[8-K] Protalix BioTherapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

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.

Insights

Regulatory affairs analyst

EU re-examination requested for Elfabrio’s E4W dosing; outcome depends on CHMP.

Protalix and Chiesi have asked the CHMP to re-examine its recent negative opinion regarding Elfabrio dosed at 2 mg/kg every 4 weeks. A re-examination allows sponsors to address committee concerns and present clarifications focused on the specified regimen.

The filing centers on the dosing proposal rather than broader efficacy or safety conclusions. The impact for EU market use hinges on the CHMP’s assessment of the E4W regimen in this review cycle.

The company attached a press release as Exhibit 99.1, which indicates the formal step taken to continue the EU dialogue on the E4W dosing proposal.

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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): November 3, 2025

Protalix BioTherapeutics, Inc.

(Exact name of registrant as specified in its charter)

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Delaware		001-33357		65-0643773
(State or other jurisdiction of incorporation)	​	(Commission File Number)	​	(IRS Employer Identification No.)
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2 University Plaza	​	​	​	​
Suite 100	​	​	​	​
Hackensack, NJ	​	​	​	07601
(Address of principal executive offices)	​	​	​	(Zip Code)

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 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))

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

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

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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. ◻

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Item 8.01 Other Events

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On November 3, 2025, 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 they have requested a re-examination of the recent negative opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the proposed dosing regimen of 2 mg/kg body weight infused every 4 weeks (E4W) for Elfabrio^® (pegunigalsidase alfa). 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 9.01Financial Statements and Exhibits

Exhibit No.		Description
99.1	​	Press Release dated November 3, 2025
104	​	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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: November 3, 2025	PROTALIX BIOTHERAPEUTICS, INC. ​ ​
	By:	/s/ Dror Bashan
		Name:	Dror Bashan
		Title:	President and Chief Executive Officer

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FAQ

What did Protalix (PLX) announce in this 8-K?

The company, with Chiesi, requested a CHMP re-examination of a negative opinion on Elfabrio’s proposed 2 mg/kg every 4 weeks dosing regimen.

Which product and dosing are involved for PLX?

Elfabrio (pegunigalsidase alfa) with a proposed dosing of 2 mg/kg infused every 4 weeks (E4W).

Which regulatory body is addressed in the filing?

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Who is Protalix’s partner in this update?

Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A.

What exhibit accompanies the disclosure?

Exhibit 99.1, a press release dated November 3, 2025.

Does the filing discuss the entire Elfabrio program?

It specifically addresses the CHMP’s negative opinion on the proposed 2 mg/kg E4W dosing and the request for re-examination.