BioShares Biotechnology Clinical Trials (BBC): $21.01, +$0.57, -27.7% YTD

BioShares Biotechnology Products (BBP): $31.55, +$0.77, +2.4% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures pointed to a higher open, while the dollar was broadly weaker ahead of comments from Federal Reserve Chair Janet Yellen at the central bank’s annual meeting in Jackson Hole
later in the week. On the economic calendar, new home sales for July, Richmond Fed’s business activity index for August and Markit’s manufacturing flash PMI data are expected. Intuit is scheduled to report fourth-quarter results after the closing bell. European
markets were led higher by housebuilder and mining shares. Asian markets edged up, while Japan’s Nikkei closed lower pressured by a weaker yen. Oil slipped below $49 a barrel on over-supply concerns and gold was little changed.

 

 

 

MARKET HIGHLIGHTS

 

Interleukin Genetics, Inc. (ILIU) a life science company focused on the genetics of chronic inflammation, today announced the publication of the article “Influence of Obesity on Periodontitis
Progression is Conditional on IL-1 Inflammatory Genetic Variation” in the Journal of Periodontology (http://www.joponline.org/doi/abs/10.1902/jop.2016.160408). 
The article is the result of a scientific collaboration with key researchers at Boston University and strongly supports the value of Interleukin-1 (IL-1) genetics in amplifying the negative impact of obesity.

 

Tokai Pharmaceuticals has determined to discontinue enrollment in its ongoing ARMOR2 expansion clinical trial of galeterone in metastatic castration-resistant prostate cancer (“mCRPC”) patients
with acquired resistance to Xtandi (enzalutamide) and not to proceed at this time with its planned study of galeterone in mCRPC patients who rapidly progress on either enzalutamide or Zytiga (abiraterone acetate). Tokai is continuing to evaluate the unblinded
data from its recently discontinued ARMOR3 clinical trial comparing galeterone to enzalutamide in treatment-naïve mCRPC patients whose prostate tumors express the AR-V7 splice variant, and is assessing potential next steps in its galeterone program.

 

Genmab A/S announced that
Janssen Pharmaceutica NV has submitted a variation to the Marketing Authorization to the EMA seeking to broaden the existing marketing authorization for daratumumab (DARZALEX) to include treatment of adult patients with multiple myeloma who have received
at least one prior therapy. The submission of the application triggers milestone payments totaling $10 million to Genmab from Janssen. The milestone payments were included in Genmab’s financial guidance for 2016 that was published on August 9, 2016. In August
2012, Genmab granted Janssen Biotech an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

 

Mallinckrodt announced that Switzerland’s Federal Department of Home Affairs (FDHA) has approved reimbursement of Extracorporeal Photopheresis (ECP) treatment for patients in Switzerland with
Bronchiolitis Obliterans Syndrome (BOS) following lung transplantation. Mallinckrodt Pharmaceuticals provides ECP therapy through its THERAKOS therapeutic platforms, including the latest generation THERAKOS CELLEXPhotopheresis System.

 

Innovative Targeting Solutions announced a research collaboration with
Janssen Biotech, one of the Janssen Pharmaceutical Companies of
Johnson & Johnson
. Under the agreement, facilitated by Johnson & Johnson Innovation, the collaboration will utilize Innovative Targeting Solutions’ proprietary HuTARG research platform to discover antibody candidates useful for modulating immune responses
in autoimmunity or cancer. The HuTARG protein engineering platform is able to engineer both T-cell receptors and fully human antibodies that bind major histocompatibility complex (MHC)/peptide complexes displaying fragments of intracellular proteins of interest.

 

Provectus Biopharmaceuticals announced that it has received a U.S. patent covering additional aspects of its process for synthesizing halogenated xanthenes, the family of compound to which rose
bengal belongs. The patent covers use of certain halogenated xanthenes in pharmaceutical compositions and as medicaments.

 

CytoDyn announced that the first of 11 HIV-1 patients receiving PRO 140 as a monotherapy in a Phase IIb extension study has reached two years of complete virologic suppression.  Four additional
patients are expected to reach the two-year benchmark in the next three weeks and five more patients are expected to reach this benchmark in approximately two months.

