⬇️

THE GOOD
Fundraises

Metsera $215M Series B to fuel obesity ambitions
GLP-1, obesity - Read more

TRex Bio $84M Series B to further immune disease therapeutic pipeline
Biologic, immune diseases, atopic dermatitis, ulcerative colitis - Read more

89bio $125M public offering
Growth factor, biologic, metabolic dysfunction-associated steatohepatitis (MASH), severe hypertriglyceridemia - Read more

Alpha Cognition $50M public offering
Small molecule, Alzheimer’s disease, mild traumatic brain injury - Read more

Medeloop $15.5M Series A, medical research acceleration AI
Medical research, AI, healthcare research - Read more

myBiometry $5M Seed raise
Medical device, remote monitoring, asthma, chronic obstructive pulmonary disease - Read more

THE GOOD
Mergers & Acquisitions

BioNTech buys into the cancer bispecific hype with $800M Biotheus buy, hoping to eventually take on Merck & Co.’s Keytruda
Bispecific antibody, solid tumor, cancer - Read more

Entero Therapeutics reverse merger with Journey Therapeutics
Antibody-drug conjugate, lymphoma, cancer - Read more

THE GOOD
Partnerships

GE Healthcare, RadNet partner on AI-enabled mammography SaaS
Mammography, software-as-a-service, AI, breast cancer - Read more

Nippon Shinyaku, Atsena Therapeutics commercialization agreement for ATSN-101 gene therapy
Gene therapy, Leber congenital amaurosis - Read more

Sanofi, Healx partner on AI-powered disease indication discovery using one of former’s late stage discontinued assets
Disease indication discovery, AI, discontinued asset repurposing, rare disease - Read more

ICU Medical, Otsuka Pharmaceutical Factory partner on bolstering North American IV solutions network
IV solutions, manufacturing, supply chain - Read more

THE GOOD
Product Launches

Medable’s clinical trial platform gets AI upgrade
Clinical trial platform, clinical out assessments - Read more

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THE BAD
Clinical Trials

Syros Pharmaceuticals’ tamibarotene, azacitidine combo misses endpoint in myelodysplastic syndrome Ph3 trial
Small molecule, myelodysplastic syndrome - Read more

Kezar Life Sciences zetomipzomib can’t catch a break, Ph2a partial clinical hold by FDA in autoimmune hepatitis
Small molecule, autoimmune hepatitis - Read more

THE BAD
Layoffs

Marinus Pharmaceuticals cuts 45% of staff and pivots within seizure focus
Small molecule, potential refractory status epilepticus, seizure - Read more

Lyra Health cuts 2% of workforce as part of non-clinical team restructuring
Digital health, workplace mental health - Read more

THE BAD
Strategic Plans

Ovid Therapeutics, Graviton Biosciences pause OV888/GV101 Ph2 plans after a mixed readout from Recursion Pharmaceuticals’ rival asset
Small molecule, cerebral cavernous malformations - Read more 

THE UGLY
Earnings & Finances

A hidden tab in a 9 month old spreadsheet cost Amgen $12B in market cap
GLP-1, obesity, bone density - Read more  

THE UGLY
Regulatory

The FDA is struggling to retain drug manufacturing site inspectors
Manufacturing site inspections, regulatory inspectors - Read more

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

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