FDA Approval for COSELA

2/16/21 11:21:53 AM ET

Biotechnology: Pharmaceutical Preparations

Health Care

New Drug Application (NDA): 214200
Company: G1 THERAPEUTICS INC

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COSELA	TRILACICLIB	300MG	INJECTABLE;INJECTION	Prescription	None	TBD	No

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214200s000lbl.pdf

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/12/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214200s000lbl.pdf

Date	Price Target	Rating	Analyst
1/30/2023	$7.00 → $10.00	Underweight → Neutral	JP Morgan
1/3/2023	$32.00 → $31.00	Buy	Needham
11/4/2021	$20.00 → $19.00	Neutral → Underweight	JP Morgan
11/4/2021	$78.00 → $71.00	Buy	HC Wainwright & Co.
11/4/2021	$41.00 → $24.00	Outperform	Raymond James
10/15/2021	$51.00	Buy	BTIG Research
9/30/2021	$24.00 → $20.00	Overweight → Neutral	JP Morgan
9/1/2021	$57.00 → $56.00	Buy	Roth Capital

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