Drug & Device Pipeline News

December 13, 2021

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Acer Therapeutics	ACER-801 (osanetant)	Induced vasomotor symptoms	IND approved by the FDA
ChemomAb	CM-101	Primary sclerosing cholangitis	IND approved by the FDA
Cyclo Therapeutics	Trappsol Cyclo	Early Alzheimer’s disease	IND approved by the FDA
MingMed Biotechnology	PRJ1-3024	Cancer	IND approved by the FDA
Nuvation Bio	NUV-422	Advanced breast cancer	IND approved by the FDA
Ocugen	OCU400 (AAV-NR2E3)	Retinitis pigmentosa resulting from genetic mutations in NR2E3 or RHO genes	IND approved by the FDA
Biotheus	PM8001	Advanced solid tumors	Phase 2 trial approved by the FDA
Trials Initiated
Biofrontera	Ameluz photodynamic therapy	Actinic keratosis	Initiation of phase 1 trial
Celldex Therapeutics	CDX-0159	Prurigo nodularis	Initiation of phase 1 trial
Iterion Therapeutics	Tegavivint in combination with osimertinib	Metastatic epidermal growth factor receptor-positive nonsmall-cell lung cancer	Initiation of phase 1 trial
Tranquis Therapeutics	TQS-168	Neurodegenerative disease	Initiation of phase 1 trial
Affimed	AFM24 in combination with atezolizumab	Solid tumors	Initiation of phase 1/2 trial
MRM Health	MH002	Mild-to-moderate ulcerative colitis	Initiation of phase 1b/2a trial
Springworks Therapeutics	Nirogacestat	Multiple myeloma	Initiation of phase 1b/2 trial
Hepagene Therapeutics	HPG1860	Nonalcoholic steatohepatitis	Initiation of phase 2a trial
Karyopharm	Selinexor	Myelofibrosis	Initiation of phase 2 trial
Ventyx Biosciences	VTX002	Moderate-to-severe ulcerative colitis	Initiation of phase 2 trial
Vir Biotech Gilead Sciences	VIR-2218, selgantolimod and nivolumab	Chronic hepatitis B virus infection	Initiation of phase 2 trial
ZZ Biotech	3K3A-APC	Amyotrophic lateral sclerosis	Initiation of phase 2 trial
Acurx Pharmaceuticals	Ibezapolstat	Clostridioides difficile infection	Initiation of phase 2b trial
Checkpoint Therapeutics	Cosibelimab in combination with chemotherapy	First-line treatment of patients with nonsquamous nonsmall-cell lung cancer	Initiation of phase 3 trial
DyDo Pharma	Firdapse (amifampridine)	Lambert-Eaton myasthenic syndrome	Initiation of phase 3 trial in Japan
Approvals
Daré Biosciences	Xaciato (clindamycin phosphate vaginal gel, 2%)	Bacterial vaginosis in females under 12 years of age	Approved by the FDA
Eli Lilly Junshi	Etesevimab (JS016/LY-CoV016) and bamlanivimab (LY-CoV555)	Treatment of mild-to-moderate COVID-19 and postexposure prophylaxis in certain high-risk pediatric patients from birth to 12 years of age	Emergency Use Authorization expanded by the FDA
Heron Therapeutics	Zynrelef (bupivacaine and meloxicam) extended-release solution	Soft tissue or periarticular instillation in adults to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures	Approved by the FDA for expanded indication
Merck	Keytruda (pembrolizumab)	Stage IIB or IIC melanoma following complete resection in patients under age 12	Approved by the FDA for expanded indication
Octapharma	Cutaquig immune globulin, subcutaneous (human)-hipp 16.5% solution	Primary humoral immunodeficiency in patients under age two	Approved by the FDA for expanded indication
Beigene EUSA	Sylvant (siltuximab for injection)	Idiopathic multicentric Castleman disease	Approved in China