FDA Approval for VOQUEZNA issued to PHATHOM PHARMACEUTICALS INC

7/18/24 10:52:01 AM ET

$PHAT

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 218710
Company: PHATHOM PHARMACEUTICALS INC

Products on NDA 218710

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VOQUEZNA	VONOPRAZAN FUMARATE	EQ 10MG BASE	TABLET; ORAL	Prescription	None	No	No
VOQUEZNA	VONOPRAZAN FUMARATE	EQ 20MG BASE	TABLET; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218710

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/17/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218710Orig1s000,215151Orig1s006ltr.pdf

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Recent Analyst Ratings for

$PHAT

Date	Price Target	Rating	Analyst
2/14/2025	$23.00	Overweight	Cantor Fitzgerald
5/3/2024	$24.00	Buy	Stifel
1/5/2024	$23.00 → $26.00	Buy	Needham
8/9/2023	$28.00	Buy	H.C. Wainwright
5/11/2023		In-line → Outperform	Evercore ISI
3/13/2023	$21.00	Buy	Craig Hallum
10/21/2022	$16.00	Buy	Jefferies
5/6/2022		Outperform → In-line	Evercore ISI

More analyst ratings

FDA Approval for VOQUEZNA issued to PHATHOM PHARMACEUTICALS INC

Products on NDA 218710

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218710

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for
$PHAT

$PHAT
Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

Director Karbe Frank was granted 10,500 shares, increasing direct ownership by 18% to 67,500 units (SEC Form 4)

Director Cola Michael F was granted 10,500 shares, increasing direct ownership by 36% to 39,798 units (SEC Form 4)

Director Fields Heidi was granted 10,500 shares, increasing direct ownership by 54% to 30,000 units (SEC Form 4)

$PHAT
Insider Purchases

Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

Director Topper James N bought $14,609 worth of shares (3,780 units at $3.86) (SEC Form 4)

Director Topper James N bought $24,462 worth of shares (7,420 units at $3.30) (SEC Form 4)

Director Topper James N bought $152,917 worth of shares (48,203 units at $3.17) (SEC Form 4)

FDA Approval for VOQUEZNA issued to PHATHOM PHARMACEUTICALS INC

Products on NDA 218710

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218710

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $PHAT

$PHAT Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

Director Karbe Frank was granted 10,500 shares, increasing direct ownership by 18% to 67,500 units (SEC Form 4)

Director Cola Michael F was granted 10,500 shares, increasing direct ownership by 36% to 39,798 units (SEC Form 4)

Director Fields Heidi was granted 10,500 shares, increasing direct ownership by 54% to 30,000 units (SEC Form 4)

$PHAT Insider Purchases

Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

Director Topper James N bought $14,609 worth of shares (3,780 units at $3.86) (SEC Form 4)

Director Topper James N bought $24,462 worth of shares (7,420 units at $3.30) (SEC Form 4)

Director Topper James N bought $152,917 worth of shares (48,203 units at $3.17) (SEC Form 4)

Recent Analyst Ratings for
$PHAT

$PHAT
Insider Trading

$PHAT
Insider Purchases