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.

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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.

Protalix BioTherapeutics reports robust Q3 earnings and advances innovative therapies

Protalix BioTherapeutics delivered strong financial performance in Q3 2024, marked by revenue growth, net income, and debt-free status, showcasing operational efficiency.
PRX-115's positive Phase I trial results and upcoming Phase II trial highlight Protalix's commitment to innovation and advancing novel therapies for unmet medical needs.
While facing challenges in regulatory dynamics and competitive landscape, Protalix has opportunities to leverage its strengths in product development and market expansion for future growth.

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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.

Protalix BioTherapeutics Announces Submission of Type A Meeting Request to the FDA

CARMIEL, Israel , June 28, 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 Dror Bashan, the Company's President and Chief Executive Officer along with Eyal Rubin, the Company's Chief Financial Officer, will participate in a fireside chat discussion hosted by Zacks Investment Research's John Vandermosten. The event will be held virtually on the Zoom platform, and management invites investors to participate via the webcast and conference details below: Webcast Details: Wednesday, June 30, 2021, 9:00 a.m.

Protalix BioTherapeutics to Participate in a Fireside Chat on June 30, 2021

Protalix shares were smashed in April on a CRL received from the FDA. The CRL made no mention of any data, but was simply a logistics issue. An FDA team could not travel to Israel to inspect Protalix Facilities, but Israel is opening up travel again on July 1.

Protalix Beaten Down By Covid Logistics, But Continues To Show Good Data

New York, New York--(Newsfile Corp. - June 5, 2021) - Pomerantz LLP is investigating claims on behalf of investors of Protalix BioTherapeutics, Inc. ("Protalix" or the "Company") (NYSE: PLX). Such investors are advised to contact Robert S. Willoughby at newaction@pomlaw.com or 888-476-6529, ext. 7980.The investigation concerns whether Protalix and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining...

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Protalix BioTherapeutics, Inc. - PLX

Protalix BioTherapeutics Inc (NYSE: PLX) and Chiesi Farmaceutici S.p.A. have provided an update on the clinical development of pegunigalsidase alfa (PRX–102) for the proposed treatment of Fabry disease.

Protalix Shares Hits 52-Week Low After Adverse Event Reported In Fabry Disease Trial With PRX-102

CARMIEL, Israel and BOSTON, June 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, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthare Group (Chiesi Group), today provided an update regarding the clinical development of pegunigalsidase alfa (PRX–102) for the proposed treatment of Fabry disease.

Protalix Biotherapeutics and Chiesi Global Rare Diseases Provide Update Regarding Clinical Development of PRX-102 for Treatment of Fabry Disease

CARMIEL, Israel, May 14, 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 first quarter ended March 31, 2021 and provided a business update. "While the receipt of the Complete Response Letter last month from the FDA was disappointing, we are encouraged that the FDA did not report any potential safety or efficacy concerns for PRX-102," said Dror Bashan, Protalix's President and Chief Executive Officer.

Protalix BioTherapeutics Reports First Quarter 2021 Financial Results and Business Update

On Friday, May 14, Protalix BioTherapeutics (AMEX:PLX) will release its latest earnings report. Here is Benzinga's outlook for the company.

Earnings Preview for Protalix BioTherapeutics

CARMIEL, Israel, May 7, 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 first quarter 2021 and business update on Friday, May 14, 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 Hold First Quarter 2021 Financial and Business Results Conference Call on May 14, 2021

Investors did not like the company's latest regulatory update.

Why Protalix BioTherapeutics Stock Is Plunging Today

CARMIEL, Israel, April 28, 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 provided an update regarding the Complete Response Letter (CRL) received from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Receipt of the CRL was announced earlier today.

Protalix BioTherapeutics Provides Update on Complete Response Letter for Pegunigalsidase Alfa from the FDA

An update from Protalix BioTherapeutics shows how a disappointing FDA decision can roil a biotech name like PLX stock. The post PLX Stock: Why Protalix BioTherapeutics Is Plunging 40% Today appeared first on InvestorPlace.

PLX Stock: Why Protalix BioTherapeutics Is Plunging 40% Today

The stock price of Protalix Biotherapeutics Inc (NYSEAMERICAN: PLX) fell by over 40% pre-market. This is why it happened.

PLX Stock: Over 40% Decrease Pre-Market Explanation

Protalix BioTherapeutics Inc (NYSE: PLX) and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici, have received a Complete Response Letter (CRL) from the FDA related to the marketing application of pegunigalsidase alfa (PRX‑102) for Fabry disease. "While disappointing, we remain confident in the strength of our data and in the depth of our program," said Dror Bashan, Protalix's President, and CEO.

Protalix Stock Falls After FDA Slaps CRL For PRX-102 Application In Fabry Disease

CARMIEL, Israel and BOSTON, April 28, 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 that they received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX‑102) for the proposed treatment of adult patients with Fabry disease.

Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA

Protalix BioTherapeutics (PLX) CEO, Dror Bashan on Q4 2020 Results - Earnings Call Transcript

CARMIEL, Israel, March 30, 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 fiscal year ended December 31, 2020 and provided a business update on recent corporate and clinical developments. "2020 was an important year for Protalix, as we continued to strengthen the clinical profile of PRX–102 for the treatment of Fabry disease and advance towards potential commercialization of our lead pipeline program," said Dror Bashan, Protalix's President and Chief Executive Officer.

Protalix BioTherapeutics Reports Fiscal Year 2020 Financial and Business Results

CARMIEL, Israel, March 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 that it will release its financial results for fiscal year 2020 and business update on Tuesday, March 30, 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 Hold Fiscal Year 2020 Financial and Business Results Conference Call on March 30, 2021

CARMIEL, Israel, March 4, 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...

Protalix BioTherapeutics to Present at the H.C. Wainwright Global Life Sciences Conference

Protalix BioTherapeutics Inc (NYSE: PLX) and its collaborating partner Chiesi Farmaceutici S.p.A. announced positive topline results from the BRIGHT Phase 3 trial evaluating pegunigalsidase alfa (PRX–102) for the potential treatment of Fabry disease.

Protalix's PRX–102 Monthly Treatment Shows Benefit In Fabry Disease

CARMIEL, Israel, Feb. 18, 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...

Protalix BioTherapeutics Completes Raise of Approximately $40 Million in Gross Proceeds

Protalix BioTherapeutics Inc (NYSE: PLX) prices the previously announced underwritten public offering of 7.6 million shares at $4.60 per share, a discount of around 21% on the last close of $5.79 on Thursday. Underwriters have an option to purchase up to an additional 1.1 million shares.

Protalix BioTherapeutics Raises $35M Via Equity At 21% Discount

CARMIEL, Israel, Feb. 11, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX, TASE: PLX) (the "Company"), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary...

Protalix BioTherapeutics Announces Pricing of its Upsized Public Offering of Common Stock

CARMIEL, Israel, Feb. 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...

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