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

https://www.biopharmcatalyst.com/
$MBRX announces 1-for-25 reverse stock split effective Dec 1, 2025, reducing outstanding shares.

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Daily Updates 11/26/25
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November 26, 2025 at 9:30 PM
$KALA secures $1.8M from David Lazar, aims for $6M total pending approval. Funding supports ongoing restructuring. $KALA $SPRC $VRCA $PHGE

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Pre-Market Updates 11/26/25
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November 26, 2025 at 1:40 PM
$ALUR: 12-month study shows 23% avg weight loss, 14% lean mass gain with Smart Capsule + tirzepatide; 100% adherence, no dropouts. #biotech

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Daily Updates 11/25/25
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November 25, 2025 at 9:30 PM
$LNAI gets first LOI for AI-powered cancer cell therapy after promising preclinical results; plans Phase I trial for solid tumors following positive FDA feedback.

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Pre-Market Updates 11/25/25
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November 25, 2025 at 1:40 PM
Piper Sandler reiterates Buy on $NXTC, $15 PT after $21.5M raise and pipeline updates. #BiotechNews

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Daily Updates 11/24/25
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November 24, 2025 at 9:30 PM
$CLSD files for Chapter 11, plans asset sale including SCS Microinjector, licensing deals, and Phase 3/IND-ready programs. $ENLV $PMN $INSP $NVO $GNTA $ADTX $NAOV $SHPH $OABI

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Pre-Market Updates 11/24/25
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November 24, 2025 at 1:40 PM
$BCAB raises $7.5M via Pre-Paid Advance deals with YA II PN and Anson funds.

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Daily Updates 11/21/25
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November 21, 2025 at 9:30 PM
BioPharmCatalyst Weekly Watchlist: Top small/mid-cap PDUFA catalysts this quarter—tickers include AGIO, OMER, CORT, MIST, NRXP. Get daily biotech insights and news. www.biopharmcatalyst.com/news/2025/bi...
November 21, 2025 at 9:15 PM
$KTTA: Phase 1 data for PAS-004 shows 71.4% disease control in BRAF-mutated tumors, no severe AEs, promising PK. Possible best-in-class MEK inhibitor. $CTNM $ANAB $SHPH $IKT $TELO $MNDR $VVOS $PBM $SINT

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Pre-Market Updates 11/21/25
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November 21, 2025 at 1:40 PM
$PBM secured GMP-grade iboga bark via PsyLabs, now processing 50kg for clinical ibogaine. Creating a sustainable, compliant supply chain for substance use disorder trials.

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Daily Updates 11/20/25
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November 20, 2025 at 9:30 PM
$ABT to buy $EXAS for $21B, adding top cancer diagnostics like Cologuard. Expands Abbott’s reach in early detection and precision oncology.

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Pre-Market Updates 11/20/25
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November 20, 2025 at 1:40 PM
$AGIO: Mitapivat met primary endpoint in Phase 3 sickle cell trial—improved hemoglobin, safe, but pain crisis reduction not statistically significant.

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Daily Updates 11/19/25
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November 19, 2025 at 9:31 PM
$CLLS reports >40% knock-in with CssDNA in HSPCs—3–5x higher than ssDNA—outperforming AAV6, advancing TALEN-based gene therapies.

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Pre-Market Updates 11/19/25
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November 19, 2025 at 1:40 PM
APYX prices 2.76M share offering at $3.62/share to raise funds.

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Daily Updates 11/18/25
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November 18, 2025 at 9:31 PM
$RPTX bought by XenoTherapeutics for $1.82/share + CVR; shares up 26%. Deal closes Q1 2026. Q3 EPS $0.08 on $11.6M revenue vs. $0.81 loss last year.

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Daily Updates 11/17/25
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November 17, 2025 at 9:30 PM
$JAZZ & $ZYME: Phase 3 Ziihera combo improved PFS/OS vs. trastuzumab in 1L HER2+ gastroesophageal cancer. sBLA planned for 1H26. $AMIX $RPTX $GTBP $APLT $PSTV $CMND $CTKB $AEMD $NUVL

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Pre-Market Updates 11/17/25
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November 17, 2025 at 1:40 PM
$AVXL will seek EMA re-exam for blarcamesine after CHMP feedback, and meet FDA about trials. Approval is not assured. $CDTX $AVDL $BCAB $AVXL $MGRX $NVNO $IVVD $TRAW $RNXT $PTHS

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Daily Updates 11/14/25
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November 14, 2025 at 9:30 PM
BioPharmCatalyst Watchlist: Key Phase 1/2 catalysts left this quarter—ASMB, GNLX, GRI, IFRX, IMRN, LSTA, MTVA, NKTR, PBM, PVLA. More news, updates: www.biopharmcatalyst.com/news/2025/bi... www.biopharmcatalyst.com/news/2025/bi...
November 14, 2025 at 9:15 PM
$MRK to acquire $CDTX for $9.2B, gaining a Phase 3, first-in-class flu antiviral (CD388) with FDA Fast Track. CD388 met Phase 2b endpoints; aligns with Merck's infectious disease strategy.

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Pre-Market Updates 11/14/25
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November 14, 2025 at 1:40 PM
$MGRX launches MangoRx Direct & PeachesRx Direct for direct access to Zepbound & Wegovy. #biotech #updates

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Daily Updates 11/13/25
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November 13, 2025 at 9:30 PM
$DAWN to acquire $MRSN: $25/share cash + up to $30.25/share CVRs tied to Emi-Le milestones; total deal value up to $285M. $KRRO $MGNX $MGRX $CMND $APLT $AEMD $BJDX $ABSI $LUCY

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Pre-Market Updates 11/13/25
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November 13, 2025 at 1:40 PM
$SLRX prices $7M offering (shares & warrants at $1.50) linked to Decoy merger; funds will support R&D, debt, & ops. Closing depends on deal completion. #biotech

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Daily Updates 11/12/25
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November 12, 2025 at 9:30 PM
$SLRX prices $7M offering tied to Decoy merger—2.51M shares, 2.15M pre-funded warrants at $1.50. Funds for R&D, debt, working capital. Closing depends on merger.

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Pre-Market Updates 11/12/25
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November 12, 2025 at 1:40 PM
$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
$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