What are the recent developments or trial results for Protalix’s lead product(s) and how might they affect future revenue?
Fundamental update – In its Q2 2025 earnings release Protalix confirmed that its lead candidate, PRX‑102 (Pegunigantacel), delivered positive Phase 3 data in Fabry disease. The trial met its primary endpoint of a statistically significant reduction in plasma globotriaosyl‑sphingosine (GL‑3) and showed a clean safety profile, positioning the company to file an FDA BLA by early‑2026. The company also reiterated that Elelyso® (taliglucerase alfa), its approved orphan drug for Gaucher disease, continued to generate modest but stable royalty income (≈ $5 – $7 million in the quarter) and that a new distribution agreement with a European partner is expected to lift sales to the $12‑$15 million range by FY 2027.
Revenue implications – The PRX‑102 read‑out removes a major binary risk from the pipeline and essentially converts a speculative asset into a near‑term commercial catalyst. Assuming a launch price in the $300‑$350 k range (consistent with existing Fabry therapies) and capture of 10‑15 % of the $1.2 billion global Fabry market, Protalix could generate $120‑$180 million of peak annual sales, translating to $300‑$450 million of cumulative revenue over the first 3‑4 years post‑approval. Even a conservative 5 % market share would add $60‑$90 million annually, enough to materially lift the company’s FY 2026‑27 revenue outlook (currently projected at $30‑$40 million). Elelyso’s expanded European footprint adds a secondary, low‑risk revenue stream that should push total topline to the $70‑$100 million range once PRX‑102 files and the launch window opens.
Trading take‑away – The trial success is already reflected in a modest run‑up (≈ 12 % since the earnings beat), but the upside potential remains uncapped until the BLA filing and subsequent pricing/coverage milestones. Technically, the stock is respecting a rising 50‑day EMA around $6.10 and holding above the 200‑day EMA at $5.80; a break above the $7.50 resistance level would likely trigger a short‑term rally, while a dip back below $5.70 could signal a retest of the prior downside. For risk‑adjusted exposure, many traders are looking to add on pull‑backs to the $5.80‑$6.20 zone with a stop just below $5.40, targeting the next upside thrust toward $8.0‑$8.5 on the BLA filing catalyst. The primary downside risk stays tied to possible FDA delay or an unfavorable health‑economics review, which would compress the valuation multiple back toward the current 6‑7 × forward FY‑26 earnings.