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Liminal BioSciences (Nasdaq: LMNL) announced a strategic shift focusing on its small molecule therapeutics platform, including fezagepras, while evaluating options for its plasma-derived therapeutics business. The company aims to minimize cash burn and streamline operations by divesting non-core assets. Currently, efforts to partner for Ryplazim have not yielded results, prompting this evaluation. The FDA has set a target action date of June 5, 2021 for Ryplazim's Biologic License Application.
Liminal BioSciences Inc. (Nasdaq: LMNL) announced FDA approval for its plasma collection center in Amherst, NY, marking a significant milestone as it expands operations in the U.S. This center, operational since early 2020, is now licensed to trade human source plasma, enhancing Liminal's ability to supply raw materials for its biopharmaceutical products. The FDA inspection that preceded this approval was conducted in September 2020. This strategic move allows Liminal to meet growing demand and support its clinical programs, which include treatments for diseases related to fibrosis and congenital plasminogen deficiency.
Liminal BioSciences (Nasdaq: LMNL) has initiated a Phase 1 clinical trial for fezagepras, an anti-inflammatory and anti-fibrotic small molecule. The trial involves healthy volunteers and aims to evaluate multiple ascending doses over 14 days, focusing on safety and pharmacokinetics. This study will help determine the optimal dosing regimen for future Phase 2 trials targeting idiopathic pulmonary fibrosis (IPF). Fezagepras has received Orphan Drug Designation from the FDA and EMA, with a global Phase 2b trial expected to start in H2-2021.
Liminal BioSciences Inc. (Nasdaq: LMNL) announced that CEO Bruce Pritchard will present a company overview at The Stifel 2020 Virtual Healthcare Conference on November 16, from 2:40 to 3:10 PM (EDT). The presentation will be webcast live, with an archived replay available for seven days. Liminal is a clinical-stage biopharmaceutical company focused on developing treatments for diseases like fibrosis. Their lead candidate, fezagepras, is set to enter Phase 1 trials in Q4-2020. Liminal also aims to submit a BLA for Ryplazim® to treat congenital plasminogen deficiency, with a PDUFA date of June 5, 2021.
Liminal BioSciences (Nasdaq: LMNL) reported its Q3 2020 financial results, highlighting a net loss of $23.3 million, down 22% from the previous year. The company announced a PDUFA target date of June 5, 2021 for Ryplazim® (plasminogen) following its BLA resubmission to the FDA. It secured $30 million from a private placement and C$29.1 million in a long-term loan from its largest shareholder. Executive changes were noted, with Bruce Pritchard stepping in as CEO, and a focus on advancing clinical trials and commercialization strategies.
Liminal BioSciences Inc. (Nasdaq: LMNL) will report its Q3 financial results after market close on November 12, 2020. A conference call to discuss these results is scheduled for November 13, 2020, at 8:30 AM ET. The company is focused on developing treatments for fibrosis-related diseases. Their lead product, fezagepras, is set to enter Phase 1 trials in Q4-2020 and has Orphan Drug Designation for idiopathic pulmonary fibrosis. Additionally, Liminal is progressing its product Ryplazim, aiming for FDA approval by June 5, 2021.
Liminal BioSciences Inc. (Nasdaq: LMNL) announced an extension of the FDA review period for its Biologics License Application (BLA) for Ryplazim® from March 5, 2021 to June 5, 2021. This decision follows a major amendment submission containing new manufacturing information. CEO Kenneth Galbraith expressed disappointment but remains committed to discussions with the FDA. A corporate update call is scheduled for November 11, 2020, to discuss these developments.
Liminal BioSciences Inc. (Nasdaq: LMNL) will announce its third-quarter financial results for the period ending September 30, 2020, on November 12, 2020, after market close. A conference call is scheduled for November 13, 2020, at 8:30 AM ET, accessible via phone or audio webcast. The company focuses on developing treatments for fibrotic diseases and is moving forward with clinical trials for its lead candidate, fezagepras. The BLA for Ryplazim, targeting congenital plasminogen deficiency, has been resubmitted with a PDUFA date of March 5, 2021.
Liminal BioSciences Inc. (NASDAQ: LMNL) announced acceptance of two abstracts for Ryplazim® at the 62nd American Society of Hematology Meeting from December 5-8, 2020. Ryplazim® is under development for treating Congenital Plasminogen Deficiency (C-PLGD), with a Biologic License Application submitted in September 2020. The abstracts highlight successful treatments and their implications for patients. With no current approved therapies for C-PLGD, Ryplazim® represents a vital potential option.
Liminal BioSciences (Nasdaq: LMNL) announced a private placement to raise approximately USD $30 million through the sale of 5,757,894 common shares and 557,894 pre-funded warrants. The funds will support clinical development for fezagepras and the FDA review of the BLA for Ryplazim®. The placement is led by a prominent U.S. public investment fund and will close around November 3, 2020. Liminal BioSciences aims to register the resale of these securities with the SEC within 30 days following the closing.