Trials Authorized

ContraFect

CF-370

Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia

IND for a phase 1 trial approved by the FDA

Terns Pharmaceuticals

TERN-701

Chronic myeloid leukemia

IND for a phase 1 trial approved by the FDA

Y-mAbs Therapeutics

CD38-SADA

Relapsed/refractory non-Hodgkin lymphoma

IND for a phase 1 trial approved by the FDA

SAB Biotherapeutics

SAB-142

Type 1 diabetes

Approval for a phase 1 trial granted by Australia’s regulatory authority

Skyline Therapeutics

SKG0106 gene therapy

Neovascular age-related macular degeneration

Approval for a phase 1/2a trial granted by China’s regulatory authority

Spago Nanomedical

177Lu-SN201

Advanced cancer

Approval for a phase 1/2a trial granted by Australia’s regulatory authority

Intellia Therapeutics

NTLA-2001 gene therapy

Transthyretin (ATTR) amyloidosis with cardiomyopathy

IND for a phase 3 trial approved by the FDA

Ascentage Pharma

APG-2575 plus acalabrutinib

Chronic lymphocytic leukemia/small lymphocytic lymphoma in patients previously treated with a BTKi

Approval for a phase 3 trial granted by China’s regulatory authority

Protembis

ProtEmbo Cerebral Embolic Protection System

Transcatheter aortic valve replacement

IDE approved by the FDA

Trials Initiated

Biomea Fusion

BMF-500

Relapsed/refractory acute leukemia

Initiation of a phase 1 trial

Flare Therapeutics

FX-909

Advanced urothelial carcinoma

Initiation of a phase 1 trial

HanAll BioPharma

Daewoong Pharmaceutical

NurrOn Pharmaceuticals

HL192

Parkinson’s disease

Initiation of a phase 1 trial

Kura Oncology

KO-2806

Advanced solid tumors

Initiation of a phase 1 trial

Radionetics Oncology

68Ga-R8760

Adrenocortical carcinoma

Initiation of a phase 1 trial

SystImmune

BL-B01D1

Metastatic/unresectable non-small cell lung cancer

Initiation of a phase 1 trial

Numab Therapeutics

NM26

Moderate-to-severe atopic dermatitis

Initiation of a phase 1a/1b trial

Amplifier Therapeutics

ATX-304

Cardiometabolic diseases

Initiation of a phase 1b trial

ClearB Therapeutics

CLB-3000 vaccine

Chronic hepatitis B

Initiation of a phase 1b trial

Virion Therapeutics

Ocean Biomedical

VRON-0200

Chronic hepatitis B

Initiation of a phase 1b trial in Hong Kong and New Zealand

Bolt Biotherapeutics

BDC-3042

Metastatic/unresectable triple-negative breast cancer, colorectal cancer, clear cell renal cell carcinoma, head and neck cancer, non-small cell lung cancer, and ovarian cancer

Initiation of a phase 1/2 trial

IMUNON

IMNN-001 plus bevacizumab

Advanced ovarian cancer

Initiation of a phase 1/2 trial

CytoAgents

CTO1681

Cytokine release syndrome in lymphoma patients receiving CAR T-cell therapy

Initiation of a phase 1b/2a trial

Carrick Therapeutics

Samuraciclib plus elacestrant

CDK4/6i resistant HR+, HER2- metastatic breast cancer

Initiation of a phase 2 trial

Cyrano Therapeutics

CYR-064

Post-viral hyposmia

Initiation of a phase 2 trial

IN8bio

INB-400

Newly diagnosed glioblastoma multiforme

Initiation of a phase 2 trial

ImmunoForge

Froniglutide

Dermatomyositis/polymyositis

Initiation of a phase 2 trial in South Korea

Inmagene Biopharmaceuticals

IMG-007

Alopecia areata

Initiation of a phase 2a trial

Ascentage Pharma

Olverembatinib plus chemotherapy

Philadelphia chromosome-positive acute lymphoblastic leukemia

Initiation of a phase 3 trial

Foresee Pharmaceuticals

FP-001

Central precocious puberty

Initiation of a phase 3 trial

Approvals

Ardelyx

Xphozah (tenapanor)

Hyperphosphatemia in adults with chronic kidney disease on dialysis

Approved by the FDA

Merck

Keytruda (pembrolizumab)

Resectable (tumors ≥4 centimeters or node positive) non-small cell lung cancer

Approved by the FDA for expanded indication

Orasis Pharmaceuticals

Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4 percent

Presbyopia

Approved by the FDA

Pfizer

Velsipity (etrasimod)

Moderately-to-severely active ulcerative colitis

Approved by the FDA

Pfizer

Braftovi (encorafenib) plus Mektovi (binimetinib)

Metastatic non-small cell lung cancer with a BRAF V600E mutation

Approved by the FDA for new indication

UCB

Bimzelx (bimekizumab-bkzx)

Moderate-to-severe plaque psoriasis

Approved by the FDA

UCB

Zilbrysq (zilucoplan)

AChR antibody-positive generalized myasthenia gravis in adults

Approved by the FDA