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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/

359 Followers  |  157 Following  |  648 Posts  |  Joined: 21.11.2024
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Posts by BioPharmCatalyst (@biopharmcatalyst.bsky.social)

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Pre-Market Updates 03/03/26

$MAIA jumps on $30M equity raise at $1.50/share, boosting funds but causing near-term dilution. Healthcare investors led; no warrants. $ITRM $HROW $CERS $IRON $ATRA $IDYA $ESLA $ENSC $LYRA

www.biopharmcatalyst.com/news/2026/ma...

03.03.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 03/02/26

$AARD paused Phase 3 HERO trial for ARD-101 in PWS due to cardiac concerns at high doses, delaying topline data and creating regulatory uncertainty.

www.biopharmcatalyst.com/news/2026/aa...

02.03.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0

BioPharmCatalyst Watchlist: Key small/mid-cap PDUFA catalysts this week. Top tickers: RCKT, RYTM, ALDX, GSK, BMY, LNTH. Full list & news: biopharmcatalyst.com www.biopharmcatalyst.com/news/2026/bi...

27.02.2026 21:15 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/27/26

$ENSC begins review of strategic options to boost shareholder value; may consider partnerships, asset sales, or other deals. No set timeline or further updates planned.

www.biopharmcatalyst.com/news/2026/en...

27.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/26/26

$CURX finished a GMP batch of Phyto-N, clearing the way for GLP studies and a planned 4Q26 IND in ulcerative colitisβ€”key step toward first-in-human trials.

www.biopharmcatalyst.com/news/2026/cu...

26.02.2026 13:40 β€” πŸ‘ 1    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/25/26

$IXHL announces 1-for-30 reverse split effective Feb 26, 2026, aiming to boost share price and maintain Nasdaq listing.

www.biopharmcatalyst.com/news/2026/ge...

25.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/24/26

$VIR partners with Astellas on prostate cancer therapy, reports positive Phase 1 data, ends 2025 with $781.6M cash.

www.biopharmcatalyst.com/news/2026/ma...

24.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/23/26

$GILD to acquire $ACLX for $115/share plus $5 CVR, securing BCMA CAR-T. Deal valued at $7.8B. FDA BLA accepted; PDUFA Dec 23, 2026. $ACLX $GILD #PremarketMovers

www.biopharmcatalyst.com/news/2026/gi...

23.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0

Biopharma Watchlist: Key Phase 1/2 catalysts this quarter. Highlights: RGNX, CYBN, PEPG, BMEA, FGEN & more. Full list: biopharmcatalyst.com www.biopharmcatalyst.com/news/2026/bi...

20.02.2026 21:15 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/20/26

$MGRX's $99/month TRT program drives 336% sales growth, 54% lower acquisition costs since Dec launch, boosting its telehealth expansion.

www.biopharmcatalyst.com/news/2026/ma...

20.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/19/26

$TRAW: Phase 2 shows ratutrelvir rivals PAXLOVID with fewer side effects, no rebound. Tivoxavir shows promise as monthly flu prevention; US study on hold for FDA feedback.

www.biopharmcatalyst.com/news/2026/pm...

19.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/18/26

$TCMD Q4 rev +21% to $103.6M, adj. EBITDA $22.9M. FY rev $329.5M, EBITDA $44.8M. Repaid $26.3M debt, $26.5M buybacks, cash $83.4M. $TCMD $SPRB $APRE $RXRX $ADVB $KLRS $MNDR $BAYRY $SHPH

www.biopharmcatalyst.com/news/2026/ta...

18.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/17/26

$CMPS: Phase 3 trials show strong results for COMP360 in depression, rapid & lasting effect, well-tolerated. NDA planned Q4 after FDA talks. $CMPS + others move pre-market.

www.biopharmcatalyst.com/news/2026/co...

17.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/16/26

Pre-market movers: $IMUX, $VTGN, $CHRS, $QNCX, $BIO, $OKYO, $JSPR, $BRTX, $ABP, $ARTL.

LINK

16.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0

BioPharmCatalyst Weekly Watchlist: Top Phase 3 catalysts left this quarter. Key tickers: OCUL, BCRX, GOSS & more. Details: www.biopharmcatalyst.com/news/2026 www.biopharmcatalyst.com/news/2026/bi...

