Pharmaceuticals

Pharmaceuticals
Biologics
Cell & Gene Therapy

C4 Therapeutics cemsidomide shows T-cell data at IMS 2026

Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Biologics
Pharmaceuticals

Absci plans Phase 2 STORYLINE trial of ABS-201 for endometriosis

Absci will launch a global, placebo-controlled Phase 2 study of its AI-designed anti-PRLR antibody ABS-201 in endometriosis patients from mid-2027.
Absci will launch a global, placebo-controlled Phase 2 study of its AI-designed anti-PRLR antibody ABS-201 in endometriosis patients from mid-2027.
Pharmaceuticals
Biologics

Avacta presents FOCUS-01 trial design and AVA6103 PDAC data at AACR

Avacta Therapeutics shared preclinical PDX data and Phase 1 trial design for its FAP-targeted peptide-drug conjugate AVA6103 at the AACR pancreatic cancer conference.
Avacta Therapeutics shared preclinical PDX data and Phase 1 trial design for its FAP-targeted peptide-drug conjugate AVA6103 at the AACR pancreatic cancer conference.
Pharmaceuticals
Biologics

ADARx Pharmaceuticals prices $446m IPO on Nasdaq

The San Diego siRNA biotech raised up to $535m including an AbbVie cornerstone placement, valuing one of 2026's larger biotech listings.
The San Diego siRNA biotech raised up to $535m including an AbbVie cornerstone placement, valuing one of 2026's larger biotech listings.
Pharmaceuticals
Biologics

Addex regains global GABAB PAM rights after Indivior R&D pullback

Addex Therapeutics has reclaimed its full GABAB positive allosteric modulator portfolio from Indivior, citing the UK firm's R&D rationalisation ahead of a planned
Addex Therapeutics has reclaimed its full GABAB positive allosteric modulator portfolio from Indivior, citing the UK firm's R&D rationalisation ahead of a planned
Pharmaceuticals
Regulatory Science

EC approves leriglitazone as first pharmacological cALD treatment

Neuraxpharm and Minoryx win EU marketing authorisation for NEZGLYAL, the first oral drug approved for cerebral adrenoleukodystrophy in young boys.
Neuraxpharm and Minoryx win EU marketing authorisation for NEZGLYAL, the first oral drug approved for cerebral adrenoleukodystrophy in young boys.
Pharmaceuticals
Diagnostics

Nanobiotix reports NBTXR3 NSCLC data and €86m raise

Nanobiotix posted H1 2026 results showing encouraging NBTXR3 response rates in lung and head and neck cancer trials, backed by a freshly raised €86 million.
Nanobiotix posted H1 2026 results showing encouraging NBTXR3 response rates in lung and head and neck cancer trials, backed by a freshly raised €86 million.
Pharmaceuticals
Biologics

Pharming wins FDA Priority Review for Joenja in lighter children

Pharming's sNDA for lower leniolisib doses in children weighing 13-27 kg with APDS has a PDUFA date of 30 January 2027.
Pharming's sNDA for lower leniolisib doses in children weighing 13-27 kg with APDS has a PDUFA date of 30 January 2027.
Cell & Gene Therapy
Biologics
Pharmaceuticals

CARVYKTI gives five-year remissions to 50% in early-line myeloma

Five-year CARTITUDE-2 data show half of early-line RRMM patients remained alive and progression-free after a single cilta-cel infusion, with no
Five-year CARTITUDE-2 data show half of early-line RRMM patients remained alive and progression-free after a single cilta-cel infusion, with no
Biologics
Pharmaceuticals

Rezolute's ersodetug shows strong interim data in tumour HI trial

Seven of eight enrolled participants met the primary endpoint in the upLIFT Phase 3 study; topline results are expected before end of 2026.
Seven of eight enrolled participants met the primary endpoint in the upLIFT Phase 3 study; topline results are expected before end of 2026.
Biologics
Pharmaceuticals
Regulatory Science

aTyr Pharma secures FDA alignment on efzofitimod Phase 3 design

aTyr Pharma has agreed a Phase 3 protocol with the FDA for efzofitimod in pulmonary sarcoidosis, with study activities due to begin in Q4 2026.
aTyr Pharma has agreed a Phase 3 protocol with the FDA for efzofitimod in pulmonary sarcoidosis, with study activities due to begin in Q4 2026.
Pharmaceuticals
Biologics

