NasdaqCM - Delayed Quote USD

Fortress Biotech, Inc. (FBIOP)

6.97

+0.37

+(5.61%)

At close: January 10 at 4:00:00 PM EST

FDA accepts Sentynl’s Menkes disease therapy NDA for priority review

Sentynl took over the therapy’s development and commercialisation from Fortress Biotech's subsidiary Cyprium Therapeutics.

Pharmaceutical Technology 5 days ago

FBIO
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones Cyprium also retains ownership over any Priority Review Voucher that may be issued at NDA approval MIAMI, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced the acceptance for

GlobeNewswire 6 days ago

FBIO

FBIOP
+5.61%
Sentynl Therapeutics Announces U.S. FDA Acceptance and Priority Review of New Drug Application for CUTX-101 (Copper Histidinate) Product Candidate for Treatment of Menkes Disease

Sentynl Therapeutics, Inc. ("Sentynl"), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. ("Zydus Group"), and Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress") announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and Priority review Sentynl's New Drug Application (NDA) for CUTX-101, the product candidate for the treatment of Menkes disease. Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the c

PR Newswire 6 days ago

FBIO

FBIOP
+5.61%
Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT™ (cosibelimab-ipdl)

UNLOXCYT is the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinomaWALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has approved UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative r

GlobeNewswire 29 days ago

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FBIOP
+5.61%
CKPT
Fortress Biotech Third Quarter 2024 Earnings: Misses Expectations

Fortress Biotech ( NASDAQ:FBIO ) Third Quarter 2024 Results Key Financial Results Revenue: US$14.6m (down 7.1% from 3Q...

Simply Wall St. last month

FBIO

FBIOP
+5.61%
Fortress Biotech: Q3 Earnings Snapshot

BAY HARBOR ISLAND, Fla. AP) — Fortress Biotech Inc. FBIO) on Thursday reported a loss of $12.9 million in its third quarter.

Associated Press Finance last month

FBIO
Fortress Biotech Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights

Emrosi approved by FDA on November 4 for the treatment of inflammatory lesions of rosacea in adults Cosibelimab PDUFA goal date of December 28 for potential approval to treat metastatic or locally advanced cutaneous squamous cell carcinoma MIAMI, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings

GlobeNewswire last month

FBIO

FBIOP
+5.61%
Avenue Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights

- Topline data in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy anticipated around year-end 2024MIAMI, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the third quarter ended September 30, 2024. “We have gen

GlobeNewswire last month

ATXI

FBIO

FBIOP
+5.61%
Checkpoint Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Updates

Biologics License Application for cosibelimab under review by U.S. FDA PDUFA goal date of December 28, 2024 WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the third quarter ended September 30, 2024, and recent corporate updates. “With the Prescription Drug User Fee Act (“PDUFA”) goal date set for next month, we await the decision by t

GlobeNewswire last month

FBIO

FBIOP
+5.61%
CKPT
Journey Medical Corporation Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights

U.S. FDA approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the treatment of inflammatory lesions of rosacea in adults; launch expected in late Q1 or early Q2 of 2025 Total revenues for the third quarter ended September 30, 2024 were $14.6 million SCOTTSDALE, Ariz., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), a commercial-stage pharmaceutical company that primarily focuses on the

GlobeNewswire last month

FBIO

FBIOP
+5.61%
DERM
Mustang Bio Receives Positive Listing Determination from Nasdaq

WORCESTER, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, today announced that by decision dated November 8, 2024, the Nasdaq Hearings Panel granted the Company’s request for an extension to evidence compliance with all applicable criteria for continued listing on The Nasdaq

GlobeNewswire last month

MBIO

FBIO

FBIOP
+5.61%
Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-108 (HSV-1 oncolytic virus) to Treat Malignant Glioma

MB-108 (HSV-1 oncolytic virus) is active and well tolerated in patients with recurrent glioblastoma in ongoing Phase 1 clinical trial Preclinical data support a novel combination of MB-108 (HSV-1 oncolytic virus) and MB-101 (IL13Rα2‐targeted CAR-T cell therapy) to optimize clinical results WORCESTER, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthrough

GlobeNewswire 2 months ago

MBIO

FBIO

FBIOP
+5.61%
Journey Medical Corporation Announces U.S. FDA Approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea

Journey Medical to host investor conference call on Monday, November 4, 2024, at 8:30 a.m. E.T.SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the FDA has approved Emrosi™ (Minocycline

GlobeNewswire 2 months ago

DERM

FBIO

FBIOP
+5.61%
Fortress Biotech Insiders Placed Bullish Bets Worth US$4.49m

Quite a few insiders have dramatically grown their holdings in Fortress Biotech, Inc. ( NASDAQ:FBIO ) over the past 12...

