FDA Approval for FUROSCIX issued to SCPHARMACEUTICALS INC

10/11/22 1:54:57 PM ET

$SCPH

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 209988
Company: SCPHARMACEUTICALS INC

Products on NDA 209988

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FUROSCIX	FUROSEMIDE	80MG/10ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209988

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/07/2022	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209988Orig1s000ltr.pdf

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Recent Analyst Ratings for
$SCPH

Date	Price Target	Rating	Analyst
9/7/2023	$20.00	Buy	Craig Hallum
12/1/2022	$25.00	Outperform	Cowen
10/21/2022	$14.00	Buy	Jefferies
10/11/2022	$11.00	Mkt Perform → Outperform	SVB Leerink
8/2/2022	$10.00	Buy	Maxim Group
9/9/2021	$6.00	Market Perform	SVB Leerink

More analyst ratings

$SCPH
Financials

Live finance-specific insights

scPharmaceuticals Inc. Reports Second Quarter 2024 Financial Results and Provides Business Update
Generated 2Q 2024 net FUROSCIX® revenue of $8.1 million, up 33% sequentially from Q1 Completed financing that extends our cash runway through expected profitability Advanced multiple FUROSCIX growth initiatives including label expansion for heart failure, sNDA submission for CKD, and positive topline pivotal PK data for our Autoinjector Company to host investor conference call and webcast today, Wednesday, August 14th, at 4:30pm ET BURLINGTON, Mass., Aug. 14, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient car
8/14/24 4:01:00 PM ET
$SCPH
Biotechnology: Pharmaceutical Preparations
Health Care
scPharmaceuticals to Announce Second Quarter 2024 Financial Results on Wednesday, August 14, 2024
BURLINGTON, Mass., Aug. 08, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that scPharmaceuticals management will host a conference call and audio webcast at 4:30 p.m. ET on Wednesday, August 14, 2024, to discuss the financial results for the second quarter 2024 and provide a business update. Participants should dial 1-877-407-9208 (domestic) or 1-201-493-6784 (international) with the conference code 13747259. To access the new Call me™ feature, which avoids hav
8/8/24 4:05:00 PM ET
$SCPH
Biotechnology: Pharmaceutical Preparations
Health Care
scPharmaceuticals Inc. Reports First Quarter 2024 Financial Results and Provides Business Update
Generated 1Q 2024 net FUROSCIX® revenue of $6.1 million, despite an estimated 10% impact to doses filled resulting from the Change Healthcare cyberattack Ended 1Q 2024 with cash and cash equivalents of $58.4 million Company to host investor conference call and webcast today, Tuesday, May 14, at 4:30pm ET BURLINGTON, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the first quarter ended March 31, 2024, and provided a business
5/14/24 4:01:00 PM ET
$SCPH
Biotechnology: Pharmaceutical Preparations
Health Care

scPharmaceuticals to Host Key Opinion Leader (KOL) Webinar on October 22, 2024
BURLINGTON, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that it will host a KOL webinar focused on a nephrologist's perspective on the use of FUROSCIX for treating fluid overload in heart failure and potential use for patients with chronic kidney disease (CKD) on Tuesday, October 22, 2024 at 1:00 PM ET. To register, click here. https://lifescievents.com/event/scpharmaceuticals/ The event will feature Dr. Michael Aaronson, MD (Lincoln Nephrolog
10/15/24 8:30:00 AM ET
$SCPH
Biotechnology: Pharmaceutical Preparations
Health Care
scPharmaceuticals to Present at the H.C. Wainwright 26th Annual Global Investment Conference
BURLINGTON, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that John Tucker, President & Chief Executive Officer, will present at the H.C. Wainwright 26th Annual Global Investment Conference on Wednesday, September 11 at 10:00AM ET. Mr. Tucker will also be meeting with investors that day. A webcast of the presentation can be accessed here or under "News & Events" in the Investor Relations section of the Company's website, www.scPharmaceuticals.
9/4/24 4:05:00 PM ET
$SCPH
Biotechnology: Pharmaceutical Preparations
Health Care
scPharmaceuticals Inc. Reports Second Quarter 2024 Financial Results and Provides Business Update
Generated 2Q 2024 net FUROSCIX® revenue of $8.1 million, up 33% sequentially from Q1 Completed financing that extends our cash runway through expected profitability Advanced multiple FUROSCIX growth initiatives including label expansion for heart failure, sNDA submission for CKD, and positive topline pivotal PK data for our Autoinjector Company to host investor conference call and webcast today, Wednesday, August 14th, at 4:30pm ET BURLINGTON, Mass., Aug. 14, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient car
8/14/24 4:01:00 PM ET
$SCPH
Biotechnology: Pharmaceutical Preparations
Health Care

FDA Approval for FUROSCIX issued to SCPHARMACEUTICALS INC

Products on NDA 209988

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209988

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $SCPH

$SCPH Financials

Live finance-specific insights

scPharmaceuticals Inc. Reports Second Quarter 2024 Financial Results and Provides Business Update

scPharmaceuticals to Announce Second Quarter 2024 Financial Results on Wednesday, August 14, 2024

scPharmaceuticals Inc. Reports First Quarter 2024 Financial Results and Provides Business Update

$SCPH Press Releases

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$SCPH Market Insights

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$SCPH Large Ownership Changes

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scPharmaceuticals to Host Key Opinion Leader (KOL) Webinar on October 22, 2024

scPharmaceuticals to Present at the H.C. Wainwright 26th Annual Global Investment Conference

scPharmaceuticals Inc. Reports Second Quarter 2024 Financial Results and Provides Business Update

scPharmaceuticals Announces Filing Acceptance Of sNDA From The FDA Seeking To Expand FUROSCIX Indication To Include Chronic Kidney Disease

HC Wainwright & Co. Reiterates Buy on scPharmaceuticals, Maintains $18 Price Target

scPharmaceuticals Q1 2024 GAAP EPS $(0.36) Beats $(0.44) Estimate, Sales $6.10M Beat $5.98M Estimate

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

Amendment: SEC Form SC 13D/A filed by scPharmaceuticals Inc.

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

$SCPH SEC Filings

SEC Form 10-Q filed by scPharmaceuticals Inc.

scPharmaceuticals Inc. filed SEC Form 8-K: Results of Operations and Financial Condition

SEC Form 8-K filed by scPharmaceuticals Inc.

$SCPH FDA approvals

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FDA Approval for FUROSCIX issued to SCPHARMACEUTICALS INC

$SCPH Insider Purchases

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Large owner Orbimed Advisors Llc bought $2,000,000 worth of shares (500,000 units at $4.00) (SEC Form 4)

$SCPH Analyst Ratings

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$SCPH Leadership Updates

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$SCPH Insider Trading

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Craig Hallum initiated coverage on scPharmaceuticals with a new price target

Cowen initiated coverage on scPharmaceuticals with a new price target

Jefferies resumed coverage on scPharmaceuticals with a new price target

Lantheus Announces Appointment of Minnie Baylor-Henry as New Board Member

Amendment: CFO and Treasurer Nokes Rachael exercised 10,445 shares at a strike of $1.66, increasing direct ownership by 17% to 72,851 units (SEC Form 4)

Director Schaeffer Leonard D exercised 11,347 shares at a strike of $2.58, increasing direct ownership by 26% to 54,451 units (SEC Form 4)

Large owner Orbimed Advisors Llc bought $2,000,000 worth of shares (500,000 units at $4.00) (SEC Form 4)

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Financials

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