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Liminal BioSciences Inc. (NASDAQ: LMNL) is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for diseases with unmet medical needs. Established originally as Prometic Life Sciences Inc., the company rebranded to its current name in October 2019 to better reflect its evolving mission.
The company operates through two core segments: Small Molecule Therapeutics and Plasma Derived Therapeutics. The Small Molecule Therapeutics segment is spearheaded by its lead product candidate, Fezagepras (PBI-4050), aimed at treating idiopathic pulmonary fibrosis, respiratory diseases, and Alström Syndrome. In parallel, the Plasma Derived Therapeutics segment focuses on plasma protein purification technologies, particularly for extracting therapeutic proteins from human plasma. One of its notable developments is Ryplazim, designed for treating congenital plasminogen deficiency.
Liminal BioSciences has a geographically diverse operational footprint with active business operations in Canada, the United Kingdom, and the United States. Reflecting its commitment to cutting-edge research, the company has a deep pipeline of projects including LMNL6511, LMNL6326, and GPR40 agonists, each targeting various metabolic, inflammatory, and fibrotic diseases.
Financially, Liminal BioSciences recently announced a definitive arrangement agreement with Structured Alpha LP (SALP) under which SALP will acquire all outstanding common shares of the company at a significant premium, solidifying investor confidence in the company's strategic direction. The transaction is expected to close by the end of September 2023, pending necessary approvals and conditions.
Overall, Liminal BioSciences stands at the forefront of biopharmaceutical innovation, driven by its integrated drug discovery platform, medicinal chemistry expertise, and a robust understanding of GPCR biology. The company's collaborations and partnerships further reinforce its potential to deliver transformative healthcare solutions to patients worldwide.
Liminal BioSciences (Nasdaq: LMNL) announced the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for USD105M, granted by the FDA in connection with Ryplazim's approval. The transaction will provide important non-dilutive capital to support ongoing development of their small molecule pipeline. PBT will receive an upfront payment upon closing, pending usual customs, including antitrust clearance. Liminal's CEO, Bruce Pritchard, emphasized this milestone as part of divesting the plasma-derived therapeutics business and reiterated commitments to advancing their clinical programs.
Liminal BioSciences (Nasdaq: LMNL) has finalized the divestment of its plasma-derived therapeutics manufacturing unit to Kedrion S.p.A. for USD 5 million. This transaction, termed the First Closing, allows Liminal to also gain 70% of the net proceeds from a Rare Pediatric Disease Priority Review Voucher sale by its subsidiary, Prometic Biotherapeutics Inc. The Second Closing remains contingent upon specific conditions being met. Liminal is focused on developing treatments for diseases with unmet needs, recently advancing its lead product, fezagepras, through clinical trials.
Liminal BioSciences (Nasdaq: LMNL) announced that Kedrion S.p.A has exercised its option to acquire Liminal's plasma-derived business, including the Ryplazim® treatment for plasminogen deficiency type 1. The transaction involves a $5 million payment at closing and a potential 70% share of net proceeds from a Rare Pediatric Disease Priority Review Voucher. The acquisition will enable Kedrion to handle all development and commercialization activities for Ryplazim®. This aligns with Liminal's strategy to refocus on its small molecule pipeline.
Liminal BioSciences (Nasdaq: LMNL) announced the results from its Annual General and Special Meeting of Shareholders on June 4, 2021. A total of 22,136,650 common shares were voted, representing 73.93% of the issued shares. All six nominees for the Board of Directors were elected with significant support, ranging from 99.41% to 99.74% of votes in favor. PricewaterhouseCoopers LLP was appointed as the company’s auditors. Additionally, an amendment to change the registered office from Quebec to Ontario was approved. Detailed voting results are available on SEDAR and SEC.
Liminal BioSciences Inc. (Nasdaq: LMNL) has received FDA approval for Ryplazim® (plasminogen, human-tvmh), marking a significant milestone as it becomes the first approved treatment for plasminogen deficiency type 1. The approval was based on a clinical trial involving 15 patients, all of whom demonstrated at least 50% improvement in lesions after 48 weeks of treatment. Additionally, a Rare Pediatric Disease Priority Review Voucher was awarded, which could secure funding for further research. The option agreement with Kedrion S.p.A. allows the potential acquisition of the Ryplazim business for $5 million.
Liminal BioSciences (Nasdaq: LMNL) has halted plans to advance fezagepras into Phase II clinical trials for Idiopathic Pulmonary Fibrosis and Phase Ia/IIb for Hypertriglyceridemia based on interim pharmacokinetic data. The company is assessing the complete PK data after the ongoing multiple ascending dose study, with no safety concerns reported so far. Additionally, the PDUFA target action date for their product Ryplazim® is set for June 5, 2021, as they await FDA approval for treating congenital plasminogen deficiency.
Liminal BioSciences (Nasdaq: LMNL) has completed the sale of its two plasma collection centers to Kedrion S.p.A. for USD 17 million. The deal includes an option for Kedrion to acquire Liminal's plasma-derived therapeutics business by June 15, 2021, with potential further payments of USD 5 million and up to 70% of any net sale proceeds from a future PRV associated with BLA approval for Ryplazim®. This transaction is expected to enhance Liminal's financial stability and support its small molecule pipeline's development.
Liminal BioSciences Inc. reported its Q1 2021 financial results, focusing on a strategic shift toward small molecule therapeutics. The company has secured a $17M deal with Kedrion for two plasma collection centers and an option for an additional $5M to acquire the plasma-derived therapeutic business. The FDA's PDUFA target action date for Ryplazim is set for June 5, 2021. Cash and equivalents were reported at $21.6M, and net loss for the quarter was $20.9M, a decrease from $27.7M in Q1 2020.
Liminal BioSciences (LMNL) has signed a binding Share Purchase Agreement with Kedrion for the sale of its plasma collection centers in Winnipeg and Amherst for USD 17 million. Additionally, Liminal has an option to sell its plasma-derived therapeutic business for USD 5 million. The deal allows Liminal to focus on its small molecule therapeutics, particularly Ryplazim, which is pending FDA approval with a PDUFA target date of June 5, 2021. Liminal may receive up to 70% of the net proceeds from a potential Priority Review Voucher.
Liminal BioSciences (LMNL) reported its fourth quarter and full year 2020 financial results, highlighting a cash position of $45.1M and revenues of $3.3M, down from $4.9M in 2019. The company initiated a Phase 1 clinical trial for fezagepras and acquired a preclinical R&D program for an OXER1 antagonist. Notable expenses included R&D costs of $11.6M in Q4 2020 and a net loss of $43.4M. Liminal aims for a PDUFA action date of June 5, 2021, for Ryplazim (plasminogen), while focusing on small molecule therapeutics.
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