Simply Wall St. 2 months ago

FBIO

FBIOP
+5.61%
Highbridge Capital Management's Strategic Acquisition of Fortress Biotech Shares

On September 30, 2024, Highbridge Capital Management LLC, a prominent New York-based hedge fund, executed a significant transaction by acquiring 2,734,854 shares of Fortress Biotech Inc (NASDAQ:FBIO). The total shares now held by the firm in Fortress Biotech amount to the same, indicating a new entry into this stock within their portfolio. This move has a notable impact, constituting 0.63% of Highbridge's portfolio and representing a 9.00% ownership in Fortress Biotech.

GuruFocus.com 2 months ago

FBIO
Journey Medical Corporation Announces DFD-29 Data Presented at 44th Fall Clinical Dermatology Conference

Poster Presented on Dermal and Systemic Pharmacokinetics of Oral DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) versus Oral Doxycycline 40 mg Capsules (Oracea®) in Healthy Subjects With its modified-release formulation, DFD-29 (40 mg) provides higher dermal concentration than doxycycline from Day 1 onward at a similar dose, expected to translate into a clinically meaningful impact for treating patients with rosacea New Drug Application for DFD-29 under review by FDA with PDU

GlobeNewswire 2 months ago

DERM

FBIO

FBIOP
+5.61%
Mustang Bio Announces Exercise of Warrants for $4 Million Gross Proceeds

WORCESTER, Mass., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, today announced that it has entered into a definitive agreement for the exercise of certain existing warrants to purchase an aggregate of 16,877,638 shares of its common stock having an exercise price of $0.237 per sha

GlobeNewswire 2 months ago

MBIO

FBIO

FBIOP
+5.61%
Avenue Therapeutics to Participate in Maxim Group’s 2024 Healthcare Virtual Summit

MIAMI, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics, will participate in a fireside chat at Maxim Group’s 2024 Healthcare Virtual Summit on Tuesday, October 15, 2024 at 1:30 PM ET. The fireside chat will be av

GlobeNewswire 3 months ago

ATXI

FBIO

FBIOP
+5.61%
Journey Medical Corporation to Participate in the 3rd Annual ROTH Healthcare Opportunities Conference

SCOTTSDALE, Ariz., Oct. 03, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (“Journey Medical” or “the Company”) (Nasdaq: DERM), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that members of Journey Medical’s management team will attend one-on-one meetings at the 3rd Annual ROTH Healthcare O

GlobeNewswire 3 months ago

FBIO

FBIOP
+5.61%
DERM
Fortress Biotech to Participate in October 2024 Investor Conferences

MIAMI, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in the following upcoming October 2024 investor conferences: Lytham Partners Fall 2024 Inv

GlobeNewswire 3 months ago

FBIO

FBIOP
+5.61%

Performance Overview

Return	FBIOP	S&P 500
YTD	+3.23%	-1.35%
1-Year	-40.11%	+22.51%
3-Year	-63.05%	+24.59%

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Fortress Biotech, Inc. (FBIOP)

FDA accepts Sentynl’s Menkes disease therapy NDA for priority review

Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease

Sentynl Therapeutics Announces U.S. FDA Acceptance and Priority Review of New Drug Application for CUTX-101 (Copper Histidinate) Product Candidate for Treatment of Menkes Disease

Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT™ (cosibelimab-ipdl)

Fortress Biotech Third Quarter 2024 Earnings: Misses Expectations

Fortress Biotech: Q3 Earnings Snapshot

Fortress Biotech Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights

Avenue Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights

Checkpoint Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Updates

Journey Medical Corporation Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights

Mustang Bio Receives Positive Listing Determination from Nasdaq

Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-108 (HSV-1 oncolytic virus) to Treat Malignant Glioma

Journey Medical Corporation Announces U.S. FDA Approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea

Fortress Biotech Insiders Placed Bullish Bets Worth US$4.49m

Highbridge Capital Management's Strategic Acquisition of Fortress Biotech Shares

Journey Medical Corporation Announces DFD-29 Data Presented at 44th Fall Clinical Dermatology Conference

Mustang Bio Announces Exercise of Warrants for $4 Million Gross Proceeds

Avenue Therapeutics to Participate in Maxim Group’s 2024 Healthcare Virtual Summit

Journey Medical Corporation to Participate in the 3rd Annual ROTH Healthcare Opportunities Conference

Fortress Biotech to Participate in October 2024 Investor Conferences

Performance Overview