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BioPharmCatalyst

@biopharmcatalyst.bsky.social
422 followers 157 following 927 posts

FDA catalyst calendar, newsletters, and more. We do not provide investment advice or recommendations. #biotech #stocks www.biopharmcatalyst.com

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BioPharmCatalyst @biopharmcatalyst.bsky.social · 2h
$ARGX ends UNITY Phase 3 in Sjögren’s after futility review; no safety issues. Positive Phase 2 celiac data from FB102 supports Phase 3 move. $ARGX among premarket movers. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 10/08/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 18h
$CRBU starts strategic review for sale/merger, halts CAR-T programs, cuts workforce to conserve capital. Major shift in clinical focus. More at BioPharmCatalyst. www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 10/07/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 07/10/2026
$LPCN: Verity Pharma got Health Canada OK for TLANDO oral capsules for male hypogonadism. Canadian launch set for late 2026, boosting North American reach. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 10/07/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 06/10/2026
$CRBU pauses vispa-cel & CB-011 CAR-T programs, cuts staff due to funding limits, despite $113.8M cash. For more biotech news, visit BioPharmCatalyst. www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 10/06/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 06/10/2026
$AVBP: Phase 3 FURVENT trial missed primary endpoint in EGFR exon 20 NSCLC, but showed clinical activity in secondary metrics. Management reviewing next steps. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 10/06/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 05/10/2026
$JAGX issues Series R preferred stock (5:1 convert ratio) as anti-dilution move; NDA filing for crofelemer on track for mid-2027. More biotech updates: BioPharmCatalyst. www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 10/05/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 05/10/2026
$PCVX soars on positive Phase 3 VAX-31 data—met safety & efficacy endpoints, showed superiority on key serotypes. 2 missed non-inferiority vs PCV21 but still passed standard threshold. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 10/05/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 02/10/2026
$QTEX's cryogenic interconnect system showed >100 dB isolation (4–8 GHz), beating flexible cables by 60 dB. More deals expected in 4Q 2026 after recent partnership. www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 10/02/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 02/10/2026
$NXL inks 10-year exclusive South American deal for Nexalin Sync, gains recurring royalties and keeps IP; first orders in, ANVISA approval anticipated for expansion. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 10/02/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 01/10/2026
$NKTR: Phase 2b rezpegaldesleukin shows lasting benefits in atopic dermatitis & alopecia. Phase 3 ZENITH trials underway, AA data expected 2027. #biotech www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 10/01/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 01/10/2026
$FHTX & $LLY ended FHD-909 development after Phase 1. Foghorn shifts focus to internal pipeline. More Pre-market Movers: $FLNA $UNCY $GLUE $LQDA $AEON $QSI $TVRD $LONA $IVA. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 10/01/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 30/09/2026
$LQDA drops 57% after court rules YUTREPIA infringes 2 patent claims. Appeal planned; label to drop PH-ILD. Legal risks remain. More at BioPharmCatalyst. www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/30/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 30/09/2026
$RFL: Phase 3 Trappsol Cyclo slowed NPC disease by 64% vs. placebo, 71% with add-on therapy. NDA filing planned Q4 2026. Safety consistent. $ERNA $SGMT $SLXN $CNTB $PYXS $NIVF $VBIO $KLRS $NRSN www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/30/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 29/09/2026
$QURE’s gene therapy for Huntington’s showed dose-dependent slowing of progression at 36 & 48 months, supporting further trials and BLA plans. www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/29/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 29/09/2026
$SLXN: SIL204 uses serum lipoproteins for vector-free KRAS siRNA delivery, enabling subQ dosing; Phase 2/3 in pancreatic adenocarcinoma ongoing. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/29/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 28/09/2026
$KOD’s Phase 3 DAYBREAK met key endpoints in wAMD. Zenkuda showed rapid retinal drying; 54% reached 6-month dosing. BLA filing for multiple indications planned Q4 2026. www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/28/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 28/09/2026
$KOD Phase 3: Zenkuda non-inferior to aflibercept in wAMD; 54% hit 6-month dosing. Supports Q4 2026 BLA filing. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/28/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 25/09/2026
$CDT approved 1-for-25 reverse split to meet listing rules. Shares drop, core strategy and risks unchanged. $CDT $AIFF $JAGX $TVRD $GCTK $LONA $ONCO $NYXH $CYCN $SCNI www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/25/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 25/09/2026
BioPharmCatalyst Watchlist: Top Phase 3 biotech catalysts for the next 6 months. Key tickers: XENE, OCGN, IRON, RNAC, DNTH, LXRX, HELP, RZLT, PCVX, MANE. More: biopharmcatalyst.com www.biopharmcatalyst.com/news/2026/se...
