BPC December 31 update

Portola PTLA +14% on approval for Prior Approval Supplement for Andexxa

Price and Volume Movers

News flow for the final trading day of 2018 was light, as e expected. Expect news flow to pick up later in the week as we approach next week’s J.P. Morgan Healthcare Conference, regarded as the most significant investor healthcare conference of the year.

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Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) announced that the FDA has approved its Prior Approval Supplement (PAS) for Andexxa, allowing for broad commercial launch in the United States. Andexxa was initially approved on May 3, 2018. Shares closed up 14% to $19.52.

Heron Therapeutics, Inc. (Nasdaq: HRTX) announced that the FDA has accepted the New Drug Application (NDA) of HTX-011 for the management of postoperative pain under priority review. The PDUFA date is April 30, 2019.

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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:

Conatus Pharmaceuticals Inc. (CNAT): $1.73; +30%.

Axsome Therapeutics, Inc. (AXSM): $2.82; +29%.

Lipocine Inc. (LPCN): $1.30; +22%.

vTv Therapeutics Inc. (VTVT): $2.65; +17%.

Marker Therapeutics, Inc. (MRKR): $5.55; +16%.

DECLINERS:

Vaxart, Inc. (VXRT): $1.88; -16%.

Constellation Pharmaceuticals, Inc. (CNST): $4.01; -12%.

Diffusion Pharmaceuticals Inc. (DFFN): $1.99; -12%.

Novus Therapeutics, Inc. (NVUS): $1.60; -11%.

OptiNose, Inc. (OPTN): $6.20; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADMP – Adamis Pharmaceuticals Corporation
Higher Dose Naloxone Injection
Opioid overdose

PDUFA PDUFA date October 31, 2019.
$109.2 million

ADMP – Adamis Pharmaceuticals Corporation
APC-8000 (sublingual tadalafil)
Erectile dysfunction

NDA Filing Refusal to file letter received February 26, 2019.
$109.2 million

HRTX – Heron Therapeutics Inc.
HTX-011
Post operative pain

PDUFA priority review PDUFA date under priority review April 30, 2019.
$1.9 billion

PTLA – Portola Pharmaceuticals Inc.
Andexxa
Factor Xa inhibitor reversal agent

Approved Prior Approval Supplement (PAS) FDA Approval announced December 31, 2018.
$2.2 billion