BPC December 12 update

Achaogen (AKAO) shares soar 148% on trial success while Ophthotech (OPHT) plunges on failed trial

Price and Volume Movers

Data from two keenly awaited Phase 3 trials released today clearly exemplified the challenges of trading biotech binary events. The perils of biotech investing together with the fruits of success were both realized as Ophthotech and Achaogen released key data of contrasting fortunes.

Achaogen, Inc. (NASDAQ:AKAO) shares soared over 148% on 128x average volume following its announcement of positive data from both its CARE and EPIC Phase 3 trials. In the EPIC trial, plazomicin, met the objective of non-inferiority compared to meropenem in patients with complicated urinary tract infections (cUTI) for the FDA primary endpoint. In its Phase 3 CARE trial, in patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE), a lower rate of mortality or serious complications was observed compared with colistin therapy, one of the few remaining antibiotics for treatment of infections due to CRE. Achaogen plans to submit a New Drug Application (NDA) in 2H 2017.

The company announced after hours that it has commenced an underwritten public offering of up to 5,750,000 shares of its common stock. Shares have fallen 8% in the after-hours session following the news.

Ophthotech Corporation (Nasdaq:OPHT) shares plunged to close down over 86% on 44x average volume following the release of data from its much-awaited Phase 3 trial of Fovista for the treatment of wet age-related macular degeneration (AMD). Patients treated with Fovista and Lucentis performed only marginally better than those on Lucentis. However, the marginal improvement was not sufficient and the primary endpoint was not met in both of its two trials.

Shares of Nektar Therapeutics (NASDAQ:NKTR), which would have been eligible for milestone payments and royalties on sales of Fovista, closed down 5.5%.

Abeona Therapeutics Inc (NASDAQ:ABEO) shares fell over 13% on 5x average volume following a bearish article listed on Seeking Alpha, which among other points noted that:

Stock promoters responsible for numerous biotech wipeouts run this “company,” while ABEO temporarily trades near the highest market capitalization in its 20-year history, while going concern questions abound.

Large cap biotech Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) lost more than $3.5b from its market cap as shares of the company plummeted by over 12% following news that David Hallal resigned as CEO of the company. In addition, its Chief Financial Officer also resigned. The company announced in November that it was conducting an investigation into allegations made by a former employee regarding inconsistencies of personnel engaged in alleged fraudulent sales practices of Soliris. An investigation was undertaken with the company noting today:

The previously announced Audit and Finance Committee investigation is nearing completion. At this point in time, the Audit and Finance Committee’s investigation has not identified any facts that require the Company to update its previously reported historical results. The Company continues to assess these matters from an accounting, disclosure and internal controls perspective, and expects to file the Form 10-Q for the period ended September 30, 2016 in January 2017 or earlier.

Other price movers (+10%):

ADVANCERS:

Apricus Biosciences Inc (NASDAQ:APRI): +57%; 23x average volume.

GTx, Inc. (NASDAQ:GTXI): +13%; 6x average volume.

Neuralstem, Inc. (NASDAQ:CUR): +12%; 3x average volume.

DECLINERS:

Sunshine Heart Inc (NASDAQ:SSH): -24%.

Opexa Therapeutics Inc (NASDAQ:OPXA): -20%.

AC Immune Ltd (NASDAQ:ACIU): -14%; 2x average volume.

Heat Biologics Inc (NASDAQ:HTBX): -13%.

Galena Biopharma Inc (NASDAQ:GALE): -13%.

Moleculin Biotech Inc (NASDAQ:MBRX): -12%.

Dipexium Pharmaceuticals Inc (NASDAQ:DPRX): -11%.


Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

NKTR
Fovista
Wet-AMD

Phase 3 Phase 3 data released December 12, 2016 - primary endpoint not met.

OPHT
Fovista
Wet age-related macular degeneration (Wet-AMD)

Phase 3 Phase 3 data released December 12, 2016 - primary endpoint not met.

FLXN
Zilretta - FX006
Osteoarthritis of the knee

PDUFA PDUFA date October 6, 2017.

AKAO
Plazomicin - EPIC trial
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data released December 12, 2016 - primary endpoint met. NDA filing due 2H 2017.

AKAO
Plazomicin - CARE
Serious bacterial infections due to carbapenem-resistant Enterobacteriaceae (CRE)

NDA Filing Phase 3 data released December 12, 2016 - primary endpoint met. NDA filing due 2H 2017.

RPRX
Proellex
Uterine fibroids (oral treatment)

Phase 2b Phase 2b data released November 14, 2016. Noted January 30, 2017 that an end of Phase 2 meeting scheduled with FDA before the end of April, 2017. However, company noted April 10, 2017 that they meeting was in fact a Type C Guidance Meeting rather than an end of Phase 2 Type B meeting. Partial clinical hold remains in place.

NVCR
Tumor Treating Fields (TTFields) - INNOVATE
Ovarian cancer

Phase 2 Phase 2 data presented December 12, 2016. Further promising PFS data released March 31, 2017.

NVCR
Tumor Treating Fields (TTFields) - PANOVA
Pancreatic cancer

Phase 2 Phase 2 data presented December 12, 2016.

ABUS
ARB-1467
Hepatitis B (HBV)

Phase 2 Phase 2 Cohort 4 data due 4Q 2017.

PPHM
Bavituximab with Radiation and Temozolomide
Glioblastoma - cancer

Phase 1/2 Phase 1/2 trial to be initiated mid-2017.

PPHM
Pembrolizumab and Bavituximab
Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase 2 Phase 2 trial to be initiated mid-2017.

RDHL
RHB-104 CEASE-MS
Multiple sclerosis

Phase 2a Phase 2a data released December 12, 2016.

ATRA
ATA 129
Epstein-Barr virus (EBV-PTLD) after solid organ transplant (SOT)

Phase 3 Phase 3 trial planned for 2017. Trial design confirmed.

ATRA
ATA 129 - MATCH
Epstein-Barr virus (EBV-PTLD) after after hematopoietic cell transplant (HCT)

Phase 3 Phase 3 trial planned for 2017. Trial design confirmed.