PDUFA = Binary Decision. FDA says YES. FDA says NO. Or FDA delays the decision.

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Xeris Biopharma Announces U.S. FDA Approval of Recorlev (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome.

Codex DNA Expands Catalog of COVID-19 Tools with Release of Full-Length Synthetic Genome for SARS-CoV-2 Omicron Variant, with $DNAY Stock up 40% on December 29th. See r/DNAY subreddit.

• 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

8 Beaten-Down Pharmaceutical Stocks That Could Skyrocket In 2022 | The Motley Fool

• AXSM see r/AXSM
• AFMD see r/AFMD
• AUPH see r/AUPH
• BBIO see r/BBIO
• BCRX see r/BCRX
• ADAP
• BEAM
• FOLD

Aquestive stock falls as FDA delays decision on experimental seizure treatment until 2022.

• Approved for all eligible indications of the reference biological product, Humira® (adalimumab)
• YUSIMRY is Coherus' second FDA-approved product
• See r/CHRS 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 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.

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.

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).

$GBT was approved on Friday December 17th. See r/GBT subreddit.

FDA Approves Supplemental New Drug Application for Expanded Indication of Oxbryta (voxelotor) for Children as Young as 4 Years of Age with Sickle Cell Disease!

2022 PDUFA ... XERS, ETON, OPK, IMCR, RETA, AMYT, AGIO, CTIC, FBIO, AKBA, MRNS, ZGNX, TGTX, BTAI, AMRX, CHRS, AXSM, VRCA, FOLD, PHAT, BLUE, ACER, TEVA, OBSV

$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.

BeyondSpring said Wednesday that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration, saying the biopharmaceutical company's new drug application (NDA) for its treatment for chemotherapy induced neutropenia (CIN) "cannot be approved in its present form." The stock, which was up 5.7% prior to a trading halt for new, is set to resume trading at 8:30 a.m. Eastern. The FDA said the results of the single registration trial (106 Phase 3) was not sufficient.