アイオニス・ファーマシューティカルズに関するコメント

$アイオニス・ファーマシューティカルズ(IONS.US)$
NEWS
“Ionis Pharmaceuticals announces positive Phase 3 results for olezarsen in treating familial chylomicronemia syndrome, showing significant reduction in triglycerides and acute pancreatitis events, potentially offering a breakthrough treatment option.
Results demonstrate olezarsen may represent a novel treatment option for this rare, life-threatening disease, for which there are no approved treatments in the U.S.”

Last week’s PDUFAs:
$アークティス・バイオセラピューティクス(ARQT.US)$ : Approved 12/15
• ZORYVE® (Roflumilast foam 0.3%)
⇒ topical foam
⇒ PDUFA: 12/16/23
⇒ NDA
⇒ Seborrheic dermatitis
$メルク(MRK.US)$ : Approved 12/15
• KEYTRUDA (pembrolizumab) + Padcev (enfortumab vedotin-ejfv)
⇒ IV injection
⇒ PDUFA: 05/09/24
⇒ sBLA
⇒ Urothelial cancer
$グラウコス(GKOS.US)$ : Approved 12/14
• iDose® TR (travoprost)
⇒ intracameral implant
⇒ PDUFA: 12/22/23
⇒ NDA
⇒ Glaucoma
$メルク(MRK.US)$ : Approved ...

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.
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$CRISPRセラピューティクス(CRSP.US)$$バーテックス・ファーマシューティカルズ(VRTX.US)$$オプティノーズ(OPTN.US)$$アークティス・バイオセラピューティクス(ARQT.US)$$カリディタス・セラピューティクス(CALT.US)$$ブルーバード・バイオ(BLUE.US)$$グラウコス(GKOS.US)$$アイオニス・ファーマシューティカルズ(IONS.US)$$アムジェン(AMGN.US)$$メルク(MRK.US)$

Hello mooers, welcome to another week of the FDA calendar. Here are what happened last week and what's coming up this week.
BIGGEST MOVERS FROM THIS WEEK
The CEO of $CNSファーマシューティカルズ(CNSP.US)$ has disclosed the acquisition of 15,000 shares at a mean price of $0.69 per share. Shares closed the week down 20% at $1.89.
$デルマタ・セラピューティクス(DRMA.US)$ received FDA approval for its proposed protocols and regulations for the Phase 3 clin...

Gapping up
In reaction to earnings/guidance:
• $カランプ(CAMP.US)$ +0.6%
Other news:
• $カノ・ヘルス(CANO.US)$ +6.1% ($ヒューマナ(HUM.US)$ in the running to acquire CANO according to WSJ)
• $コーセプト・セラピューティックス(CORT.US)$ +4.5% (extends deal with Optime Care to March 31 2024)
• $LPLインベストメント・ホールディングス(LPLA.US)$ +4.1% (reports monthly activity for August)
• $デンツプライ・シロナ(XRAY.US)$ +3% (names new CFO)
• $iPath Series B S&P 500 VIX Short-Term Futures ETN(VXX.US)$ +2.9% (tr...