Protalix Biotherapeutics

Protalix Biotherapeutics, Inc. is a biopharmaceutical company, which engages in the development, production, and commercialization of recombinant therapeutic proteins based on plant cell based expression system. Its products include Alidornase alfa, PRX-115 and PRX-11. The company was by Yoseph Shaaltiel in 1993 and is headquartered in Hackensack, NJ.

Earnings data Q4 2020

Earnings data Q1 2021

Earnings data Q2 2021

Earnings data Q3 2021

Earnings data Q4 2021

Earnings data Q1 2022

Earnings data Q2 2022

Earnings data Q3 2022

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Earnings data Q1 2023

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Earnings data Q3 2023

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Earnings data Q3 2024

Protalix BioTherapeutics excels in Q2 with milestone achievements and revenue growth

Protalix BioTherapeutics delivered strong financial performance in Q2 2023, driven by milestone achievements and revenue growth.
The company's robust balance sheet, successful product launches, and focus on innovation position it well for future success.
While facing challenges in a competitive market, Protalix has opportunities to expand market presence, drive innovation, and enhance shareholder value.
Strategic execution and continued focus on profitability will be key for Protalix to capitalize on opportunities and navigate industry challenges.

Protalix BioTherapeutics navigates mixed Q3 results, eyes pipeline advancements

Protalix BioTherapeutics reported a mixed financial performance in Q3 2023, with revenue fluctuations and cost management efforts impacting the bottom line. The company remains focused on advancing its pipeline candidates and commercial launches to drive future growth and market success.
Despite challenges in revenue streams and cost structures, Protalix demonstrated operational stability and strategic decision-making in navigating market dynamics. The company's strong leadership team, diverse product portfolio, and ongoing clinical programs position it well for future opportunities and growth.
Overall, Protalix BioTherapeutics showcased resilience amidst external events, with a strategic focus on product approvals, cost optimization, and clinical advancements. The company's financial stability, strong cash reserves, and commitment to innovation underscore its competitive position in the biopharmaceutical industry.

Protalix BioTherapeutics reports stellar Q4 performance and growth opportunities

Protalix BioTherapeutics delivered strong financial results in Q4 2023, driven by the successful launch of Elfabrio and cost-saving measures.
Strategic leadership additions and a robust cash position position the company well for future growth and innovation.
While challenges persist in sustaining growth and managing costs, opportunities in new drug development and market expansion offer promising avenues for Protalix.

Protalix BioTherapeutics reports Q1 progress with promising pipeline advancements

Protalix BioTherapeutics navigated revenue challenges with cost management and maintained financial stability through a strong cash position.
Progress in the pipeline with PRX-115's positive Phase I results and upcoming Phase II trial signals potential growth opportunities.
Analyst inquiries underscore the importance of addressing safety concerns, conducting robust trials, and effectively positioning products in a competitive market.

Protalix BioTherapeutics advances PRX-115 for uncontrolled gout treatment

Protalix BioTherapeutics showcased promising results for PRX-115 in uncontrolled gout, with plans for Phase II trial and a focus on renal rare diseases.
Despite a net loss in Q2 2024, the company's strong cash position supports operations and strategic R&D efforts for future growth.
Challenges in financial performance call for cost management strategies, while opportunities lie in clinical advancements and innovative product development.

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Protalix BioTherapeutics Inc (AMEX:PLX) shares are surging Monday after the company said its Phase 3 trial for the treatment of Fabry disease met its primary endpoint. Fabry disease is an inherited disease resulting in progressive accumulation of abnormal deposits of a fatty.

Why Protalix BioTherapeutics Stock Is Soaring

CARMIEL, Israel and BOSTON, April 4, 2022 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research focused healthcare Group (Chiesi Group), today announced topline results from the BALANCE pivotal Phase III clinical trial evaluating pegunigalsidase alfa (PRX–102), 1 mg/kg, administered every two weeks, compared to agalsidase beta (Fabrazyme®) for the treatment of Fabry disease.

