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Msg  33802 of 34026  at  8/1/2020 11:28:13 AM  by

Cougar3


Small/mid cap Biotech stocks with PDUFA dates slated for August/September


 

Small/mid cap Biotech stocks with PDUFA dates slated for August/September:

Drug Stage Catalyst Market Cap

AQST – Aquestive Therapeutics Inc.

Libervant - AQST-203

Epileptic seizures

PDUFA PDUFA date September 27, 2020.
$176.6 million

BHC – Bausch Health Companies Inc., ETON – Eton Pharmaceuticals Inc.

EM-100

Allergic conjunctivitis

PDUFA CRL issued July 12, 2019. NDA resubmitted with new PDUFA date of August 10, 2020.
$6.5 billion

BMRN – BioMarin Pharmaceutical Inc.

Valoctocogene roxaparvovec (BMN 270)

Hemophilia A

PDUFA priority review PDUFA date under priority review August 21, 2020.
$21.7 billion

DBVT – DBV Technologies S.A.

Viaskin Peanut

Peanut allergy - ages 4 to 11 years

PDUFA PDUFA date August 5, 2020 (likely to be extended). Advisory Committee meeting slated for May 15, 2020 has been cancelled.
$451.1 million

EGRX – Eagle Pharmaceuticals Inc.

Ryanodex

Exertional heat stroke (EHS)

PDUFA PDUFA date July 8, 2020 postponed until August 8, 2020 by FDA due to reallocation of resources as a result of COVID19.
$634.9 million

FENC – Fennec Pharmaceuticals Inc.

Pedmark (sodium thiosulfate)

Cisplatin-Induced Hearing Loss

PDUFA priority review PDUFA date under priority review August 10, 2020.
$214.1 million

GLPG – Galapagos NV, GILD – Gilead Sciences Inc.

Filgotinib

Rheumatoid arthritis (RA)

PDUFA NDA filing announced December 19, 2019. PDUFA estimate under priority review August 19, 2020.
$12 billion

LPCN – Lipocine Inc.

TLANDO - LPCN 1021

Men with low testosterone (Low T)

PDUFA PDUFA date August 28, 2020
$73.7 million

MESO – Mesoblast Limited

Remestemcel-L (MSC-100-IV)

acute graft versus host disease (aGVHD) in children

PDUFA priority review PDUFA date under priority review September 30, 2020. FDA Oncologic Drugs Advisory Committee meeting scheduled for August 13, 2020.
$1.6 billion

MNK – Mallinckrodt plc

Terlipressin

Hepatorenal syndrome (HRS) Type 1

PDUFA PDUFA date September 12, 2020. Advisory Committee Meeting July 15, 2020 voted 8-7 that the benefits outweigh the risks.
$188.3 million

PTCT – PTC Therapeutics Inc., RHHBY – Roche Holding Ltd ADR (Sponsored)

Risdiplam (RG7916)

Spinal Muscular Atrophy (SMA) Type 1

PDUFA priority review PDUFA date extended to August 24, 2020.
$3 billion

TCDA – Tricida Inc.

TRC 101

Chronic kidney disease

PDUFA PDUFA date August 22, 2020. Company noted July 15, 2020 that the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments.
$668.4 million

TRVN – Trevena Inc.

Oliceridine (TRV130)

Moderate to severe acute pain

PDUFAPDUFA date August 7, 2020.


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