Achaogen (AKAO) achieved another milestone this week as it completed the enrollment of 609 patients in its Phase 3 clinical trial, EPIC, evaluating lead product candidate plazomicin for the treatment of patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP) (kidney infection). The primary objective is to demonstrate non-inferiority to meropenem (within a 15% margin) as determined by the difference in composite microbiological eradication and clinical cure rate in the intent-to-treat population at both Day 5 and test-of-cure visits.

AKAO has been struggling in recent weeks but the stock remains in my conviction buy list. I currently have a price target of $23 on the stock and believe we could see movement ahead of the major catalyst early next year.

Kamada Files BLA for Post-Exposure Rabies Treatment- Kamada (KMDA) and its collaboration partner Kedrion S.p.A. announced the filing of a Biologics License Application (BLA) in the U.S. seeking approval of Kamada's post-exposure rabies treatment human anti-rabies immune globulin (IgG). A decision is expected in mid-2017. If approved, Kedrion expects to commence commercial launch in mid-2017.

Roche Announces Results from Phase 3 Clinical Trial OAK- Swiss drug maker Roche (RHHBY) announced that results from a Phase 3 trial, OAK, showed that its TECENTRIQ (atezolizumab) statistically significantly improved overall survival (OS) compared to docetaxel chemotherapy in patients with locally advanced/metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemo. The data will be presented at an upcoming medical conference. OAK is one of eight ongoing Phase 3 studies assessing TECENTRIQ in lung cancer. It has Breakthrough Therapy status in the U.S. for the treatment of PD-1-positive NSCLC whose disease has progressed after platinum-based chemo (and after targeted therapy for those with EGFR-positive or ALK-positive tumors).

AstraZeneca Announces Results From A Five-Year Study of SYMBICORT- AstraZeneca (AZN) announced results from a five-year safety study comparing its asthma med SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol to budesonide (an inhaled corticosteroid) alone showed a comparable risk of serious asthma-related events and lower risk of asthma exacerbations. Specifically, the trial showed statistical non-inferiority (7.3% higher risk) of SYMBICORT to budesonide in the time to first asthma-related event (hazard ratio: 1.073) and a 16.5% lower risk (hazard ratio: 0.835) of asthma exacerbations versus budesonide.

GenVec Says Novartis Committed to Developing CGF166- GenVec (GNVC) disclosed in a regulatory filing that its licensee Novartis (NVS) remains fully committed to developing gene therapy candidate CGF166, GNVC’s lead product candidate, for the treatment of severe-to-profound hearing loss. Earlier this week, Novartis announced that it was dissolving its internal cell and gene therapy unit as a result of the evolution of its internal organizational design. Novartis had licensed CGF166 back in January 2010.

Amgen’s Collaboration Partner Servier Exercises Option to Commercialize Omecamtiv Mecarbil- Amgen (AMGN) announced that its cardiovascular collaborator Servier exercised its option to commercialize omecamtiv mecarbil for the treatment of chronic heart failure in Europe and the Commonwealth of Independent States, including Russia. In addition, the Phase 3 development program will move forward in collaboration with omecamtiv mecarbil discoverer Cytokinetics (CYTK).

Amgen also announced that it has obtained global development and commercialization rights from Boehringer Ingelheim for BI 836908 (AMG 420), a bispecific T cell engager (BiTE) to a potential target for multiple myeloma called B-cell maturation antigen (BCMA). Phase 1-stage BI 836908 was originally licensed to Boehringer by Micromet before it was acquired by Amgen in 2012. Financial terms of the deal have not been disclosed.

OncoMed Completes Enrollment in Mid-Stage Study of Demcizumab- OncoMed Pharmaceuticals (OMED) announced that it has completed the enrollment of 207 subjects in its Phase 2 clinical trial, YOSEMITE, evaluating demcizumab as first-line treatment of metastatic pancreatic cancer. Top-line data from the study is expected to be announced in the first half of next year. The study will compare the safety and efficacy of demcizumab, in combination with standard-of-care (SOC) therapy to SOC alone. The primary endpoint is progression-free survival. Secondary endpoints include overall survival, response rate and biomarker analyses.

Array BioPharma (ARRY) announced that the FDA has accepted for review its New Drug Application (NDA) seeking approval of lead product candidate binimetinib for the treatment of advanced NRAS mutation-positive melanoma, a subgroup of melanoma associated with a poor prognosis. The PDUFA date has been set on June 30th, 2017.

