Drug & Device Pipeline News

February 28, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
4D Pharma	MRx0005 and MRx0029	Parkinson’s disease	IND approved by the FDA
Armata Pharmaceuticals	AP-PA02	Noncystic fibrosis bronchiectasis	IND approved by the FDA
Valbiotis	TOTUM•854	Hypertension	Approval for two phase 2/3 trials granted by the FDA
Aulos Bioscience	AU-007	Solid tumors	Approval for a phase 1/2 trial granted by Australia’s regulatory authority
Trials Initiated
EpicentRx	RRx-001	Recurrent or progressive malignant solid and central nervous system tumors in children	Initiation of phase 1 trial
Innovent Biologics	IBI325	Advanced solid tumors	Initiation of phase 1 trial
Maze Therapeutics	MZE001	Pompe disease	Initiation of phase 1 trial
Kahr Bio	DSP107	Acute myeloid leukemia and myelodysplastic syndrome	Initiation of phase 1b trial
Arrowhead Pharmaceuticals	ARO-C3	Complement to various mediated diseases	Initiation of phase 1/2 trial
Edison Oncology	Orotecan (irinotecan HCI oral solution)	Recurrent pediatric solid tumors	Initiation of phase 1/2 trial
Vaxcyte	VAX-24	Invasive pneumococcal disease and pneumonia	Initiation of phase 1/2 trial
Evelo Biosciences	EDP1815	Atopic dermatitis	Initiation of phase 2 trial
MyMD Pharmaceuticals	MYMD-1	Delaying aging	Initiation of phase 2 trial
Noema Pharma	NOE-101	Trigeminal neuralgia	Initiation of phase 2b trial
Biohaven Pharmaceuticals	Nurtec ODT (rimegepant)	Chronic rhinosinusitis with or without nasal polyps	Initiation of phase 2/3 trial
Moderna	mRNA-1345	Respiratory syncytial virus	Initiation of phase 3 portion of phase 2/3 trial
Cytokinetics	Aficamten	Symptomatic obstructive hypertrophic cardiomyopathy	Initiation of phase 3 trial
Horizon Therapeutics	Teprotumumab	Thyroid eye disease	Initiation of phase 3 trial in Japan
Orpha Labs AG	ORL-101	Leukocyte adhesion deficiency type 2	Initiation of phase 3 trial
Approvals
Agios	Pyrukynd (mitapivat)	Hemolytic anemia in adults with pyruvate kinase deficiency	Approved by the FDA
Abbott	CardioMEMS HF System	Early-stage heart failure	Approved by the FDA
Medtronic	InterStim X	Bladder and bowel control	Approved by the FDA
Lupin Pharmaceuticals	Solosec (secnidazole)	Bacterial vaginosis	Approved by the FDA for expanded indication
Moderna	Spikevax	COVID-19	Approved in Australia
Novavax	Nuvaxovid	COVID-19	Approved in Canada