BioShares Biotechnology Clinical Trials (BBC): $20.45, -$0.23, -29.6% YTD

BioShares Biotechnology Products (BBP): $30.76, +$0.03, -0.02% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed after minutes of the U.S. Federal Reserve’s latest meeting showed policymakers were divided over whether to raise interest rates soon. Applied Materials
and Gap Inc are expected to report results after the closing bell. Investors await August business index data from the Philadelphia Federal Bank, Leading Index change for July and weekly jobless claims data scheduled to release later in the day. Europe’s main
bourses followed Asian stocks higher after market participants interpreted the Fed minutes as moderately positive for risk-taking. The dollar hit a seven-week low against a basket of major currencies, while gold steadied. Brent reversed gains after earlier
trading briefly above $50 a barrel for the first time in six weeks. 

 

 

MARKET HIGHLIGHTS

 

Eiger BioPharmaceuticals announced the pricing of its underwritten public offering of 1,250,000 shares of its common stock at a price to the public of $16.00 per share, before underwriting discounts
and commissions.  All of the shares of common stock to be sold in the offering are to be sold by Eiger.  The gross proceeds from the offering to Eiger are expected to be $20.0 million, after deducting underwriting discounts and commissions and estimated offering
expenses payable by Eiger.  In addition, Eiger has granted to the underwriters a 30-day option to purchase up to 187,500 additional shares of common stock at the public offering price, less underwriting discounts and commissions.

 

Aimmune Therapeutics announced that management will host a conference call to highlight the results of an independent academic clinical trial demonstrating the ability of low-dose oral immunotherapy
to induce sustained unresponsiveness in peanut-allergic children under three years of age. Management will also discuss the potential positive implications of these results for the company’s ongoing development program of AR101, its biologic oral immunotherapy
for desensitization of patients with peanut allergy. AR101 is currently under investigation in the Phase 3 PALISADE trial enrolling peanut-allergic patients 4-55 years of age.

 

Bloomberg reported that
Raptor Pharmaceutical jumped in early trading after Retrophin was said to be considering an acquisition of the company. Retrophin is considering the deal to boost growth in treatments for rare diseases, according to people familiar with the matter.
No final agreement has been reached and the companies could decide against a deal, the people said, asking not to be identified because the deliberations are private. Raptor, which has a market value of about $589 million, has also attracted interest from
other drugmakers, the people said.

 

 

InVivo Therapeutics Holdings announced that Northwestern Medicine in Chicago, IL has been added as a clinical site for The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal
Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury. Surgeries will be performed at the Northwestern Memorial Hospital, an 894-bed Level I trauma center.

 

Auris Medical Holding AG announced top-line results from the Phase III TACTT2 trial with Keyzilen (AM-101) in acute inner ear tinnitus. The TACTT2 trial did not meet the two co-primary efficacy
endpoints of statistically significant changes in tinnitus loudness and tinnitus burden compared to placebo. Data from the TACTT2 trial support the positive safety profile established in previous studies, and results from the second Phase III trial, TACTT3,
are expected in the fourth quarter of 2016.

 

Cerulean Pharma announced top-line results from the Company’s Phase II, randomized, multi-center clinical trial of its lead candidate, CRLX101, in combination with Avastin (bevacizumab) in the
treatment of patients with advanced renal cell carcinoma (RCC). The study demonstrated no statistically significant difference in median PFS and objective response rate for the CRLX101 combination compared to SOC. Median PFS was 3.7 months for the CRLX101
combination compared with a median PFS of 3.9 months for SOC. The 95% confidence interval for PFS for the CRLX101 combination was 2.0 months to 4.3 months and for SOC was 2.2 months to 5.4 months. Objective response rate by independent radiological review
for patients who received the CRLX101 combination was 5% compared to 14% for SOC. The CRLX101 and Avastin combination appeared to be safe and well-tolerated and the safety and tolerability profile of the combination was consistent with that observed in previous
studies. Following the news, JMP analyst Michael King downgraded to “market perform” from “market outperform;”
Roth analyst Joseph Pantginis decreased his price target to $2.50 from $9;
Janney analyst Debjit Chattopadhyay downgraded the stock to “neutral” from “buy and established a fair value estimate to $1.00;
Leerink analyst Michael Schmidt downgraded the stock to “market perform” from “outperform” and decreased his price target to $1.50 from $8.00.

 

Portola Pharmaceuticals announced that it has received a CRL from the FDA regarding its BLA for AndexXa (andexanet alfa). An FDA-designated Breakthrough Therapy, AndexXa is in development for
patients treated with a direct (apixaban, rivaroxaban, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Currently, there is no FDA-approved antidote for Factor
Xa inhibitors. In the CRL for AndexXa, the FDA requested that Portola provide additional information primarily related to manufacturing. The agency also asked for additional data to support inclusion of edoxaban and enoxaparin in the label, and indicated it
needs to finalize its review of the clinical amendments to Portola’s post-marketing commitments that recently were submitted.

