Record mula sa primary source
Decision-gradeNaitakda ang petsa ng PDUFA
Replimune: RP1 PDUFA itinakda sa Abril 10, 2026 para sa anti-PD-1 failed melanoma
Ayon sa presentasyon sa JPM 2026, may malapit na PDUFA date na Abril 10, 2026 para sa RP1 sa anti-PD-1 failed melanoma. Iniulat ng kumpanya na handa na ang kanilang commercial team para sa paglulunsad, na may 150 accounts na handa sa unang araw. Ang pagpapatala sa confirmatory IGNYTE-3 trial ay nasa tamang iskedyul, at ang interim OS analysis ay binalak para sa 2H 2027.
Mahahalagang fact
- Na-file
- Ene 12, 2026, 01:00 PM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Positibo
- Kumpanya
REPLReplimune- Asset
- RP1
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Abr 10, 2026 · Walang naitalang resulta
- Mga handang account
- 150
- Malalim na iniksyon
- ~1,200
- Mga pasyenteng ginamot
- ~1,000
- Maaabot na mga pasyente
- ~10K
Sipi mula sa source
EX-99.1 2 tm262890d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 © 2026 Replimune Group Inc. JPM 2026 Presentation Click to edit Master title style 1 Click to edit Master text styles Igniting a systemic immune response to cancer with oncolytic immunotherapy January 14, 2026 JPM Healthcare Conference © 2025 Replimune Group Inc. © 2026 Replimune Group Inc. 2 Safe harbor Any statements contained herein that are not statements of historical facts may be deemed to be forward - looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the advancement, timing and sufficiency of our clinical trials or financial status, patient enrollments in our existing and planned