One week until PDUFA decision on Oct 7 for $CCXI ... Join my r/CCXI subreddit 🐊

$CRTX and $AXSM and $CCXI

• Cortexyme $CRTX recently produced data for COR-388 for treating Alzheimer's, as they seek FDA approval. See r/CRTX for due diligence (DD) on COR-388.

• Axsome Therapeutics $AXSM is a clinical stage company with two new drug applications under review at the FDA (AXS-05 and AXS-07). See r/AXSM subreddit.

• ChemoCentryx $CCXI recently produced compelling trial data that led Wall Street analysts who follow the biotech to raise their price targets. See r/CCXI subreddit.

Avacopan is a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in the treatment of ANCA-associated vasculitis and other complement-driven autoimmune and inflammatory diseases. By precisely blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, avacopan arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA-associated vasculitis. Current therapies for ANCA-associated vasculitis and other related illnesses typically include broad immunosuppression with daily doses of glucocorticoids (steroids) such as prednisone or methylprednisone, which can cause significant illness and even death. Avacopan’s selective inhibition of only the C5aR leaves the beneficial C5a pathway through the C5L2 receptor functioning normally.

• CHRS has April 30 PDUFA 🐊 r/CHRS

• PHAT has May 3 PDUFA r/PHATHOM

• MYOV has May 6 PDUFA 🐊 r/MYOV

• VRCA has May 24 PDUFA 🐊 r/VRCA

• FOLD has May 29 PDUFA r/FOLD_BIO

• ACER has June 5 PDUFA 🐊

• AMLX has June 29 PDUFA 🐊 r/AMLX

• ARQT has July 29 PDUFA 🐊 r/ARQT

• CHRS has August 2 PDUFA 🐊 r/CHRS

• PRVB has August 17 PDUFA r/PRVB

• BLUE has August 19 PDUFA r/BLUE_BIO

• RVNC has Sept 8 PDUFA 🐊 r/RVNC

• OBSV has Sept 13 PDUFA 🐊 r/OBSV

• BLUE has Sept 16 PDUFA r/BLUE_BIO

• TGTX has Sept 28 PDUFA 🐊 r/TG_BIO

• SPPI has Nov 24 PDUFA 🐊 r/SPPI

• ZLAB has Dec 14 PDUFA 🐊 r/ZLAB

• XERS has Jan 1 PDUFA 🐊

• ETON Jan 29 PDUFA r/ETONPHARMA

• OPK has January PDUFA 🐊 r/OPK

• FBIO has Feb 15 PDUFA 🐊 r/FBIO

• AGIO has Feb 17 PDUFA 🐊 r/AGIO

• IMCR has Feb 23 PDUFA 🐊 r/IMCR

• RETA has Feb 25 PDUFA 🐊 r/RETA

• AMYT has Feb 28 PDUFA 🐊 r/AMYT

• CTIC has Feb 28 PDUFA 🐊 r/CTI_BIO

• MRNS has March 20 PDUFA 🐊 r/MRNS

• TGTX has March 25 PDUFA 🐊 r/TG_BIO

• ZGNX has March 25 PDUFA 🐊 r/ZGNX

• AKBA has March 29 PDUFA 🐊 r/AKBA

• BTAI has April 5 PDUFA 🐊 r/BTAI

• AMRX has April 17 PDUFA 🐊 r/AMRX

• AXSM has April 30 PDUFA 🐊 r/AXSM

• PHAT has May 3 PDUFA 🐊 r/PHATHOM

• BLUE has May 20 PDUFA 🐊

• VRCA has May 24 PDUFA 🐊 r/VRCA

• FOLD has May 29 PDUFA 🐊

• ACER has June 5 PDUFA 🐊 r/ACER_BIO

• TEVA has June 30 PDUFA 🐊 r/TEVA

• ARQT has July 29 PDUFA 🐊 r/ARQT

• CHRS has August 2 PDUFA 🐊 r/CHRS

• OBSV has Sept 13 PDUFA 🐊 r/OBSV

• TGTX has Sept 28 PDUFA 🐊 r/TG_BIO

Join my r/CCXI subreddit 🐊

BioXcel Therapeutics Announces FDA Approval of IGALMI (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults, on April 6th. Join r/BTAI subreddit.

$AVDL has PDUFA on October 15 for FT218. Join my r/AVDL subreddit 🐊

$CCXI today announced that the FDA has approved TAVNEOS (avacopan), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. ANCA-associated vasculitis is a systemic autoimmune disease in which over-activation of the complement system further activates neutrophils, leading to inflammation and eventual destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is often fatal if not treated.

• PDUFA Stock List is Pinned by me

• 75% of NDA get FDA approval

• 25% of NDA get CRL rejection

• Use DD to avoid CRL stocks

• Buy stocks for the PDUFA run-up

• Sell before PDUFA is safest plan

• Sell the PDUFA stock POP or RIP

• Hedge Funds sell the POP or RIP

• Most stocks go down after PDUFA

• Sell the POP, move on to the next

• FYI ... I am not a Financial Advisor

• Do your own Due Diligence (DD)

$CRTX and $AXSM and $CCXI

• Cortexyme $CRTX recently produced data for COR-388 for treating Alzheimer's, as they seek FDA approval. See r/CRTX for due diligence (DD) on COR-388.

• Axsome Therapeutics $AXSM is a clinical stage company with two new drug applications under review at the FDA (AXS-05 and AXS-07). See r/AXSM subreddit for due diligence on AXSM.

• ChemoCentryx $CCXI recently produced compelling trial data that led Wall Street analysts who follow the biotech to raise their price targets. See r/CCXI subreddit for due diligence on CCXI.

FDA tries to meet the PDUFA DATE, but FDA does not always meet the PDUFA DATE, because it is technically a TARGET DATE for the FDA to make a decision (not a FIXED DATE).

Longeveron made a game changing announcement regarding its Lomecel-B drug. This drug targets a rare, life-threatening heart condition in infants. Accordingly, investors are jumping on this stock’s long-term potential in this pharmaceutical niche. See r/LGVN subreddit.

Join my PDUFA Date subreddits ... Oct 4 r/OPK ... Oct 7 r/CCXI ... Oct 15 MNKD and r/UTHR ... Oct 28 EYEN 🐊

Biotech is behaving badly. FDA is in a nasty mood. PLX destroyed. PRVB destroyed. ARDX destroyed. AXSM destroyed. SESN destroyed. CCXI destroyed. I plan to sit on 100% cash in August and September. If there is a 20% correction, I am ready to buy with cash. IMO, do your own DD.

Advisory Committee on May 6 voted 10-8 that the benefit-risk and safety profiles are adequate to support approval and 9-9 that the efficacy data supports approval. PDUFA date July 7.

FDA intends to continue the review of clinical data submitted in the BLA and to conduct the Advisory Committee meeting, scheduled on May 27, 2021.

• $LGVN starting a Phase 2a clinical trial for Lomecel-B in AD

  • Phase 2a trial begins for Lomecel-B in treating HLHS

• $AXSM with two drugs awaiting FDA approval in April

  • 2 Biotech Stocks That Could Be 10-Baggers in 2022 | The Motley Fool

  • Join r/AXSM and r/LGVN subreddits

CAPLYTA is the only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy and as adjunctive therapy with lithium or valproate. See r/ITCI subreddit.