 

Juniper Pharmaceuticals announced that a recently completed Phase IIb clinical trial evaluating its 10% lidocaine bioadhesive vaginal gel, COL-1077, for the reduction of pain intensity in women
undergoing an endometrial biopsy with tenaculum placement did not achieve its primary and secondary endpoints. The safety and pharmacokinetic (PK) profiles of COL-1077 were consistent with what has been observed in prior clinical trials of the lidocaine bioadhesive
vaginal gel. Northland analyst David Buck downgraded Juniper Pharmaceuticals
to “market perform” from “outperform” and decreased his price target to $6.07 from $15, citing the surprising failure of COL-1077 in Phase 2b studies as its Lidocaine 10% gel failed to meet its primary and secondary endpoints with Juniper then announcing
it has dropped development.  

 

Horizon Pharma announced that the USPTO has granted a Notice of Allowance for U.S. patent application number 14/563,000 (U.S. publication number 2015-0141388), entitled “Delayed-Release Glucocorticoid
Treatment of Rheumatoid Disease” that covers Horizon’s U.S. approved medicine RAYOS (prednisone) delayed-release tablets. The Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent
after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire August 3, 2027. After issuance, Horizon plans to list the patent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations,
or Orange Book. This will be the eighth U.S. patent to be listed in the Orange Book for RAYOS.

 

Sagent Pharmaceuticals announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech
Private Limited and distributed by Sagent. Sagent has initiated this voluntary recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The
particulate matter has been identified as iron oxide.

 

Intercept Pharmaceuticals announced that the New England Journal of Medicine published the key results of the Phase III POISE trial of Ocaliva (obeticholic acid) for the treatment of patients
with primary biliary cholangitis, formerly known as primary biliary cirrhosis (PBC). On a background of standard of care or given as monotherapy, Ocaliva met the primary endpoint of the POISE trial and improved multiple biochemical disease markers as compared
to placebo with high statistical significance.

 

Hemispherx Biopharma announced that it will effect a 1-for-12 reverse stock split of its common stock. At the annual meeting of the Company’s stockholders held earlier, the stockholders approved
an amendment to the Company’s Certificate of Incorporation to effect the reverse stock split at a ratio in the range of 1-for-8 to 1-for-12. After the meeting, the Board of Directors approved the implementation of the reverse stock split at a ratio 1-for-12.
The Company anticipates that the reverse stock split will be effective on August 26, 2016, and the Company’s common stock will begin trading on a split-adjusted basis on August 29, 2016.

 

Soligenix announced that the Office of Orphan Products Development of the FDA has granted orphan drug designation to the active ingredient dusquetide for treatment of macrophage activation syndrome
(MAS). Dusquetide has previously received orphan drug designation for the treatment of acute radiation syndrome (ARS). Dusquetide is an innate defense regulator (IDR), a new class of short, synthetic peptides that accelerates bacterial clearance and resolution
of tissue damage while modulating inflammation following exposure to a variety of agents including bacterial pathogens, trauma, radiation and/or chemotherapy.

 

Teva Pharmaceutical announced that the European Commission has granted marketing authorization for CINQAERO (reslizumab) in the 28 countries of the European Union (EU) in addition to Norway,
Liechtenstein and Iceland. CINQAERO is a humanized interleukin-5 antagonist monoclonal antibody for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product
for maintenance treatment.

 

Symphogen announced that Kirsten Drejer, M.Sc., Ph. D., Co-founder, Chief Executive Officer and Director will transition from an executive operational role to an independent member of the Board
of Directors. In parallel, Martin Olin, M.Sc., E*MBA, now Chief Financial Officer, has been promoted effective 1st September to Chief Executive Officer and member of the Board of Directors. Kirsten Drejer is proposed to be elected to the Board of Directors
as an independent member and will, through a transition period, be a working Board member assisting Martin Olin.

 

Zymeworks announced that the FDA has granted Orphan Drug Designation to Zymeworks’ lead investigational products ZW25 and ZW33 for the treatment of ovarian cancer. Orphan drug designation qualifies
Zymeworks for a number of development incentives including tax credits for clinical testing and marketing exclusivity for a period of seven years if ZW25 or ZW33 is approved for this indication.

 

Nordic Nanovector announced that the first cohorts of both Arm 3 and 4 of the expanded Lymrit 37-01 clinical study with Betalutin have been completed. Betalutin is a novel anti-CD37 targeting
Antibody Radionuclide Conjugate in development for the treatment of major types of non-Hodgkin lymphoma (NHL), including Follicular Lymphoma (FL).

