Article 223-16 of general regulation of French Autorité des Marchés Financiers
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Monthly information related to total number of voting rights and shares composing the share capital – July 1, 2024
Basel, 04 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis with a hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival (OS) at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature. The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes the phase II and phase III cohorts. The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified. Based on these results, patients and investigators will be unblinded and we intend to halt the study. A communication will be sent to the investigators and results will be shared with health authorities and subsequently presented at an upcoming medical meeting.
NEW YORK, July 03, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (the “Company”) (Nasdaq: PBM) announced that it received a notification letter dated June 27, 2024, from the Listings Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the closing bid price per share of the Company’s common shares was below $1.00 for a period of 30 consecutive business days and that the Company did not meet the minimum bid price requirement set forth in Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Rule”).
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Psyence Biomedical Ltd. Receives Nasdaq Notification Regarding Minimum Bid Price Deficiency
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 04, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:?HCM; HKEX:?13) today announces that the New Drug Application (“NDA”) for tazemetostat for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) has been accepted for review and granted Priority Review by the China National Medical Products Administration (“NMPA”).
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HUTCHMED Announces NDA Acceptance in China for Tazemetostat for the Treatment of Relapsed or Refractory Follicular Lymphoma with Priority Review...
NAARDEN, The Netherlands and MIAMI, July 03, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that the Compensation Committee of NewAmsterdam’s Board of Directors approved the grant of inducement share options covering an aggregate of 195,000 of NewAmsterdam’s ordinary shares to three non-executive new hires. The share options were granted as an inducement material to the employees’ acceptance of employment with NewAmsterdam pursuant to the NewAmsterdam Pharma Company N.V. 2024 Inducement Plan (the “2024 Inducement Plan”) and in accordance with Nasdaq Listing Rule 5635(c)(4).
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NewAmsterdam Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
VALNEVA
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Declaration of shares and voting rights - Valneva SE - June 30, 2024
Oxurion announces the results of the Extraordinary General Meeting (EGM) held on 4 July 2024 and convenes a new EGM on 24 July 2024.
Sheridan, Wyoming, USA, July 04, 2024 (GLOBE NEWSWIRE) -- Rafarma Pharmaceuticals (OTC: RAFA) - Rafarma Pharmaceuticals is pleased to announce its participation in the scientific conference on radioembolization using Yttrium 90 microspheres for the treatment of cancer at Severance Hospital in Seoul, South Korea. It is one of the largest university hospitals in South Korea and is of strategic importance to the country.
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Rafarma pharmaceutical updates: registration of Rafarma microspheres in South Korea
Basel, 05 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the United States Food and Drug Administration (US FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to 80 million people globally.1-4 The Vabysmo PFS will become available to United States (US) retina specialists and their patients in the coming months.
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FDA approves Roche’s Vabysmo prefilled syringe (PFS) for three leading causes of vision loss
PRESS RELEASE – PRIVILEGED INFORMATION
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Medsenic, subsidiary of BioSenic SA, extends key patent to the United States