Immunology

Innovent licenses IBI355 rights to Spero for up to $1.1bn

Innovent Biologics has agreed an exclusive licence deal worth up to $1.1bn with Spero Therapeutics, granting Spero the rights to develop, research, manufacture and commercialise IBI355, also known as SP001, outside Greater China.

Odyssey Therapeutics raises $213m via Series D

Odyssey Therapeutics has closed a $213m Series D financing round, aimed at advancing its portfolio of clinical and preclinical medicines for autoimmune and inflammatory diseases.

Insignis Therapeutics’ IN-001 clinical programme receives positive FDA response

Insignis Therapeutics has received a positive response from the US Food and Drug Administration (FDA) on IN-001 clinical programme for needle-free anaphylaxis treatment.

Astria Therapeutics’ navenibart gains orphan medicinal status from EC

Astria Therapeutics received the European Commission's orphan medicinal product designation (OMPD) for navenibart (STAR-0215) to treat hereditary angioedema (HAE).

Johnson & Johnson seeks FDA approval for generalised myasthenia gravis therapy

Johnson & Johnson has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the approval of nipocalimab, aimed at treating individuals with generalied myasthenia gravis (gMG).

Q32 Bio concludes merger deal with Homology Medicines

Clinical stage biotechnology company Q32 Bio has announced the conclusion of its merger with Homology Medicines, for an undisclosed sum.

Precision receives payments from TG Therapeutics for azer-cel

Precision BioSciences has received upfront cash payment and equity investment totalling $17.5m from TG Therapeutics for an exclusive licence to develop Azercabtagene Zapreleucel (azer-cel).

Kymera receives FDA fast track designation for KT-333

Kymera Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for KT-333 to treat Relapsed/Refractory (R/R) Cutaneous T-Cell Lymphoma (CTCL) and Peripheral T-Cell Lymphoma (PTCL).

EC grants CMA to Janssen’s Talvey for multiple myeloma

The European Commission (EC) has granted conditional marketing authorisation (CMA) to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Talvey (talquetamab) for the treatment of relapsed and refractory multiple myeloma (RRMM) in adult patients who received a minimum of three prior lines of therapies.