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Protalix BioTherapeutics, Inc. (DE)

PLX
Richly ValuedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$2.7
▼ -0.01 · -0.37%

Financials

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52W LOW $1.6052W HIGH $3.19
Volume
972.85 K
Value Traded
1.89 M
Short % Float
3.72%
-0.37%Week
+1.12%1 Month
+10.66%3 Month
+17.39%6 Month
-28.08%5 Year
-99.97%All Time

Cash Data

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Key Stats

Market Cap
217.54 M
EPS (TTM)
0.24
P/E Ratio
11.48
Ent. Value
176.89 M
Total Shares
80.56 M
Float Shares
77.45 M
Insiders
3.88%
Institutions
19.40%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 2 topline data readout
PRX-115
Uncontrolled gout
Phase 2Enzyme Replacement Therapies (ERT)Digestive System
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PoA blends historical approval base rates, trial design score and FDA review track record.

PLX Catalyst Timeline

Dated clinical, regulatory and corporate events for Protalix BioTherapeutics, Inc. (DE)

Catalyst Timeline

Dated clinical, regulatory & corporate events for Protalix BioTherapeutics, Inc. (DE)

712Total events
10Upcoming
217Tier-1 (high impact)
2007 to 2028Coverage

Upcoming catalysts 2

T2Quarterly Update
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T1Partnership / License
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Event history 50

●Quarterly UpdateCorporate
Conference call and webcast to discuss Q2 2026 results
●Enrollment UpdatePRX-115Trial
Phase 2 RELEASE study actively enrolling
uncontrolled goutsource ↗
●Quarterly UpdateCorporate
First quarter 2026 financial results reported
▲MHRA MilestoneElfabrioApprovedEx-US Regulatory
MHRA approved 2mg/kg every-4-weeks dosing regimen for Elfabrio in adults with Fabry disease
Fabry diseasesource ↗
▲EU ApprovalElfabrioApprovedEx-US Regulatory
EC approved E4W dosing regimen for Elfabrio
Fabry diseasesource ↗
●Quarterly UpdateCorporate
Fiscal year 2025 financial results and business update
◆Enrollment UpdatePRX-115Trial
Phase 2 trial actively enrolling
uncontrolled goutsource ↗
▲EU ApprovalElfabrioApprovedEx-US Regulatory
European Commission approval of 2mg/kg every-4-weeks dosing regimen for Elfabrio
Fabry diseasesource ↗
▲CHMP Positive OpinionElfabrioApprovedEx-US Regulatory
CHMP positive opinion recommending additional dosing regimen for Elfabrio
Fabry diseasesource ↗
▲Milestone PaymentElfabrioApprovedCorporate
Protalix entitled to $25 million regulatory milestone payment from Chiesi
Fabry diseasesource ↗
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Past FDA Catalysts and PDUFA Decisions

How PLX actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2022-06-30pegunigalsidase alfa (PRX-102) Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D27 / 100
Pipeline Score
$9M
Pipeline Value
Richly Valued
Valuation Signal
1
Drugs Scored
0.0x
rNPV / MCap
Top 77%
Micro Cap
(rank 507 of 658)
Percentile Rank
Protalix BioTherapeutics, Inc. (DE) faces pipeline headwinds (27/100), with $112M risk-adjusted pipeline value, led by PRX-115 in Gout (Phase 2).
Showing 1 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
PRX-115 Small moleculeNCT05745727GoutPhase 2 COMPLETED 214Feb 1, 2025
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Clinical Trial Results

Readouts, endpoints and source filings for every PLX program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
PRX-115 uncontrolled goutPhase 12024-08-14Results from the first seven cohorts of the phase I clinical trial of PRX-115 for the treatment of uncontrolled gout are encouraging.Read MoreProtalix BioTherapeutics Reports Second Quarter 2024 Financial and Business Results Company to host conference call and webcast today at 8:30 a.m.Read More
Scroll for more · summaries link to the source press release
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Inside Trades

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InsiderSideSharesPriceValueDate
Bashan DrorDirector, Officer (PRESIDENT AND CEO)Buy 56,000 188,516 held$1.81 12/19/2025
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
Opaleye Management Inc. 0.1 % (-83.3 %) 737.00 K 340.00 K -86.28% ( -2.14 M)
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Options Data

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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-16
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Real-Time Option Chain

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Competitive positioning

How PLX ranks across every disease it competes in

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PLX News

PLX
Sep 8, 2026
PLXConferences/Events

Protalix BioTherapeutics to Participate in Upcoming September 2026 Investor Conferences

Protalix BioTherapeutics will participate in two investor conferences in New York City from September 14-16, 2026. Gilad Mamlok, the company's CFO, will present at the H.C. Wainwright Conference and engage in a fireside chat at the Morgan Stanley Conference. Live webcasts of these events will be available for investors.

Read more →
PLX
Aug 12, 2026
PLXGeneral
▲ +7.8%on this news

Protalix BioTherapeutics Reports Second Quarter 2026 Financial and Business Results

Protalix BioTherapeutics reported a strong financial performance for the second quarter of 2026, with revenues from goods sold reaching $19.8 million, an increase of $4.4 million compared to the same period in 2025. The total revenue for the year to date is $53.6 million, indicating robust growth largely attributed to the sales of Elfabrio®.

