BioShares Biotechnology Clinical Trials (BBC): $22.25, +$0.48, -23.4% YTD

BioShares Biotechnology Products (BBP): $33.04, +$0.03, +7.2% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures edged higher as investors await comments from Federal Reserve Chair Janet Yellen, due tomorrow, for clues about the next interest rate hike. Building permits and housing starts are on the economic calendar. Adobe, FedEx and KB Homes are likely to report after the closing bell. European markets held steady with a rally in chemical stocks offsetting weaker energy shares that fell on the back of lower oil prices due to oversupply concerns. Asian stocks closed mostly lower as investors counted down to Wednesday’s Bank of Japan policy decision amid speculation the central bank will make crucial changes to its massive easing program. The dollar and gold were near-flat.

 

 

MARKET HIGHLIGHTS

 

Windtree Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AEROSURF® (lucinactant for inhalation) for the treatment of premature infants with respiratory distress syndrome (RDS). AEROSURF is a novel, investigational combination drug/device product that is being developed to deliver aerosolized KL4 surfactant to premature infants with RDS, potentially reducing the need for invasive endotracheal intubation and mechanical ventilation to administer surfactant therapy.

 

Following the Israeli Ministry of Health’s approval to start a Phase I/II trial in leukemia patients, Cellect Biotechnology’s Chairman, Kasbian Nuriel Chirich, Chief Executive Officer, Shai Yarkoni, and Deputy Chief Executive Officer and Chief Financial Officer, Ronen Twito, purchased the company’s ADSs and warrants.  Following the transaction, the three officers own approximately 28.5% of the Company’s outstanding ordinary shares.

 

TiGenix NV reported its business and financial highlights for the first half of 2016.  During the first half 2016, total revenues remained stable at EUR 0.9 million when compared to the same period of 2015. Revenues mainly represented royalties and other operating income received from Sobi.  As a result, the loss for the first half 2016 amounted to EUR 9.4 million, compared to EUR 10.6 million for the same period in 2015.

 

Palatin Technologies announced financial results for its fourth quarter and fiscal year ended June 30, 2016.  Palatin reported a net loss of $(13.4) million, or $(0.09) per basic and diluted share, for the quarter ended June 30, 2016, compared to a net loss of $(12.1) million, or $(0.09) per basic and diluted share, for the same period in 2015.  For the year ended June 30, 2016, Palatin reported a net loss of $(51.7) million, or $(0.33) per basic and diluted share compared to a net loss of $(17.7) million, or $(0.15) per basic and diluted share for the year ended June 30, 2015.  Palatin’s cash, cash equivalents and investments were $9.4 million as of June 30, 2016, compared to cash and cash equivalents of $27.3 million at June 30, 2015. 

 

Zealand Pharma sponsored an educational symposium on short bowel syndrome (SBS) to help increase awareness and understanding of the need for better care and treatment options for patients. Zealand has a proprietary GLP-2 peptide agonist, glepaglutide, in Phase II development for short bowel syndrome.

 

VBI Vaccines announced that it has completed enrollment and initial dosing of all participants in the Phase I clinical study to evaluate its preventative cytomegalovirus ("CMV") vaccine candidate.  The Phase I study is designed to assess the safety and tolerability of VBI’s CMV vaccine candidate in 128 healthy CMV-negative adults. The study will also measure levels of vaccine-induced CMV neutralizing antibodies that may prevent CMV infection. Preliminary results are anticipated in the first half of 2017.

 

Can-Fite BioPharma announced the peer reviewed scientific journal Molecular Medicine Report has published an article titled, "A3 adenosine receptor agonist, CF102, protects against hepatic ischemia/reperfusion injury following partial hepatectomy." The article reports the results of preclinical studies conducted by Can-Fite, showing the Company’s liver cancer drug candidate CF102 protects the liver from ischemia/reperfusion injury and regenerates liver cells following partial hepatectomy.

