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BioPharmCatalyst
@biopharmcatalyst.bsky.social
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FDA catalyst calendar, newsletters, and more. We do not provide investment advice or recommendations. #biotech #stocks

https://www.biopharmcatalyst.com/
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$ENGN's Phase 2 data: 63% overall complete response in BCG-unresponsive NMIBC, 62% at 6 months, well tolerated.

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Daily Updates 11/11/25
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November 11, 2025 at 9:30 PM
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$COGT: Phase 3 bezuclastinib+sunitinib in GIST showed mPFS 16.5 vs 9.2 mo, ORR 46% vs 26%. NDA planned 1H26. Full data at future meeting.

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Pre-Market Updates 11/11/25
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November 11, 2025 at 1:40 PM
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$GLTO completed the acquisition of Damora Therapeutics, a biotech developing antibody treatments for mutant calreticulin (mutCALR)-driven Myeloproliferative Neoplasms (MPNs), including ET and Myelofibrosis (MF).
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November 10, 2025 at 9:50 PM
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$ELDN’s tegoprubart shows positive Phase 2 kidney transplant results: 12-month mean eGFR improved.

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Daily Updates 11/10/25
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November 10, 2025 at 9:30 PM
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$COGT: Bezuclastinib+sunitinib in GIST showed median PFS 16.5 vs. 9.2 mo (control), ORR 46% vs. 26%. NDA planned 1H 2026. Full results at future meeting.

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Pre-Market Updates 11/10/25
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November 10, 2025 at 1:40 PM
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$ELDN's tegoprubart showed positive Phase 2 kidney transplant results: 12-month mean eGFR improvement reported.

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Daily Updates 11/07/25
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November 7, 2025 at 9:30 PM
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BioPharmCatalyst Weekly Watchlist: Key Phase 3 catalysts for $MESO, $SLS, $MGTX, $XOMA, $BLTE, $IMVT, $CAPR, $ERAS, $CGON, $CGEM. Stay updated on biotech moves! #biotech #Watchlist www.biopharmcatalyst.com/news/2025/bi...
November 7, 2025 at 9:15 PM
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$GMED gets Hold from Needham & Stifel after Q3 beat; U.S. Spine strong, but leasing pressure weighs. Stifel PT: $64.

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Pre-Market Updates 11/07/25
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November 7, 2025 at 1:40 PM
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$URGN’s UGN-103 hit 77.8% 3-mo CR in Phase 3 UTOPIA, matching prior data; FDA says results support NDA submission. Key regulatory milestone.

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Daily Updates 11/06/25
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November 6, 2025 at 9:30 PM
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$RXST beat Q3 revenue estimates with $30.3M vs. $25.3M expected, despite a 14% YoY drop. $SGMO $PACB $ESPR $NMRA $PHAR $PEN $VCEL $LNAI $SNN among notable pre-market movers.

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Pre-Market Updates 11/06/25
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November 6, 2025 at 1:40 PM
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$LNAI’s 2nd-gen dendritic cell therapy showed full tumor regression in mouse models of pancreatic cancer, boosting its clinical outlook.

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Daily Updates 11/05/25
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November 5, 2025 at 9:30 PM
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$BHVN drops premarket after FDA rejects Vyglxia (troriluzole) approval. $SLNO $NPCE $RDHL $RIGL $PSNL $VCYT $CDNA $CNTA $AKTX movers.

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Pre-Market Updates 11/05/25
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November 5, 2025 at 1:40 PM
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$PRLD will prioritize its mutant-selective JAK2V617F inhibitor and KAT6A degrader programs while pausing clinical development of its SMARCA2-selective degraders.

$EVOK $PRLD $ARTL $RLMD $NCEL $TCMD $TERN $CSTL $AIM $ADTX

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November 4, 2025 at 9:52 PM
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$EVOK to be acquired by QOL Medical for $11/share, a 139.7% premium. Deal closes by end of 2025. $EVOK $PRLD $SRPT $TCMD $CMPS $HRTX $ACOG $ABP $STIM $CLNN

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Pre-Market Updates 11/04/25
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November 4, 2025 at 1:40 PM
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$CRBP plans a public offering to fund oncology/obesity pipeline. Jefferies & Piper Sandler are bookrunners. 30-day option for extra shares.

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Daily Updates 11/03/25
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November 3, 2025 at 9:30 PM
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$PHIO Phase 1b: PH-762 showed ≥50% tumor clearance in 10/18 cSCC patients, no toxicities, with one 100% cleared. Promising non-surgical option for skin cancer.

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Pre-Market Updates 11/03/25
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November 3, 2025 at 1:40 PM
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$CRBP plans stock/warrant offering to fund oncology & obesity programs; Jefferies & Piper Sandler are bookrunners with a 30-day 15% upsizing option.

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Daily Updates 10/31/25
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October 31, 2025 at 8:30 PM
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BioPharmCatalyst Weekly Watchlist: Top biotech stocks & key catalysts to watch ($RGNX, $REPL, $SNY, $ALDX, $NKTR & more). Stay updated on news & movers! www.biopharmcatalyst.com/news/2025/bi...
October 31, 2025 at 8:15 PM
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$ATEC Q3 revenue up 30% YoY to $197M, adj. EBITDA $26M. Raised 2025 guidance: $760M revenue, $91M EBITDA. Strong surgeon adoption, positive cash flow.

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Pre-Market Updates 10/31/25
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October 31, 2025 at 12:40 PM
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$ADTX announces 1-for-113 reverse split effective Nov 3, 2025, to meet Nasdaq requirements. Symbol remains unchanged. #BiotechUpdate

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Daily Updates 10/30/25
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October 30, 2025 at 8:30 PM
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$INTS published phase 1/2 results on INT230-6 for advanced cancers: 75% disease control, 11.9 mo median survival. Study in eBioMedicine.

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Pre-Market Updates 10/30/25
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October 30, 2025 at 12:40 PM
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$ERNA partners with Cellipont for cGMP manufacturing of ERNA-101, aiming to make ovarian tumors more responsive to immunotherapy. Strong preclinical results.

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Daily Updates 10/29/25
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October 29, 2025 at 8:30 PM
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$PPBT hits manufacturing milestone for IM1240 tri-specific antibody, boosting safety/efficacy against tumor evasion. High-yield, high-purity process achieved. $AKBA $GNTA $NLSP $RNTX $BBIO

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Pre-Market Updates 10/29/25
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October 29, 2025 at 12:40 PM
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$ARQT reported third-quarter ZORYVE revenue of $99.2M, up 122% YoY and 22% QoQ, driven by broad adoption. ZORYVE cream 0.05% for pediatric atopic dermatitis launches by the end of October following FDA approval.

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October 28, 2025 at 8:51 PM
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$SBFM gains on Health Canada nod for Domperidone via Nora Pharma, targeting Canada’s $533M market. Boosts generic drug portfolio. #Premarket #Stocks

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Pre-Market Updates 10/28/25
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October 28, 2025 at 12:40 PM