BioShares Biotechnology Clinical Trials (BBC): $19.03, +$0.14, +3.4% YTD

BioShares Biotechnology Products (BBP): $33.93, -$0.12, +3.6% YTD

 

 

MARKET COMMENTARY

 

World stocks hit a 19-month high as strong Japanese trade data, stellar company earnings and hopes that U.S. President Donald Trump will press ahead with a large fiscal spending package, boosted investor sentiment. Markets will watch for corporate earnings from some major companies including AT&T, Boeing, eBay, Qualcomm and Western Digital. Monthly home prices data is on the economic calendar. The Aussie dollar slumped after inflation data undershot expectations, rekindling hopes of one more cut in interest rates, while U.S. dollar fell against the yen. Oil fell more than a percent on rising U.S. inventories. Gold traded lower as Chinese demand ebbed ahead of the Lunar New Year festival, with some analysts warning of further declines as prices for the metal could be due for a technical correction.

 

 

MARKET HIGHLIGHTS

 

DelMar Pharmaceuticals announced the opening of enrollment of a Phase II study of VAL-083 at the University of Texas MD Anderson Cancer Center in Houston, Texas.  The Phase II study of VAL-083 (dianhydrogalactitol) in patients with MGMT-unmethylated, Avastin (bevacizumab)-naïve recurrent glioblastoma will enroll 48 patients in a single-arm design to determine if treatment with VAL-083 improves overall survival, compared to historical control.  Further information regarding the clinical trial can be found on DelMar’s website and at clinicaltrials.gov (clinicaltrials.gov identifier:  NCT02717962).

 

Neovacs announced the recommendation of its Scientific Advisory Board to extend the development of IFN Kinoid to a new indication, Type 1 Diabetes, with the objectives of obtaining preclinical proof of concept in 2017 and initiating clinical development for this program in the first half of 2018. IFN Kinoid is also currently in Phase IIb testing for treatment of Lupus and recently received U.S. FDA Fast Track designation in this indication.

 

Advaxis pointed to research published in the journal Cancer which underscores the need for more access to screenings, improved clinical care and new therapeutic options for all women with cervical cancer.

 

OSE Immunotherapeutics SA announced today that the Independent Data Monitoring Committee (IDMC) for the Company’s international pivotal Phase 3 clinical study (Atalante 1) of Tedopi® for the treatment of non-small cell lung cancer (NSCLC) has unanimously recommended continuation of the trial, without asking for modifications.

 

TxCell announced the launch of a capital increase through the issue of new shares with warrants attached with shareholders’ preferential subscription rights.  The issue is expected to raise gross proceeds of approximately 11 million euros should all the New Shares with Warrant attached be subscribed for.

 

Orexigen Therapeutics announced that Laboratorios Farmacéuticos Rovi, S.A. has launched Mysimba in Spain. Mysimba is approved by the EMA for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension). ROVI will market Mysimba as part of their diversified pharmaceutical portfolio under the terms of our distributorship agreement signed in August 2016.

 

Dow Jones reported that Novartis said it may spin off its ailing eye-care business Alcon, one year into a slower-than-expected turnaround for that business. Separately, Novartis said earnings and revenue for the whole business fell in the fourth quarter, largely due to the strength of the dollar. It also announced a share buyback worth up to $5 billion. Net income fell 11% to $936 million in the three months to Dec. 31, compared with $1.05 billion in the same period a year earlier, while revenue declined 2% to $12.32 billion. Adjusting for the strength of the dollar, revenue and net income were flat, as falling sales from old cancer medicine Gleevec offset growth of some of Novartis’s newer drugs. Novartis said it expected 2017 sales to be broadly in line with last year at constant currencies, with new drugs offsetting Gleevec’s decline. It said core operating income this year would be broadly in line or decline at a low single digit percentage from 2016, at constant currencies.

 

AbbVie announced the start of two Phase II clinical trial programs to evaluate ABBV-8E12, an investigational anti-tau antibody, in patients with early Alzheimer’s disease and progressive supranuclear palsy (PSP). In recognition of the lack of treatment options available to patients with PSP, the FDA granted Fast Track Designation to ABBV-8E12. The FDA and EMA also granted Orphan Drug Designations to ABBV-8E12 for PSP.