 

Mainstay Medical International plc announced the one-year results from the ReActiv8-A Clinical Trial, an international, multi-centre, prospective, single arm trial for ReActiv8 in people with disabling CLBP and few other treatment options.  The one-year results show sustained performance in the ReActiv8-A Clinical Trial at the one-year follow-up with a clinically important, statistically significant and lasting improvement in the study’s key endpoints for pain (NRS), disability (ODI) and quality of life (EQ-5D).

 

Basilea Pharmaceutica announced that Basilea Pharmaceutica International has entered into a license and distribution agreement with Unimedic Pharma AB for Basilea’s antifungal CRESEMBA (isavuconazole) and antibiotic Zevtera (ceftobiprole) in the Nordic countries, including Sweden, Denmark and Norway, and Finland. Under the terms of the agreement, Unimedic is granted an exclusive license to import and commercialize isavuconazole and ceftobiprole in the region. Basilea will be eligible to receive upfront and sales milestone payments. Basilea will remain the marketing authorization holder and Unimedic will be responsible for commercialization and distribution of isavuconazole and ceftobiprole in these countries.

 

Ocera Therapeutics will be presenting a corporate overview at the Ladenburg Thalmann 2nd Annual Healthcare Conference on September 27, 2016.

 

Zogenix will present a corporate update at the Ladenburg Thalmann 2016 Healthcare Conference on Tuesday, September 27th, and will participate in a fireside chat at the LEERINK Partners Rare Disease & Immuno-Oncology Roundtable Series on Wednesday, September 28th.

 

Aradigm Corporation will present a corporate overview at the Ladenburg Thalmann 2016 Healthcare Conference on Tuesday, September 27, 2016.

 

Advaxis will present a company overview at the Aegis Capital Corporation’s 2016 Growth Conference on September 21st.

 

Allergan and Tobira Therapeutics announced that they have entered into a definitive agreement under which Allergan will acquire Tobira for an upfront payment of $28.35 per share, in cash, and up to $49.84 per share in Contingent Value Rights (CVRs) that may be payable based on the successful completion of certain development, regulatory and commercial milestones, for a total potential consideration of up to $1.695 billion. The Boards of Directors of both companies have unanimously approved the transaction.

 

Regeneron Pharmaceuticals and Teva Pharmaceutical Industries announced a global agreement to develop and commercialize fasinumab, Regeneron’s investigational NGF antibody in Phase III clinical development for osteoarthritis pain and in Phase II development for chronic low back pain. Under the terms of the agreement, Teva will pay Regeneron $250 million upfront and share equally in the global commercial value, as well as ongoing research and development costs of approximately $1 billion.

 

Puma Biotechnology announced that the FDA has accepted for review the NDA for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin(R))-based therapy.

 

Bristol-Myers Squibb announced that the EMA validated its type II variation application, which seeks to extend the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

 

Lannett Company announced that it received approval from the FDA of its ANDA for Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the therapeutic equivalent to the reference listed drug, Suboxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg.  According to IMS, total U.S. sales in 2015 of Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, at Average Wholesale Price (AWP) were approximately $270 million. 

 

Amgen announced that the Phase III GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound) trial evaluating the effect of Repatha (evolocumab) on coronary artery disease (CAD) met its primary and secondary endpoints. The GLAGOV study is a large serial coronary intravascular imaging trial designed to test whether treatment with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha modifies atherosclerotic plaque build-up in the coronary arteries of patients already treated with optimized statin therapy.

 

Karolinska Development AB announced that its portfolio company BioArctic AB has entered into a strategically important collaboration with AbbVie to develop and commercialize BioArctic’s portfolio of antibodies directed against alpha-synuclein for the treatment of Parkinson’s disease and other potential indications.

 

Regen BioPharma announced completion of experiments demonstrating immunological effects of its novel NR2F6 small molecule modulators. These experiments were conducted in collaboration with Dr. Xiaojing Ma, Professor of Microbiology and Immunology at Weill Cornell Medical College.