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 25/09/2026
$AIFF teams up with NeuroSigma to add Monarch eTNS ADHD treatment to its network, merging brain mapping tech with non-invasive therapy for kids. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/25/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 24/09/2026
$PRME gets FDA IND OK for PM647 to treat alpha-1 antitrypsin deficiency, clearing path for US trials and advancing prime-editing drugs. $GCTK $JAGX $HCWB $VKTX $ACAD $SRZN $DNA $ARTL $CYCN www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/24/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 24/09/2026
$ATYR set Phase 3 trial for efzofitimod in sarcoidosis, using Week 48 FVC as the main endpoint; launch in Q4 2026 depends on funding/partnership. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/24/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 23/09/2026
$GCTK shifts capital to Lōkahi's asset acquisitions; Glucotrack stays on CGM, prioritizing LT-100 & expanding ai² for late-stage therapies. $ARTL $VTGN $BMEA $IMVT $JAGX $TLSA $CVKD $CGEM $SLXN www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/23/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 23/09/2026
$VTGN: 12-month Phase 3 data for fasedienol in social anxiety shows strong tolerability (1.6% discontinuation) and LSAS/SPIN score gains, despite mixed efficacy. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/23/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 22/09/2026
$JAGX got FDA fee waivers through FY27, aims mid-2027 NDA for Mytesi, and advances global SBS trials. $JAGX $VKTX $CMPX $ENLV $FLNA $BMEA $INDP $MAZE $SLXN $CYCN www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/22/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 22/09/2026
$VKTX up on trial data: Biweekly dosing sustained 97% weight loss; weekly led to more loss. Safety profile similar to placebo, minimal side effects. $VKTX $BIAF $LXEO $ELDN www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/22/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 21/09/2026
$GRAL up after FDA docs back Galleri cancer test's high specificity. Key concerns: moderate sensitivity, reimbursement, adoption. $CUE $HELP $HYFT $ABVX $MRNA $IVVD $SLXN $MBRX $CYCN www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/21/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 21/09/2026
$CUE up on positive Phase 2 CUE-221 results in CSU, meeting all primary/secondary endpoints with strong efficacy and safety vs placebo. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/21/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 18/09/2026
$XENE filed NDA for azetukalner in seizures after strong trial data; psychiatry trial delayed to 2027 over safety. Shares fell 22% to $44.94. www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/18/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 18/09/2026
Sept 18, 2026: BioPharmCatalyst weekly watchlist—top biotech catalysts left this quarter. Key tickers: KOD, ACAD, KYTX, ORKA, CLDX. More insights in our daily newsletter. www.biopharmcatalyst.com/news/2026/se...
