BioPharmCatalyst
@biopharmcatalyst
FDA catalyst calendar, newsletters, and more. We do not provide investment advice or recommendations. #biotech #stocks
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$REPL shares closed up following the resignation of U.S. FDA Commissioner Marty Makary. See More Biotech Updates👇 www.biopharmcatalyst.com/news/2026/re...
$ERNA shares closed up following new investor segment highlighting the potential of ERNA-101 to address critical gaps in ovarian cancer treatment... See More Biotech Updates👇 www.biopharmcatalyst.com/news/2026/er...
$IOBT filed for Chapter 7 bankruptcy on March 31, 2026, ceased operations, and initiated liquidation proceedings in the U.S. Bankruptcy Court. $APLS $IOBT $PEPG $CNTA $PSTV $CTXR $CGTX $PASG $ITRM $FBLG See More Biotech Updates👇 www.biopharmcatalyst.com/news/2026/ap...
$PEPG reported Phase 2 FREEDOM2-DM1 data from the 5 mg/kg multiple ascending dose cohort of PGN-EDODM1 in myotonic dystrophy type 1 $ITRM $ELAB $PEPG $KZR $ICU $ARTL $CMND $CDT $FBLG $AIM See More Biotech Updates👇 www.biopharmcatalyst.com/news/2026/it...
BioPharmCatalyst Weekly #Watchlist BioPharmCatalyst Weekly Watchlist: Final 2025 Catalyst $OMER $CORT $CYTK $VNDA $OTLK $RARE $RLYB $VYTX $MTVA $GNLX www.biopharmcatalyst.com/news/2025/bi...
$CYTK announced that the FDA has approved MYQORZO (aficamten), 5 mg, 10 mg, 15 mg, 20 mg tablets for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/am...
$JANX announced updated interim data from its Phase 1a and Phase 1b clinical trials of JANX007, a PSMA-directed TRACTr, in patients with metastatic castration-resistant prostate cancer (mCRPC). See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/po...
$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). See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/ga...
$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 See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/pr...
$ANRO announced a successful FDA meeting supporting accelerated development of ALTO-207 for treatment-resistant depression, with a $50 million private placement expected to fund a Phase 3 trial launch by early 2027. See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/re...
$ENTA reported Phase 2b data for zelicapavir in high-risk RSV outpatients, showing clinically meaningful symptom resolution improvements across multiple endpoints. See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/en...
$XAIR subsidiary NeuroNOS received FDA Orphan Drug Designation for BA-101 in glioblastoma. $RAPP $TLPH $DNTH $SMMT $IDYA $SINT $EDAP $XAIR $STTK See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/ra...
$AIFF announced a partnership with HealingMaps and Advanced Behavioral Strategies to integrate its FDA-cleared, AI-driven EEG brain health platform. $BNTX $THAR $PMN $VANI $QURE $CERO See More Pre-market Movers www.biopharmcatalyst.com/news/2025/bi...
$VALN announced that the FDA has suspended the license for IXCHIQ, citing four new reports of serious adverse events consistent with chikungunya-like illness. The suspension of the license is effective immediately and requires See More Pre-market Movers👇 www.biopharmcatalyst.com/news/2025/va...
BioPharmCatalyst Weekly #Watchlist Key Phase 3 Catalyst Left for the Quarter $ATYR $PRAX $ATAI $IONS $RNXT $NVAX $BNOX $VRNA $CYTK $MLTX $CGEM $IRD www.biopharmcatalyst.com/news/2025/ke...
$ATNF shares rose after a $156 million private offering, boosting its Ethereum reserves. This follows a $425M placement led by over 60 institutional and crypto investors. See More Biotech Updates👇https://www.biopharmcatalyst.com/news/2025/180-life-sciences-atnf-private-offering-drio-drio-earnings
$YMAB will be taken private by SERB Pharmaceuticals in an all-cash deal: SERB will launch a tender at $8.60/sh (≈$412 M equity value), a 105% premium to the prior close See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/y-...
$STAA will be acquired by $ALC for $1.5 billion, or $28 per share, representing a 51% premium over its closing price on August 4, 2025. The acquisition includes STAAR's EVO lenses. See More Pre-market Movers 👇 www.biopharmcatalyst.com/news/2025/st... $ADAP $SOPH $AZN $VRTX $CYCC $CRSP $STTK
$BTAI shares closed up after an H.C. Wainwright analyst reiterated a Buy rating and $8 PT, citing the imminent top-line readout from the pivotal SERENITY At-Home P3 safety trial of sub-lingual film BXCL501 (IGALMI) in schizophrenia. See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/ca...
BioPharmCatalyst Weekly #Watchlist Key Near-term Catalysts $NVCR $CLLS $CLNN $BEAM $CRDL $CLNN $MLTX $ENLV $MTSR www.biopharmcatalyst.com/news/2025/ke...
$XCUR's GPC-100 study for stem-cell mobilization in multiple myeloma patients completed its Phase 2, with topline data expected in Q4 2025. It's fast dosing could simplify logistics, with plans for AML and partnerships. See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/4d...
$4DMT announced 52-week and 60-week results from their SPECTRA clinical trial for 4D-150 in diabetic macular edema (DME). See More Pre-market Movers 👇 www.biopharmcatalyst.com/news/2025/4d... $BTAI $BIO $MNOV $AVTR $KZIA $UTHR
$GRI reported 6-week interim biomarker data from its Phase 2a IPF trial of GRI-0621, showing reduced fibrogenesis markers and a net fibrolytic profile in treated patients. See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/so... $SNGX $INDV $ALNY $IXHL $GRI $VCEL $APLS $PSTV
$SNGX reported results from an eight-patient Phase 2a study of SGX945 (dusquetide) in Behçet’s-related ulcers, showing a 40% efficacy improvement over historical placebo See More Pre-market Movers 👇 www.biopharmcatalyst.com/news/2025/so... $ENSC $IHXL $DYAI $APLS $PBM $PRME
$DYAI has initiated an underwritten public offering of its common stock, with terms and timing subject to market conditions. See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/vy... $VYNE $REPL $CRDF $LRMR $ANIK $ATRC $ACRS $IXHL
$VYNE reported that its Phase 2b trial of Repibresib gel in nonsegmental vitiligo failed to meet its primary and key secondary endpoints (F-VASI50 and F-VASI75) at week 24. See More Pre-market Movers 👇 www.biopharmcatalyst.com/news/2025/vy... $REPL $CAPR $CRDF $LRMR $ANIK $ATRC $ACRS
$DRRX will be acquired by $BHC, which includes its novel therapeutic molecule, larsucosterol, an epigenetic modulator that has shown promise in Phase 2 trials for alcoholic hepatitis. See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/du...
$CLDI received FDA Fast Track designation for CLD-201 (SuperNova), its allogeneic adipose stem-cell loaded oncolytic virus, for the treatment of soft tissue sarcoma. See More Pre-market Movers 👇 www.biopharmcatalyst.com/news/2025/du... $DRRX $SCNI $SLRX $FULC $SRPT $APLS $NVO $ADAP $NEO
$ADAP will sell TECELRA, lete-cel, afami-cel, and uza-cel to US WorldMeds for $55M upfront and up to $30M in milestones. See More Biotech Updates👇 www.biopharmcatalyst.com/news/2025/ce...