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PLX
Aug 5, 2026
PLXConferences/Events

Protalix BioTherapeutics to Announce Second Quarter 2026 Financial Results and Business Update on August 12, 2026

Protalix BioTherapeutics will announce its financial results for Q2 2026 on August 12, 2026. The company will host a conference call at 8:00 a.m. EDT to discuss these results and recent corporate developments. Protalix focuses on innovative therapeutics for rare diseases and has a unique plant cell-based expression system for producing recombinant proteins.

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PLX
May 21, 2026
PLXPhases

PROTALIX BIOTHERAPEUTICS C O R P O R A T E P R E S E N T A T I O N J u n e 2024 PROTALIX BIOTHERAPEUTICS Pioneering solutions to transform the treatment of rare diseases C O R P O R A T E P R E S E N T A T I O N M a y 20

Protalix Biotherapeutics presented updates on its pipeline and financial status in June 2024, highlighting advanced clinical stages for drugs targeting rare diseases. The company aims to capitalize on the growing market for therapies such as Elfabrio, which is expected to capture significant market share in treating Fabry disease. Additionally, promising data from the ongoing Phase 1 study of PRX-115 for uncontrolled gout reinforces its best-in-class potential and is anticipated to drive future growth. Protalix's strong partnership with Chiesi and solid financial position further underpin its strategic goals in rare disease treatments.

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PLX
May 13, 2026
PLXConferences/Events

Protalix BioTherapeutics Reports First Quarter 2026 Financial and Business Results

Protalix BioTherapeutics reported its first quarter 2026 financial results, highlighting positive momentum with ongoing partnerships and clinical advancements. The company reaffirmed its strategic priorities and financial outlook, driven by recent regulatory achievements for its product Elfabrio and continued enrollment in clinical studies for its candidate PRX-115. The management emphasized a strong financial position and a focus on developing therapies for rare diseases. Despite the positive outlook, they acknowledged various risks associated with commercialization and potential disruptions due to regional conflicts.

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PLX
May 6, 2026
PLXGeneral

Protalix BioTherapeutics to Announce First Quarter 2026 Financial Results and Business Update on May 13, 2026

Protalix BioTherapeutics will announce its financial results for Q1 2026 and provide a business update on May 13, 2026. The company will host a conference call at 8:00 a.m. EDT to discuss these results and recent corporate developments. Participants can access the call via phone or webcast, with a replay available afterward.

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PLX
Mar 18, 2026
PLXConferences/Events
▼ -20.8%on this news

Protalix BioTherapeutics Reports Fiscal Year 2025 Financial and Business Results

Protalix BioTherapeutics reported its fiscal year 2025 financial and business results, highlighting important advancements such as the European Commission's approval of the E4W dosing regimen for its product Elfabrio. The company emphasized a strong commercial outlook and the progress of its clinical pipeline, including the active enrollment in Phase 2 trials for PRX-115. As they move into 2026, Protalix aims to enhance profitability and expand its product offerings in rare diseases, while acknowledging existing risks related to market dynamics and regulatory challenges.

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PLX
Mar 11, 2026
PLXConferences/Events

Protalix BioTherapeutics to Announce Fiscal Year 2025 Financial Results and Business Update on March 18, 2026

Protalix BioTherapeutics will announce its fiscal year 2025 financial results and provide a business update on March 18, 2026. The company will host a conference call to discuss these results and recent corporate developments. Protalix is known for its innovative therapeutics for rare diseases, including products developed through its proprietary plant cell-based expression system.

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PLX
Mar 9, 2026
PLXFDA Updates
▲ +9.9%on this news

Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Approval of Additional Dosing Regimen of Every Four Weeks for Elfabrio® (pegunigalsidase alfa)

Chiesi Global Rare Diseases and Protalix BioTherapeutics announced that the European Commission has approved a new dosing regimen for Elfabrio (pegunigalsidase alfa) for adults with Fabry disease. The regimen allows for administration every four weeks instead of every two weeks, providing greater flexibility for patients. This decision follows a positive opinion from the EMA and aims to ease the treatment burden for patients and their families.

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PLX
Feb 11, 2026
PLXPhases
▲ +8.1%on this news

Forward-Looking Statements This presentation contains forward-looking statements that involve risks and uncertainties within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, an

Protalix Biotherapeutics is advancing its initiatives with Elfabrio for Fabry disease, which recently received positive opinion from the EMA for an expanded dosing regimen. The company is strengthening its position in the market through strategic partnerships, particularly with Chiesi, providing a robust foundation for growth. Additionally, Protalix is actively enrolling patients in the Phase 2 trial for PRX-115, a treatment for uncontrolled gout, aiming to address significant unmet medical needs in this area.

