Strongbridge Biopharma

Strongbridge Biopharma’s primary focus has been to build its franchise around rare endocrine disorders, which includes product candidates for the treatment of endogenous Cushing’s syndrome and acromegaly, two rare diseases with a high unmet need for innovative treatment options. Given the well-identified and concentrated prescriber base addressing its target markets, the Company intends to use a small, focused sales force to market its products, if approved, in the United States, European Union and other key global markets. The Company intends to identify and in-license or acquire products or product candidates that would be complementary to its existing rare endocrine franchise or that would form the basis for new rare disease franchises.

Xeris Biopharma Holdings

CHICAGO & DUBLIN & TREVOSE, Pa.--(BUSINESS WIRE)--Xeris Pharmaceuticals, Inc. (“Xeris”) (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, and Strongbridge Biopharma plc (“Strongbridge”) (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced th

Xeris Pharmaceuticals, Inc. to Acquire Strongbridge Biopharma plc in Stock and CVR Transaction, Creating an Innovative Leader in Endocrinology and Rare Diseases

The FDA has accepted to review Strongbridge Biopharma plc's (NASDAQ: SBBP) marketing application for Recorlev (levoketoconazole) to treat endogenous Cushing's syndrome. Earlier than anticipated, the Company received the official Day 74 letter from the FDA.

Strongbridge Bio's Recorlev US Application For Cushing's Syndrome Under Review, Potential Approval In Early 2022

Strongbridge Biopharma plc (SBBP) CEO John Johnson on Q1 2021 Results - Earnings Call Transcript

Strongbridge Biopharma (SBBP) delivered earnings and revenue surprises of -10.00% and 2.00%, respectively, for the quarter ended March 2021. Do the numbers hold clues to what lies ahead for the stock?

Strongbridge Biopharma (SBBP) Reports Q1 Loss, Tops Revenue Estimates

Shares of Strongbridge Biopharma (NASDAQ:SBBP) fell 3.7% in pre-market trading after the company reported Q1 results. Quarterly Results Earnings per share rose 42.11% over the past year to ($0.11), which missed the estimate of ($0.10).

Recap: Strongbridge Biopharma Q1 Earnings

~ Reports KEVEYIS ®  (dichlorphenamide) First Quarter 2021 Revenue of $8.4 Million, a 25 Percent Increase Compared to $6.7 Million of Revenue During First Quarter of 2020 ~

Strongbridge Biopharma plc Reports First Quarter 2021 Financial Results and Provides Corporate Update

On Wednesday, May 12, Strongbridge Biopharma (NASDAQ:SBBP) will release its latest earnings report. Benzinga's report can help you figure out the ins and outs of the earnings release.

Strongbridge Biopharma Earnings Preview

DUBLIN, Ireland and TREVOSE, Pa., May 06, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that it will host a conference call with members of Strongbridge's management team on May 12, 2021 at 8:30 a.m. ET to discuss the Company's first quarter 2021 financial results and corporate highlights. The conference call will follow the anticipated release of the Company's financial results earlier that day.

Strongbridge Biopharma plc to Host First Quarter 2021 Financial Results Conference Call on May 12, 2021

Strongbridge Biopharma (SBBP) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Will Strongbridge Biopharma (SBBP) Report Negative Q1 Earnings? What You Should Know

SBBP has an approved product and a late-stage pipeline. However, Cushing's syndrome is a highly-differentiated market.

Strongbridge: Approved Drugs, Near-Term Catalysts, Still Not Convinced

RECORLEV® (levoketoconazole) Treatment Demonstrates Clinically Meaningful Improvements in Cortisol Control and Clinical Benefit in Patients with Cushing's Syndrome and Comorbid Diabetes Mellitus

Strongbridge Biopharma plc Announces Publication of Diabetes Subgroup Analysis from Phase 3 SONICS Study of RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing's Syndrome in Frontiers in Endocrinology

Strongbridge Biopharma plc (NASDAQ: SBBP) has announced detailed results from the previously reported Phase 3 LOGICS study of Recorlev (levoketoconazole) in patients with endogenous Cushing's syndrome. Data were presented at the Annual Meeting of the Endocrine Society.

