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FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy (SMA)

Posted: February 13, 2025 at 2:44 am

Basel, 12 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for an Evrysdi® (risdiplam) tablet for people living with spinal muscular atrophy (SMA). Evrysdi is the only non-invasive disease-modifying treatment for SMA. The 5 mg Evrysdi tablet can either be swallowed whole or dispersed in water.

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FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy (SMA)

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Genmab Files Annual Report with the U.S. Securities and Exchange Commission

Posted: February 13, 2025 at 2:44 am

Media ReleaseCOPENHAGEN, Denmark; February 12, 2025

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Genmab Files Annual Report with the U.S. Securities and Exchange Commission

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Orion Corporation: Disclosure Under Chapter 9 Section 10 of the Securities Market Act (BlackRock, Inc.)

Posted: February 13, 2025 at 2:44 am

ORION CORPORATION STOCK EXCHANGE RELEASE – MAJOR SHAREHOLDER ANNOUNCEMENTS12 FEBRUARY 2025 at 21.00 EET

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Orion Corporation: Disclosure Under Chapter 9 Section 10 of the Securities Market Act (BlackRock, Inc.)

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Mdxhealth to Present Fourth Quarter and Full Year 2024 Financial Results and Corporate Update on February 26

Posted: February 13, 2025 at 2:44 am

Company to Host Conference Call with Live Q&A, February 26, 2025, at 4:30pm ET / 22:30 CET

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Mdxhealth to Present Fourth Quarter and Full Year 2024 Financial Results and Corporate Update on February 26

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Bio-Path Holdings Provides Update from Phase 1/1b Clinical Trial of BP1002 for Treatment of Refractory/Relapsed Acute Myeloid Leukemia

Posted: February 13, 2025 at 2:44 am

Study Progresses to Fourth Higher 90 mg/m2 Dose Cohort

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Bio-Path Holdings Provides Update from Phase 1/1b Clinical Trial of BP1002 for Treatment of Refractory/Relapsed Acute Myeloid Leukemia

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Galapagos Reports Full Year 2024 Results and Provides Fourth Quarter Business Update

Posted: February 13, 2025 at 2:44 am

Compelling clinical results for GLPG5101 in three NHL indications underscore potential of innovative decentralized cell therapy platform to deliver fresh, fit cells, in median seven days vein-to-vein

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Galapagos Reports Full Year 2024 Results and Provides Fourth Quarter Business Update

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Ascendis Pharma A/S Announces Share Repurchase Program & Net Settlement of Certain RSUs

Posted: February 13, 2025 at 2:44 am

– Expected use of approximately $25 million in first quarter of 2025 intended to preserve approximately 200,000 ADSs held as treasury shares

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Ascendis Pharma A/S Announces Share Repurchase Program & Net Settlement of Certain RSUs

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Rezolute Reports Second Quarter Fiscal 2025 Financial Results and Provides Business Update

Posted: February 13, 2025 at 2:44 am

Ersodetug, a novel, fully human monoclonal antibody for the treatment of hyperinsulinism (HI), receives Breakthrough Therapy Designation and Orphan Drug Designation

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Rezolute Reports Second Quarter Fiscal 2025 Financial Results and Provides Business Update

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Vaxcyte to Report Fourth Quarter and Full Year 2024 Financial Results on February 25, 2025

Posted: February 13, 2025 at 2:44 am

SAN CARLOS, Calif., Feb. 12, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, announced today that it will report financial results for the fourth quarter and full year 2024 after market close on February 25, 2025. Company management will host a conference call and webcast beginning at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a business update.

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Vaxcyte to Report Fourth Quarter and Full Year 2024 Financial Results on February 25, 2025

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Senseonics Holdings, Inc. Schedules Fourth Quarter and Full Year 2024 Earnings Release and Conference Call for March 3, 2025 at 4:30 P.M. Eastern Time

Posted: February 13, 2025 at 2:44 am

GERMANTOWN, Md., Feb. 12, 2025 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced that it plans to release its fourth quarter and full year 2024 financial results after market close on Monday, March 3, 2025.

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Senseonics Holdings, Inc. Schedules Fourth Quarter and Full Year 2024 Earnings Release and Conference Call for March 3, 2025 at 4:30 P.M. Eastern Time

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