Dynavax Technologies Stock Forum

$Dynavax Technologies (DVAX.US)$
Dynavax Announces Preliminary Unaudited Fourth Quarter and Full Year 2024 Financial Highlights
HEPLISAV-B revenue grew 26% YoY to $268 million in 2024
Q4 2024 revenue increased 39% YoY to $71 million
Strong cash position of $714 million
New $30 million DoD contract for plague vaccine development
Expected market expansion to $900 million by 2030 with 60% target market share
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$Dynavax Technologies (DVAX.US)$ Dynavax Awarded $30M Contract With U.S. Department of Defense >DVAX
Dow Jones· 3 mins ago

$Dynavax Technologies (DVAX.US)$
Dynavax Technologies Down Over 7%, On Track for Largest Percent Decrease Since August 2022 -- Data Talk
Dow Jones· 2 mins ago2mins
Dynavax Technologies Corporation ( DVAX ) is currently at $12.42, down $0.97 or 7.21%
--Would be lowest close since Nov. 7, 2024, when it closed at $12.02
--On pace for largest percent decrease since Aug. 17, 2022, when it fell 10.39%
--Currently down three of the past four days
--Currently down two consecutive days; down 8.1% ov...

$Dynavax Technologies (DVAX.US)$
Dynavax Announces $200 Million Share Repurchase Program
Dynavax (DVAX) reported strong Q3 2024 financial results, with HEPLISAV-Bachieving record quarterly net product revenue of $79.3 million, up 27% year-over-year. The company's total revenues reached $80.6 million, a 16% increase from Q3 2023. HEPLISAV-B's U.S. market share grew to 44%, with particularly strong performance in retail pharmacy (55%) and IDN segments (56%). The company expects the hepatitis B...

📣 2 PDUFAs left in May!
🗓️ Last week’s PDUFAs:
$Amgen (AMGN.US)$ : Approved 5/16 🎉
⇒ Imdelltra (Tarlatamab-dlle)
‣ extensive-stage SCLC
‣ PDUFA date: 6/12/24 (BLA)
$Bristol-Myers Squibb (BMY.US)$ : Approved 5/15 🎉
⇒ Breyanzi®
‣ Follicular lymphoma
‣ PDUFA date: 5/23/24 (sBLAs)
$Dynavax Technologies (DVAX.US)$ : CRL 5/14 🙁
⚠️ insufficient data
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S (ASND.US)$ : Review extended to 8/14/24 🤔
⇒ YORV...

$Dynavax Technologies (DVAX.US)$ Reuters· 1 min ago
Dynavax: Crl States Application Did Not Provide Sufficient Data to Support Full Evaluation of Effectiveness or Safety of 4-Dose Regimen of Heplisav-B

$Dynavax Technologies (DVAX.US)$ Still on FDA PDUFA calendar today for sBLA 5/13/24

See summary 👇
📣 4 PDUFAs upcoming in May:
$Dynavax Technologies (DVAX.US)$ : 🤔
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S (ASND.US)$ : 🤔
⇒ YORVIPATH®
‣ hypoparathyroidism
‣ PDUFA date: 5/14/24 (NDA)
$Bristol-Myers Squibb (BMY.US)$ : 🤔
⇒ Breyanzi®
‣ PDUFA dates: (sBLAs)
‣‣ 5/23/24 (r/r follicular lymphoma)
‣‣ 5/31/24 (r/r mantle cell lymphoma)
🗓️ Last week’s PDUFAs:
$X4 Pharmaceuticals (XFOR.US)$ : Approved 4/29 🎉
⇨ XOLREMDI (mavorixafor)
‣ WHI...

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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