 

Insys Therapeutics announced enrollment of the first patient in a Phase II clinical trial for the treatment of cocaine dependence using its pharmaceutical cannabidiol (CBD) product candidate.
The study is being conducted by Dr. Didier Jutras-Aswad, MD, at the University of Montreal Hospital Research Center (CRCHUM) and is supported by the Canadian Institutes of Health Research (CIHR) and the Company.

 

Immunomedics announced that adding an inhibitor of ATP-binding cassette (ABC) transporters to sacituzumab govitecan, the company’s lead antibody-drug conjugate (ADC) for solid cancer therapy,
increased the median survival of mice bearing a SN-38-resistant human gastric cancer cell line. Results from this preclinical study were published in Molecular Cancer Therapeutics.

 

Xenetic Biosciences announced that it has commenced a collaboration with
Excivion to develop a vaccine against Zika and dengue viruses. As part of the collaboration, Xenetic’s proprietary IMUXEN Technology will be used to develop the vaccine. Excivion is a private UK company that has developed a proprietary antigen design
platform for viral vaccines which it is applying to flavivirus infections.

 

Aclaris Therapeutics announced positive results from its Phase II clinical trial (WART-201), of A-101 Topical solution (A-101) for the treatment of common warts (verruca vulgaris). A-101 is a
proprietary formulation of high-concentration hydrogen peroxide currently under development as a prescription treatment for common warts.

 

BeiGene announced that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct clinical trials in China with BGB-290, a highly
potent and selective PARP inhibitor. China is the third territory in which BGB-290 has received approval to conduct clinical trials, in addition to Australia and the United States. Data from the Phase I proof-of-concept trial of BGB-290 were previously presented
at the 2015 AACR-NCI-EORTC conference.

 

ARCA biopharma announced that the 100(th) patient has been randomized into GENETIC-AF, a seamless design Phase IIB/III clinical trial evaluating Gencaro (bucindolol hydrochloride) as a potential
treatment for atrial fibrillation. This represents two-thirds of the minimum number of patients needed for a pre-specified Phase IIB interim efficacy analysis. Based on the current enrollment rate, the Company expects to randomize at least 150 patients into
the trial by the end of 2016. The GENETIC-AF Data Safety Monitoring Board (DSMB) will conduct an interim efficacy, safety and futility analysis of data from at least 150 patients with evaluable data. The Company expects the outcome of this interim analysis
in the second quarter of 2017.

 

Diffusion Pharmaceuticals announced that its Board of Directors approved an amendment to the Company’s certificate of incorporation effecting a 1-for-10 reverse split of all outstanding common
stock. Diffusion’s stockholders previously approved the reverse split on July 21, 2016. Both the record date and effective date for the reverse stock split will be August 17, 2016 and, following the reverse split, Diffusion intends to uplist to the NASDAQ
Capital Market.

 

OncoMed Pharmaceuticals announced the pricing of an underwritten public offering of 5,500,000 shares of its common stock at a public offering price of $10.00 per share. Net proceeds to OncoMed
from this offering are expected to be approximately $51.4 million after underwriting discounts and commissions and estimated offering expenses. The offering is expected to close on or about August 23, 2016, subject to customary closing conditions. The Company
has granted the underwriters of the offering the right for a period of 30 days to purchase up to an additional 825,000 shares of common stock at the public offering price, less underwriting discounts and commissions.
Leerink Partners is acting as sole book-running manager for the proposed offering.
Wells Fargo Securities and JMP Securities are acting as co-managers.

 

BioPharmX announced that it entered into a private placement transaction for the sale of $1,575,000 in shares of the Company’s common stock and has entered into arrangements to issue unsecured
and secured convertible promissory notes as described below in an aggregate principal amount of $1,500,000, generating a total of $3,075,000 in gross proceeds under these financing events.

 

Valeant Pharmaceuticals International announced that it has obtained the requisite lender approval for an amendment to its credit facility. The Company expects to close the amendment next week,
subject to customary closing conditions.

 

 

ANALYST RECOMMENDATIONS

 

HC Wainwright analyst Shaunak Deepak initiated coverage of
Karyopharm Therapeutics with a “buy” rating and $15 price target, citing Karyopharm has employed several clever strategies to optimize the likelihood of clinical “wins” selinexor, including subgroup analyses in its clinical trials and enlisting leading
cancer centers to conduct investigator sponsored trials.  

 

Piper Jaffray analyst Joshua Schimmer decreased his price target of
BioMarin to $107 from $120, citing model changes.

 

Following Agilent Technologies’
earnings, Baird analyst Catherine Ramsey increased her price target to $52 from $48;
Jefferies analyst Brandon Couillard increased his price target to $53 from $51.

 

JP Morgan
analyst Tycho Peterson upgraded Luminex to “neutral” from “underweight” and increased his price target to $22 from $18, citing Operational and core business improvements.