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PhaseBio Pharmaceuticals (Nasdaq: PHAS) reported significant progress in its lead program, bentracimab, with enrollment completed for pivotal trials. The Phase 3 REVERSE-IT trial has enrolled 143 patients, and the Phase 2b trial has completed enrollment of 200 subjects. Financially, the company recorded $64.5 million in cash, with sublicense revenue of $10.3 million from a licensing agreement with Alfasigma. However, a net loss of $28.7 million was reported, up from the prior year, driven by increased R&D expenses.
PhaseBio Pharmaceuticals (Nasdaq: PHAS) announced the enrollment of the first 143 patients in its Phase 3 REVERSE-IT trial for bentracimab, which is designed to reverse the antiplatelet effects of ticagrelor. Of those enrolled, 138 patients required urgent surgery or an invasive procedure. The trial aims to recruit approximately 200 patients with major bleeding. The company is preparing a Biologics License Application (BLA) for submission to the FDA in mid-2022 and expects interim results from the first 100 patients later this year.
PhaseBio Pharmaceuticals (Nasdaq: PHAS) announced the approval of its IND application for bentracimab by China's NMPA, allowing patient enrollment in the REVERSE-IT trial. Bentracimab, a monoclonal antibody, aims to reverse the antiplatelet effects of ticagrelor in cases of major bleeding or urgent surgery. This trial, a pivotal Phase 3 study, is expected to include patients from China later in 2021. The collaboration with SFJ Pharmaceuticals allows PhaseBio to retain commercial rights in China while seeking partners for marketing rights in the Asia-Pacific region.
PhaseBio Pharmaceuticals (Nasdaq: PHAS) announced that CEO Jonathan P. Mow will participate in a fireside chat at the William Blair Biotech Focus Conference 2021 on July 15, 2021, from 1:00 to 1:45 PM EDT. The event will be available via live webcast on the company's website, with a replay accessible for 90 days post-event. PhaseBio specializes in therapies for cardiopulmonary diseases and is advancing its pipeline, including bentracimab and pemziviptadil.
PhaseBio Pharmaceuticals (Nasdaq: PHAS) has entered an exclusive licensing agreement with Alfasigma S.p.A. for the commercialization of bentracimab in the EU, UK, and other territories. The deal includes a $20 million upfront payment and potential earnings of up to $190 million based on sales milestones. Bentracimab, designed to reverse antiplatelet effects of ticagrelor, is currently in late-stage clinical development. The agreement allows PhaseBio to focus on developing bentracimab, while Alfasigma will handle regulatory approvals and marketing, aiming to address critical unmet needs in antiplatelet therapy.
PhaseBio Pharmaceuticals (Nasdaq: PHAS) presented significant healthcare cost data at the Virtual ISPOR 2021 Conference, revealing that patients initiating P2Y12 inhibitor therapy faced higher healthcare costs compared to those on factor Xa inhibitors or dabigatran. Analysis showed similar on-therapy costs between these groups, with P2Y12 inhibitor patients incurring greater costs related to bleeding events pre-therapy. CEO Jonathan P. Mow emphasized the unmet need for a reversal agent for P2Y12 inhibitors, highlighting bentracimab's potential as a solution in managing bleeding risks.
PhaseBio Pharmaceuticals (Nasdaq: PHAS) presented real-world evidence at the American College of Cardiology's 70th Annual Scientific Session, analyzing patient outcomes related to antithrombotic therapies. The study highlighted that patients on P2Y12 inhibitors exhibited a higher burden of comorbid conditions and comparable bleeding risks to those on factor Xa inhibitors and dabigatran. Notably, the lack of effective reversal agents for P2Y12 inhibitors underscores an unmet medical need. This data suggests potential implications for surgical procedures among these patients.
PhaseBio Pharmaceuticals (Nasdaq: PHAS) reported advancements in its clinical and corporate strategies during Q1 2021. The company is progressing with its pivotal Phase 3 clinical trial for bentracimab, with 60 of an estimated 100 patients enrolled, aiming for a Biologics License Application (BLA) submission in mid-2022. Additionally, PhaseBio has signed a commercial scale manufacturing agreement with BioVectra to support bentracimab's production. The successful execution of these plans could pave the way for the first ticagrelor reversal agent.
PhaseBio Pharmaceuticals (Nasdaq: PHAS), a clinical-stage biopharmaceutical company, announced that CFO John Sharp will present a company overview at the 20th Annual Needham Virtual Healthcare Conference on April 15, 2021, at 11:00 AM ET. Interested investors can access the live and archived webcast on PhaseBio's website. The company focuses on developing innovative therapies for cardiopulmonary diseases, with a pipeline that includes bentracimab, pemziviptadil, and PB6440.
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS) has completed an underwritten public offering of 18,400,000 shares at $3.50 each, raising approximately $64.4 million in gross proceeds. This offering included the full exercise of the underwriters’ option for an additional 2,400,000 shares. The offering was conducted under a shelf registration statement declared effective by the SEC on January 8, 2020. Joint book-running managers for the offering were Cowen, Stifel, and William Blair, with Needham & Company acting as lead manager.