I would like to start a overview of Biopharma Catalysts, including FDA approvals and binary data read-outs. Focus will be on small to medium market cap companies. It will exclude FDA approvals that previously have received an CRL (complete response later = “rejection”) and data read outs that are highly controversial in the scientific community (= biopharma meme stocks).
As a reminder, FDA approval have a fix date where the approval can be expected (PDUFA) with typical three outcomes: approved, CRL (rejected, you have re-submit) and additional data request/push out of the PDUFA by max. 3 months. Even if it’s approved the label that the product will receive is very important. The label describes, very simplified, for what patients and with what pre-conditions the product is approved. It includes as well how the product is positioned in the treatment choice (first-line, second line, …) for the disease and any required risk evaluation and mitigation (REMS). In the past there was typical a run-up to the PDUFA, but it’s not guaranteed, especially in this market. The best way to play it as to play the run-up, cover your cost basis and get a free FDA approval ticket. In some cases, we see a heavy “sell the news event” after FDA approval, even worse when its combined with limited label that the product received.
Data read-outs doesn’t have a specific date but understanding when a clinical trial started to recruit patients and when it was closed helps to understand the timeline. In addition, typical the companies share high level timelines (Q1, Q2, …) in their earnings and press release. Often big medical conferences as leveraged as well to publish data.
Please let me know if you came across an interesting catalyst, i am happy to do the DD.
Date
Ticker
Catalyst
Due Diligence
Outcome
December 14, 2022
KYMR
Data Phase 1: KT-474 Hidradenitis suppurativa / atopic dermatitis
Some reflections and what could we do better in 2023
To my surprise so far the plays have a 100% win rate. I believe the continued focus on science and research will help to keep the win-rate positive. Obviously the risk of biopharma plays remains very high, so expect some big red plays as part of this thread.
Data read outs, binary or not, will have a strong focus for me in 2023. The reason is that it requires more research and at the same time provides a higher reward. Given the complexity of data read outs it provides as well more opportunities in terms of how to play it while FDA approvals are limited in their direction.
FDA approval plays seems to be less profitable vs. years ago but remain a good scalping opportunity. Looking at TGTX play I made more profit in the run-up vs. if I would have kept through the approval thanks to IV. I guess that data read outs doesn’t have a specific date, requires more knowledge and are “less public” plays in our favor.
Talking about profitable, even with a high win rate I believe there is an opportunity to make sure the trades are more profitable by having a better trading strategy (@The_Ni thanks for your thoughts on TGTX)
An additional focus for 2023 will be the catalyst of a application submission as we missed some highly profitable plays (see missed plays list)
We missed as well 4 highly profitable data read outs (ICCM, VRNA, ALT, ATNX) that were not on my radar. So please let me know if you have data sources you are levering or if you came across an interesting play.
This is a good example of why understanding the study design and the results are important. The company announced positive results and highlighted that they achieved statistical significance by demonstrating a 33% proteinuria reduction. At the same time analysts expected a 40%, best case 50% reduction, to allow for future commercialization. So, high likelihood that it will never make it to the market.
As a result of these positive data, Vera plans to advance atacicept into pivotal Phase 3 development in the first half of 2023, subject to and following discussions with the U.S. Food and Drug Administration. The full data sets from the ORIGIN clinical trial will be presented at a future medical meeting.
today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that no action will be taken on the Company’s new drug application (NDA) for vonoprazan on or prior to the current Prescription Drug User Fee Act (PDUFA) target action date of January 11, 2023.
the FDA has requested additional stability data demonstrating that levels of NVP remain below that limit throughout the proposed shelf life of the pr
Phathom no longer expects product launches for H. pylori or erosive esophagitis in the first quarter of 2023.
(sorry for the spam) Please be patient with entries on open plays such as RAIN, INZY, CYBN, KRYS and ORMP. They all had a decent run up the last 2 weeks between 10-30%, so do not rush into a position. For example @Fllwoman and i covered already our cost basis on ORMP.
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.
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.
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.
