Day One Biopharmaceuticals Stock Forum

$Aquestive Therapeutics(AQST.US)$
👉🏻Libervant for pediatric - global sales $2-300+ million per year. HUGE 💵 ** Libervant for adults - Globally is at least double that of pediatrics 500 Mil+ 👉🏻 Anaphylm - global sales $1 billion per year if not more FINALLY 👉🏻 AQST 108 (epinephrine cream) for dermatology- Multi hundred millions. ** REACAP Revenue 📈🚀🥇💯 (buyout) hummm 🤔⏰ Small market cap of $328 million is very undervalued. If you added the potential for Libervan...

🗓️ Last week’s PDUFAs:
$Supernus Pharmaceuticals(SUPN.US)$ : CRL 4/8/24 🙁
⇒ SPN-830
⇒ OFF episodes in PD
⇒ NDA
⇒ PDUFA: 4/5/24
$Legend Biotech(LEGN.US)$ & $Johnson & Johnson(JNJ.US)$ : Approved 🎉
⇒ CARVYKTI (cilta-cel)
⇒ Multiple myeloma
⇒ sBLA
⇒ PDUFA: 4/5/24
$AstraZeneca(AZN.US)$ : Approved 🎉
⇒ Enhertu
⇒ HER2+ solid tumors
⇒ sBLA
⇒ PDUFA: Q2 2024
$2seventy bio(TSVT.US)$ & $Bristol-Myers Squibb(BMY.US)$ : Approved 🎉
⇒ Abecma
⇒ Multiple myeloma
⇒ sBLA
⇒ Delayed PDUFA
$Vanda Pharmaceuticals(VNDA.US)$...

See Biotech companies with cancer assets 👇
⇨ held by 5 biopharma-focused hedge funds! 🔥
$Arcellx(ACLX.US)$ : Anito-cel (Ph 2)
$Adaptimmune Therapeutics(ADAP.US)$ : Afami-cel (PDUFA) ⏳
$Bicycle Therapeutics(BCYC.US)$ : BT8009 (Ph 1/2)
$Centessa Pharmaceuticals(CNTA.US)$ : LB101 (Ph 1/2)
$Day One Biopharmaceuticals(DAWN.US)$ : Tovorafenib (PDUFA) (check comments for details)
$Fate Therapeutics(FATE.US)$ : FT576 (Ph 1)
$Fusion Pharmaceuticals(FUSN.US)$ : FPI-2265 (Ph 2)
$GRCL: ...

📣 Ahead of AACR24, which starts this Friday, 🔬
here are 6 cancer readouts to watch this quarter:
$ImmunityBio(IBRX.US)$ : Anktiva ▻ PDUFA ▻ Bladder CA
$Day One Biopharmaceuticals(DAWN.US)$ : Tovorafenib ▻ PDUFA ▻ Glioma
$GlycoMimetics(GLYC.US)$ : Uproleselan ▻ Ph3 ▻ AML
$FibroGen(FGEN.US)$ : Pamrevlumab ▻ Ph3 ▻ Pancreatic CA
$Viracta Therapeutics(VIRX.US)$ : Nana-val ▻ Ph3 ▻ Lymphoma

The FDA PDUFA Calendar is a chronological calendar of PDUFA target dates as well as Advisory meetings (ADCOMM). PDUFA target dates are dates by which the FDA aims to deliver their decision regarding an NDA or BLA filing. These decisions can however come before the PDUFA target date.
$Vanda Pharmaceuticals(VNDA.US)$$Legend Biotech(LEGN.US)$$Supernus Pharmaceuticals(SUPN.US)$$ImmunityBio(IBRX.US)$$Aquestive Therapeutics(AQST.US)$$X4 Pharmaceuticals(XFOR.US)$$Liquidia(LQDA.US)$$Neurocrine Biosciences(NBIX.US)$$Moderna(MRNA.US)$$Day One Biopharmaceuticals(DAWN.US)$
...

$Day One Biopharmaceuticals(DAWN.US)$
$DAWN received a priority review with a PDUFA on April, 30, 2024 based on FIREFLY-1 Phase II readout. In the meantime, $DAWN was awarded Priority Review Voucher(PRV) upon approval. It is reported to have a sell-price ranging from 67M to 350M, a huge value addition upon approval.
Tovorafenib is the candidate under evaluation. It is a type II RAF inhibitor, targeting both mutation and fusion BRAF alterations. This pan-RAF inhibitor is superior to...

$SPDR S&P Biotech ETF(XBI.US)$
The biotech sector faced challenges in the previous year, mainly attributed to high inflation and interest rates, particularly impacting small-cap biotech firms in the difficult fundraising environment of summer 2023.
As a consequence, numerous companies experienced a significant drop in their market caps, with some even falling below the 100 million mark, a rarity...

$Day One Biopharmaceuticals(DAWN.US)$ Day One Announces FDA Acceptance Of NDA And Priority Review For Tovorafenib In Relapsed Or Progressive Pediatric Low-Grade Glioma