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Topline Results from the 24-Month Phase III BALANCE Clinical Trial of PRX-102 for the Treatment of Fabry Disease

Protalix BioTherapeutics (PLX) CEO, Dror Bashan on Q4 2021 Results - Earnings Call Transcript

CARMIEL, Israel, March 31, 2022 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the fiscal year ended December 31, 2021 and provided a business update on recent corporate and clinical developments. "2021 was a year of continued progress towards our key operational, clinical and regulatory goals," said Dror Bashan, Protalix's President and Chief Executive Officer.

Protalix BioTherapeutics Reports Fiscal Year 2021 Financial and Business Results

Company to host conference call and webcast at 8:30 a.m. EDT CARMIEL, Israel, March 24, 2022 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE:  PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that it will release its financial results for fiscal year 2021 and provide a business update on Thursday, March 31, 2022.

Protalix BioTherapeutics to Hold Fiscal Year 2021 Financial and Business Results Conference Call on March 31, 2022

Protalix BioTherapeutics Inc (NYSE: PLX) and Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A, have announced final results from the BRIGHT Phase 3 trial of pegunigalsidase alfa (PRX‑102) for Fabry disease.  The results indicate that treatment with 2 mg/kg.

Protalix Bio, Chiesi Release Final Results From Late-Stage PRX-102 Trial In Fabry Disease

CARMIEL, Israel and BOSTON , March 18, 2022 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell‑based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research focused healthcare Group (Chiesi Group), today announced final results from the BRIGHT Phase III clinical trial evaluating pegunigalsidase alfa (PRX‑102) for the potential treatment of Fabry disease.

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of the BRIGHT Phase III Clinical Trial Evaluating PRX-102 for the Treatment of Fabry Disease

CARMIEL, Israel and BOSTON, Feb. 24, 2022 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced the submission of a Marketing Authorization Application (MAA) via centralized procedure to the European Medicines Agency (EMA) for pegunigalsidase alfa (PRX–102) for the proposed treatment of adults with Fabry disease, and the subsequent validation of the MAA by the EMA.

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce the Submission of a Marketing Authorization Application to the European Medicines Agency for PRX-102 for the Treatment of Fabry Disease

CARMIEL, Israel, Feb. 3, 2022 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that there will be two poster presentations regarding the Company's pegunigalsidase alfa or PRX–102 candidate under development for the treatment of Fabry disease at the 18th Annual WORLDSymposium™ 2022, taking place February 7-11, 2022 at the Manchester Grand Hyatt in San Diego, California. Presentation Details: "Safety and Efficacy of Pegunigalsidase Alfa Administered Every 4 Weeks in Patients with Fabry Disease: Results from the Phase 3, Open-label, BRIGHT Study," to be presented virtually by Mr.

Protalix BioTherapeutics to Participate in the 18th Annual WORLDSymposium™ 2022

Protalix concluded its Type A meeting with the US Food and Drug Administration (FDA), providing a way forward with its lead indication PRX-102. Protalix published top line results of the interim analysis of its BALANCE trial on June 2, 2021 and announced completion of the treatment period on October 15, 2021.

Protalix Biotherapeutics: Is It Worth The Wait?

CARMIEL, Israel, Dec. 22, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced the following letter from its President and Chief Executive Officer, Dror Bashan, to its stockholders and the investment community. Dear Protalix Stockholders, As we look back and reflect on this past year, I am proud of our team and of the progress we have made in a time of continued Covid-19-related uncertainty across all corners of the globe.

Protalix BioTherapeutics Issues 2021 Letter to Stockholders

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Protalix BioTherapeutics, Inc. (PLX) CEO Dror Bashan on Q3 2021 Results - Earnings Call Transcript

CARMIEL, Israel, Nov. 15, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the third quarter ended September 30, 2021 and provided a financial and business update on recent corporate, clinical and regulatory developments. "We are pleased with the progress we have made over the past few weeks with respect to the regulatory path forward with PRX-102 for the treatment of Fabry disease with both the U.S. Food and Drug Administration and the European Medicines Agency," stated Dror Bashan, Protalix's President and Chief Executive Officer.

Protalix BioTherapeutics Reports Third Quarter 2021 Financial Results and Provides Financial and Business Update

CARMIEL, Israel, Nov. 8, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that it will release its financial results for the third quarter 2021 and provide a financial and business update on Monday, November 15, 2021. The Company's management will host a conference call to discuss the financial results and provide a financial and business update on recent corporate, clinical and regulatory developments at 8:30 a.m.

