Knight Therapeutics Announces Regulatory Approval of TAVALISSE(TM) in Brazil

• On May 8, 2026, Knight announced ANVISA (Brazil) approval of TAVALISSE® (fostamatinib) for chronic immune thrombocytopenia (ITP) in adults who failed prior therapy.
• The approval follows an earlier rejection that had been appealed; it opens a sizable Latin American market, with launch expected in H2 2026.
• One day earlier, the company reported Q1 2026 results: record revenues of $148.4 M (+69 % YoY), Adjusted EBITDA of $27.9 M (+130 %), and raised full‑year revenue guidance to $510‑$525 M (from $490‑$510 M).
• The May 8 release emphasizes Knight’s ability to navigate complex Latin American regulatory systems and adds another branded oncology/specialty product to its regional portfolio.

• Context of prior setbacks & follow‑through:
  At year‑end 2025 (March 19 release), Knight disclosed ANVISA had rejected the original TAVALISSE filing; the company appealed and was accepted for review. The May 8 approval therefore represents a successful recovery from a known risk, not a complete surprise but a positive resolution that keeps the regional expansion on track.
• Alignment with company narrative:
  Since mid‑2025, Knight has been systematically executing a two‑pronged strategy: (1) integrating the Paladin/Sumitomo acquisitions to dominate Canadian specialty pharma, and (2) rolling out oncology/rare‑disease products across Latin America. The TAVALISSE approval in Brazil is the latest in a long string of regulatory wins for the Latin American pipeline (Minjuvi in Argentina, Mexico, Brazil; Pemazyre in Brazil/Mexico; Bapocil in Colombia; new submissions for Niktimvo and Minjuvi FL).
• Financial weight:
  At $148 M quarterly revenue and a market cap of ~$845 M, the incremental revenue from TAVALISSE in Brazil will be modest initially. ITP is a niche indication; clinical data show 18 % stable platelet response, limiting the addressable patient pool. However, the approval reinforces the broader thesis that Knight can become the partner of choice for innovative therapies in Latin America, which supports valuation multiple expansion.
• Market reaction:
  The stock closed at $8.35 on May 7 after the record quarter, already pricing in a strong positive tone. The May 8 approval will likely provide additional buying interest, though much of the good news may have been anticipated given the appeal had been accepted.
• Comparison with Q1 guidance raise:
  The guidance increase was driven by the core Canadian portfolio and existing launches; TAVALISSE is not yet included in 2026 numbers because launch occurs H2. Thus, it represents incremental upside to the already upgraded forecast.

Overall, the TAVALISSE approval is a solid, positive development that adds a piece to the Latin American puzzle. It is not a “game changer” on its own—the company is already firing on many cylinders—but it qualifies as Material‑Positive because it closes a previous regulatory uncertainty and adds a new, sellable asset in the largest Latin American market.

• Knight Therapeutics is a Montreal‑headquartered specialty pharmaceutical company focused on acquiring, in‑licensing, and commercializing innovative and branded generic products in Canada and Latin America.
• Flagship strategy:
  Knight transformed its scale with two game‑changing transactions in June 2025:
• Acquisition of Paladin Pharma (Canadian assets) for ~$90 M plus inventory and holdbacks, adding a broad portfolio and commercial infrastructure.
• License & asset purchase from Sumitomo Pharma America (Orgovyx, Myfembree, vibegron, mature products) for $25.4 M upfront plus milestones.
• These deals, combined with Knight’s existing agreements with Incyte (tafasitamab, pemigatinib, retifanlimab, axatilimab) and Rigel (fostamatinib LATAM), position Knight as a multi‑pillar specialty pharma:
• Oncology: Minjuvi, Pemazyre, Trelstar, Niktimvo (pipeline).
• Women’s health: Myfembree, Bijuva, Imvexxy.
• CNS/ADHD: JORNAY PM, Qelbree (pipeline).
• Dermatology: WYNZORA.
• Other: Orgovyx (prostate cancer), TAVALISSE (ITP).