Protalix BioTherapeutics, Inc. filings document a commercial-stage biopharmaceutical issuer with NYSE American-listed common stock and a business built around recombinant therapeutic proteins produced through ProCellEx®. The company’s Form 8-K reports cover operating results, financial condition, business and clinical updates, corporate presentations, stockholder communications and regulatory events involving Elfabrio®.
Protalix’s proxy materials describe board governance, executive compensation, equity awards and shareholder voting matters. Its regulatory disclosures also identify material event reporting around European regulatory actions for Elfabrio, collaboration-related communications with commercialization partners, and the capital-market status of its common stock.
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) reported an insider transaction by a director on a Form 4. On 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.
Protalix BioTherapeutics (PLX) announced a regulatory update and investor materials. Together with partner Chiesi Global Rare Diseases, the company reported that the EMA’s Committee for Medicinal Products for Human Use issued a negative opinion on adding a dosing regimen of 2 mg/kg infused every 4 weeks for Elfabrio (pegunigalsidase alfa). The currently approved regimen of 1 mg/kg infused every 2 weeks remains in place.
The company also furnished an October 2025 corporate presentation on its website. A related press release and the presentation were provided as exhibits.
Forster Eliot, a director of Protalix BioTherapeutics, Inc. (PLX), reported transactions on 09/03/2025 showing an acquisition of equity awards. The filing discloses 7,500 restricted shares of common stock awarded under the companys amended 2006 Stock Incentive Plan, held indirectly through a trust and vesting in 12 equal quarterly installments commencing on the grant date. The reporting person also received 15,000 stock options with a $1.64 exercise price that were granted the same date; those options vest in 12 equal quarterly installments and expire on 09/03/2035. The Form 4 also notes existing options to buy 85,715 shares at $1.75 expiring 09/14/2033. The document is signed by an attorney-in-fact on 09/04/2025.