BPC January 05 update

Neurocrine (NBIX) Adcom cancelled; OncoGenex (OGXI) reverse merger - shares up 65%; Stemline (STML) up 30% following trial update

Price and Volume Movers

OncoGenex Pharmaceuticals Inc (NASDAQ:OGXI) shares have surged in the after-hours session and are currently trading up 65% to $0.96. The company announced a reverse merger with  Achieve Life Science, Inc. Achieve shareholders will own 75% of the combined company, while OncoGenex holders will own the remaining 25%. Following completion of the merger, expected to close by mid-2017, OncoGenex Pharmaceuticals, Inc. will be renamed Achieve Life Sciences, Inc.

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced that the FDA has cancelled the Psychopharmacologic Drugs Advisory Committee meeting for INGREZZA for the treatment of tardive dyskinesia, originally scheduled for February 16, 2017. The PDUFA date under priority review of April 11, 2017 remains unchanged. Shares of the company are currently up 7% to $44.15 in the after-hours session.

Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS) shares closed up 21% to $1.76 on 38x average volume following its announcement of a partnership to work with French pharmaceutical company, Servier. Pieris will receive $31.3 upfront and will be eligible for up to $338m in milestone payments for PRS-332, currently in preclinical development. Pieris will also be eligible for up to $201m each for three other programs.

Stemline Therapeutics Inc (NASDAQ:STML) shares have risen 30% to $11.35 in the after-hours session following an update regarding its ongoing Phase 2 trial of SL-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). Enrollment of the trial is due to completed in 1Q 2017 with a Biologics License Application (BLA) filing due in 2H 2017. The company noted that the FDA has agreed that an additional small cohort in its current Phase 2 trial will be sufficient for a BLA submission. The company received Breakthrough Therapy Designation for SL-401 in August 2016, allowing to expedite the development and review of SL-401.

Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) announced that it has formed a license agreement with  CSL Behring Recombinant Facility AG for the development of its preclinical candidate, M230. Momenta will receive an upfront payment of $50m, with up to $550m to be received pending the company meeting certain clinical, regulatory and sales milestones. Shares of the company have risen 8% to $15.50 in the after-hours session.

Shares of GenVec Inc (NASDAQ:GNVC) rose 19% to $4.02 on 7x average volume. The company announced today that it has entered into an option agreement with Washington University in St. Louis to license intellectual property and technology related to gene editing and pulmonary endothelial cell targeting.

Otonomy, Inc. (Nasdaq:OTIC) shares rose 11% to $17.95 following news that it met the primary endpoint in its Phase 3 trial of OTIPRIO in patients with acute otitis externa (AOE), also known as swimmer's ear. The company expects to file a supplemental New Drug Application (sNDA) with in 1H 2017.

CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) announced that the full clinical hold on pacritinib trials has now been removed. The drug, which has completed two Phase 3 trials in patients with primary myelofibrosis will undergo a further trial at a lower dose. Shares of the company closed up 12% to $4.46 on 15x average volume.

The Medicines Company (NASDAQ:MDCO) shares are currently trading up 10% to $39.00 in the after-hours session following news that Regenron (NASDAQ:REGN) has been ordered to remove its cholestrol drug, Praluent, following a patent lawsuit with Amgen's (NASDAQ:AMGN) Repatha. The Medicines Company is also developing a PCSK9 inhibitor cholesterol drug which will be moving into Phase 3 development.

Other major price movers (+10%):


EnteroMedics Inc (NASDAQ:ETRM): $3.97; +90%; 62x average volume.

Cerecor Inc (NASDAQ:CERC): $1.17; +32%; 4x average volume.

Prana Biotechnology Limited (NASDAQ:PRAN): $2.54; +33%; 38x average volume.

Fibrocell Science Inc (NASDAQ:FCSC): $0.849; +25%; 22x average volume.

Halozyme Therapeutics, Inc. (NASDAQ:HALO): $12.61; +18%; 14x average volume.

Vital Therapies Inc (NASDAQ:VTL): $5.30; +12%.

Orexigen Therapeutics, Inc.(NASDAQ:OREX): $3.78; +11%; 9x average volume.

Zosano Pharma Corp (NASDAQ:ZSAN): +0.97; +11%.

Sorrento Therapeutics Inc (NASDAQ:SRNE): $6.00; +10%;



AEterna Zentaris Inc. (NASDAQ:AEZS): $3.00; -18%; 10x 9x average volume.

Ardelyx Inc (NASDAQ:ARDX): $12.95; 10%; 6x 9x average volume.


Full pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancer

Phase 2 Phase 2 enrollment completed - noted March 23, 2017. Update on patients enrolled in Stages 1 and 2 at EHA June 23, 2017 with top-line data from Stage 3 due 2H 2017.

Tardive dyskinesia

Approved Approved April 11, 2017.

Acute otitis externa

Phase 3 Phase 3 trial met primary endpoint - January 5, 2017. PDUFA date for sNDA filing March 2, 2018.

Pacritinib - PAC203

Phase 3 PERSIST-2 data released August 2016. One of two primary endpoints met. Additional trial commenced enrollment - noted August 1, 2017.

Pancreatic cancer

Phase 3 Phase 3 dosing initiated March 2016. Phase 2 data released January 5, 2017. Oral presentation of Phase 2 data at ASCO June 4, 2017 showed ORR of 45%.

LPCN 1021
Men with low testosterone (Low T)

PDUFA CRL issued June 2016. NDA resubmitted with new PDUFA February 8, 2017.

Refractory status epilepticus (RSE)

Phase 2 Phase 2 trial to commence in 2H 2017.

Postpartum depression

Phase 2 Phase 2 data due in 2H 2017.

CDKL5 disorder

Phase 2 Phase 2 preliminary CDKL5 cohort data released January 23, 2017. Top-line data released September 11, 2017.

IgA nephropathy

Phase 2 Phase 2 preliminary data released January 5, 2017. Enrollment of second cohort to be completed in 2017 with data due in 2018.

Plantar fasciitis

Phase 2 Phase 2 data due 4Q 2017.

RT002 - SAKURA 1
Moderate to severe glabellar (frown) lines

Phase 3 Phase 3 completion of enrollment announced March 8, 2017. Data due 4Q 2017.

Cervical dystonia

Phase 2 Phase 2 additional data released May 18, 2017 with additional data released June 5, 2017.

C. difficile Infection

Phase 2b Phase 2b topline data released January 5, 2017. Primary endpoint met. Phase 3 trial to be initiated 1H 2018.


Phase 3 Phase 3 trial data due released February 13, 2017 - primary endpoints met.