Liminal Biosciences Inc. (NASDAQ: LMNL) stock declined by 3.13% at the last close whereas the LMNL stock price surged by 55.72% in the after-hours trading session. Liminal Biosciences is a biopharmaceutical business dedicated on researching, developing, and commercializing innovative medicines for patients with unmet medical needs, primarily fibrosis-related disorders such as respiratory, liver, and kidney illnesses.
LMNL reported that Ryplazim has been authorized by the US Food and Drug Administration (FDA) for treating patients with plasminogen deficiency type 1 (hypoplasminogenia) via its subsidiary, Prometic Biotherapeutics Inc., which holds the biological license application for Ryplazim. Ryplazim is the first FDA-approved medication for this rare genetic condition as a result of this approval.
In a single-arm, open-label clinical trial, the effectiveness of Ryplazim in pediatric and adult patients with plasminogen deficiency type 1 was assessed. A total of 15 patients were included in the study, with baseline plasminogen activity levels ranging from 5% to 45 percent of normal. All patients were given Ryplazim at a dose of 6.6 mg/kg every two to four days for 48 weeks in order to achieve at least a 10% rise in individual trough plasminogen activity over baseline and to treat the disease’s clinical symptoms. In the clinical trial, Ryplazim was well received.
Efficacy was determined based on the overall rate of clinical success at 48 weeks, which was classified as 50% of patients with visible or other measurable non-visual lesions improving by 50% or more from baseline in lesion number/size or functioning effect. At least 50% recovery in the number or size of lesions was seen in all patients having any lesion at baseline.
Liminal BioSciences decided to enter into a deal with Kedrion S.p.A. (Kedrion) in May 2021 as part of the sale of Liminal Biosciences’ plasma collection centres in Winnipeg, Manitoba and Amherst, New York. Kedrion has the right to purchase the remaining amount of Liminal Biosciences’ plasma-derived therapeutics business. Also, for an exercise price of US$5 million, Kedrion will have the option to purchase the Ryplazim Company, entitling Liminal BioSciences to receive up to 70% of the net revenues from the sale of a PRV.
The voting results from LMNL’s virtual Annual General and Special Meeting of Shareholders (“AGM”) were revealed on June 4, 2021. A total of 22,136,650 common shares were polled, accounting for 73.93 percent of the votes linked to Liminal Biosciences’ issued and outstanding common shares.