 

BeiGene announced the initiation of a global, randomized Phase III trial of its investigational Bruton’s Tyrosine Kinase (BTK) inhibitor BGB-3111 in patients with Waldenström’s macroglobulinemia (WM). The study is designed to determine whether the quality of response with BGB-3111 in WM is superior to that of ibrutinib, the currently approved BTK inhibitor. Approximately 170 patients are expected to be enrolled at clinical sites in North America, Europe, Australia, and New Zealand.

 

Aldeyra Therapeutics provided an update on its Phase III clinical programs in noninfectious anterior uveitis and Sjögren-Larsson Syndrome.

 

Five Prime Therapeutics announced that the EC has granted orphan designation for cabiralizumab (FPA008) for the treatment of tenosynovial giant cell tumour, localised and diffuse type, also known as Pigmented Villonodular Synovitis (PVNS), a locally aggressive tumor of the synovium.

 

Eisai announced that a Phase III clinical trial (Study 304) of its in-house discovered and developed  anticancer agent Lenvima (lenvatinib mesylate, "lenvatinib") against  the comparator sorafenib as a first-line treatment for patients with  unresectable hepatocellular carcinoma has achieved its primary endpoint. Study 304 is a multicenter, randomized, open-label, global Phase III study  comparing the efficacy and safety of lenvatinib versus sorafenib, a standard  treatment for advanced hepatocellular carcinoma, as a first-line treatment for  patients with unresectable hepatocellular carcinoma. In the study, 954  patients were randomized in a 1:1 ratio to receive lenvatinib 12 mg or 8 mg  once a day, depending on baseline body weight (n=478) or sorafenib 400 mg  twice a day (n= 476).   Treatment was continued until disease progression or unacceptable toxicity.

 

Esperion Therapeutics announced completion of patient enrollment in the global pivotal Phase III long-term safety and tolerability study of bempedoic acid. Enrollment of this study was completed ahead of schedule in approximately 2,000 patients treated with bempedoic acid or placebo at high cardiovascular disease (CVD) risk with hypercholesterolemia whose LDL-C is not adequately controlled with current lipid-modifying therapies. Top-line results from this study are expected by Q2 2018.

 

ßXTL Biopharmaceuticals announced the Company has authorized The Bank of New York Mellon, as depository, to effect on February 10, 2017 a change in the ratio from one Depositary Share ("DS") representing twenty ordinary shares to a new ratio of one DS representing one hundred ordinary shares. For the Company’s DS holders, this ratio change will have the same effect as a reverse split on the XTL DSs on the basis of one new DS for every five old DSs held. The ordinary shares of XTL will not be affected by this change in the DS to ordinary share ratio.

 

Researchers with Exosome Sciences, a diagnostic subsidiary of Aethlon Medical, announced plans to initiate a clinical study involving retired NFL players and a data-supported biomarker candidate to detect and monitor Chronic Traumatic Encephalopathy (CTE) in living individuals.  CTE is a neurodegenerative disease that has often been found in American football players, boxers and other individuals with a history of repetitive head trauma. At present, CTE diagnosis is determined after death through an analysis of brain tissue.

 

Globavir Biosciences announced the approval of their PanGlob Dengue rRT-PCR kit from the Ministry of Health & Family Welfare in India. Globavir and its Indian distribution partner, Suyog Diagnostics Private Limited, a Mumbai-based diagnostic technologies distribution company, are working to launch the test this upcoming monsoon season (May–September) when dengue is most prevalent and problematic

 

Myovant Sciences announced it has initiated a Phase III clinical program consisting of two international clinical trials, LIBERTY 1 and LIBERTY 2, to evaluate the safety and efficacy of relugolix in women with heavy menstrual bleeding associated with uterine fibroids. Relugolix is an oral, once-daily, small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that decreases estrogen and progesterone. It will be evaluated with and without low-dose hormonal add-back therapy.

 

Voyager Therapeutics announced the publication of new preclinical data highlighting markedly reduced tau pathology including neurofibrillary tangles and neurodegeneration following treatment with a single dose of an adeno-associated virus (AAV) vector designed to administer a tau monoclonal antibody, PHF1, to the hippocampus of mutant tau transgenic mice.  Scientists at Voyager, including Wencheng Liu, Ph.D., and Steven Paul, M.D., president and chief executive officer of Voyager, working in collaboration with colleagues at Weill Cornell Medical College, carried out the study and published the results in a recent issue of the Journal of Neuroscience.

