Welcome to our dedicated page for Protalix Biother SEC filings (Ticker: PLX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The SEC filings page for Protalix BioTherapeutics, Inc. (PLX) provides access to the company’s official U.S. Securities and Exchange Commission disclosures. As a NYSE American–listed biopharmaceutical issuer focused on rare disease therapeutics and recombinant proteins produced via its ProCellEx® plant cell-based system, Protalix uses these filings to report material events, financial results, governance decisions and capital markets activities.
Investors can review Form 8-K filings that Protalix has used to announce quarterly financial and business results, clinical and regulatory updates for products such as Elfabrio® and PRX–115, changes in executive leadership, entry into or amendments of material agreements, and outcomes of legal or stockholder matters. Other SEC reports, including annual and quarterly reports, provide detailed discussions of revenue from sales of Elfabrio and Elelyso®, collaboration structures with partners like Chiesi, Pfizer and Fiocruz, and the status of development programs such as PRX–119.
For those monitoring corporate finance and ownership, this page also surfaces filings related to equity offerings and governance, such as amendments to at-the-market offering agreements and disclosures about stockholder meetings and executive compensation arrangements. Together, these documents help explain how Protalix funds its operations, manages risk and aligns management incentives.
Stock Titan enhances this information with AI-powered summaries that highlight key points from lengthy SEC documents, helping readers quickly understand the implications of Protalix’s 10-K and 10-Q reports, 8-K current reports and other submissions. Real-time updates from EDGAR ensure that new filings appear promptly, while structured access to transaction-related disclosures and governance items supports deeper due diligence on PLX.
Protalix BioTherapeutics reported that the European Commission approved a 2 mg/kg every‑4‑weeks dosing regimen for Elfabrio (pegunigalsidase alfa) in adults with Fabry disease who are stable on enzyme replacement therapy. The decision adds an alternative to the existing every‑two‑weeks schedule in the European Union.
Based on this approval, Protalix is entitled to receive a $25 million regulatory milestone payment from its partner Chiesi Global Rare Diseases. The company notes that the new regimen is not approved in the United States, where the FDA‑approved dose remains 1 mg/kg every two weeks.
Protalix BioTherapeutics disclosed that MAK Fund, MAK Capital and Michael A. Kaufman reported beneficial ownership of 4,649,599 shares of Common Stock, representing 5.8% of the class.
The filing states the 4,649,599 shares are beneficially owned as of 03/04/2026, using an outstanding share base of 80,421,181 Common Stock as of November 1, 2025, per the company’s Form 10-Q filed November 13, 2025. The reporting persons disclose shared voting and dispositive power over these shares.
Protalix BioTherapeutics, Inc. furnished a new corporate presentation as part of a current report. On February 11, 2026, the company posted this corporate presentation to its website and made it available to investors as Exhibit 99.1 to a Form 8-K.
The company notes that this presentation, included under Item 7.01, is being provided for informational purposes and is not deemed “filed” under the Exchange Act, which limits potential liability and controls how it can be incorporated into other SEC filings.
Protalix BioTherapeutics reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of a new dosing regimen for Elfabrio for Fabry disease. The proposed regimen is 2 mg/kg given every four weeks for adult patients who are stable on enzyme replacement therapy.
The announcement was made together with Protalix’s development and commercialization partner, Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., highlighting their collaboration on Elfabrio in the rare disease space.
Protalix BioTherapeutics, Inc. reported that on January 5, 2026 it issued a press release that included a letter the company released to its stockholders. This information is being made available to investors through a current report on Form 8-K.
The press release and stockholder letter are furnished as Exhibit 99.1, meaning they are provided for informational purposes and are not treated as “filed” for liability purposes under Section 18 of the Exchange Act or automatically incorporated into other SEC filings. Protalix’s common stock trades on the NYSE American under the symbol PLX.
Protalix BioTherapeutics, Inc. insider transaction: the company’s President and CEO, who also serves as a director, reported buying 56,000 shares of common stock of Protalix BioTherapeutics, Inc. on 12/19/2025 at a price of $1.81 per share. After this purchase, the insider directly owns 188,516 common shares and indirectly holds an additional 2,344,418 shares through a trust. The filing notes that, to qualify for certain tax benefits under Section 102 of the Israeli Tax Ordinance, securities issued to an employee in connection with the company’s plan must be registered in the name of a trustee.
Protalix BioTherapeutics, Inc. (PLX)11/18/2025, the director sold 168 shares of common stock at $1.87 per share, coded as a sale. Following this transaction, the director reported 0 shares held directly and 7,500 shares held indirectly through a trust.
The filing notes that, to qualify for certain tax benefits under Section 102 of the Israeli Tax Ordinance, securities issued under the company’s 2006 Stock Incentive Plan must be registered in the name of a trustee.
Protalix BioTherapeutics (PLX) filed its Q3 2025 10‑Q, highlighting steady operations and pipeline updates. Total revenue reached $43.6 million for the nine months ended September 30, 2025, up from $35.2 million a year ago, driven by product sales to partners. Q3 revenue was $17.9 million. The company posted Q3 net income of $2.4 million, while recording a nine‑month net loss of $1.1 million.
Cash and cash equivalents were $13.6 million, with $15.7 million in short‑term deposits. Operating cash flow was $(14.0) million for the nine months, partly offset by $9.2 million from financing, including $6.8 million raised under its Sales Agreement and $2.4 million from exercises. Approximately $15.7 million in capacity remained under the Sales Agreement as of September 30, 2025.
Leases were amended, extending options through December 31, 2031; right‑of‑use assets were remeasured by $3.1 million. The company reported its cash resources are sufficient for at least 12 months. Recent updates include an effective IND for PRX‑115 Phase 2, a CHMP negative opinion on Elfabrio’s E4W dosing with re‑examination requested, and a CFO transition. Shares outstanding were about 80,421,181 as of November 1, 2025.
Protalix BioTherapeutics furnished a Form 8-K noting it issued a press release with financial results for the fiscal quarter ended September 30, 2025 and provided a business and clinical update.
The press release is included as Exhibit 99.1. In accordance with General Instruction B.2, the information, including Exhibit 99.1, is furnished and not deemed filed under the Exchange Act.
Protalix BioTherapeutics (PLX) reported that, together with partner Chiesi Global Rare Diseases, it has requested a re-examination of the European Medicines Agency’s CHMP negative opinion on the proposed dosing regimen for Elfabrio (pegunigalsidase alfa). The request pertains to a regimen of 2 mg/kg infused every 4 weeks (E4W).
The company furnished a press release as Exhibit 99.1 with additional details. This update reflects an ongoing EU regulatory process focused specifically on the proposed E4W dosing for Elfabrio.