CHMP backs new Elfabrio regimen for Protalix (NYSE: PLX) patients

Rhea-AI Filing Summary

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.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): January 30, 2026

Protalix BioTherapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-33357		65-0643773
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

2 University Plaza				07601
Suite 100				(Zip Code)
Hackensack, NJ
(Address of principal executive offices)

Registrant’s telephone number, including area code 201-696-9345

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, $0.001 par value	PLX	NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01 Other Events

On January 30, 2026, Protalix BioTherapeutics, Inc., a Delaware corporation (the “Company”), issued a press release, together with its development and commercialization partner, Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of the 2 mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio^® in Fabry disease adult patients stable with an ERT (Enzyme Replacement Therapy) treatment. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits

Exhibit No.		Description
99.1		Press Release dated January 30, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 30, 2026	PROTALIX BIOTHERAPEUTICS, INC.
	By:	/s/ Dror Bashan
		Name:	Dror Bashan
		Title:	President and Chief Executive Officer

FAQ

What did Protalix BioTherapeutics (PLX) announce about Elfabrio?

Protalix BioTherapeutics announced a positive CHMP opinion recommending approval of a new Elfabrio dosing regimen. The opinion supports a 2 mg/kg every-four-weeks schedule for Fabry disease adults who are stable on enzyme replacement therapy, reflecting regulatory progress in Europe.

What new Elfabrio dosing regimen is CHMP recommending for Protalix (PLX)?

The CHMP recommends a 2 mg/kg every-4-weeks Elfabrio regimen for Fabry disease adult patients who are stable with an existing enzyme replacement therapy. This would provide an alternative dosing schedule to currently treated patients if formally approved by European authorities.

Which patients are targeted by the new Elfabrio regimen from Protalix (PLX)?

The regimen targets adult Fabry disease patients stable on ERT. Specifically, it is intended for adults already receiving enzyme replacement therapy, offering a 2 mg/kg every-four-weeks dosing option if the recommendation from CHMP is ultimately adopted by European regulators.

What role does Chiesi play in Protalix (PLX) Elfabrio update?

Chiesi Global Rare Diseases is Protalix’s partner for Elfabrio. Protalix issued the announcement together with Chiesi, its development and commercialization partner, underscoring their joint effort to advance and commercialize Elfabrio for Fabry disease patients in relevant markets.

Is the Elfabrio dosing change for Protalix (PLX) already approved in Europe?

No, CHMP has issued a positive opinion recommending approval. This opinion is an important regulatory step within the European Medicines Agency process, but it precedes any final authorization decision by European authorities on the 2 mg/kg every-four-weeks Elfabrio regimen.