Protalix BioTherapeutics to Release Third Quarter 2021 Financial Results and Provide a Financial and Business Update on November 15, 2021

CARMIEL, Israel and BOSTON, Oct. 15, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced the final dosing of the last patient in the phase III BALANCE clinical trial of pegunigalsidase alfa (PRX–102), or the BALANCE Study, for the proposed treatment of Fabry disease.

Protalix Biotherapeutics and Chiesi Global Rare Diseases Announce Final Dosing of Last Patient in Phase III BALANCE Clinical Trial PRX-102 for the Treatment of Fabry Disease

The stock price of Protalix Biotherapeutics Inc (NYSEAMERICAN: PLX) fell by over 8% during intraday trading today. This is why it happened.

PLX Stock: Why It Fell Today

CARMIEL, Israel and BOSTON, Oct. 11, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today provided a regulatory update regarding pegunigalsidase alfa (PRX–102) for the proposed treatment of Fabry disease which included an announcement of the receipt of the official Type A (End-of-Review) meeting minutes from the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received for the PRX–102 Biologics License Application (BLA) confirming a potential pathway for resubmission of a BLA for PRX–102.

Protalix Biotherapeutics and Chiesi Global Rare Diseases Provide Regulatory Update on PRX-102 for the Treatment of Fabry Disease

CARMIEL, Israel, Aug. 26, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ®  plant cell-based protein expression system, today announced that it has completed exchanges (the "Exchanges") of the Company's outstanding 7.50% Senior Secured Convertible Notes due 2021 (the "2021 Notes") with institutional note holders of a substantial majority of the 2021 Notes. Participating institutional note holders include funds managed by Highbridge Capital Management, LLC, UBS O'Connor LLC, Citigroup Global Markets, Whitebox Advisors and Tulip Capital.

Protalix BioTherapeutics Announces Closing of Private Note Exchange

Protalix BioTherapeutics, Inc. (PLX) CEO Dror Bashan on Q1 2021 Results - Earnings Call Transcript

CARMIEL, Israel, Aug. 16, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the second quarter ended June 30, 2021 and provided a financial and business update. "We continue to work closely with the FDA to address the issues raised in the Complete Response Letter received in April for PRX-102 for the proposed treatment of adult patients with Fabry disease," said Dror Bashan, Protalix's President and Chief Executive Officer.

Protalix BioTherapeutics Reports Second Quarter 2021 Financial Results and Financial and Business Update

CARMIEL, Israel, Aug. 13, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced the entry into definitive agreements (the "Exchange Agreements") relating to exchanges (the "Exchanges") of an aggregate of $54.65 million principal amount of the Company's outstanding 7.50% Senior Secured Convertible Notes due 2021 (the "Existing Notes") for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024 (the "Exchange Notes"), $25.90 million in cash, and accrued and unpaid interest through the closing date. The Exchanges are expected to close as soon as practicable, subject to satisfaction of certain closing conditions.

Protalix BioTherapeutics Announces Private Note Exchange

CARMIEL, Israel, Aug. 9, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that it will release its financial results for the second quarter 2021 and financial and business update on Monday, August 16, 2021. The Company's management will host a conference call to discuss the financial results and provide a business update on recent corporate and clinical developments at 8:30 a.m.

Protalix BioTherapeutics to Release Second Quarter 2021 Financial Results and Provide a Financial and Business Update on August 16, 2021

Protalix BioTherapeutics Inc (NYSE: PLX) has submitted a Type A Meeting request to the FDA regarding PRX-102 Complete Response Letter it received in April. The FDA issued the response letter for pegunigalsidase alfa (PRX-102) in Fabry disease, though no reasons were cited in the letter.

Protalix Stock Is Trading Higher On Meeting Request To FDA For Fabry Disease Candidate Application

CARMIEL, Israel, Aug. 2, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated April 27, 2021 regarding the Biologics License Application (BLA) for pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease. The Type A Meeting is expected to occur within 30 days of the FDA's receipt of the meeting request.

News for Protalix Biotherapeutics Stock (PLX)