Elicio Therapeutics AMPLIFY-7P data selected for ESMO 2026 oral slot

Phase 2 KRAS-targeting immunotherapy data will be presented at ESMO Congress in Madrid on 23 October, informing a refined Phase 3 strategy.
Phase 2 KRAS-targeting immunotherapy data will be presented at ESMO Congress in Madrid on 23 October, informing a refined Phase 3 strategy.
Biologics
Pharmaceuticals

IMUNON reports 14.7-month OS gain from Phase 2 ovarian cancer trial

IMUNON's IMNN-001 showed a 14.7-month median overall survival advantage over standard care in a 112-patient Phase 2 study, as its
IMUNON's IMNN-001 showed a 14.7-month median overall survival advantage over standard care in a 112-patient Phase 2 study, as its
Cell & Gene Therapy
Pharmaceuticals

Ligand commits up to $47m to back AvenCell's allogeneic CAR-T pipeline

Ligand Pharmaceuticals will fund AvenCell Therapeutics in tranches tied to clinical milestones, taking a royalty on all current and future pipeline assets.
Ligand Pharmaceuticals will fund AvenCell Therapeutics in tranches tied to clinical milestones, taking a royalty on all current and future pipeline assets.
Pharmaceuticals
Regulatory Science

MediciNova completes double-blind phase of COMBAT-ALS ibudilast trial

MediciNova has finished the double-blind portion of its 234-patient Phase 2b/3 ALS trial and expects topline results by end of 2026.
MediciNova has finished the double-blind portion of its 234-patient Phase 2b/3 ALS trial and expects topline results by end of 2026.
Pharmaceuticals
Biologics

Satellos wins FDA IND clearance for forazapadin in FSHD

Satellos Bioscience has cleared an IND for its AAK1 inhibitor in a second muscle disease, backed by US$5m from the FSHD Canada Foundation.
Satellos Bioscience has cleared an IND for its AAK1 inhibitor in a second muscle disease, backed by US$5m from the FSHD Canada Foundation.
Biologics
Cell & Gene Therapy
Pharmaceuticals

Transgene reports 100% DFS at 41 months for TG4050 HNSCC vaccine

Transgene's personalised neoantigen vaccine TG4050 maintained 100% disease-free survival at over three years in resected head and neck cancer, with Phase 2 topline
Transgene's personalised neoantigen vaccine TG4050 maintained 100% disease-free survival at over three years in resected head and neck cancer, with Phase 2 topline
Biologics
Pharmaceuticals

Scancell secures $25m BlackRock debt facility to fund iSCIB1+ Phase 3

The Oxford immuno-oncology company has agreed a structured loan facility with BlackRock to help finance its registrational melanoma trial, due to start by end
The Oxford immuno-oncology company has agreed a structured loan facility with BlackRock to help finance its registrational melanoma trial, due to start by end
Pharmaceuticals

Nuvectis NXP200 wins Breakthrough Therapy Designation in China for HGG

China's CDE has granted Breakthrough Therapy Designation to NXP200, a brain-penetrant BRAF inhibitor, for recurrent BRAF V600-mutant high-grade glioma.
China's CDE has granted Breakthrough Therapy Designation to NXP200, a brain-penetrant BRAF inhibitor, for recurrent BRAF V600-mutant high-grade glioma.
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject and BARDA align ZEPIZURE paediatric plan with FDA

An additional $4.7m in non-dilutive BARDA funding extends Crossject's ZEPIZURE development contract through June 2030, bringing total support to $48m.
An additional $4.7m in non-dilutive BARDA funding extends Crossject's ZEPIZURE development contract through June 2030, bringing total support to $48m.
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