 

Apricus Biosciences announced that Ferring Pharmaceuticals, the Company’s new partner in Finland and Denmark, has officially completed the transfer of the marketing authorizations for Vitaros in those countries.

 

Zafgen has recently initiated dosing in the multiple ascending dose (MAD) cohorts of its ongoing Phase I clinical trial of ZGN-1061. The initiation of the MAD portion was triggered following a review of the initial safety and tolerability data from the first two cohorts of the single ascending dose (SAD) portion of the clinical trial. ZGN-1061 is a second-generation, differentiated MetAP2 inhibitor in development for severe and complicated obesity indications.

 

Takeda Pharmaceutical Company Limited and Zydus Cadila announced a partnership to tackle chikungunya, an emerging infectious disease in Africa, Asia and the Indian subcontinent.

 

Actinium Pharmaceuticals announced that the Company has selected Vector Oncology as its Clinical Research Organization (CRO) for its anticipated Actimab-A Phase II clinical trial.

 

Lubris BioPharma announced positive results of a clinical trial that showed recombinant human lubricin demonstrated significant improvement in both signs and symptoms of dry eye disease compared to sodium hyaluronate (HA). Results are published in the September issue of The Ocular Surface.

 

BioLineRx announced the initiation of a Phase IIa trial investigating BL-8040 in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with metastatic pancreatic cancer.

 

Shire announced that its wholly owned subsidiary, Shire Acquisitions Investments Ireland Designated Activity Company, priced its inaugural public offering of $12.1 billion aggregate principal amount of senior notes. The offering consists of four series of senior notes:  $3.3 billion 1.900% Senior Notes due 2019; $3.3 billion 2.400% Senior Notes due 2021; $2.5 billion 2.875% Senior Notes due 2023; and $3.0 billion 3.200% Senior Notes due 2026  The notes are expected to be issued on September 23, 2016, subject to customary closing conditions. Shire intends to use the net proceeds to fully repay amounts outstanding under its January 2016 bridge facilities agreement, which were used to finance its acquisition of Baxalta Incorporated, and for general corporate purposes.

 

TherapeuticsMD announced the acceptance of the NDA for Yuvvexy, the conditionally-approved trade name for TX-004HR, by the FDA. Yuvvexy is an investigational bio-identical 17β-estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women. The NDA acceptance by the FDA in its 74-day letter indicates that the application is sufficiently complete to permit a substantive review. The PDUFA target action date for the completion of the FDA’s review is May 7, 2017.

 

Galapagos announced a share capital increase arising from warrant exercises. Galapagos issued 60,320 new ordinary shares on 19 September 2016, for a total capital increase (including issuance premium) of €603,289.80.

 

Advanced Accelerator Applications S.A. announced that the Accelerated Assessment timeline for the EMA review of the MAA for Lutathera, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of neuroendocrine tumors (NETs), has been modified to a standard review period due to additional clarifications requested by the EMA, as well as their request to inspect one of AAA’s contract research organizations (CRO).

 

Cancer Genetics entered into a partnership with the Bio Analytical Research Corporation (BARC), a global central laboratory supporting clinical trials and serving large pharmaceutical and biotech companies globally, including in Europe, Africa, China, Australia and the USA.

 

Nanotherapeutics announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the company a contract for advanced biologics manufacturing services as part of a multiple award IDIQ (Indefinite Delivery/Indefinite Quantity) pool. The contract has a maximum ceiling of $159.4 million and a performance period of up to 10 years.

 

Synthetic Biologics announced that following the completion of a previously planned interim analysis by an independent Interim Analysis Committee (IAC), enrollment has been completed in its Phase IIb randomized, placebo-controlled, proof-of-concept clinical trial for SYN-004 (ribaxamase).

