Biopharma Catalyst (FDA Approvals & Data Read outs)

The positive upward trend continues today for some of the open plays: INZY up 17%, CYBN up 12%, RAIN up 13%.

ORMP dropped 12% in the last hour, three theories: 1. (bad) news leak, 2. profit taking of a 40% run up the last month, 3. fear of a bad Friday after hours news, there is some history with biopharma companies.

IBRX is on a downtrend due to lack of news, there wassome expectations that IBRX would share a high level outcome of their meetings with the FDA from late December.

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Don’t think this needs a separate thread but AMLX got a 50$ price target from BofA last week.
OI on their calls increased and IV as well.

Only catalyst I could find for January was an adverse effect study for their already approved drug for ALS, AMX0035.
For February, they’re waiting on the approval for their MAA from the EMA so that I think will be the most important short term catalyst.

I’ll keep this on my watchlist and create a new thread if needed.

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https://www.streetinsider.com/dr/news.php?id=21046981&gfv=1

CinCor Pharma, Inc. (NASDAQ: CINC) today announced that it has entered into a definitive agreement with AstraZeneca (NASDAQ: AZN) under which AstraZeneca has agreed to acquire CinCor.

https://www.marketwatch.com/amp/story/phathom-pharma-shares-rise-on-positive-heartburn-treatment-trial-results-271673264380

PHAT up 20% pre-market, got hammered couple of days ago with a delayed fda approval

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Some talk around IMGN releasing some form of update on their Mirasol trial today at JPM.

Waiting for a decent entry around 4.25 to enter a small position.

IV is around 200%.

Announced my position on VTGN and VCNX a while ago and finally found time to share my thoughts on Vaccinex (VCNX) – Initial Phase 1b data read out in mid-2023 and topline results in 2024 and VistaGen Therapeutics (VTGN) - Phase 2a data read out in Q1 2023

MRSN got a 12$ price target at Citigroup, looking to enter with a small position. OI on calls has jumped significantly.

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Biotech Tracker vF - Parallax - Substack.xlsx (1.4 MB)

There might be some gems in this file.

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Adding RETA to my watchlist for the PDUFA on Feb 28th.

Same deal, IV is jacked but it doesn’t make sense to do anything significant now.

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@genti

Can you check $NOTV? I would be interested in your opinion. Its not directly “pharma” play, but they are directly “selling shovels” to pharma industry as they are providing NHPs as the only of 2 companies in US and also providing testings etc… They currently make their market cap in revenue in 2 months… I started thread with well written DD already.

They are currently being held withing fairly low range by 50% of dark pool trades.

They should have around their market cap held in NHPs in cambodia atm, around 130m. (They dropped coz lawsuits of illegal imports, which has been basically figured out by now) if they release the news on their ER in 10 days or so, they might very well double from current market price.

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No active play as part of this thread, but it shows that the FDA becomes very strict what is see an major amendment after submission.

Looking at SMMT today. IV sitting around 500% with high premiums even for the end of this week.

Offering record date is on the 6th so I don’t see a major catalyst for selling pressure until then.
https://www.businesswire.com/news/home/20230130005214/en/Summit-Therapeutics-Announces-Timing-for-Rights-Offering-for-Up-to-500-Million

As always be careful with these plays as they’re high risk.

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ASLAN Pharmaceuticals (ASLN) - Upcoming Catalyst (early July) - Phase 2b TREK-AD trial to treat atopic dermatitis (AD) added.

Parking here for further research.

Parking slot for 2023 & 2024 Upcoming Catalyst that i would like to do more research:

Neurocrine Biosciences Inc. (NBIX)

  • Valbenazine: Dyskinesia Due to Cerebral Palsy (DCP) - Phase 3 top-line data due in 2024
  • Valbenazine: Schizophrenia - Phase 3 top-line data due in 2024.
  • NBI-921352: Focal Onset Seizure in Adults - Phase 2 data due in 2H 2023.
  • TAK-041 / NBI-1065846: Anhedonia in depression - Phase 2 topline data due in 2H 2023.
  • NBI-921352: SCN8A developmental and epileptic encephalopathy - Phase 2 data due 2H 2023
  • Crinecerfont - (CAHtalyst): Congenital Adrenal Hyperplasia (CAH) - adults - Phase 3 top-line data due in 2H 2023.
  • Crinecerfont - (CAHtalyst Pediatric Study) - Congenital Adrenal Hyperplasia (CAH) - children - Phase 3 top-line data due in 2H 2023.
  • Valbenazine - (KINECT-HD): PDUFA date for August 20, 2023.

argenx SE (ARGX)

  • Efgartigimod: COVID-19-mediated postural orthostatic tachycardia syndrome (POTS) - Phase 2 data due in 4Q 2023
  • Efgartigimod - (ADAPT-SC): Primary Immune Thrombocytopenia (ITP) - Phase 3 top-line data due in 2H 2023.
  • Efgartigimod (ARGX-113) - (ADVANCE): Immune thrombocytopenia (ITP) - Phase 3 subcutaneously (SC) trial data due in 2H 2023.
  • Efgartigimod (ARGX-113) - (ADDRESS): Pemphigus foliaceous and vulgaris (PV) - Phase 3 top-line data due in 2H 2023.
  • ARGX-117: Multifocal motor neuropathy (MMN) - Phase 2 trial data due in mid-2023.
  • Efgartigimod (ARGX-113) and Enhanze - (ADHERE)- Phase 2 top-line data due in 2Q 2023.
  • Efgartigimod - (ADAPTsc): Generalized Myasthenia Gravis (gMG) - PDUFA priority review date of June 20, 2023.

Roivant Sciences (ROIV)

  • Namilumab: Sarcoidosis - Phase 2 data due in 1H 2024.
  • Brepocitinib: Systemic lupus erythematosus (SLE) - Phase 2b top-line data due in 2H 2023.
  • RVT-2001: Transfusion-Dependent Anemia in Patients with Lower-Risk MDS - Phase 1/2 initial data due in 2H 2023.
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NBIX DD added, i start to shift towards catalyst in the 2nd half of the year so i can catch the run-up which was very decent (between 30*-100%) on majority of the plays so far.

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Sharing some thoughts from @ballfondler and myself on TF regarding the upcoming RETA PDUFA on Feb 28.

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Found this FDA calendar today, should be useful to find research targets.

https://www.fdatracker.com/fda-calendar/

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Adding PRAX to my watchlist. 1Q 23 their EMBOLD study should be reviewed by the FDA. IV sitting at ~500% with some good premiums for March puts.

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