BioShares Biotechnology Clinical Trials (BBC): $22.08, +$0.17, +19.9% YTD

BioShares Biotechnology Products (BBP): $36.79, +$0.34, +12.3% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were marginally higher on rising expectations for first-quarter corporate profits. On the economic front, investors will look forward to existing homes sales and flash reading of Markit’s composite PMI. European markets were broadly lower and the euro steadied below three-week high as investors retreated from risky bets ahead of the first round of France’s Presidential election that is seen as too close to call. Asian stocks recorded a mixed trading day. Oil prices edged lower over doubts that an OPEC-led production cut will restore balance to an oversupplied market. Gold was little changed as risk-averse investors sought refuge in the safe-haven asset.

 

 

MARKET HIGHLIGHTS

 

DelMar Pharmaceuticals announced that it has closed its previously announced registered public offering of an aggregate of 2,769,232 shares of common stock and warrants to purchase an aggregate of 2,076,924 shares of common stock at a price to the public of $3.25 per share and related warrant. The warrants have an exercise price of $3.50 per share, are immediately exercisable and have a term of exercise of five years.  Rodman & Renshaw, a unit of H.C. Wainwright & Co., acted as exclusive placement agent for the offering.

 

Rockwell Medical announced that it has filed definitive proxy materials with the U.S. Securities and Exchange Commission (“SEC”) in connection with the company’s upcoming 2017 Annual Meeting of Shareholders (“Annual Meeting”) to be held on June 1, 2017. The proxy statement and other important information related to the Annual Meeting can be found on the company’s website at www.rockwellmed.com.

 

Eiger BioPharmaceuticals announced additional supportive and encouraging lonafarnib (LNF) data from the LOWR HDV (LOnafarnib With Ritonavir in Hepatitis Delta Virus) Program presented at The International Liver Congress™ 2017, in Amsterdam, Netherlands.  After 24 weeks of treatment, all-oral lonafarnib-based regimens (LNF 25 mg or 50 mg BID + Ritonavir, or RTV) suppressed HDV-RNA below the limit of quantitation in 36% of patients, and 60% achieved ALT normalization.  The addition of PEG IFN to LNF 25 mg BID + RTV (triple therapy) suppressed HDV-RNA below the limit of quantitation in 80% of patients, and 78% achieved ALT normalization.  In patients treated for 48 weeks with triple therapy of PEG IFN + LNF 25 mg BID + RTV, PCR-negativity was achieved in 67% of patients at the end of treatment.

 

Onconova Therapeutics announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Onconova also expects to grant to the underwriter for the offering a 45-day option to purchase an additional 15% of the shares of common stock offered in the public offering. All of the shares to be sold in the offering are to be sold by Onconova. Onconova intends to use the net proceeds from the offering to support development of rigosertib for treatment in higher risk MDS.

 

Aurinia Pharmaceuticals announced additional 48-week results from its global Phase IIb AURA-LV (AURA) study in lupus nephritis (LN) during the National Kidney Foundation 2017 Spring Clinical Meetings in Orlando, FL. In addition to the trial meeting its complete and partial remission (“CR”/”PR”) endpoints at 48 weeks, all pre-specified secondary endpoints that have been analyzed to date were also met at 48 weeks. These pre-specified endpoints include: time to CR and PR (speed of remission); reduction in Systemic Lupus Erythematosus Disease Activity Index or SLEDAI score; and reduction in urine protein creatinine ratio (UPCR) over the 48-week treatment period. The data were presented during the late-breaking session by lead author Dr. Samir Parikh, a clinical investigator for the study and Assistant Professor of Clinical Nephrology at the Ohio State University.

 

VBL Therapeutics announced that the Independent Data Safety Monitoring Committee (DSMC) met to conduct its second safety review of the Phase 3 GLOBE Study investigating ofranergene obadenovec (VB-111) in recurrent glioblastoma (rGBM).  The DSMC is an independent multidisciplinary group that conducts detailed reviews of un-blinded study data, discusses potential safety concerns and provides recommendations regarding trial continuation. The committee reviewed the GLOBE safety data collected through a cutoff date in March 2017 and unanimously recommended that the study continue as planned.

 

Onxeo S.A. has received the EnterNext Tech 40 Label and is thus admitted to the “Tech 40” index.  The “Tech 40” label is an initiative launched two years ago by Euronext to give more prominence to outstanding Tech companies listed on the various European markets covered by EnterNext (Amsterdam, Brussels, Lisbon and Paris).  The 40 companies receiving this label were chosen by a committee of independent European experts based on their business, financial and stock market performances.

