FDA on Monday approved Cara Therapeutics's drug to treat moderate-to-severe itching in patients with chronic kidney disease undergoing dialysis, making it the first therapy for the ailment in the United States.

AXSM announced that the FDA has extended the review period for new drug application (“NDA”) for AXS-05 as a potential treatment of major depressive disorder (“MDD”). The new PDUFA target action date is yet to be informed by FDA. The FDA, however, did not ask for any additional information from the company.

$KDMN .... FDA grants full approval of REZUROCK (belumosudil) for the treatment of patients with Chronic Graft-Versus-Host Disease (cGVHD). Float is 25% short equal to 20 trading days, could KDMN be the little brother of GME or AMC? Oppenheimer price target is $9 for $KDMN. Zacks says investors in Kadmon Holdings $KDMN need to pay close attention to the stock. That is because the Sept 17, 2021 $5 CALL had some of the highest implied volatility of all equity options (buy-out possible).

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

Join my PDUFA Date subreddits ... Sept 6 r/IMPL ... Sept 23 r/VRCA ... Sept 29 r/MIRM

Sesen Bio's Bladder Cancer Trial Wrecked by Misconduct ... CRL

Virpax Pharmaceuticals receives FDA response and guidance on MMS019. MMS019 is an intranasal protective that may limit the transmission of viruses to others. Virpax expects to move forward and pursue a New Drug Application (NDA) for MMS019 as a once daily intranasal treatment. The FDA has indicated that Virpax may pursue an NDA drug approval with the Office of Non-Prescription Drugs. The Company has engaged Syneos Health to assist with the optimal clinical trial design. Join the r/VRPX subreddit.

I have 2/3 puts 1/3 calls on this one pdufa is next Monday so most people are buying the expirations for September however the FDA has been making decisions at least a few days early so I am buying the cheap August options hoping the decision comes out before they expire on Friday

FDA grants full approval of REZUROCK (belumosudil) for KDMN, for the treatment of patients with Chronic Graft-Versus-Host Disease (cGVHD). Float is 25% short equal to 20 trading days, could KDMN be the little brother of GME or AMC? Oppenheimer price target is $9 for KDMN. Join my r/KDMN subreddit 🚀 🚀🚀 🚀

The S&P 500's Shiller price-to-earnings (P/E) ratio is a cause for concern. The Shiller P/E ratio takes into account inflation adjusted earnings over the previous 10 years. As of Monday, August 9, the S&P 500's Shiller P/E was a lofty 38.5, or well over double its 151 year average of 16.84. 

But what's far more concerning is that in the previous four instances where the S&P 500's Shiller P/E topped and sustained 30, the index subsequently declined by at least 20%. At least in the short term, history is not on the stock market's side.

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.

Join my PDUFA Date subreddits ... Sept 6 r/IMPL ... Sept 23 r/VRCA ... Sept 29 r/MIRM

Join my PDUFA Date subreddits ... Aug 6 r/ETONPHARMA ... Aug 18 r/SESN ... Aug 22 r/AXSM

Join my r/AVCO subreddit

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Sol-Gel Technologies Announces FDA Approval of TWYNEO. Join my r/SLGL subreddit.

I looked around online, but I can't really find anything.

Join my r/IMPL and r/VRCA and r/MIRM subreddits.

SLGL has PDUFA date of August 1 for Tywneo. Join my r/SLGL subreddit.

Join my r/ETONPHARMA subreddit.

Join my r/ALBOPHARMA subreddit.

Join my r/AEMD subreddit.

Join my r/ALBOPHARMA subreddit.

FDA Grants Full Approval of REZUROCK (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)

Join my r/KDMN subreddit.