FDA Approval for ZORYVE issued to ARCUTIS BIOTHERAPEUTICS INC

12/15/23 5:01:31 PM ET

$ARQT

Biotechnology: Pharmaceutical Preparations

Health Care

Get the next $ARQT alert in real time by email

New Drug Application (NDA): 217242
Company: ARCUTIS BIOTHERAPEUTICS INC

Products on NDA 217242

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZORYVE	ROFLUMILAST	0.3%	FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217242

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2023	ORIG-1	Approval	Type 3 - New Dosage Form and Type 4 - New Combination	STANDARD		Label is not available on this site.

Get the next $ARQT alert in real time by email

Chat with this insight

Save time and jump to the most important pieces.

Recent Analyst Ratings for
$ARQT

Date	Price Target	Rating	Analyst
8/28/2024	$15.00	Buy	Jefferies
1/3/2024	$4.00 → $8.00	Neutral → Buy	Mizuho
10/26/2023	$57.00 → $4.00	Buy → Neutral	Mizuho
10/13/2023	$32.00 → $6.00	Buy → Neutral	Goldman
9/7/2022	$46.00	Buy	Needham
3/17/2022	$45.00	Buy	Goldman
3/2/2022	$35.00 → $37.00	Overweight	Morgan Stanley
11/19/2021	$50.00 → $35.00	Overweight	Morgan Stanley

More analyst ratings

$ARQT
Market Insights

Live Market Insights

Arcutis Submits Supplemental NDA For ZORYVE Foam To The FDA For The Treatment Of Scalp And Body Psoriasis In Adults And Adolescents Ages 12 And Over
Approximately 40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp Once-daily ZORYVE foam significantly improved both scalp and body psoriasis in a Phase 2b and a pivotal Phase 3 trialData also show rapid reduction in scalp itch as soon as 24 hours after first applicationZORYVE foam demonstrated a favorable safety and tolerability profileWESTLAKE VILLAGE, Calif., July 23, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) for ZO
7/23/24 8:17:08 AM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care
Arcutis To Host ZORYVE Cream 0.15% FDA Approval Call With Key Opinion Leader On Monday, July 29, 2024 at 8:30am ET
Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will host a virtual Key Opinion Leader (KOL) event featuring a leading dermatology and immune-mediated skin disease expert to discuss the unmet need and current treatment landscape for individuals with mild to moderate atopic dermatitis (AD). The event will highlight the differentiating features of and commercialization plans for ZORYVE® (roflumilast) cream 0.15%, which recently received FDA approval for the treatment of AD in adults and children down to age 6. Details for the event are as follows:Monday, July 29
7/22/24 8:06:50 AM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care
FDA Approves Expanded Use Of Arcutis Biotherapeutics' Eczema Drug For Patients As Young As 6 Years
On Tuesday, the FDA approved Arcutis Biotherapeutics Inc’s (NASDAQ:ARQT) supplemental new drug application (sNDA) for Zoryve (roflumilast) cream, 0.15%, for mild to moderate atopic dermatitis in patients six years of age and older. “Today marks the third FDA approval of a commercial product for Arcutis in just the last two years, and we are thrilled to be able to offer ZORYVE cream 0.15% as a new steroid-free treatment option to children and adults living with AD,” said Frank Watanabe, president and CEO of Arcutis. Arcutis intends to make Zoryve cream 0.15% widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of July. In the firs
7/10/24 11:23:23 AM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care