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 18/09/2026
$TCRT filed a new patent for its neoantigen TCR discovery tech; no clinical, regulatory, or financing updates related to its current obesity focus. $TCRT $LTRN $XENE $NUWE www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/18/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 17/09/2026
$XBIO to merge with Santersus AG in all-stock deal; new Nasdaq entity "SNTS." Santersus holders get ~85%, Xenetic ~15%. #BiotechUpdate www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/17/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 17/09/2026
$LGVN's Phase 2b trial for laromestrocel in HLHS infants failed primary endpoint; no significant benefit seen at 12 months (p=0.83). www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/17/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 16/09/2026
$TPST inks exclusive deal for CD7 CAR-T tech; Ph1 BCMA/GPRC5D myeloma data show in vivo expansion, no severe CRS/ICANS. LNP platform set for clinic later this year. #biotech www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/16/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 16/09/2026
🚨 October 2026 PDUFA Preview 🚨 👁️ $IRD – Presbyopia eye drop label expansion (10/17) 🧪 $GSK / $IONS – Priority Review for a functional Hepatitis B cure (10/26) 🧬 $INO – Surgery-sparing DNA medicine for rare respiratory tumors (10/30) www.biopharmcatalyst.com/october-2026... #Biotech #PDUFA #stocks
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 16/09/2026
$ARTL: Oral ART27.13 cut mouse obesity by ~20%, matching semaglutide. Combo hit ~40%. Phase 2 also ongoing for glaucoma and cachexia. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/16/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 15/09/2026
$TPST inks exclusive deal for CD7 CAR-T tech, with early dual-target MM data showing no severe CRS/ICANS. LNP platform to enter clinic soon. #BiotechUpdates www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/15/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 15/09/2026
$CNTB: Phase 2 asthma data shows significant FEV1 improvement, 66% treatment failure drop (NS), placebo-like safety. COPD results due soon. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/15/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 14/09/2026
$CLLS shifts to in vivo gene-editing for APOC3 & PCSK9, aims for Ph1 data in 2027-28; ends lasme-cel/eti-cel work to extend cash runway to H2 2028. www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/14/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 14/09/2026
$DFTX rises after 2nd positive Phase 3 GAD study; DT120 ODT shows significant 5.1-point benefit at 12 weeks. $SCNI $CAPR $CLLS $CRBP $ARMP $DERM $EDSA $XRTX $SLS also active pre-market. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/14/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 11/09/2026
$GTBP hosts live presentation today at 2PM ET on TriKE NK cell tech, sharing updates on therapy progress, dose data, and upcoming clinical milestones. www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/11/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 11/09/2026
BioPharmCatalyst Weekly Watchlist: Top biotech stocks & key catalysts for Q3. Tickers: ABEO, XOMA, CCCC, BFRI, RGNX, MNOV, KYTX, IMMP, OCGN, CGEM. Full list: biopharmcatalyst.com/news www.biopharmcatalyst.com/news/2026/se...
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 11/09/2026
$KPTI secured temporary debt relief after missing a $15.8M payment, highlighting financial stress as it advances its myelofibrosis program. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/11/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 10/09/2026
$TNON jumped after repaying $5.16M in debt early, improving its balance sheet and reducing dilution risk. $AEON $NRSN $SLXN $CDT $INDP $BYSI $CRDF $LEXX $CYCN www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/10/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 10/09/2026
$TNON jumps premarket after repaying $5.16M in notes early, boosting balance sheet & removing conversion risk. $TNON $RADX $IRD $NRSN $CDT $AEON $ENLV $NXL $BHVN $EOCN www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/10/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 09/09/2026
$LEXX gains $5.9M from warrant exercises at $12.92, plus $2.6M Aussie tax refund—funds support operations and R&D through 2027. #BiotechUpdates www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/09/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 09/09/2026
$BIAF regains Nasdaq compliance, resolving delisting risk after meeting minimum bid price. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/09/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 08/09/2026
$LEXX raises $5.9M via warrant exercises at $12.92, plus $2.6M tax refund, funding ops & R&D through 2027. $LEXX $PDSB $JAGX $PHVS $ROIV $BJDX $ONCO $NRSN $BTAI $CDT www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/08/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 08/09/2026
$IMRN gains on US distribution deal for PROIBS, expanding its digestive health lineup; focus remains on distribution, not clinical trials or fundraises. www.biopharmcatalyst.com/news/2026/bi...
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Pre-Market Updates 09/08/26
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BioPharmCatalyst @biopharmcatalyst.bsky.social · 07/09/2026
$IMRN inks US deal with Calmino for PROIBS, expanding its digestive health range. Focus is on distribution, not trials or new funding. $IMRN $CMND $JAGX $NRSN $MODD $ONCO $BTAI $CDT www.biopharmcatalyst.com/news/2026/bi...
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Daily Updates 09/07/26
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