FDA Approval for VELSIPITY issued to PFIZER INC

10/13/23 1:08:03 PM ET

$PFE

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New Drug Application (NDA): 216956
Company: PFIZER INC

Products on NDA 216956

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VELSIPITY	ETRASIMOD	2MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216956

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/2023	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

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Recent Analyst Ratings for
$PFE

Date	Price Target	Rating	Analyst
12/10/2024	$29.00	Neutral	BofA Securities
11/15/2024	$25.00	Underperform	Wolfe Research
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2/23/2024	$36.00	Buy	Guggenheim
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FDA Approval for VELSIPITY issued to PFIZER INC

Products on NDA 216956

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216956

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for $PFE

$PFE Press Releases

Fastest customizable press release news feed in the world

Pfizer's Sasanlimab in Combination with BCG Improves Event-Free Survival in Patients with BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer

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SEC Form 10-Q filed by Pfizer Inc.

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Director Gottlieb Scott bought $28,240 worth of shares (1,000 units at $28.24), increasing direct ownership by 11% to 10,000 units (SEC Form 4)

Gottlieb Scott bought $79,401 worth of shares (3,000 units at $26.47), increasing direct ownership by 50% to 9,000 units (SEC Form 4)

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$PFE Insider Trading

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SEC Form 4 filed by Director Smith James C

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October 25, 2024 - FDA Roundup: October 25, 2024

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$PFE Large Ownership Changes

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SEC Form SC 13G/A filed by Pfizer Inc. (Amendment)

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