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PLX
Jan 30, 2026
PLXFDA Updates
▲ +13%on this news· ran to +40% by day 3

Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for an Additional Dosing Regimen of Every Four Weeks for Elfabrio (pegunigalsidase alfa)

Chiesi Global Rare Diseases and Protalix BioTherapeutics received a positive recommendation from the CHMP for an every-four-week dosing regimen of Elfabrio (pegunigalsidase alfa) for Fabry disease treatment. This follows a re-examination and could greatly reduce the treatment load for patients currently required to visit infusion centers every two weeks. Although the new regimen is not approved in the U.S., it represents a significant step forward in treatment flexibility and patient care. A decision from the European Commission is expected by March 2026.

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PLX
Jan 5, 2026
PLXGeneral

Protalix BioTherapeutics Letter to Stockholders

Protalix BioTherapeutics provided an update expressing its focus on growth and innovation for rare diseases in 2026. The company highlighted the promising results of PRX-115 for uncontrolled gout, which could address significant treatment gaps. Additionally, Protalix is strengthening its renal pipeline with PRX-119. The company also noted solid commercial performance through its collaborations with Chiesi and Pfizer, despite facing a negative opinion from EMA regarding Elfabrio, necessitating an appeal.

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PLX
Nov 13, 2025
PLXConferences/Events
▼ -9.8%on this news

Protalix BioTherapeutics Reports Third Quarter 2025 Financial and Business Results

Protalix BioTherapeutics has reported its financial results for the third quarter of 2025, indicating total revenues of $17.9 million and a 24% increase in revenues for the first nine months compared to the previous year. CEO Dror Bashan highlighted the encouraging data from the company's phase 1 clinical trial of PRX-115, suggesting its potential as an innovative treatment for uncontrolled gout. Furthermore, Protalix maintains a robust cash position of $29.4 million, adequate for at least the next year, although revenues showed a slight decline in the recent quarter compared to 2024. The company is planning to initiate a phase 2 trial for PRX-115 later this year.

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PLX
Nov 3, 2025
PLXFDA Updates

Chiesi Global Rare Diseases and Protalix BioTherapeutics Seek Re-examination from the EMA for the Negative Opinion for Elfabrio (pegunigalsidase alfa) Alternative Dosing Regimen of Every Four Weeks in the EU

Chiesi Global Rare Diseases and Protalix BioTherapeutics are requesting a re-examination by the EMA regarding a negative opinion on an alternative dosing regimen for Elfabrio (pegunigalsidase alfa). The proposed regimen involves infusing 2 mg/kg every four weeks, whereas the existing regimen of 1 mg/kg every two weeks remains approved. The companies aim to address the unmet medical needs of patients with Fabry disease throughout this process. Notably, the existing marketing authorization for Elfabrio stays in force while the re-examination is pending.

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PLX
Sep 2, 2025
PLXConferences/Events
▲ +5.8%on this news

Protalix BioTherapeutics to Present at the H.C. Wainwright 27th Annual Global Investment Conference Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of...

Protalix BioTherapeutics, Inc. (NYSE American:PLX) announced that its President and CEO, Dror Bashan, will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025. The conference, held at the Lotte New York Palace Hotel, will include one-on-one meetings between management and registered investors. Protalix focuses on developing recombinant therapeutic proteins through its proprietary ProCellEx plant cell-based expression system and has recently gained FDA approval for its second product, Elfabrio.

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PLX
Aug 14, 2025
PLXConferences/Events
▼ -5.6%on this news

Protalix BioTherapeutics Reports Second Quarter 2025 Financial and Business Results

Protalix BioTherapeutics reported strong financial results for Q2 2025, showcasing a 50% increase in revenues driven mainly by the sales of Elfabrio. The company highlights a promising partnership with Chiesi for commercialization efforts in the Fabry disease market, anticipated to grow significantly by 2030. Additionally, Protalix is preparing to launch a Phase 2 trial for PRX-115, a treatment targeting uncontrolled gout. However, the company remains cautious about potential fluctuations in product orders and the impact of regional conflicts on operations.

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PLX
Jul 21, 2025
PLXGeneral

Protalix BioTherapeutics Appoints Gilad Mamlok as its New Senior Vice President and Chief Financial Officer

Protalix BioTherapeutics has appointed Gilad Mamlok as the new Senior Vice President and Chief Financial Officer, effective August 24, 2025. He succeeds Eyal Rubin, who will assist in the transition until October 2025. Mamlok has extensive experience in healthcare finance and is expected to contribute significantly to the company's growth strategy. The company has recently experienced momentum with the approval of its product Elfabrio and has a robust development pipeline.

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PLX
May 9, 2025
PLXConferences/Events
▼ -40.5%on this news

Protalix BioTherapeutics Reports First Quarter 2025 Financial and Business Results

Protalix BioTherapeutics reported strong first quarter results for 2025, with revenues from goods increasing by 170% compared to the previous year. The company highlighted progress in its clinical pipeline, particularly the promising results of PRX-115 from its Phase I trial for gout, indicating plans to proceed to a Phase II trial later this year. Despite these positive developments, the company reported a net loss of approximately $3.6 million for the quarter, and the cost of goods sold has seen a significant increase.

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About Protalix BioTherapeutics, Inc. (DE)

Hackensack, NJ 226 employees protalix.com
Headquarters2 UNIVERSITY PLAZA, HACKENSACK, NJ, 07601
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