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BioPharmCatalyst
@biopharmcatalyst.bsky.social
350 followers 160 following 520 posts
FDA catalyst calendar, newsletters, and more. We do not provide investment advice or recommendations. #biotech #stocks

https://www.biopharmcatalyst.com/
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$GLTO completed the acquisition of Damora Therapeutics, a biotech developing antibody treatments for mutant calreticulin (mutCALR)-driven Myeloproliferative Neoplasms (MPNs), including ET and Myelofibrosis (MF).
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November 10, 2025 at 9:50 PM
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$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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$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.

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October 20, 2025 at 8:36 PM
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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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September 29, 2025 at 8:34 PM
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$XAIR subsidiary NeuroNOS received FDA Orphan Drug Designation for BA-101 in glioblastoma.

$RAPP $TLPH $DNTH $SMMT $IDYA $SINT $EDAP $XAIR $STTK

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September 8, 2025 at 8:38 PM
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$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

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September 5, 2025 at 12:40 PM
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$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

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August 25, 2025 at 12:35 PM
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BioPharmCatalyst Weekly #Watchlist

Key Phase 3 Catalyst Left for the Quarter

$ATYR $PRAX $ATAI $IONS $RNXT $NVAX $BNOX $VRNA $CYTK $MLTX $CGEM $IRD

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August 15, 2025 at 8:50 PM
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$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.

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August 12, 2025 at 8:39 PM
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$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

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August 5, 2025 at 8:49 PM
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$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.

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$ADAP $SOPH $AZN $VRTX $CYCC $CRSP $STTK
August 5, 2025 at 12:26 PM
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$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.

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August 4, 2025 at 8:37 PM
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BioPharmCatalyst Weekly #Watchlist

Key Near-term Catalysts

$NVCR $CLLS $CLNN $BEAM $CRDL $CLNN $MLTX $ENLV $MTSR

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August 1, 2025 at 8:46 PM
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$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.

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August 1, 2025 at 8:42 PM
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$4DMT announced 52-week and 60-week results from their SPECTRA clinical trial for 4D-150 in diabetic macular edema (DME).

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$BTAI $BIO $MNOV $AVTR $KZIA $UTHR
August 1, 2025 at 12:20 PM
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$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.

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$SNGX $INDV $ALNY $IXHL $GRI $VCEL $APLS $PSTV
July 31, 2025 at 8:28 PM
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$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

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$ENSC $IHXL $DYAI $APLS $PBM $PRME
July 31, 2025 at 12:23 PM
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$DYAI has initiated an underwritten public offering of its common stock, with terms and timing subject to market conditions.

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$VYNE $REPL $CRDF $LRMR $ANIK $ATRC $ACRS $IXHL
July 30, 2025 at 8:28 PM
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$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.

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$REPL $CAPR $CRDF $LRMR $ANIK $ATRC $ACRS
July 30, 2025 at 12:28 PM
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$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.

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July 29, 2025 at 8:48 PM
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$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.

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$DRRX $SCNI $SLRX $FULC $SRPT $APLS $NVO $ADAP $NEO
July 29, 2025 at 12:20 PM
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$ADAP will sell TECELRA, lete-cel, afami-cel, and uza-cel to US WorldMeds for $55M upfront and up to $30M in milestones.
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July 28, 2025 at 8:45 PM
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$CELC reported topline Phase 3 VIKTORIA-1 results in HR+/HER2-, PIK3CA wild-type advanced breast cancer: gedatolisib combinations significantly reduced progression risk

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$CRVO $ATHE $STXS $ADAP
July 28, 2025 at 12:14 PM
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$ LYEL entered a private placement with institutional and accredited investors to raise up to $100 million ($50 million upfront) by selling shares at $13.32

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$ATNF $IXHL $LYEL $NXTC $ABSI $ACXP $SRPT
July 25, 2025 at 8:20 PM
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$PHIO signed a US drug‑substance development and CGMP manufacturing deal for its lead INTASYL siRNA candidate PH‑762

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$ATNF $PHIO $IXHL $LYEL $NXTC $ABSI $ACXP $SRPT $EW
July 25, 2025 at 12:25 PM