 

Caladrius Biosciences announced that three additional clinical sites, including UCSF Benioff Children’s Hospital San Francisco, under the direction of investigator Stephen Gitelman, MD, have opened to enroll subjects for the Company’s Phase II clinical trial of CLBS03 in type 1 diabetes, The Sanford Project: T‑Rex Study.  The other clinical sites include University of Florida Diabetes Institute (under Michael Haller, MD) and the Harold Schnitzer Diabetes Health Center at Oregon Health & Science University (under Ines Guttman-Bauman, MD).  These sites will contribute to the continued enrollment of subjects in the trial to meet the total of 111. The study is evaluating CLBS03 (the Company’s product candidate consisting of autologous expanded regulatory T cells, or Tregs) as a treatment for recent-onset type 1 diabetes (T1D).

 

DePuy Synthes announced an exclusive agreement in the U.S. between DePuy Synthes Sales and Pacira Pharmaceuticals to co-promote EXPAREL, a long-lasting, non-opioid, local analgesic administered at the orthopaedic surgical site. The agreement allows DePuy Synthes to promote EXPAREL across its joint reconstruction, spine, sports medicine, and trauma businesses to help with postsurgical patient pain. This will further enhance the company’s portfolio and reach in the operating room while also helping hospital customers better achieve their Triple Aim goals of improving clinical outcomes, reducing costs and enhancing patient satisfaction.

 

NeuroVive Pharmaceutical announced that its Taiwan-based subsidiary’s research resources and activities will be redirected to the parent company NeuroVive Pharmaceutical AB. At a NeuroVive Pharmaceutical Asia, Inc. shareholders’ meeting, an agreement was approved in which the continued operations in the Taiwan subsidiary will be sold to the current Taiwanese shareholders. Under the agreement, NeuroVive Pharmaceutical AB will receive approximately 5 million SEK before transaction costs. In addition, NeuroVive and its collaboration partner Foundation Asia Pacific Ltd. will reacquire the Hong Kong based subsidiary, NeuroVive Pharmaceutical Asia Ltd., which holds the Asian territorial licensing rights for NeuroSTAT and the agreements with the Chinese company Sihuan Pharmaceutical and Sanofi Korea. The Hong Kong company will be owned by NeuroVive Pharmaceutical AB (approx. 82.5%) and Foundation Asia Pacific Ltd. (approx. 17.5%). On closing, other assets previously licensed to the NeuroVive Asia group will be returned to NeuroVive Pharmaceutical AB.

 

 

ANALYST RECOMMENDATIONS

 

Rodman & Renshaw analyst Raghuram Selvaraju downgraded Genvec to “neutral” from “buy” and decreased his price target to $7 from $15, citing acquisition by Intrexon.

 

HC Wainwright analyst Corey Davis increased his price target of Pacira to $48 from $43, citing 2017 is expected to be a year of fresh data for Exparel and a chance to regain preferred hospital formulary access.

 

Leerink analyst Jason Gerberry decreased his price target of Endo International to $12 from $15, citing management’s outlook for US generics is more pessimistic than street forecasts.

 

JP Morgan analyst Michael Weinstein decreased his price target of Endologix to $7 from $9, citing a revised 2018 revenue forecast, representing a slight discount with the company’s broader peer group.

 

Raymond James analyst Reni Benjamin initiated coverage of Organovo Holdings with an “outperform” rating and $5 price target, citing the company is at the early stages of exploring the potential of 3D printed tissue in a variety of therapeutic approaches, including the development of an organ patch for patients with liver injury.

 

Baird analyst Brian Skorney initiated coverage of Reata Pharmaceuticals with an “outperform” rating and $43 price target, citing multiple readouts over the next two years in high unmet need indications and a valuation implying more failures than successes.

 

Oppenheimer analyst Hartaj Singh decreased his price target of Pieris Pharmaceuticals to $9 from $10, citing a pushed back launch year for both PRS-080 and PRS-060 by one year.