Amgen announced that the FDA has approved its supplemental Biologics License Application (sBLA) to include new data supporting the use of BLINCYTO (blinatumomab) in pediatric patients with Philadelphia chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL). The approval was granted under the agency's accelerated review process.

NeuroMetrix (NURO) announced that China’s State Intellectual Property Office issued a patent covering the core technology in its DPNCheck device, a point-of-care test for peripheral neuropathies. The patent claims cover the novel integrated design of the product in addition to automation algorithms and consumable biosensors.

The USPTO’s Patent Trial and Appeal Board (PTAB) has, again, ruled in favor of Mylan (MYL) in its inter partes review of patents covering Teva Pharmaceutical Industries' (TEVA) Copaxone (glatiramer acetate injection) 40mg/mL. It found that U.S. Patent No. 8,969,302 is unpatentable.

No deals and collaborations to report.

AmpliPhi Biosciences (APHB) has filed a Form S-1 with the U.S. Securities Exchange and Commission (SEC).

No IPOs to report.

Intec Pharma (NTEC) reported a loss of $0.18 per share in its second quarter. The company ended the quarter with $14.5 million in cash and cash equivalents on its balance sheet.

Forward Pharma (FWP) reported a loss of $0.27 per share in its second quarter, missing consensus forecast by a penny. The company ended the quarter with $161.6 million in cash and cash equivalents on its balance sheet.

Aytu BioScience (AYTU) reported a loss of $5.09 per share in its fourth quarter. The company reported revenue of $0.94 million, up 422.2% on a year-over-year basis.

Cellect Biotechnology (APOP) reported a loss of $0.01 per share in its second quarter. The company ended the quarter with cash and cash equivalents of $1.4 million.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
AbbVie (ABBV) Raymond James Financial Initiation Outperform



ACADIA Pharmaceuticals (ACAD) Cowen and Company Reiterate Outperform



Alcobra (ADHD) Goldman Sachs Group Reiterate Buy N/A N/A
Audentes Therapeutics (BOLD) Wedbush Reiterate Outperform


CoLucid Pharmaceuticals (CLCD) Piper Jaffray Cos. Reiterate Overweight


Cynapsus Therapeutics (CYNA) Janney Montgomery Scott Downgrade From Buy to Neutral N/A N/A
Cytokinetics (CYTK) Needham & Company LLC Price Target Set Buy


Relypsa (RLYP) Wedbush Downgrade From Outperform to Neutral N/A N/A
Relypsa (RLYP) BTIG Research Downgrade From Buy to Neutral N/A N/A

No insider buys to report.

No insider sells to report.

Novo Nordisk (NVO) announced that its President and CEO Lars Rebien Sorensen will retire at the end of 2016. EVP and head of Corporate Development Lars Fruergaard Jorgensen will succeed him effective January 1, 2017. EVP and head of Region China, Pacific & Marketing Jakob Riis has been appointed EVP and head of North America Operations replacing Jesper Hoiland. EVP and head of International Operations Maziar Mike Doustdar expands his responsibilities to all ex-U.S. territories. The business consists of five regions: Europe; Latin America; Africa, Asia, Middle East & Oceania; Japan & Korea and Region China. EVP and head of Europe Jerzy Gruhn demoted to SVP and head of Europe reporting to Mr. Doustdar.

NYSE- InVitae (NVTA) shares were among the major movers on the NYSE. The stock closed 6.24% higher.

NASDAQ- Cynapsus Therapeutics (CYNA) shares were among the major gainers on the NASDAQ. The stock closed 116.23% higher. Aquinox Pharmaceuticals (AQXP) shares ended the day 15.25% higher. Karyopharm Therapeutics (KPTI) ended the day 11.56% higher. Cytokinetics (CYTK) shares were among the major losers on the NASDAQ. The stock closed 13.01% lower. Arcadia Biosciences (RKDA) shares ended the day 7.37% lower. WAVE Life Sciences (WVE) ended the day 6.66% lower.

NYSEMKT- Mast Therapeutics (MSTX) shares were among the major movers on the NYSEMKT. The stock closed 18.28% higher.

OTC- Amarantus Bioscience Holdings (AMBS) shares were among the major movers on the OTC market. The stock closed 6.22% higher.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Abbott Laboratories (ABT)




AbbVie (ABBV)




Abeona Therapeutics (ABEO)








ACADIA Pharmaceuticals (ACAD)




Acasti Pharma (ACST)




Acceleron Pharma (XLRN)




AcelRx Pharmaceuticals (ACRX)




Achaogen (AKAO)




Achillion Pharmaceuticals (ACHN)