13.02.2026 21:15 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/13/26

$IMUX issues warrants for up to 229M shares at $0.873, aiming to raise $200M. Warrants expire 30 days after Phase 3 data or Feb 2031. Supports commercial plans. $IMUX $VTGN $CHRS

www.biopharmcatalyst.com/news/2026/im...

13.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/12/26

$NVCR jumps after FDA OKs Optune Pax for advanced pancreatic cancer, first new treatment in decades. Phase 3 showed improved survival.

www.biopharmcatalyst.com/news/2026/no...

12.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/11/26

$UPB's Phase 2 asthma drug cut exacerbations by 56% & improved lung function. $UPB, $QNCX, $STIM, $ELAB among notable pre-market movers.

www.biopharmcatalyst.com/news/2026/up...

11.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/10/26

$EVMN up on positive Phase 2a EVO301 data in atopic dermatitis: 33% placebo-adjusted EASI at week 12, clean safety, moving to Phase 2b.

www.biopharmcatalyst.com/news/2026/ev...

10.02.2026 13:40 β€” πŸ‘ 1    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/09/26

$TNON projects Q4 revenue of $1.45M–$1.48M, reaffirming a strong 2025 outlook.

www.biopharmcatalyst.com/news/2026/te...

09.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0

BioPharmCatalyst Weekly Watchlist: Key biotech catalysts for GOSS, RGNX, PVLA, KOD, ALDX & more in the next 6 months. Daily insights & news. Full list: biopharmcatalyst.com www.biopharmcatalyst.com/news/2026/bi...

06.02.2026 21:15 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/06/26

$NVST Q4: Core sales +10.8%, adj. EBITDA +22% ($111M), EPS +58%. FY25: Sales +6.5%, EBITDA +26%. Returned $166M via buybacks. 2026 EPS guide: $1.35-$1.45, sales +2-4%.

www.biopharmcatalyst.com/news/2026/he...

06.02.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/05/26

$ALGN beats Q4 estimates with strong Invisalign demand. EPS $3.29, revenue $1.05B. Q1 guidance in line, though margin below. Needham: Hold, outlook "achievable." $ALGN #premarket

www.biopharmcatalyst.com/news/2026/al...

05.02.2026 15:07 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 02/05/26

$ALGN beats earnings & revenue estimates on strong Invisalign demand; guides Q1 revenue $1.01-$1.03B, margin below consensus. Needham maintains Hold, outlook "fairly achievable."

www.biopharmcatalyst.com/news/2026/al...

05.02.2026 15:05 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 01/29/26

$SER gets FDA OK for IND on SER-252 in Parkinson’s; Phase 1b trial to start, leveraging 505(b)(2) pathway for faster development. $SER #PremarketMovers

www.biopharmcatalyst.com/news/2026/fr...

29.01.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Daily Updates 01/28/26

$ENVB launches $1.5M direct offering to fund neuroplastogenic drug programs and operations. #BiotechUpdates

www.biopharmcatalyst.com/news/2026/en...

28.01.2026 21:30 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 01/28/26

$CALC ends Phase 2 KOURAGE trial in AKI due to safety concerns. No drug-related deaths. Will review data, continue pancreatitis trial, and advance second CRAC inhibitor.

www.biopharmcatalyst.com/news/2026/ca...

28.01.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Daily Updates 01/27/26

$NTLA FDA lifts clinical hold on MAGNITUDE-2 Phase 3 trial for ATTRv-PN. More biotech tickers: $PHGE $CRDF $NUWE $ABOS $USBC $PMN $CING $MBAI $DRMA

www.biopharmcatalyst.com/news/2026/bi...

27.01.2026 21:30 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Pre-Market Updates 01/27/26

$CRDF: Interim Phase 2 shows onvansertib combo boosts efficacy in 1L RAS-mut mCRC vs. SoC. Outperforms FOLFOX combo. #PremarketMovers

www.biopharmcatalyst.com/news/2026/ca...

27.01.2026 13:40 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0
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Daily Updates 01/26/26

$MBAI regains Nasdaq compliance, moving closer to merger with MBody AI. #BiotechUpdates

www.biopharmcatalyst.com/news/2026/ch...

26.01.2026 21:30 β€” πŸ‘ 0    πŸ” 0    πŸ’¬ 0    πŸ“Œ 0