BPC December 23 update

Merry Xmas as FDA awards priority review for Portola (PTLA) NDA – shares soar 34%

Price and Volume Movers

Portola Pharmaceuticals Inc (NASDAQ:PTLA) delivered an early Christmas present to investors when it announced during market hours that the FDA has accepted its New Drug Application (NDA) of betrixaban for the treatment of extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. Furthermore, the FDA assigned a priority review shortening the standard review period from 10 months to six months. The PDUFA date is June 24, 2017. Shares soared to close up 34% to $25.06 on 10x average volume.

Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) shares rose 25% to $2.00 on 14x average volume. The company announced after hours a reverse merger with PLx Pharma Inc. Dipexium stockholders will own 23.25% of the new company that will be renamed PLx Pharma Inc.

Meanwhile, Tokai Pharmaceuticals Inc (NASDAQ:TKAI), which announced its reverse merger yesterday saw its shares retrace most of Thursday’s gains to close down 12% to $1.07 on 2x average volume.

Strongbridge Biopharma plc, (Nasdaq:SBBP) shares dropped by over 30% to $2.50 on 85x average volume following its announcement that it will issue 14m shares to at a price of $2.50 per share for proceeds of $35m as well as warrants to purchase 7m shares. The company also noted that recruitment in its Phase 3 SONICS trial of COR-003 (levoketoconazole) for the treatment of endogenous Cushing’s syndrome has been slower than expected. The company now expects that the trial will be fully enrolled in 2Q 2017, with top-line data due in 1Q 2018.

Synergy Pharmaceuticals Inc (NASDAQ:SGYP) shares surged to close up 22% to $5.77 on 8x average volume. The company announced yesterday that its second of two pivotal Phase 3 clinical trials of plecanatide, in patients with irritable bowel syndrome with constipation (IBS-C), met its primary endpoint. The company is due to file a supplemental New Drug Application (sNDA) in 1Q 2017, pending approval of its NDA of Plecanatide in patients with Chronic idiopathic constipation (CIC). The PDUFA data is January 29, 2017.

Neothetics, Inc. (NASDAQ:NEOT) announced the initiation of its Phase 2 trial of LIPO-202 for the reduction of submental subcutaneous fat. Data are due late 2Q 2017. The company had already guided that its Phase 2 trial would be initiated this month but traders still bid up the stock to close up 20% to $1.15 on 14x average volume.

Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced after hours that the FDA has approved SPINRAZATM (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. Shares are currently up 7% in the after hours session to $57.10. 

Other major price movers (+10%):

ADVANCERS:                                                                     

Moleculin Biotech Inc (NASDAQ:MBRX): $1.97; +30%; 2x average volume.

Conatus Pharmaceuticals Inc (NASDAQ:CNAT): $4.43; +18%; 3x average volume.

Acasti Pharma Inc (NASDAQ:ACST): $1.33; +15%; 32x average volume.

Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR): $1.59; +16%; 1.5x average volume.

Flexion Therapeutics Inc (NASDAQ:FLXN): $20.71; +12%.

Apricus Biosciences Inc (NASDAQ:APRI): $1.32; +11%.

Revance Therapeutics Inc (NASDAQ:RVNC): $21.70; +11%.

DECLINERS:

Opexa Therapeutics Inc (NASDAQ:OPXA): $0.97; -12%


A special Merry Christmas to all readers of BioPharmCatalyst.

The Weekly Watch List will be out as per usual over the holiday weekend, while the daily updates will be back following the break on Tuesday December 27.

Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

PTLA
Betrixaban (The APEX Study)
Venous thromboembolism (VTE) Prevention

PDUFA priority review PDUFA date under priority review June 24, 2017. Phase 3 data released March 2016 did not meet primary endpoint.

AERI
Rhopressa
Glaucoma

PDUFA PDUFA date February 28, 2018. Advisory Committee planned.

NEOT
LIPO-202
Reduction of localized fat deposits under the chin (submental fat)

Phase 2 Phase 3 endpoints not met December 2015. Phase 2 trial initiated December 23, 2016 with data due June 2017.

IONS
SPINRAZA - Nusinersen
Spinal muscular atrophy (SMA)

Approved Approved December 23, 2016.

SBBP
COR-003 (levoketoconazole) - LOGICS
Endogenous Cushing’s syndrome

Phase 3 Phase 3 enrollment from second trial to begin mid-2017 with top-line data expected in 3Q 2018.

SBBP
COR-003 (levoketoconazole) - SONICS
Endogenous Cushing’s syndrome

Phase 3 Phase 3 top-line data due 1Q 2018.