 

Aeglea BioTherapeutics names Anthony Quinn, M.B Ch.B, Ph.D., FRCP as interim chief medical officer, effective immediately.  Dr. Quinn also serves on the Company’s Board of Directors and, most recently, was executive vice president, chief medical officer and head of research & development at Synageva BioPharma Corp. until its acquisition by Alexion Pharmaceuticals in 2015.  F. Andrew Dorr, M.D., the Company’s previous interim chief medical officer, will transition his work to focus on the clinical development of the Company’s oncology programs.

 

XBiotech announced that the EMA rendered a negative “trend” vote after meeting with the Company to discuss the “Day 180 List of Outstanding Issues” related to the Company’s MAA for its candidate antibody for the treatment of colorectal cancer. A negative trend vote means it is unlikely that a positive CHMP opinion related to the Company’s MAA will be attained at the formal decision vote scheduled in May, and that additional steps would need to be taken to potentially gain marketing approval.

 

Aevi Genomic Medicine announced updated responder data from a subset of genomically identified patients in the SAGA trial of AEVI-001 in adolescent Attention Deficit Hyperactivity Disorder (ADHD). The new data will be presented at the 6(th) World Congress on ADHD in Vancouver, Canada on April 21, 2017. Key results of the trial include: Identification of nine genes that are predictive of clinically meaningful and statistically significant response [ADHD-Rating Scale (ADHD-RS) reduction of 17.6, p < .005] in the SAGA trial. These genes include certain glutamate metabotropic receptors (GRM) and neurodevelopmental genes and are found in approximately 10% of pediatric ADHD patients. One of the neurodevelopmental genes, contactin-4 (CNTN4) previously identified as important in Autism Spectrum Disorder (ASD), was highly enriched in the responder population (43%) and represents approximately 5% of pediatric ADHD patients. CNTN4 mutation phenotype is more severe with a higher prevalence of emotional dysregulation, including: anger control, risk taking, inappropriate movements and sounds.  All CNTN4 mutation positive patients on treatment (n=6) had clinically meaningful and statistically significant response to AEVI-001 (ADHD-RS reduction of 20.8, p=.03). 

 

Neurocrine Biosciences announced that long-term safety and efficacy data from the KINECT 3 Phase III extension study of INGREZZA (valbenazine) capsules for the treatment of adults with tardive dyskinesia will be presented as a platform presentation at the American Academy of Neurology (AAN) Annual Meeting April 22-28, 2017 in Boston. Additionally, two posters representing additional data from several clinical trials of INGREZZA will be presented, including an analysis of its pharmacologic characteristics.

 

Atara Biotherapeutics announced that it has entered into a clinical trial collaboration agreement with Merck, to evaluate Atara Bio’s allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes (CTL), or ATA129, in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum resistant or recurrent EBV-associated NPC. The Phase I/II trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination and is planned for initiation in 2018.

 

AbbVie announced high SVR(12 )rates were achieved with 8 weeks of treatment with its investigational, once-daily, ribavirin-free, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) in patients with challenging to treat genotype 3 (GT3) chronic hepatitis C virus (HCV) infection. In results from the Phase III ENDURANCE-3 study, 95 percent (n=149/157) of GT3 chronic HCV infected patients without cirrhosis and who are new to treatment achieved sustained virologic response at 12 weeks post-treatment (SVR(12)) following 8 weeks of treatment with G/P. These new data will be featured as an oral presentation today at The International Liver Congress (ILC) 2017 in Amsterdam, The Netherlands. Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.

 

Gilead Sciences announced results from an open-label, proof-of-concept study evaluating GS-0976, an investigational inhibitor of Acetyl-CoA carboxylase (ACC), in patients with nonalcoholic steatohepatitis (NASH). The data, from ten patients treated with GS-0976 20 mg taken orally once daily for 12 weeks, indicated that treatment was associated with statistically significant improvements in liver fat content and noninvasive markers of fibrosis, via inhibition of hepatic de novo lipogenesis (DNL). The late-breaking data were presented today during a general session at The International Liver Congress 2017 in Amsterdam (#GS-009).

