BPC April 05 update

Gilead GILD and ​Celgene CELG file regulatory applications; Nano-cap ​Vital VTL +146% on reverse merger

Price and Volume Movers

Gilead Sciences, Inc. (NASDAQ: GILD) announced it has submitted a supplemental New Drug Application (sNDA) to the FDA for Descovy for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV. A Priority Review voucher was submitted with the filing, leading to an anticipated review time of six months, which would result in a PDUFA date around October 4, 2019.

Vital Therapies, Inc. (Nasdaq: VTL) shares closed up 146% to $0.51 following confirmation Thursday of its reverse merger and name change to Immunic, Inc. with shares trading under the ticker “IMUX” from mid-April.

Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) announced the submission of their Biologics License Application (BLA) for luspatercept, for the treatment of adults with myelodysplastic syndromes (MDS)-associated anemia.

Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) shares closed down 16% to $6.01 following news noted after hours Thursday that it is discontinuing development of MM-310, for the treatment of solid tumors.

Syros Pharmaceuticals (NASDAQ: SYRS) shares closed down 23% to $7.48 following news of a public offering of common and preferred stock together with warrants, also announced after hours Thursday.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume

ADVANCERS:

CEL-SCI Corporation (CVM): $5.50; +21%.

AVEO Pharmaceuticals, Inc. (AVEO): $1.08; +16%.

Oramed Pharmaceuticals Inc. (ORMP): $4.18; +16%.

Kiniksa Pharmaceuticals, Ltd. (KNSA): $20.39’ +15%.

Zynerba Pharmaceuticals, Inc. (ZYNE): $8.73; +13%.

DECLINERS:

Outlook Therapeutics, Inc. (OTLK): $6.11; -20%.

Daré Bioscience, Inc. (DARE): $1.31; -13%.

Diffusion Pharmaceuticals Inc. (DFFN): $3.68; -11%.

TRACON Pharmaceuticals, Inc. (TCON): $1.39; -7%.

Avadel Pharmaceuticals plc (AVDL): $1.24; -6%.


Pipeline Database Updates

Drug Stage Catalyst Market Cap

GILD – Gilead Sciences Inc.
F/TAF (Descovy)
Pre-exposure prophylaxis

PDUFA priority review sNDA filed April 5, 2019. Likely PDUFA date under priority review of October 4, 2019.
$85.6 billion

TROV – TrovaGene Inc.
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)

Phase 1/2 Phase 1/2 presentation at ESMO September 27, 2019.
$11.3 million

URGN – UroGen Pharma Ltd.
MitoGel - UGN-101
Urothelial Carcinoma

Phase 3 Initiation of rolling NDA announced December 17, 2018. Phase 3 data May 5, 2019 noted 59% CR. 6-month CR durability 89%. Full Phase 3 data due 2H 2019.
$668.9 million

XLRN – Acceleron Pharma Inc.
Luspatercept
Myelodysplastic syndromes (MDS) cancer

PDUFA PDUFA date April 4, 2020.
$2.2 billion