RGNX
REGENXBIO Inc.
stock NASDAQ

Clinical holds on one program affecting another is classic FDA overcaution, but it creates this limbo where nobody knows if we're talking weeks or months for resolution. The biotech sector has been brutal lately for anything with regulatory uncertainty - RGNX is trading like it's priced for worst case scenario already. I'd be watching how they handle the next earnings call communication more than trying to time any bounce here. https://aimytrade.io/ticker/RGNX?utm_source=reddit&utm_medium=comment&utm_campaign=biotech_stocks

RGNX Whats next

So I went through all the February catalysts and pulled out what actually looks interesting. Not gonna list everything, just the ones worth paying attention to imo.
**PDUFA Dates (FDA says yes or no)**
The big ones this month:
|Date|Ticker|Drug|Indication|Why it matters|
|:-|:-|:-|:-|:-|
|Feb 1|VNDA|Hetlioz|Depressive disorder|Small cap, binary event, been running into the date|
|Feb 8|RGNX|RGX-121|Hunter syndrome (MPS II)|Gene therapy, priority review, could be huge for rare disease space|
|Feb 9|FBIOP|CUTX-101|Wilson's disease|Tiny $68M cap, this thing moves 50%+ either way|
|Feb 12|JAZZ|JZP-458|ALL (leukemia)|$6.4B cap, priority review, adds to their oncology portfolio|
|Feb 15|BHVN|Undisclosed|\-|$2.2B cap, watching this one|
|Feb 17|ALDX|Reproxalap|Dry eye|They've had a rough history with FDA, third time's the charm?|
|Feb 25|ASND|TransCon hGH|Growth hormone deficiency|$13B cap, should be straightforward approval|
|Feb 26|PGEN|PRGN-3005|Gene therapy|Priority review, $240M cap, high risk high reward|
|Feb 28|CRNX|Paltusotine|Acromegaly|Oral therapy in injectable-dominated market, could disrupt|
**Phase 3 readouts I'm watching**
|Date|Ticker|Drug|Indication|Notes|
|:-|:-|:-|:-|:-|
|Feb 3|UCBJY|Bimekizumab|Psoriasis|Big pharma, probably priced in already|
|Feb 3|UCBJY|Risankizumab|Psoriatic Arthritis|Same day double feature|
|Feb 10|4502.T|TAK-881|Primary Immunodeficiency|Takeda, large cap|
|Feb 15|CMPS|Psilocybin|Treatment Resistant Depression|This one's interesting, psychedelics finally getting real trials|
|Feb 15|AVDL|FT218|Narcolepsy|$1.3B cap|
|Feb 15|KOD|KSI-101|Macular Edema|Small cap ophthalmology play|
|Feb 20|NVO|Semaglutide|Obesity|Novo with more GLP-1 data, the obesity war continues|
|Feb 20|NVO|Cagrilintide|Obesity|Same day, combo data|
|Feb 20|NVO|Tirzepatide|Diabetes|Triple header from Novo|
**The small caps I find interesting (higher risk)**
FBIOP at $68M with PDUFA Feb 9 - these micro caps can move 100%+ on approval. Wilson's disease is rare, if they get it the stock reprices completely.
PGEN at $240M with priority review gene therapy - PRGN-3005 for solid tumors. Gene therapy is still hit or miss but priority review is a good sign.
KOD at $76M with Phase 3 data Feb 15 - Tarcocimab for diabetic retinopathy also reading out end of Jan.
**What I'm personally watching closest**
CRNX (Feb 28) - Paltusotine for acromegaly. The oral vs injectable dynamic is real, if this gets approved it's a big deal for patients who don't want injections. Market seems to be pricing in approval already tho.
CMPS (Feb 15) - Psilocybin for treatment resistant depression. I know it sounds meme-y but the science is actually solid. If this works it opens up a whole new therapeutic area.
I track all this stuff on a platform I built (CatalystAlert) - happy to answer questions about any of these names. Been following biotech catalysts for a while now.
What are you guys watching this month?