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Category Archives: Global News Feed

HilleVax to Present at the 42nd Annual J.P. Morgan Healthcare Conference

BOSTON, Jan. 03, 2024 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that it will present at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California on Monday, January 8, 2024 at 4:30 p.m. EST / 1:30 p.m. PST. HIL-214, HilleVax’s investigational virus-like particle (VLP) based vaccine for the prevention of moderate-to-severe norovirus-related acute gastroenteritis, and the related ongoing Phase 2b study NEST-IN1 will be topics of discussion.

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HilleVax to Present at the 42nd Annual J.P. Morgan Healthcare Conference

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Burning Rock Announces Receipt of Notification from NASDAQ

GUANGZHOU, China, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today announced that it has received written notification from the staff of the Listing Qualifications Department of the Nasdaq Stock Market LLC (“NASDAQ”) dated December 29, 2023, indicating that for the last 30 consecutive business days, the closing bid price for the Company’s American depositary shares (the “ADSs”) was below the minimum bid price of US$1.00 per share requirement set forth in NASDAQ Listing Rule 5450(a)(1). The NASDAQ notification letter has no current effect on the listing or trading of the Company’s securities on NASDAQ.

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Burning Rock Announces Receipt of Notification from NASDAQ

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FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older

WESTLAKE VILLAGE, Calif., Dec. 15, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. ZORYVE foam provides rapid disease clearance and significant reduction in itch, with nearly 80% of individuals achieving the primary efficacy endpoint of IGA Success and just over 50% of individuals reaching complete clearance at Week 8 in the STRATUM trial. ZORYVE is a once-daily steroid-free foam and the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.

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FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older

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Santhera’s AGAMREE® (Vamorolone) Approved in the European Union for the Treatment of Duchenne Muscular Dystrophy

Pratteln, Switzerland, December 18, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces that AGAMREE® (vamorolone) has been approved in the European Union (EU) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, independent of the underlying mutation and ambulatory status. The European Medicines Agency (EMA) acknowledged clinically important safety benefits of AGAMREE with regards to maintaining normal bone metabolism, density and growth compared to standard of care corticosteroids, alongside similar efficacy [1]. In addition, patients who switched from a standard of care corticosteroid to AGAMREE maintained the efficacy benefit while recovering their growth and bone health.

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Santhera’s AGAMREE® (Vamorolone) Approved in the European Union for the Treatment of Duchenne Muscular Dystrophy

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Ultimovacs Announces Completion of Exploratory Phase I TENDU Study of TET Vaccine Technology Platform Meeting the Primary Endpoint

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Ultimovacs Announces Completion of Exploratory Phase I TENDU Study of TET Vaccine Technology Platform Meeting the Primary Endpoint

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MDxHealth Announces Completion of Transition to Single Listing on Nasdaq

NEWS RELEASE – REGULATED INFORMATIONDECEMBER 18, 2023, 1:00 AM ET / 07:00 AM CET

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MDxHealth Announces Completion of Transition to Single Listing on Nasdaq

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