$ARQT
Financials

Live finance-specific insights

Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update
Third quarter net product revenues for ZORYVE® (roflumilast) franchise of $44.8M, with $22.0M for ZORYVE cream 0.3%, $20.3M for ZORYVE topical foam 0.3%, and $2.5M for ZORYVE cream 0.15%; sales growth of 452% vs. Q3 '23 and 45% vs. Q2 '24Continued gross-to-net (GTN) improvement with blended GTN across products now in the low 50 percent range, improving from the high 50 percent range last quarterSustained growth in prescriptions for both cream and foam, with total U.S. franchise unit demand increase of 25% quarter over quarterSupplemental New Drug Application (sNDA) for ZORYVE foam accepted by Food & Drug Administration (FDA) for the treatment of scalp and body psoriasis in adults and adolesc
11/6/24 4:00:00 PM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care
Arcutis to Report Third Quarter 2024 Financial Results and Participate in an Upcoming Investor Conference
Quarterly investor conference call and webcast is scheduled for Wednesday, November 6 at 4:30 p.m. ETArcutis management will also participate in the Guggenheim Securities Healthcare Innovation Conference in November WESTLAKE VILLAGE, Calif., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will report third quarter 2024 financial results and provide a business update on Wednesday, November 6, 2024 after the U.S. financial markets close. The Company will also host a conference call and webcast the same day at 4:30 p.m. ET. A
10/23/24 4:00:00 PM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care
Arcutis Announces Second Quarter 2024 Financial Results and Provides Business Update
Second quarter net product revenues for ZORYVE® franchise of $30.9M, with $17.3M for ZORYVE (roflumilast) cream 0.3%, and $13.6M for ZORYVE (roflumilast) topical foam, 0.3%; sales growth of 547% vs. Q2 '23 and 43% vs. Q1 '24Continued gross-to-net (GTN) improvement with blended GTN across products now in the high 50 percent range, improving from the low 60 percent range last quarterSustained growth in prescriptions for both cream and foam, with total U.S. franchise unit demand increase of 42% quarter over quarterEntered into ZORYVE co-promotion agreement with Kowa Pharmaceuticals America, Inc., expanding promotional efforts to primary care and pediatric offices in the United StatesSubmitted S
8/14/24 4:00:00 PM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care

$ARQT
Leadership Updates

Live Leadership Updates

Arcutis Appoints L. Todd Edwards as Chief Commercial Officer
Industry veteran with deep commercial experience in dermatology and immunologyAyisha Jeter appointed Senior Vice President, Marketing and Market Access WESTLAKE VILLAGE, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the appointment of Todd Edwards as Chief Commercial Officer (CCO), effective immediately. Mr. Edwards brings to Arcutis over 25 years of sales, market access, marketing, and general management experience from leading companies in dermatology and immunology, including Incyte, UCB, and AbbVie. "We are t
9/27/23 8:00:00 AM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care
Arcutis Announces Leadership Transition
Senior Vice President and Chief Commercial Officer (CCO) Ken Lock Stepping DownAyisha Jeter Appointed Interim CCO WESTLAKE VILLAGE, Calif., May 24, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced a leadership change. Ken Lock, who has served as Senior Vice President and Chief Commercial Officer (CCO) since October 2019, is stepping down to attend to personal matters effective June 2, 2023. During this transition period, Arcutis' Vice President of Market Access, Ayisha Jeter, has been appointed interim CCO. Mr. Lock's contributions t
5/24/23 5:00:03 PM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care
Arcutis Appoints Mas Matsuda as General Counsel and Corporate Secretary
WESTLAKE VILLAGE, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the appointment of Mas Matsuda, Esq. as General Counsel and Corporate Secretary. Mr. Matsuda joins Arcutis from Halozyme Therapeutics Inc. and succeeds Keith Klein, Esq. who announced his retirement after a successful 30-year industry career. In this role, Mr. Matsuda will oversee all legal and compliance matters for the Company. "On behalf of our entire team, we'd like to thank Keith for his considerable contributions to our efforts in establishing Arcutis as a le
12/16/21 8:00:00 AM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care

Arcutis' ZORYVE® (roflumilast) Awarded Best Eczema Treatment by Glamour
ZORYVE cream 0.15% is the first once-daily, Food and Drug Administration (FDA)-approved topical treatment for mild to moderate atopic dermatitisZORYVE, a next-generation topical phosphodiesterase-4 (PDE4) inhibitor, recognized for redefining topical treatment drug delivery for immune-mediated skin diseases and for its proprietary formulation WESTLAKE VILLAGE, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis' ZORYVE® (roflumilast) cream 0.15% has received Glamour's 2024 Health and Wellness award for Best Eczema
11/13/24 8:00:00 AM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care
Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update
Third quarter net product revenues for ZORYVE® (roflumilast) franchise of $44.8M, with $22.0M for ZORYVE cream 0.3%, $20.3M for ZORYVE topical foam 0.3%, and $2.5M for ZORYVE cream 0.15%; sales growth of 452% vs. Q3 '23 and 45% vs. Q2 '24Continued gross-to-net (GTN) improvement with blended GTN across products now in the low 50 percent range, improving from the high 50 percent range last quarterSustained growth in prescriptions for both cream and foam, with total U.S. franchise unit demand increase of 25% quarter over quarterSupplemental New Drug Application (sNDA) for ZORYVE foam accepted by Food & Drug Administration (FDA) for the treatment of scalp and body psoriasis in adults and adolesc
11/6/24 4:00:00 PM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care
Arcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
WESTLAKE VILLAGE, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 50,000 restricted stock units of Arcutis' common stock as well as options to purchase an aggregate of 50,000 shares of Arcutis' common stock to five newly hired employees. These awards were approved by the Compensation Committee of Arcutis' Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of November 1, 2024, as an inducement material to the new employees entering into em
11/4/24 4:00:00 PM ET
$ARQT
Biotechnology: Pharmaceutical Preparations
Health Care

