$Day One Biopharmaceuticals (DAWN.US)$
$DAWN在2024年4月30日通過FIREFLY-1 Phase II試驗的優先審查(PDUFA)後,得到了優先審查券(PRV)的獎勵。據報導,一經通過核准,其賣價範圍從6700萬至35000萬不等,這將是一大增值。
Tovorafenib是正在評估的候選藥物。這是一種II型RAF抑製劑,專門瞄準突變和融合型BRAF變異。該泛RAF抑製劑優於市面上的第一代RAF抑製劑,包括dabrafenib、encorafenib和vemurafenib,這些藥物已經在BRAF V600突變驅動的黑色素瘤患者中顯示出臨床效益。
$DAWN在2024年4月30日通過FIREFLY-1 Phase II試驗的優先審查(PDUFA)後,得到了優先審查券(PRV)的獎勵。據報導,一經通過核准,其賣價範圍從6700萬至35000萬不等,這將是一大增值。
Tovorafenib是正在評估的候選藥物。這是一種II型RAF抑製劑,專門瞄準突變和融合型BRAF變異。該泛RAF抑製劑優於市面上的第一代RAF抑製劑,包括dabrafenib、encorafenib和vemurafenib,這些藥物已經在BRAF V600突變驅動的黑色素瘤患者中顯示出臨床效益。
已翻譯
$傑龍 (GERN.US)$
我認為在《柳葉刀》上發表的Phase III結果並不令人印象深刻。
1. 40%達到終點,相比於接受安慰劑的15%(這里值得懷疑)
2. 91%的3-4級TEAE,與ESA和luspatercept(目前的標準照護)相比簡直難以置信
3. 即使获得批准,也只有非常有限的患者愿意接受治疗
我認為在《柳葉刀》上發表的Phase III結果並不令人印象深刻。
1. 40%達到終點,相比於接受安慰劑的15%(這里值得懷疑)
2. 91%的3-4級TEAE,與ESA和luspatercept(目前的標準照護)相比簡直難以置信
3. 即使获得批准,也只有非常有限的患者愿意接受治疗
已翻譯
1
$NRX Pharmaceuticals (NRXP.US)$
1.NRX100:
IV Ketamine, treat acute suicidality, applied for accelerated approval in 2024 (need an estimate) FYI: nasal ketamine is approved and sold under SPRAVATO® by Janssen. Here Janssen used a chiral isomer of ketamine called esketamine for depression
Planned spin-out and term sheet in hand
3.5 million of targeting patients;
Formulation is unique (concentration and alteration to limit abuse) Give caregiver a more legit way to prescribe ketamine...
1.NRX100:
IV Ketamine, treat acute suicidality, applied for accelerated approval in 2024 (need an estimate) FYI: nasal ketamine is approved and sold under SPRAVATO® by Janssen. Here Janssen used a chiral isomer of ketamine called esketamine for depression
Planned spin-out and term sheet in hand
3.5 million of targeting patients;
Formulation is unique (concentration and alteration to limit abuse) Give caregiver a more legit way to prescribe ketamine...
已翻譯
1
$Iovance Biotherapeutics (IOVA.US)$ 糟糕…昨天買進了😭應該等今天的折扣。
已翻譯
1
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$Iovance Biotherapeutics (IOVA.US)$
Tumor infiltrating lymphocytes(TILs) cell therapy will see the transfomation from benchside to bedside after ~30 years of dedicated academic and industrial efforts!
1. Why TILs cell therapy has a high likelihood of getting a nod from FDA?
In this field, Iovance and the Netherlands Cancer Research are at the forefront of TILs development, both with a primary focus on advanced melanoma—a substantial market characterized by unm...
Tumor infiltrating lymphocytes(TILs) cell therapy will see the transfomation from benchside to bedside after ~30 years of dedicated academic and industrial efforts!
1. Why TILs cell therapy has a high likelihood of getting a nod from FDA?
In this field, Iovance and the Netherlands Cancer Research are at the forefront of TILs development, both with a primary focus on advanced melanoma—a substantial market characterized by unm...
4
1
已翻譯
1