 

Stemline Therapeutics announced that the FDA has granted Breakthrough Therapy Designation to SL-401, a targeted therapy directed to the interleukin-3 receptor (CD123), for the treatment of blastic
plasmacytoid dendritic cell neoplasm (BPDCN).

 

Cempra announced that the EMA has validated the company’s MAA seeking approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired bacterial
pneumonia (CABP, also referred to as community-acquired pneumonia (CAP) in the EU).

 

Teligent announced that its Estonian subsidiary, Teligent OÜ, has received approval of the company’s New Drug Submission (NDS) from Health Canada’s Therapeutic Products Directorate for Gentamicin
Injection USP 40mg/mL in 2mL ampoules. This is the first drug approval for Teligent OÜ and will be distributed by Teligent’s business in Canada.

 

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.

 

Laboratory Corporation of America Holdings announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, or HSR Act, applicable to the acquisition of
Sequenom by LabCorp has expired.

 

Galapagos reported the initiation of the FINCH global Phase III program investigating the efficacy and safety of 100 mg and 200 mg filgotinib once daily, in rheumatoid arthritis (RA) patient
populations, ranging from early stage to biologic-experienced patients. The FINCH program includes three studies with filgotinib. FINCH 1 is a 52-week, randomized, placebo- and adalimumab-controlled study in combination with methotrexate (MTX) in an expected
1,650 patients who have had inadequate response to MTX. The primary endpoint is ACR20([1]) at week 12. The study will also include radiographic assessment at weeks 24 and 52. FINCH 2 is a 24-week, randomized, placebo-controlled study in an expected 423 patients
who are on conventional disease-modifying anti-rheumatic drugs (cDMARD), and have had an inadequate response to biological treatment. The primary endpoint is ACR20 at week 12.  FINCH 3 is a 52-week, randomized study in an expected 1,200 MTX-naïve patients
to study filgotinib in combination with MTX, as well as monotherapy. The primary endpoint is ACR20 at week 24. Radiographic progression will also be assessed.

 

BioStem Technologies announced that it has acquired its first FDA approved branded generic drug (ANDA), Granisol Oral Solution (“Granisol”), an effective medicine for preventing nausea and vomiting
associated with cancer chemotherapy and radiation treatments.

 

Perrigo announced it has received tentative approval from the FDA for the generic version of Suprep (sodium sulfate/potassium sulfate/magnesium sulfate) oral solution. The drug is indicated for
the treatment of cleansing of the colon in preparation for colonoscopy in adults.

 

Sophiris Bio announced the pricing of an underwritten public offering of 6,500,000 of its common shares and related warrants to purchase 4,875,000 of its common shares with an exercise price
of $4.00 per share, offered at a combined price to the public of $4.00 per share and related warrant. The gross proceeds from this offering to Sophiris are expected to be $26.0 million, before deducting underwriting discounts and commissions and other estimated
offering expenses payable by Sophiris. Sophiris has granted the underwriters a 30-day option to purchase up to an aggregate of 975,000 additional common shares and related warrants to purchase 731,250 of its common shares. The offering is expected to close
on or about August 26, 2016, subject to customary closing conditions. Piper Jaffray & Co. is acting as sole book-running manager for the offering.
Maxim Group is acting as co-manager for the offering.

 

CEL-SCI announced it has entered into a definitive agreement with institutional investors to purchase approximately 10 million shares of its common stock and warrants exercisable for up to approximately
5 million shares of its common stock for gross proceeds of $5 million. The warrants will be exercisable six months following the date of issuance, will expire on the fifth anniversary of the initial exercise date and have an exercise price of $0.55 per share.
The closing of the offering is expected to take place on or about August 26, 2016, subject to the satisfaction of customary closing conditions.
Rodman & Renshaw, a unit of H.C. Wainwright & Co. acted as the exclusive placement agent in connection with the offering.

 

 

ANALYST RECOMMENDATIONS

 

Chardan Capital
analyst Keay Nakae initiated coverage of Caladrius Biosciences with a “buy” rating and $6.50 price target, citing Caladrius is an intriguing microcap story that warrants a fresh look by investors.

 

Following Pfizer’s
announcement they will acquire Medivation, Credit Suisse analyst Kennen MacKay downgraded Medivation to “neutral” from “outperform” and increased his price target to $81.50 from $72;
Stifel analyst Thomas Shrader downgraded Medivation to “hold” from “buy”.