 

Aquinox Pharmaceuticals announced the pricing of an underwritten public offering of 5,350,000 shares of its common stock at a price to the public of $12.25 per share. In addition, Aquinox has granted the underwriters a 30-day option to purchase up to 802,500 additional shares of common stock at the public offering price. Leerink Partners, Canaccord Genuity and Guggenheim Securities are acting as joint book-running managers for the offering. Needham & Company is acting as lead manager.

 

KVK Tech announced that the FDA has approved Lomaira (phentermine hydrochloride USP) 8 mg tablets CIV, a low-cost, low-dose prescription medicine used for a short period of time (a few weeks) for weight reduction in adults with an initial body mass index (BMI) of 30 or more (obese) or 27 or more (overweight) with at least one weight-related condition such as controlled high blood pressure, diabetes, or high cholesterol. Lomaira should be used together with regular exercise and a reduced-calorie diet.

 

Frazier Healthcare Partners announced that Amit Jain has joined the firm as an Operating Partner on the Growth Buyout team. He will assist the Growth Buyout group with identifying and executing opportunities in the pharma services space.

 

Bellerophon Therapeutics announced the planned transition of Fabian Tenenbaum, current Chief Financial Officer and Chief Business Officer, to Chief Executive Officer of the company, succeeding Jonathan Peacock, who will retain his position as Chairman of the Board and remain actively involved. The transition will be completed by year-end.

 

Aegerion Pharmaceuticals announced the appointment of Remi A. Menes as chief commercial officer, effective immediately.

 

GlaxoSmithKline said it had chosen Emma Walmsley, head of consumer healthcare, as its new chief executive, after considering internal and external candidates.

 

 

ANALYST RECOMMENDATIONS

 

First Analysis analyst Joseph Munda decreased his price target of NantHealth to $17 from $18, citing sluggish GPS Cancer orders, lower revenue, and earnings outlook through 2018.

 

Leerink analyst Seamus Fernandez revised his price target of the following companies: Novartis increased to $89 from $86; Eli Lilly decreased to $104 from $105; Pfizer decreased to $36 from $37.

 

Deutsche Bank analyst Gregg Gilbert resumed coverage of Valeant with a “hold” rating and $30 price target, citing VRX will be reporting on a new segment structure starting with 3Q results in late Oct / early Nov, and other major changes may occur, including but not limited to changes in debt structure, material divestments of products and geographies, and a new outlook from a recently-hired CFO.

 

Chardan analyst Gbola Amusa initiated coverage of Novartis with a “buy” rating and $95 price target, citing risk-reward dynamics on nearing catalysts for the company’s pivotal Phase III wet AMD franchise, and the likelihood of long-term Novartis share price performance.

 

Leerink analyst Michael Schmidt increased his price target of Exelixis to $15 from $12, citing higher Cabometyx estimates, near-term driven by analysis of recent Rx trends and longer-term by favorable MEDACorp KOL feedback on the potential of Cabometyx in renal cell carcinoma.

 

Following the FDA granting accelerated approval of Sarepta’s Eteplirsen, SunTrust analyst Edward Nash increased his price target to $52 from $48; Wedbush analyst Heather Behanna increased her price target to $66 from $36; Cowen analyst Ritu Baral upgraded the stock to “outperform” from “neutral” and established a $64 price target.

 

HC Wainwright analyst Corey Davis initiated coverage of the following companies: AERI Pharmaceuticals with a “buy” rating and $66 price target; Inotek with a “buy” rating and $22 price target.

 

Ladenburg analyst Jeffrey Cohen initiated coverage of Viveve Medical with a “buy” rating and $22 price target, citing VIVE is a women’s health company strongly committed to advancing new solutions to improve women’s overall well-being and quality of life.

 

Goldman analyst Isaac Ro revised his price target of the following companies: Laboratory Corporation of America increased to $140 from $139; Exact Sciences decreased to $17 from $18.

 

Bank of America Merrill Lynch analyst Tazeen Ahmad increased her price objective of Ultragenyx to $85 from $74, citing positive data for KRN23 in two indications.