PLX: CHMP declines monthly Elfabrio dosing; biweekly remains in place

Rhea-AI Filing Summary

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.

Insights

Biopharma regulatory analyst

CHMP rejected a less frequent Elfabrio dosing option.

The disclosure states CHMP issued a negative opinion on adding a 2 mg/kg every 4 weeks regimen for Elfabrio, while the 1 mg/kg every 2 weeks regimen remains approved. This limits labeled flexibility to the existing schedule.

Commercially, a monthly option can support patient convenience and market uptake, so its absence may weigh on adoption relative to biweekly dosing. The filing does not quantify impact or outline next steps.

Key items are the current EU label and any future updates if the partners pursue further regulatory interactions. Subsequent company communications may clarify pathways following this opinion.

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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): October 17, 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 7.01 Regulation FD Disclosure

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On October 17, 2025, Protalix BioTherapeutics, Inc., a Delaware corporation (the “Company”) posted a corporate presentation to its website. A copy of the corporate presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 to this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 8.01 Other Events

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On October 17, 2025, 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 that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a negative opinion on the request to approve the dosing regimen of 2 mg/kg body weight infused every 4 weeks for Elfabrio^® (pegunigalsidase alfa), in addition to the currently approved dosing regimen of 1 mg/kg body weight infused every 2 weeks. A copy of the press release is attached as Exhibit 99.2 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	​	October 2025 Corporate Presentation
99.2	​	Press Release dated October 17, 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: October 17, 2025	PROTALIX BIOTHERAPEUTICS, INC. ​ ​
	By:	/s/ Dror Bashan
		Name:	Dror Bashan
		Title:	President and Chief Executive Officer

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