$SPRB rose after FDA granted Breakthrough Therapy status to tralesinidase alfa for Sanfilippo B. US approval filing planned for Q1 2026. #biotech
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$SPRB rose after FDA granted Breakthrough Therapy status to tralesinidase alfa for Sanfilippo B. US approval filing planned for Q1 2026. #biotech
www.biopharmcatalyst.com/news/2025/sp...
$BMEA raises $25.3M via public offering at $2.05/unit, selling 11.2M shares & 1M pre-funded warrants; 3-year warrants exercisable at $2.50. 30-day option for more shares/warrants.
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$BMEA: Icova Phase II shows 1.8% HbA1c drop at 9 months, works in GLP-1 failures, safe; new Phase II trials start Q4 2025.
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$SKYE: Nimacimab missed Phase 2a solo weight loss goal, but combo with semaglutide showed significant extra loss, safe profile. Advancing combo in obesity.
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$EVAX to share new EVX-01 biomarker & immune data at SITC 2025; 2-yr Phase 2 KEYTRUDA combo results at ESMO 2025. More biotech news: $PALI $ANRO $OVID $IMAB $BOLT $APLIF $CLNN $SPRC $OCEA
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BioPharmCatalyst Weekly Watchlist: Top biotech stocks with Phase 1/2 catalysts in 6 months. Key tickers: IFRX, BCYC, SNY, CYBN. #biotech #stocks www.biopharmcatalyst.com/news/2025/bi...
03.10.2025 20:15 β π 0 π 0 π¬ 0 π 0$ANRO gets FDA Fast Track for ALTO-101 in schizophrenia cognitive impairmentβno approved therapies yet, supporting faster development. $PALI $OVID $IMAB $QNTM $JAZZ $CLPT $DBVT $ZYBT $ADGM
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$TSHA gets FDA Breakthrough Therapy status for TSHA-102 gene therapy in Rett syndrome; pivotal trial protocol aligned for upcoming BLA. More biotech news below.
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$NBTX: Phase 1 data in esophageal cancer showed 85% disease control, 69% response. Well tolerated. More patients enrolling. Presented at ASTRO 2025.
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$APLIF & Vitalex get up to $40M NIAID funding for VXV-01 fungal vaccine, supporting manufacturing, preclinical, IND, and Phase 1 trials over 5 years.
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$FBIO falls after FDA cites manufacturing issues for CUTX-101; no efficacy/safety concerns. Sentynl to fix and resubmit for Menkes disease.
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$ANAB to split into two public companies by 2026: one for royalties/milestones, one for immunology drugs. Virtual event for ANB033 on Oct 14. #biotech
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$ADXN posts Q2 net loss of 1.84M CHF (β0.02/share), down from 12.88M CHF profit last year. #Premarket $SPRC $QLGN $NLSP $BIAF $ARTL $PHIO $IPHA $SILO $SCYX
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$ENTA reported Phase 2b data for zelicapavir in high-risk RSV outpatients, showing clinically meaningful symptom resolution improvements across multiple endpoints.
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$DWTX acquires rights to SP16 in stock deal (7.31% equity). Phase 1b trial for CIPN starts 1H 2026; Halneuron Phase 2b interim data due Dec 2025. $MRUS $RDHL $MLTX $APLT $IOBT $PSTV $POAI $LRMR $CLLS
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$BIAFβs CyPath Lung test detected early Stage 1A lung cancer & avoided invasive procedures, proving useful when imaging is unclear. #BiotechUpdates
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BioPharmCatalyst Weekly #Watchlist: Top biotech stocks & Phase 3 catalysts in next 6 months. $COGT $RZLT $DVBT $BLTE $IMVT $TGTX. Full list: biopharmcatalyst.com/news/2025 www.biopharmcatalyst.com/news/2025/bi...
26.09.2025 20:15 β π 0 π 0 π¬ 0 π 0$LEXX to sell 2.67M shares at $1.50/share in a direct offering. #BiotechNews $PEPG $SPRC $EVAX $PSTV $IMRX $RENB $VINC $LPTX $ZYBT $CURX
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$BIAF: CyPath Lung test detected Stage 1A lung cancer early, helped avoid invasive procedures in 2 cases, boosting diagnostic value.
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$PFE to buy $MTSR for up to $70/share (cash + CVRs), boosting obesity pipeline; deal valued at $7.2B. $QLGN $MBX $HSDT $KOD $CYCN $HOWL $THAR $SPRC
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$PFE to buy $MTSR for up to $70/share ($7.2B total), boosting obesity and cardiometabolic pipeline. $QLGN $MBX $MTSR $CCCC $HSDT $GRI $TARA $GPCR $THAR $BRTX
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$SABS shares promising SAB-142 data at EASD, advancing Phase 2b trial in new-onset Type 1 diabetes. Strengthens clinical & advocacy ties. #biotech #T1D
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BioPharmCatalyst Weekly Watchlist: Biotech movers to watch as Q3 ends. Key tickers: $TGTX, $ZYNE, $FBIO, more. Get daily updates & catalysts! www.biopharmcatalyst.com/news/2025/bi...
19.09.2025 20:15 β π 0 π 0 π¬ 0 π 0$RVPH raised $9M via a 27M share offering at $0.335/share to fund its CNS, inflammatory, and cardiometabolic drug pipeline.
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$REPL held a Type A FDA meeting on RP1+nivolumab BLA; no clear accelerated approval path yet. Reviewing feedback for next steps.
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$ETNB to be acquired by Roche for $14.50/share cash + up to $6.00/share CVR, maximizing potential equity value.
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BioPharmCatalyst Weekly Watchlist: Key PDUFA dates left this quarter. Top biotech stocks: $TGTX, $ZYNE, $MLTX, $BNOX, $FBIO, $SGMT, $ATYR, $PRAX, $SRRK, $CRNX. www.biopharmcatalyst.com/news/2025/bi...
18.09.2025 09:37 β π 0 π 0 π¬ 0 π 0$SPRC jumps after AutoMax merger faces court delay due to deal uncertainties. Stay granted amid closing condition concerns. #BiotechUpdates
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