Drug & Device Pipeline News

November 22, 2021

Company	Drug/Device	Medical Condition	Status
Trials Authorized
InnoCare Pharma	ICP-189	Advanced solid tumors	IND approved by the FDA
MyMD Pharmaceuticals	MYMD-1	Aging	IND approved by the FDA for a phase 2 trial
Paradigm Biopharmaceuticals	Zilosul (pentosan polysulphate sodium)	Knee osteoarthritis pain	IND approved by the FDA for a phase 3 trial
Vitro Biopharma	AlloRx stem cells	Pitt Hopkins syndrome	IND approved by the FDA
Cardialen	MultiPulse therapy	Paroxysmal and persistent atrial fibrillation	IDE approved by the FDA
Paracrine	Celution system to deliver adipose derived regenerative cells	Diabetic foot ulcers	IDE approved by the FDA
MimiVax	SurVaxM	Newly diagnosed glioblastoma	Approval for a phase 2b trial granted by the FDA
Emergex Vaccines	COVID-19 vaccine	COVID-19	Approval for a phase 1 trial granted by Switzerland’s regulatory authority
Gannex Pharma	ASC42	Primary biliary cholangitis	Approval for phase 2 and 3 trials granted by China’s regulatory authority
HebaBiz Biotech	Clevudine (L-FMAU)	Chronic hepatitis B virus	Approval for phase 3 trial granted by China’s regulatory authority
Trials Initiated
Revelation Biosciences	REVTx-99	Allergic rhinitis and chronic nasal congestion without polyps	Initiation of phase 1b trial in Australia
Eureka Therapeutics	ET140203 ARTEMIS T-cell therapy	Pediatric cases of relapsed or refractory hepatoblastoma, hepatocellular neoplasm not otherwise specified or hepatocellular carcinoma	Initiation of phase 1/2 trial
Graphite Bio	GPH101	Sickle cell disease	Initiation of phase 1/2 trial
Inozyme Pharma	INZ-701	ENPP1 deficiency in adults	Initiation of phase 1/2 trial
NiKang Therapeutics	NKT2152	Clear-cell renal-cell carcinoma	Initiation of phase 1/2 trial
Rafael Pharmaceuticals	CPI-613 (devimistat)	Clear-cell sarcoma	Initiation of phase 1/2 trial
Biosight	Aspacytarabine (BST-236)	Relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia	Initiation of phase 2 trial
Dermata Therapeutics	DMT310	Moderate-to-severe rosacea	Initiation of phase 2 trial
Oryzon	Vafidemstat	Schizophrenia	Initiation of phase 2b trial in Spain
Saniona	Tesomet	Hypothalamic obesity	Initiation of phase 2b trial
Merck	Verquvo (vericiguat)	Chronic heart failure and reduced ejection fraction in patients who have not had a recent worsening heart-failure event	Initiation of phase 3 trial
Approvals
Merck	Keytruda	Adjuvant treatment of patients with renal-cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions	Approved by the FDA for expanded indication
PharmaEssentia	Besremi (ropeginterferon alfa-2b-njft)	Polycythemia vera	Approved by the FDA
AbbVie	Skyrizi (risankizumab)	Active psoriatic arthritis in adults	Approved by the European Commission