Strongbridge Biopharma Stock Trading Higher On Detailed Recorlev Data In Cushing's Syndrome

The stock price of Strongbridge Biopharma plc (NASDAQ: SBBP) increased by over 25% during pre-market trading. This is why it happened.

SBBP Stock Price Increases Over 25% Pre-Market: Why It Happened

~ As Previously Reported, LOGICS Met its Primary Endpoint with Statistical Significance ~

Strongbridge Biopharma plc Presents Detailed Results from Pivotal Phase 3 LOGICS Study of RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing's Syndrome at the 2021 Annual Meeting of the Endocrine Society (ENDO)

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DUBLIN, Ireland and TREVOSE, Pa., March 15, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that management will present at Oppenheimer's 31st Annual Healthcare Conference on Wednesday, March 17, at 10:00 a.m. ET.   The conference is being held virtually.

Strongbridge Biopharma plc to Present at Oppenheimer's 31st Annual Healthcare Conference

Strongbridge Biopharma plc's (SBBP) CEO John Johnson on Q4 2020 Results - Earnings Call Transcript

Strongbridge Biopharma (SBBP) delivered earnings and revenue surprises of 15.38% and 1.04%, respectively, for the quarter ended December 2020. Do the numbers hold clues to what lies ahead for the stock?

Strongbridge Biopharma (SBBP) Reports Q4 Loss, Tops Revenue Estimates

Shares of Strongbridge Biopharma (NASDAQ:SBBP) moved higher by 0.6% in pre-market trading after the company reported Q4 results. Quarterly Results Earnings per share increased 56.00% over the past year to ($0.11), which beat the estimate of ($0.12).

Recap: Strongbridge Biopharma Q4 Earnings

~ Submitted New Drug Application (NDA) for RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing's Syndrome to U.S. Food & Drug Administration ~

Strongbridge Biopharma plc Reports Fourth Quarter and Full-Year 2020 Financial Results and Provides Corporate Update

Strongbridge Biopharma plc (NASDAQ: SBBP) has submitted a marketing application seeking approval for Recorlev (levoketoconazole) for the treatment of endogenous Cushing's syndrome, to the FDA. Endogenous Cushing's syndrome is a rare endocrine disease caused by chronic elevated cortisol exposure, often resulting in a benign tumor of the pituitary gland.

Strongbridge Biopharma Shares Are Trading Higher On Filing Recorlev US Application For Endocrine Disease

~ RECORLEV® (levoketoconazole) New Drug Application is Supported by Previously-Reported Positive and Statistically Significant Results from the Phase 3 SONICS and LOGICS Studies ~

Strongbridge Biopharma plc Announces Submission of New Drug Application for RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing's Syndrome to the U.S. Food & Drug Administration

DUBLIN, Ireland and TREVOSE, Pa., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that it will host a conference call with members of Strongbridge's management team on Wednesday, March 3, 2021 at 8:30 a.m. ET to discuss the Company's fourth quarter and full-year 2020 financial results and corporate highlights. The conference call will follow the anticipated release of the Company's financial results earlier that day.

Strongbridge Biopharma plc to Host Fourth Quarter and Full-Year 2020 Financial Results Conference Call on March 3, 2021

The stock price of Strongbridge Biopharma plc (NASDAQ: SBBP) is trading at over 50% pre-market. This is why it happened.

SBBP Stock Price Increases Over 50% Pre-Market: Why It Happened

Strongbridge Biopharma is looking at a major inflection year in 2021. In early January, the company provided strong preliminary fourth-quarter guidance but the major catalyst this year is the potential FDA approval of RECORLEV.

News for Strongbridge Biopharma Stock (SBBP)