€451M Revolving Credit Facility refinanced with a maturity extended to February 2029 Issuance of a €200M Perpetual Deeply Subordinated Hybrid Bond subscribed by Sanofi €54M product capacity reservation for five products and further amendments to the global Manufacturing and Supply Agreement (MSA) agreed with Sanofi “The completion of the financing is an instrumental step in the execution of EUROAPI’s strategic roadmap” said Ludwig de Mot, Chief Executive Officer. “Combined with further developm

Approval is based on Phase III INAVO120 results, showing the Itovebi™ (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting1 This approval helps address an urgent unmet need in breast cancer for people with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease, associated with poor prognosis2,3 Itovebi is Roche’s first targeted therapy approved for people with HR-positive disease

Oct. 10, 2024 -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced an agreement with Roche to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq®) and bevacizumab, the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), into a pivotal Phase 3 trial for the first-line treatment of unresec

– Company has received a No Objection Letter from Health Canada in response to submission of its Phase 1 Clinical Trial Application (CTA) – The study is a Phase 1 Single Ascending Dose (SAD) /Multiple Ascending Dose (MAD) and food effects (FE) and includes multiple dose treatment of UC patients; Global UC market is expected to grow to nearly $10 Billion by 2028 Oct. 10, 2024 -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a biopharmaceutical company focused o

Investigational agent in development as a one dose treatment or prevention of seasonal and pandemic influenza A dose ranging, Phase 1 study in healthy volunteers demonstrated positive tolerability results and plasma levels in the predicted therapeutic window, enabling selection of Phase 2 dose Preclinical data showed potent inhibition of drug-resistant and bird influenza viruses Phase 2 study expected to begin in H1 2025 Improved therapy is an important need for both seasonal and pandemic flu Oc

AI (Artificial Intelligence) and ML (Machine Learning) drug discovery collaboration will accelerate the development of small molecules as orally available host-targeted broad-spectrum medical countermeasures Host-directed antiviral drugs have the potential to enhance the immune response to viruses from a range of viral families Tonix was awarded a contract with the U.S. Department of Defense for up to $34 million for the accelerated development of its host-directed broad-spectrum antiviral progr

Safety, pharmacokinetics and target engagement data from first-in-human Phase 1 clinical trial in healthy volunteers will potentially enable rapid advancement of IMSB301 into Phase 1b/2 clinical studies in Type I interferonopathies Oct. 08, 2024 -- ImmuneSensor Therapeutics, a clinical-stage biotherapeutics company focused on the development of first- and best-in-class inhibitors and agonists targeting the cGAS-STING pathway to address diverse peripheral and CNS indications in inflammation,

Zealand Pharma provides U.S. regulatory update on dasiglucagon in congenital hyperinsulinism U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for dasiglucagon in CHI for up to three weeks of dosing due to the timing of a third-party manufacturing facility reinspection The reinspection of the facility was completed in August/September 2024 for which a new inspection classification is pending Zealand remains committed to working with the FDA and the third-party manufac

Oct. 08, 2024 -- Oragenics Inc. (NYSE American: OGEN), a company focused on developing new treatments for brain-related health conditions, has completed a key study for their new concussion drug, ONP-002. This drug is designed to be delivered through the nose, which could help it reach the brain quickly after a head injury. The recent study shows that the drug successfully targets areas inside the nose that are connected to the brain. This makes it more likely to reach and treat the brain afte

Oct. 08, 2024 -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced a regulatory update from the U.S. Food and Drug Administration (FDA). The FDA Review Division has determined that there does not appear to be a need for an advisory committee meeting at this time for the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment