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Major progress in development of vilobelimab Phase III study in PG announced following detailed feedback and recommendations from the U.S. Food and Drug Administration (FDA); clinical trial protocol submitted; first patient expected around mid-2023 Fast Track and Orphan Drug desig...
Multi-national, randomized, controlled adaptive Phase III design for vilobelimab in ulcerative pyoderma gangrenosum (PG) Trial size to be adapted upon interim analysis with planned total patient number between approximately 50 and 100 patients FDA review of application for emergen...
Summary I explain why I've added Organigram to my tax loss selling basket. I also review the company's performance and risks. Finally, I recap my entire 2022 tax loss selling basket of stocks, some of which I didn't have time to write up individually. Tax Loss Selling Strategy...
Summary Sichuan Kelun-Biotech will partner seven preclinical antibody-drug conjugate assets with Merck in a deal that pays Kelun-Biotech $175 million upfront and up to $9.3 billion in milestones - the third ADC deal between the two companies this year. LianBio announced that Pfizer will...
InflaRx ( NASDAQ: IFRX ) amended an existing co-development agreement with Staidson (Beijing) BioPharmaceuticals (together with its affiliates, STS) to support efforts for regulatory approval of COVID-19 drug BDB-001 in China. The company said BDB-001, an anti-C5a antibody w...
InflaRx will provide access to certain clinical, manufacturing and regulatory documentation for vilobelimab to facilitate STS’s regulatory filings in China STS plans to request regulatory approval in China for its own anti-C5a-antibody BDB-001 for the treatment of COVID-19 based on...
InflaRx press release ( NASDAQ: IFRX ): Q3 GAAP EPS of -€0.18. On September 30, 2022, the Company’s total funds available were approximately €93.2 million, composed of cash and cash equivalents of €18.0 million and marketable securities of ...
Randomized, double-blind, placebo-controlled Phase I trial of orally administered complement inhibitor INF904 initiated Study designed as single ascending dose to determine safety, tolerability and pharmacokinetics in healthy volunteers Future development in complement...
Vilobelimab earns Orphan Drug and Fast Track designation for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients - Emergency Use Authorization (EUA) submitted to U.S. Food and Drug Administration (FDA) PANAMO Phase III study results in severe CO...
German clinical-stage biopharma InflaRx ( NASDAQ: IFRX ) on Thursday said it had submitted an emergency use approval request to the U.S. FDA for its monoclonal antibody vilobelimab to treat critically ill COVID-19 patients. The company also said it was granted a fast track...
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JENA, Germany, June 24, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced today that GOHIBIC (vilobelimab) has been selected by the Biomedical Advanced Research and Development ...
Thought leaders in complement inhibition, chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) provide compelling new insights into the strong development rationales, potential differentiation and medical role of INF904 in initially targeted indications and inflammation & imm...
JENA, Germany, May 21, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced data presented at the American Thoracic Society (ATS) 2024 International Conference that is being held f...