Top Tweets for #Pdufa
July PDUFA watch: Key FDA decisions across oncology, rare disease, CNS, nephrology & women's health - Orviglance, Orca‑T, Atacicept, Gedatolisib, Rivoceranib+Camrelizumab, SARCLISA combo, Centanafadine, FUROSCIX, MR‑100A‑01. Follow @consultoctavus for updates. #PDUFA #PharmaNews
#PDUFA #FDA approval days for July:
07 $VERA ATACICEPT. IgA nephropathy (IgAN)
07 $AZN / $DSKYF ENHERTU. HER2+ early breast cancer (post-neoadjuvant)
17 $CELC GEDATOLISIB. HR+/HER2- PIK3CA wild-type advanced breast cancer
23 $028300 RIVOCERANIB (RESUB). 1L unresectable hepatocellular carcinoma
23 $SNY SARCLISA SC. Multiple myeloma
24 $OTSKF CENTANAFADINE. ADHD in children, adolescents and adults
26 $MNKD FUROSCIX ReadyFlow Autoinjector. Edema in chronic heart failure / CKD
29 $NRXP KETAFREE. Preservative-free IV ketamine
29 $CAPR DERAMIOCEL . Duchenne muscular dystrophy
29 $OTLK ONS-5010/LYTENAVA (RESUB). Macular degeneration
30 $VTRS LOW DOSE ESTROGEN WEEKLY PATCH. Contraception
Q3 $TAK RUSFERTIDE. Polycythemia vera in adults
Q3 $ROIV BREPOCITINIB. Dermatomyositis
Q3 $TAK OVEPOREXTON (TAK-861). Narcolepsy Type 1
2H $MRK KEYTRUDA + Trodelvy. 1L PD-L1+ metastatic TNBC
2H $MRK KEYTRUDA QLEX + Trodelvy. 1L PD-L1+ metastatic TNBC
May '26 brings key #PDUFA decisions shaping pharma’s next wave-from gMG and HER2+ breast cancer to Alzheimer’s, pediatric diabetes, and ADHD. These milestones signal innovation, market shifts, and pipeline momentum. Stay tuned for what’s next. #Pharma #Biotech #DrugDevelopment
.@ViridianThera’s Reveal-2 beats expectations with elegrobart in #TED (free w/one-time registration) https://t.co/phttXgHVC4 #biopharma #ThyroidEyeDisease #ocular #PDUFA
$CAPR has an excellent risk to reward profile. Its highly derisked. Its superior to $SRPT for #DMD w/o those side effects & treatments in the pipeline from $RGNX $PTCT $SLDB $DYN. Excited about their #exosomal pipeline. Aug #PDUFA date could be a rising tide for all #exosome drug development companies. Put $JAZZ $MAJI $LMMY on your watchlists.https://t.co/OlzrZCQhgk
📡 What’s on the FDA Radar #PDUFA
Recent Outcomes:
April 10 | $REPL - RP1 (Advanced Melanoma) - CRL
April 13 | $TVTX - FILSPARI® (Focal segmental glomerulosclerosis - Approved
Pending FDA Decisions:
April 23 | $GRCE - GTx-104 (Aneurysmal Subarachnoid Hemorrhage)**
April 28 | $MRK - Doravirine/islatravir (Virologically Suppressed HIV-1 Infection)
April 30 | $AXSM - AXS-05 (Alzheimer's disease)**
** Big & Suspected Movers: Upcoming biopharma catalyst events expected to move a stock ±20% or more.
For a full view of all April PDUFA dates and events, please refer to the attached calendar graphic.
$TVTX
FDA approved sparsentan in FSGS
Label aligns with KDIGO guidelines for managing pts with FSGS
Only drug approved in FSGS, will add 2B++ to the peak revenue
MC 2.8B with peak sales 3B is cheap by any standards
Will let my 20c and 25c convert to shares
It comes down to this: #PDUFA date for #RP1 by @Replimune is TOMORROW, April 10. I never thought it would come down to the wire like this. What will @US_FDA do?
#melanoma experts and patients alike are wondering. The bottom line truly is that this is a unique drug that has helped people who FAILED everything else. I've seen it myself.