 

PTC Therapeutics announced it has completed its acquisition of all rights to Emflaza (deflazacort) for the treatment of Duchenne muscular dystrophy (DMD) in the U.S. Execution of the asset purchase agreement setting forth the terms of the acquisition was announced on March 16, 2017. Financial terms of the acquisition include a total upfront consideration of $140 million paid to Marathon Pharmaceuticals. Marathon is also entitled to receive payments from PTC based on annual net sales of Emflaza beginning in 2018, which PTC expects will range as a percentage of net sales between the low to mid-20s on a blended average basis. In addition, Marathon has the opportunity to receive a single $50 million sales-based milestone.

 

Atara Biotherapeutics announced that its collaborating investigators at the Queensland Institute of Medical Research (QIMR Berghofer) and The University of Queensland are reporting interim Phase I trial results from the autologous version of ATA188, or autologous ATA188, in patients with primary or secondary progressive MS (PPMS and SPMS, respectively), at the 69(th) AAN Annual Meeting in Boston, Massachusetts.

 

Jounce Therapeutics announced enrollment of patients into the Phase II portion of the company’s Phase I/II ICONIC study of JTX-2011. JTX-2011 is a monoclonal antibody targeting ICOS, a protein found on the surface of certain T cells within many solid tumors.

 

Cempra announced the company is presenting eight abstracts highlighting solithromycin and the need for new treatments for community-acquired bacterial pneumonia (CABP) at the 27(th) European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna, Austria.

 

BeiGene announced that the first patient was dosed in a pivotal clinical trial of BGB-A317, an investigational anti-PD-1 antibody, in Chinese patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

 

Valeant Pharmaceuticals International announced that following the evaluation and approval of its Patient Access and Pricing Committee (PAPC), the company has decided to list SILIQ (brodalumab) injection, at $3,500 per month, which is the lowest injectable biologic psoriasis treatment currently on the market. SILIQ will also be included in the company’s patient access program to further offer financial support and access to patients. SILIQ, a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis, is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. SILIQ is the only product that included the psoriasis area and severity index (PASI 100) during clinical trials as a primary endpoint. The sales and marketing of SILIQ are expected to commence in the U.S. during the second half of 2017.

 

Apricus Biosciences announced the pricing of an underwritten public offering of an aggregate of 5,030,000 units, with each unit consisting of one share of Apricus common stock and one warrant to purchase 0.75 of a share of common stock, at a public offering price of $1.40 per unit.  The shares of common stock and warrants are immediately separable and will be issued separately in this offering. Apricus’ gross proceeds from this offering are expected to be approximately $7.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses, and excluding any proceeds Apricus may receive upon exercise of the warrants to be issued in this offering.  The offering is expected to close on or about April 26, 2017, subject to the satisfaction of customary closing conditions.

 

Syros Pharmaceuticals announced that it has entered into a stock purchase agreement with several institutional accredited investors for the private placement of 2,592,591 shares of common stock at a purchase price of $13.50 per share, yielding expected gross proceeds of $35 million. The purchase price for the shares represents an 8.8% discount to the average closing price of the Company’s common stock over the 30 trading days prior to the entry into the stock purchase agreement. The private placement is expected to close on or about April 26, 2017, subject to the satisfaction of customary closing conditions. The private placement was anchored by Samsara BioCapital, a new biotech investment firm founded by Srini Akkaraju, M.D., Ph.D., alongside a number of existing and new institutional investors. J.P. Morgan Securitiesand Cowen and Company, LLC acted as placement agents to the Company in connection with the offering.

 

 

ANALYST RECOMMENDATIONS

 

Citi analyst Liav Abraham removed Allergan from the “US Focus List” and increased her price target to $270 from $245, citing the company’s higher quality assets and growth profile, pipeline optionality, and stronger balance sheet vs. the peers.

 

BTIG analyst Robert Hazlett initiated coverage of Cascadian Therapeutics with a “buy” rating and $13 price target, citing Cascadian is focused on the development of Tucatinib, a novel, oral highly selective HER2 inhibitor for breast cancer.

 

Maxim analyst Lauren Chung initiated coverage of GW Pharmaceuticals with a “buy” rating and $135, citing GW’s lead product, Epidiolex, an orphan drug designated oral CBD (cannabidiol), showed positive results in three P3 trials for Dravet (DS) and Lennox-Gastaut syndromes (LGS).

 

Barclays analyst Geoff Meacham revised his price target of the following companies: Biogen to $360 from $380; Celgene to $125 from $120; Gilead to $85 from $90; Vertex to $100 from $90.