Annexon Inc (ANNX)

$ANNX where is the update?

$ANNX upcoming catalyst that management has guided for Q3: The update on the BLA filing for GBS, which they have guided as blockbuster potential (excess of $1 billion in annual sales). This may be optimistic, but regardless, it will be impactful. Conventional BLAs take approximately 10 months, but the new FDA protocol on the fast track could reduce the timing for approval to 2 months. While remote, if ANNX secured the 2-month track, it could result in ANNX establishing a revenue source in 2025 and potentially breaking even in 2026. Significance could result in ANNX being financially self-sufficient (profitable) and not requiring dilutive financing. The company confirms that the 600+ patients in its GA phase 3 trial have been enrolled. While no data will be released, the trial investigators' adoption of securing such a large patient enrollment in such an expedited time reflects very positively on clinicians' and patients' enthusiasm for their drug. Remember, this is a multibillion-dollar TAM (total addressable market) with over 1,000,000 patients in the US alone. Finally, an update on the POC(proof of concept) for their oral drug in the autoimmune disease. The efficacy, safety, and expansion into other indications will directly affect the Velocity and direction of this catalytic event. In summary, three impactful events are lurking around the corner for ANNX shareholder, individually and collectively these events could significantly impact the stock price with many permutations of outcomes.

$ANNX BIG squeeze coming in

$ANNX buy the pump and sell the dump like a good little lemming. Whew

$ANNX IMO, that 'recovery' yesterday, I think could evaporate. and retrace. Lots of at least unethical and immoral and possibly illegal info being exchanged that was not available to the public. I could see another round of lawyers lining up. Can anyone cite an example of a stock that has dropped that much in a day but continue to go up thereafter? In my observations, they generally seem to retrace back to and below that low. Hope I am wrong and they get approval - new and way better treatments for GBS are needed.

$ANNX maybe the ceo is great and has exits but his communication and managing the stock is an F

$ANNX sold rest, holding 2.05 only

$ANNX Pretty insane day today. That drop was too much, got a lot of people panicing searching for bad news. I added a few more on the drop at around $2.20. Did not think it was going to drop sub $2 or I would have waited to buy.

$ANNX In June, the FDA expanded its acceptance of RWE (real-world evidence study), hence the bogus and deceptive claim that ANNX’s GBS required additional data, which is false and contrary to the amended FDA protocol. In essence, the fraudulent claim was purely a means for the institution to create retail panic so that it could further accumulate. I suspect that additional amendments to the FDA drug approval process may, in fact, benefit ANNX’s GBS and possibly result in a condensed timing of their BLA acceptance to two months under the Commissioner’s National Priority Voucher (CNPV), announced by the FDA commissioner on June 17th. https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests The GBS published phase 3 data is robust and demonstrated statistical significance against both placebo and IVIG. No approved therapies are available for GBS, with only IVIG as a non-approved option for a very harsh disease. In addition, the company has embarked and will have phase 3 top-line data in GA. Over 1,000,000 people in the US alone suffer from this eye disease, which can result in total vision loss. This is a multi-billion-dollar space in the US with no approved therapy that provides vision preservation. ANNX’s drug is the only drug to demonstrate this in their phase 2 trial (already derisked), hence their rapid enrollment and accelerated timing of their phase 3 trial. In comparison, look at Regeneron’s GA phase 3 trial, which is delayed despite the company having $17 billion in the bank, due to the inferiority of their drug versus ANNX. ANNX will release human proof of concept for an oral small molecule (drug) for an autoimmune disease, with the potential to expand into larger indications, multi-billion-dollar markets. Due to manufacturing cost, a small molecule is the holy grail in drug development. The release of a successful Proof of concept would be significant, especially if the safety and efficacy profile is attractive. ANNX has $267 million, providing ample capital for major inflection points. I’m very biased since I have a significant shareholding. I welcome any comments, but I detest market manipulation intended to hurt retail investors, especially based on false data. Good luck, longs.

$ANNX Perhaps the dimwit is referring to this An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study) Which is USA and Europe with 30 patients planned, however ClinTrial.gov is not yet listing locations.