As a number of us noted in an open letter last year, their objections don't make sense to those of us who treat many melanoma patients.
Well written consideration here: https://t.co/jpKSwkJQYo via @biospace
$REPL $TVTX $OCUL
( 続き )
PDUFA （ 処方薬ユーザーフィー法 ） に基づく決定事項に注目
$TVTX （ 巣状分節性糸球体硬化症 に対する FILSPARI 適応拡大 ）→4月13日
#Biotechnology #PDUFA #Stock
( 続く ) ⬇️
Biotech catalysts heating up - potential stock movers ahead!
Watch these PDUFA decisions: $REPL (RP1 + nivo in advanced melanoma) → April 10
$TVTX (FILSPARI label expansion in FSGS) → April 13
Plus: Ocular Therapeutix $OCUL additional Phase 3 eye data ~April 11, and more data readouts coming.
Rare disease, oncology & ophthalmology in focus. Volatility expected.
DYOR! #Biotech #PDUFA #Stocks
Counting down to @Replimune #RP1 #PDUFA date (April 10). Continuing to hope @US_FDA sees the lifesaving benefit of this drug. Attaching a letter from my colleagues in Europe.
#Thinksabio #Biotech #PDUFA #FDA #DrugApproval #BiotechStocks #Trading #SpecStocks #Catalyst #Healthcare
$IBRX
ImmunityBio Completes Enrollment in Pivotal Randomized Trial Evaluating ANKTIVA® Plus BCG Versus BCG Alone in BCG-Naïve Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
EVP and Chief Commercial Officer Bryan Downey describes @CingulateInc's sales and marketing strategy for CTx-1301. $CING #CTx-1301 #ADHD #PrecisionTimedRelease #PTR #NASDAQ #Biotech #BioPharma #FDA #FDAApproval #PDUFA #NDA #DrugDelivery #ExtendedRelease
https://t.co/NPssTD2CoL
EVP & Chief Commercial Officer Bryan Downey explains @CingulateInc's commercialization efforts and how young adult women fit in as patients, caregivers & decision makers for family health care.
$CING
CTx-1301 #ADHD #PTR #NASDAQ #Biotech #BioPharma #FDA #PDUFA #NDA
https://t.co/idpSsmMMsT
#Thinksabio #Biotech #PDUFA #FDA #DrugApproval #BiotechStocks #Trading #SpecStocks #Catalyst #Healthcare
$MRK
MERCK & CO: KEYTRUDA REDUCES DISEASE PROGRESSION RISK BY 28%
EVP and Chief Commercial Officer Bryan Downey explains Indegene’s role in @CingulateInc's commercialization efforts for CTx-1301 in ADHD. $CING
#PrecisionTimedRelease #PTR #NASDAQ #Biotech #BioPharma #FDA #FDAApproval #PDUFA #NDA #ControlledRelease #Dexmethylphenidate
https://t.co/DEH4V3BHvg
As we advance to CTx-1301’s 31May26 target action date, @CingulateInc SVP of Market Access Rick Arce explains how to get payors on board. $CING
#PrecisionTimedRelease #PTR #NASDAQ #Biotech #BioPharma #FDA #FDAApproval #PDUFA #NDA #DrugDelivery #ExtendedRelease #Dexmethylphenidate
https://t.co/7WiBtgcxhL
𝗙𝗲𝗯𝗿𝘂𝗮𝗿𝘆 𝟮𝟬𝟮𝟲 𝗢𝘂𝘁𝗹𝗼𝗼𝗸: 𝗞𝗲𝘆 𝗙𝗗𝗔 𝗣𝗗𝗨𝗙𝗔 𝗠𝗶𝗹𝗲𝘀𝘁𝗼𝗻𝗲𝘀 𝗦𝗵𝗮𝗽𝗶𝗻𝗴 𝗕𝗶𝗼𝗽𝗵𝗮𝗿𝗺𝗮
We analyze the science, competitive dynamics & strategic implications so you stay ahead
#PDUFA #FDA #Biopharma #RareDisease #Oncology #DrugApproval #Biotech
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