FDA Approval for ZORYVE issued to ARCUTIS BIOTHERAPEUTICS INC

Products on NDA 217242

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217242

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $ARQT

$ARQT Market Insights

Live Market Insights

Arcutis Submits Supplemental NDA For ZORYVE Foam To The FDA For The Treatment Of Scalp And Body Psoriasis In Adults And Adolescents Ages 12 And Over

Arcutis To Host ZORYVE Cream 0.15% FDA Approval Call With Key Opinion Leader On Monday, July 29, 2024 at 8:30am ET

FDA Approves Expanded Use Of Arcutis Biotherapeutics' Eczema Drug For Patients As Young As 6 Years

$ARQT Large Ownership Changes

This live feed shows all institutional transactions in real time.

Amendment: SEC Form SC 13G/A filed by Arcutis Biotherapeutics Inc.

Amendment: SEC Form SC 13G/A filed by Arcutis Biotherapeutics Inc.

Amendment: SEC Form SC 13G/A filed by Arcutis Biotherapeutics Inc.

$ARQT Insider Trading

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

Officer Matsuda Masaru was granted 4,875 shares and sold $17,190 worth of shares (1,775 units at $9.68), increasing direct ownership by 2% to 181,373 units (SEC Form 4)

Officer Burnett Patrick converted options into 18,477 shares and sold $712,621 worth of shares (69,226 units at $10.29), decreasing direct ownership by 28% to 128,669 units (SEC Form 4)

Director Curran Terrie sold $94,238 worth of shares (8,687 units at $10.85), decreasing direct ownership by 46% to 10,139 units (SEC Form 4)

$ARQT Financials

Live finance-specific insights

Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update

Arcutis to Report Third Quarter 2024 Financial Results and Participate in an Upcoming Investor Conference

Arcutis Announces Second Quarter 2024 Financial Results and Provides Business Update

$ARQT Leadership Updates

Live Leadership Updates

Arcutis Appoints L. Todd Edwards as Chief Commercial Officer

Arcutis Announces Leadership Transition

Arcutis Appoints Mas Matsuda as General Counsel and Corporate Secretary

$ARQT Press Releases

Fastest customizable press release news feed in the world

$ARQT FDA approvals

Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

Arcutis' ZORYVE® (roflumilast) Awarded Best Eczema Treatment by Glamour

Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update

Arcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

FDA Approval for ZORYVE issued to ARCUTIS BIOTHERAPEUTICS INC

FDA Approval for ZORYVE issued to ARCUTIS BIOTHERAPEUTICS INC

$ARQT Analyst Ratings

Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

Jefferies initiated coverage on Arcutis Biotherapeutics with a new price target

Arcutis Biotherapeutics upgraded by Mizuho with a new price target

Arcutis Biotherapeutics downgraded by Mizuho with a new price target

$ARQT SEC Filings

SEC Form 144 filed by Arcutis Biotherapeutics Inc.

SEC Form 144 filed by Arcutis Biotherapeutics Inc.

SEC Form 144 filed by Arcutis Biotherapeutics Inc.

$ARQT Insider Purchases

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

Heron Patrick J bought $199,994 worth of shares (21,052 units at $9.50) (SEC Form 4)

Watanabe Todd Franklin exercised 59,525 shares at a strike of $1.68 and bought $9,334 worth of shares (1,463 units at $6.38), increasing direct ownership by 13% to 515,145 units (SEC Form 4)

Recent Analyst Ratings for
$ARQT

$ARQT
Market Insights

$ARQT
Large Ownership Changes

$ARQT
Insider Trading

$ARQT
Financials

$ARQT
Leadership Updates

$ARQT
Press Releases

$ARQT
FDA approvals

$ARQT
Analyst Ratings

$ARQT
SEC Filings

$ARQT
Insider Purchases