Protalix Biother Stock Price, News & Analysis

Protalix BioTherapeutics (NYSE American: PLX) and Chiesi Global Rare Diseases received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application for pegunigalsidase alfa (PRX-102) intended for treating Fabry disease. The companies are evaluating the regulatory feedback to outline steps for potential approval. Despite the setback, executives express confidence in their clinical data and commitment to advancing the treatment. The PRX-102 BLA was granted Priority Review by the FDA, emphasizing its potential significance in addressing unmet medical needs in Fabry patients.

Protalix BioTherapeutics (PLX) reported financial results for FY 2020, highlighting revenues of $16.2 million from sales and $46.7 million from licenses, marking increases from 2019. The net loss narrowed to $6.5 million, or $0.22 per share, compared to a loss of $18.3 million in 2019. The company advanced its clinical trials, notably for PRX–102, with a significant PDUFA date set for April 27, 2021. Protalix also secured funding through a $40.2 million public offering in February 2021, strengthening its financial position to support upcoming milestones.

Protalix BioTherapeutics, Inc. (NYSE American: PLX) will release its fiscal year 2020 financial results and provide a business update on March 30, 2021, at 8:30 a.m. EDT. The company will host a conference call to discuss recent corporate and clinical developments. Protalix specializes in recombinant therapeutic proteins using its proprietary plant cell-based expression system, ProCellEx. The call will be accessible via domestic and international numbers, and will be webcast live on the company's website.

Protalix BioTherapeutics (NYSE American: PLX) will present a corporate overview at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. CEO Dror Bashan's recorded presentation will be available from 7:00 am ET on March 9 at this link. A webcast will also be accessible on Protalix's event calendar page, with a replay available for 90 days. Protalix specializes in recombinant therapeutic proteins through its ProCellEx® system, with its first product approved by the FDA in May 2012.

Protalix BioTherapeutics (PLX) and Chiesi Global Rare Diseases announced positive topline results from the BRIGHT Phase III trial of PRX–102, aimed at treating Fabry disease. The trial showed that 2 mg/kg of PRX–102, administered every four weeks, was well tolerated and maintained stable clinical presentation in adult patients. Encouragingly, no new anti-drug antibodies were formed, and 80% of participants opted for an extension study, indicating strong patient satisfaction. Results also demonstrated stable effectiveness, with no significant adverse events reported, paving the way for potential market approval.

Protalix BioTherapeutics (NYSE American: PLX) has successfully completed a capital raise, garnering approximately $40 million in gross proceeds. The funds will be used for clinical trials, research and development, and general corporate purposes. CEO Dror Bashan highlighted achievements during the pandemic and expressed optimism regarding the upcoming commercial launch of a new treatment option. CFO Eyal Rubin noted the addition of institutional investors and a strengthened balance sheet, aiming to accelerate clinical trials. The company remains focused on pipeline development and shareholder value.

Protalix BioTherapeutics, Inc. (NYSE American: PLX) announced the pricing of its underwritten public offering of 7,608,695 shares at $4.60 each, aiming to raise approximately $32.9 million post-underwriting expenses. The offering is set to close on February 17, 2021. Proceeds will support clinical trials, R&D activities, and general corporate purposes. BofA Securities is the book-running manager for the offering, which includes a 30-day option for underwriters to acquire an additional 1,141,304 shares.

Protalix BioTherapeutics (NYSE American: PLX) has announced a public offering of 6,500,000 shares of its common stock, with an additional option for underwriters to purchase 975,000 more. Proceeds will fund clinical trials, research, and general corporate purposes. The offering is pursuant to an effective shelf registration statement. BofA Securities is the book-running manager, with Oppenheimer & Co. as co-manager. This initiative aims to support Protalix's development of recombinant therapeutic proteins, including treatments for Fabry disease and respiratory conditions.

Protalix BioTherapeutics (PLX) announced an exclusive license agreement with SarcoMed USA for alidornase alfa (PRX-110), designed for treating human respiratory diseases, including sarcoidosis. Protalix will receive an initial payment of $3.5 million, with potential milestone payments and royalties on net sales. The parties plan to negotiate supply agreements within 60 days. Alidornase alfa received Orphan Drug Designation from the FDA in July 2020, aimed at rare diseases affecting fewer than 200,000 individuals in the U.S.