Every 8-K that Protalix BioTherapeutics, Inc. (PLX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow PLX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full PLX filings page.
Protalix BioTherapeutics, Inc. reported substantially stronger results for the quarter and six months ended June 30, 2026. Total revenue for the first half of 2026 was $53.6 million, up from $25.8 million in 2025, and net income turned to a $22.1 million profit from a $3.5 million loss. Second quarter 2026 revenue was $19.9 million versus $15.7 million a year earlier, with net income of $3.8 million versus $0.2 million.
Growth was driven by higher revenues from selling goods, primarily continued global penetration of Elfabrio, and a $25.0 million milestone payment from Chiesi related to EU dosage approval. Cash and cash equivalents plus short-term deposits totaled $40.7 million at June 30, 2026, and the company states it has no outstanding debt or warrants. Management reaffirmed its 2026 revenue expectations and highlighted progress in the PRX-115 Phase 2 RELEASE trial and preclinical programs focused on rare renal indications, while indicating that future license and R&D service revenues are expected to be minimal aside from potential regulatory milestones.
Protalix BioTherapeutics held its 2026 annual stockholder meeting, where investors approved all proposals presented. Stockholders elected eight directors, with Eliot Richard Forster, Ph.D. receiving 32,871,013 votes for and 2,379,140 withheld, alongside 10,705,177 broker non-votes.
Investors approved, on a non-binding advisory basis, the compensation of the company’s named executive officers, with 28,368,614 votes for and 6,683,937 against. They also approved an amended and restated 2006 Stock Incentive Plan, increasing the shares available under the plan from 17,475,171 to 20,975,171.
Stockholders ratified the appointment of Kesselman & Kesselman, a member of PricewaterhouseCoopers International Limited, as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 42,958,243 votes for, 2,001,734 against, and 995,352 abstentions.
Protalix BioTherapeutics, Inc. filed a current report stating that on May 21, 2026 it posted a new corporate presentation on its website. The presentation is furnished as Exhibit 99.1 and, under the cited Exchange Act instructions, is treated as furnished rather than filed for liability purposes.
Protalix BioTherapeutics reported sharply improved first quarter 2026 results. Total revenue rose to $33.8M for the quarter ended March 31, 2026, up from $10.1M a year earlier, driven mainly by $26.3M of license and R&D service revenue, including a milestone tied to Elfabrio’s European progress.
The company generated net income of $18.3M versus a net loss of $3.6M in the prior-year period, with diluted EPS at $0.22. Cash and cash equivalents increased to $41.0M, supporting a debt-free balance sheet. Management reaffirmed its 2026 revenue outlook and highlighted ongoing enrollment in the PRX-115 Phase 2 RELEASE gout study and continued focus on rare renal disease programs.
Protalix BioTherapeutics reported fiscal year 2025 results showing total revenue of $52,744 thousand, slightly below 2024’s $53,399 thousand, and a net loss of $6,604 thousand compared with net income of $2,932 thousand in 2024. Basic loss per share was $(0.08).
Operating income swung from a $3,917 thousand profit in 2024 to a $5,500 thousand operating loss in 2025, driven by higher cost of goods sold and increased research and development spending. Total assets rose to $82,346 thousand, with stockholders’ equity increasing to $48,230 thousand as of December 31, 2025.
The company highlighted European Commission approval of the every‑four‑weeks dosing regimen for Elfabrio for Fabry disease, continued Phase 2 enrollment for PRX‑115 in uncontrolled gout, and a strategic focus on rare renal indications, noting a profitable commercial base, no outstanding debt or warrants, and an upcoming conference call to discuss the results.
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, 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 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.
Protalix BioTherapeutics, Inc. entered into a new letter agreement on August 22, 2025 amending its existing at-the-market equity offering program with H.C. Wainwright & Co., LLC. The change updates the prior sales agreement so that future at-the-market sales of common stock can be made under Protalix’s new shelf registration statement on Form S-3 (Registration No. 333-286802).
The company also filed as exhibits the amendment itself and a legal opinion from its counsel, Mayer Brown LLP, confirming the legality of the shares that may be sold under this updated program.
Protalix BioTherapeutics, Inc. disclosed that it furnished a press release announcing its financial results for the fiscal quarter ended June 30, 2025 and provided a business and clinical update. The press release is furnished as Exhibit 99.1 to the Current Report on Form 8-K. The filing notes that the furnished information is not deemed "filed" under Section 18 of the Exchange Act and, therefore, is not incorporated by reference into registration statements or other filings unless specifically stated.
Protalix BioTherapeutics (NYSE:PLX) filed an 8-K disclosing the results of its 2025 Annual Meeting held on June 26, 2025.
- Eight directors elected: top nominee received 22.4 M votes for versus 1.9 M withheld; 12.7 M broker non-votes across the slate.
- Say-on-pay approved: 16.4 M for, 7.5 M against, 0.38 M abstentions, 12.7 M broker non-votes.
- PwC Israel ratified as auditor for FY 2025: 34.9 M for, 1.6 M against, 0.46 M abstentions.
No additional material actions or strategic updates were reported.