BioShares Biotechnology Clinical Trials (BBC):  $19.79, -$0.30, -31.9% YTD

BioShares Biotechnology Products (BBP): $30.37, -$0.17, -1.5% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures struggled for direction ahead of a keynote speech by U.S. Federal Reserve Chair Janet Yellen. Investors also keenly awaited growth figures, U-Mich sentiment data, and corporate
profits for the second quarter to help gauge strength of the economy, vis-à-vis an interest rate hike by the Fed. European markets were lower. Asian markets closed mixed, with Japanese shares touching three-week lows. The dollar broadly edged lower, while
safe-haven gold held steady. Oil dipped after the Saudi energy minister Khalid Al-Falih tempered expectations of strong market intervention by producers during talks next month.

 

 

MARKET HIGHLIGHTS

 

BIOPHYTIS announced the enrollment of the first volunteers in the pharmacokinetics study SARA-PK. The first step of the study will to compare pharmacokinetics and safety of Sarconeos, after escalating
single dose administrations in elder and young healthy volunteers.

 

OPKO Health announced that at a Special Shareholder Meeting held on August 25, 2016 shareholders of
Transition Therapeutics holding approximately 93% of the outstanding common shares, voted to approve the previously announced agreement under which OPKO Health will acquire Transition Therapeutics. The acquisition is subject to final approval of the
Ontario Superior Court Justice. The Court hearing for the final order is scheduled to take place on August 29, 2016, and the acquisition is expected to close on September 1, 2016.

 

Can-Fite BioPharma reported financial results for the six months ended June 30, 2016. Can-Fite’s net loss for the six months ended June 30, 2016 was U.S. $2.95 million compared with a net loss
of U.S. $2.15 million for the same period in 2015. The increase in net loss for the first half of 2016 was primarily attributable to an increase in research and development expenses offset by an increase in financial income, net.  As of June 30, 2016, Can-Fite
had cash and cash equivalents of U.S. $12.07 million as compared to U.S. $17.17 million at December 31, 2015.

 

TG Therapeutics announced that the FDA has granted orphan drug designation for TG-1101 (ublituximab) the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, for the treatment of patients
with neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD). There are currently no FDA approved treatments for NMO or NMOSD.

 

Hemispherx Biopharma announced that it has received approval of its NDA from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial sale of rintatolimod
(U.S. tradename: Ampligen) in the Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).  The product will be marketed by GP Pharm, Hemispherx’s commercial partner in Latin America. 

 

Spotlight Innovation has entered into a Sponsored Research Agreement with Florida State University (FSU) to support research directed by FSU Prof. Hengli Tang aimed at developing safe and effective
drugs to treat patients infected with Zika virus.

 

Cempra announced the publication of its pivotal Phase III study, SOLITAIRE-IV, comparing the efficacy and safety of intravenous-to-oral solithromycin to intravenous-to-oral moxifloxacin for the
treatment of community-acquired bacterial pneumonia (CABP) in Clinical Infectious Diseases.

 

PharmAthene announced that after discussions with the Biomedical Advanced Research and Development Authority (BARDA) the Company has withdrawn the protest filed on August 5, 2016.

 

Portola Pharmaceuticals announced that interim results from its ongoing Phase IIIb/IV ANNEXA(TM)-4 trial of AndexXa (andexanet alfa), a Factor Xa inhibitor antidote, will be featured in an oral
Late-Breaking Science Hot Line session at the European Society of Cardiology (ESC) 2016 Congress, which will take place from August 27–31 in Rome. The data also will be featured in the ESC’s Hot Line — Preventive Strategies II press conference on Tuesday,
August 30, at 9:00 a.m. CEST.

 

BirchBioMed announced that a unique and ground-breaking topical treatment developed by University of British Columbia (UBC) researchers to prevent scarring has completed a Health Canada approved
Phase I trial.

 

Zomedica Pharmaceuticals announced the closing of the first tranche of its recently announced non-brokered private placement offering of up to 10,000,000 common shares (each a “Common Share”)
at a price of C$1.50 per Common Share.

 

M Pharmaceutical announced that it has undertaken a non-brokered private placement of up to $2,000,000 in convertible debentures. The debentures will bear interest of 10% per annum for a term
of 3 years, and be convertible into common shares of the Company at a conversion price of $0.075 per share. Interest on the debentures will be pre-paid by the issuance of units at a price of $0.08 per unit, each unit consisting of one common share and one
common share purchase warrant entitling the holder to acquire one additional common share for $0.08 for a period of two years.  Proceeds will be used to arrange manufacturing and testing of the Companies reformulated orlistat drug, starting the regulatory
process around the same, and for general administrative expenses. The Company may pay finders fees to qualified finders in relation to this placement.

 

 

ANALYST RECOMMENDATIONS

 

Guggenheim analyst William Tanner added Novavax to the “Best Ideas List” with a “buy” rating and $25 price target, citing the release of top-line data from the Phase III Resolve trial
of the RSV vaccine in older adults.

 

Following Vanda Pharmaceuticals’
announcement the U.S. District Court for Delaware ruled in favor of Vanda in the Fanapt ANDA litigation,
JMP analyst Jason Butler increased his price target to $22 from $18; Brean
analyst Difei Yang increased her price target to $24 from $20.