EMINENZ
Posted - 58 minutes from now
$URGN easy gains from this level into pdufa june. Rock solid company with great science.
bubbarayjr
Posted - 20 hours ago
$URGN thoughts on IP protection and ADCOM? been burned on both before but really like the clinical results and science here.
Hotresearchsgoldenage
Posted - 1 day ago
$URGN can’t help but buy today .
Cellphones6213
Posted - 2 days ago
$URGN we hit 52 week low this morning 😅
I decided to jump back in at $11 even though I fear it hasn’t stopped sinking, because I know that it’s highly likely that the upside absolutely dwarfs the likely downside. This had a successful offering much higher than the current price, and has a near term catalyst. I think it’s a safe bet. But it’s definitely a bet…
mh_aina
Posted - 2 days ago
$URGN doubled down at 11.5$
This is dirt cheap if they get the upcoming approval
BioStick123
Posted - 5 days ago
$URGN can anyone comment on whether $TYRA TYRA-300 is a competitor to UGN-102
Hotresearchsgoldenage
Posted - 1 week ago
$URGN I guess we sit till June 0f 2025
Richdenimjohnson
Posted - 1 week ago
$URGN expecting everyone who got in higher to sell in December, waiting for June. Hopefully this gets pushed lower so we can spend our Xmas money on bargains pre June
BioStick123
Posted - 1 week ago
$URGN time to wake up
Avangard
Posted - 1 week ago
$URGN When is the next PDUFA here?
erohsik
Posted - 1 week ago
$URGN Range bound till next June
BioStick123
Posted - 1 week ago
@Kingjake26 I am $VRNA , $GERN , and $URGN (new on URGN)
RocketThief
Posted - 1 week ago
$URGN have been adding in the $12s, eventually this will bounce and I’ll cut loose some higher priced shares
EMINENZ
Posted - 1 week ago
$URGN easy 30-40% until next pdufa. buy here.
Polip
Posted - 2 weeks ago
$URGN I really would like to know who is on the other side of this trade selling at the upper bollinger band. I like to believe it is a stupid trainee at GS
EMINENZ
Posted - 2 weeks ago
$URGN loaded some more
oldpoorboy
Posted - 2 weeks ago
$URGN $IMNM till the end of time.
YungBull100
Posted - 2 weeks ago
$URGN oh let’s go!!!
lob11
Posted - 2 weeks ago
$URGN
BioStick123
Posted - 2 weeks ago
$URGN good sales on Jeymetlo.
DonCorleone77
Posted - 2 weeks ago
$URGN UroGen Pharma reports Q3 EPS (55c), consensus (82c) Reports Q3 revenue $25.2M, consensus $24.2M."The recent FDA acceptance of our New Drug Application for UGN-102 marks a significant milestone in our mission to deliver breakthrough treatments to patients," said Liz Barrett, President and Chief Executive Officer of UroGen. "Supported by robust clinical evidence, we believe UGN-102 has the potential to redefine the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer and provide longer treatment-free intervals for patients that currently face the burden of repetitive surgeries under general anesthesia. We look forward to a potential FDA approval by the PDUFA target action date of June 13, 2025. If approved, we believe UGN-102 will represent a paradigm shift in care, addressing a total market opportunity of over $5 billion. Our team is fully focused on preparing for a successful commercial launch of UGN-102, if approved, in 2025."
BioStick123
Posted - 2 weeks ago
$URGN $30+ by approval.
BioStick123
Posted - 2 weeks ago
@Stocktor take a look at $URGN
Night_Owl_Biotech
Posted - 2 weeks ago
$AUTL PDUFA date = 11/16/24. AUTL closed @ $4.55 on 10/28/24 then fell 26% over the next 3 days on no news/SEC filing of substance. We're unaware of any clinical data release of a comp either We have no idea if the FDA will approve AUTL's Obe-Cel nor if the PDUFA date will be extended The table on the top of the attachment notes all PDUFA dates extended since 1/1/23 (except for the 4 noted). In 10 of 14, extension was disclosed well before PDUFA. Only 2 extensions were disclosed on or around PDUFA. This is not investment advice as we have no idea whether or not the FDA will respond to AUTL's submission by PDUFA The bottom table notes all oncology focused NDA/BLA submissions since 1/1/2023. Our records indicate only 1 oncology focused submission resulted in a CRL As always, our data could be inaccurate. Please let us know if we missed one Other near-term oncology focused PDUFA incl $ZYME 11/29/24 $SNDX 12/26/24 (2nd this year) $CKPT 12/28/24 $URGN 6/13/25
CliffordCapital
Posted - 10/31/24
$URGN bought Small
ivocsev
Posted - 10/30/24
$URGN nice
BioStick123
Posted - 10/29/24
$URGN Hoping we have at least a few more months to load up.
DonCorleone77
Posted - 10/28/24
$URGN UroGen Pharma reports durability of response results from ENVISION study UroGen Pharma announced that new long-term durability of response results from the Phase 3 ENVISION study of investigational drug UGN-102 in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer were published online in the Journal of Urology. In ENVISION, UGN-102 treatment was associated with an unprecedented 82.3% 12-month duration of response, or DOR, by Kaplan-Meier estimate in patients who achieved complete response, or CR, at three months after the first instillation of investigational drug UGN-102 for intravesical solution. The DOR Kaplan-Meier estimates at 15 months and 18 months after three-month CR were both 80.9%. The ENVISION trial previously met its primary endpoint by demonstrating that patients treated with UGN-102 had a 79.6% CR rate at three months following the first instillation of UGN-102. UroGen initiated the submission of a rolling new drug application, or NDA, to the FDA for UGN-102 as a treatment for LG-IR-NMIBC in January and completed the NDA submission in August, ahead of schedule. The FDA accepted the NDA for UGN-102 with a PDUFA goal date of June 13, 2025. The most common treatment-emergent adverse events, or TEAEs, in the ENVISION trial were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. TEAEs were typically mild-to-moderate in severity and resolved or resolving. The ENVISION trial demonstrated a similar safety profile to that observed in other studies of UGN-102.
RonIsWrong
Posted - 10/28/24
$URGN URGN ENVISION Trial Results Published in the Journal of Urology Report 82.3% Duration of Response 12 Months after Achieving Complete Response for UGN-102, Potentially First FDA-Approved Non-Surgical Treatment for LG-IR-NMIBC The Kaplan-Meier Estimate of Duration of Response at 12 Months in Patients Who Achieved a Complete Response at Three Months was 82.3% Patients Receiving UGN-102 had a 79.6% Complete Response Rate at Three Months Side Effect Profile Consistent with Previous Clinical Trials of UGN-102
