BioShares Biotechnology Clinical Trials (BBC): $21.77, +$0.11, +18.3% YTD

BioShares Biotechnology Products (BBP): $36.71, +$0.22, +12.1% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed as investors remained on the sidelines before the earnings season starts. Stock markets in Asia and Europe trended lower as investors remained cautious because of geopolitical tensions in the Middle East and the Korean peninsula. The dollar inched towards three-week highs drawing support from U.S. rate hike expectations, while gold prices slipped. Oil prices rose as another shutdown at Libya’s largest oilfield and heightened tension over Syria following U.S. missile attacks raised supply concerns.

 

 

MARKET HIGHLIGHTS

 

Rockwell Medical announced today a poster presentation at the National Kidney Foundation Spring Clinical Meeting, Wednesday, April 19th at 6:00PM – 7:30PM EDT during the opening session in the exhibit hall at the Swan and Dolphin Exhibit Hall in Orlando, FL.

 

Albireo Pharma announced that it will host a Key Opinion Leader breakfast meeting focused on rare pediatric liver diseases at the Lotte New York Palace in New York City on Wednesday, April 12, 2017, from 8:00 a.m. to 9:30 a.m. ET.

 

TherapeuticsMD announced that, on April 7, 2017, the Company received a letter from the U.S. Food and Drug Administration (FDA) stating that, as part of the FDA’s ongoing review of the Company’s new drug application (NDA) for TX-004HR, the Company’s applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severe dyspareunia (vaginal pain during sexual intercourse), a symptom of vulvar and vaginal atrophy (VVA), in post-menopausal women, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. The letter states that the notification does not reflect a final decision on the information under review.  The letter does not specify the deficiencies identified by the FDA and at this time the Company is not aware of the nature of the deficiencies. The Company intends to work with the FDA to understand the nature of the deficiencies and resolve them as quickly as possible.

 

Valneva SE announced today that it will be holding two presentations on Lyme disease and mosquito-transmitted diseases on April 11, 2017 at the 17th World Vaccine Congress in Washington DC. Over 600 vaccine specialists will converge to the event.

 

MediciNova announced that an abstract regarding a mouse model study that examined the potential clinical efficacy of MN-166 for glioblastoma (GBM) has been accepted for presentation at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 2-6, 2017 in Chicago, Illinois.

 

Cytori Therapeutics announced that the FDA has approved an Investigational Device Exemption (IDE) for a pilot clinical trial to evaluate Cytori Cell Therapy in patients with thermal burn injury. This trial, named the RELIEF trial, is a continuation of Cytori’s ongoing research and development efforts under its contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.

 

Geron announced that Janssen Research & Development has completed the second internal data reviews of IMerge and IMbark, the clinical trials of the telomerase inhibitor imetelstat in lower risk myelodysplastic syndromes (MDS) and relapsed or refractory myelofibrosis (MF), respectively. For IMerge, the benefit/risk profile of imetelstat in the treated patients supports continued development in lower risk myelodysplastic syndromes. A data package and proposed trial design refinements are planned to be provided to the FDA. For IMbark, the current results suggest clinical benefit and a potential overall survival benefit associated with imetelstat treatment in relapsed or refractory myelofibrosis; the trial will continue unchanged to evaluate maturing efficacy and safety data, including an assessment of overall survival.

 

Intellipharmaceutics International announced that Purdue Pharma L.P.Purdue Pharmaceuticals L.P.The P.F. Laboratories, Inc.Rhodes Technologies, and Grünenthal GmbH have commenced patent infringement proceedings against the Company in the United States District Court for the District of Delaware in respect of the Company’s NDA filing for its Rexista product candidate (abuse-deterrent oxycodone hydrochloride extended release tablets) with the FDA.

 

Akorn confirmed that Akorn is currently in discussions with Fresenius Kabi, a subsidiary of Fresenius SE & Co. KGaA concerning a potential acquisition of Akorn.

 

Mesoblast announced that the Phase III trial of its allogeneic mesenchymal precursor cell (MPC) product candidate MPC-150-IM in patients with moderate to advanced chronic heart failure (CHF) was successful in the pre-specified interim futility analysis of the efficacy endpoint in the trial’s first 270 patients. It is expected that the trial will enroll in total approximately 600 patients. After notifying the Company of the interim analysis results, the trial’s Independent Data Monitoring Committee (IDMC) additionally stated that they had no safety concerns relating to MPC-150-IM and formally recommended that the trial should continue as planned.

 

NantCell, part of the NantWorks ecosystem of companies, announced that the FDA has granted Orphan Drug Designation to the company’s Ganitumab, Insulin Growth Factor-1R (IGF-1R) monoclonal antibody therapy for the treatment of patients with Ewing sarcoma.

 

InVivo Therapeutics announced that the Brigham and Women’s Hospital (BWH) in Boston, MA 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. BWH is a teaching hospital of Harvard Medical School and hosts one of the largest neurosurgical intensive care units in the country.

 

OncoMed Pharmaceuticals reported top-line results from the company’s Phase II YOSEMITE clinical trial of demcizumab (anti-DLL4, OMP-21M18) in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in previously untreated patients with metastatic pancreatic cancer.  The randomized Phase II “YOSEMITE” trial was designed to assess the efficacy and safety of demcizumab plus standard-of-care chemotherapy in first-line metastatic pancreatic cancer with the primary endpoint of progression-free survival and a secondary endpoint of overall survival.  The trial did not meet the primary endpoint of progression-free survival.  Additionally, the interim median overall survival analysis did not show a benefit for demcizumab in combination with Abraxane plus gemcitabine compared to the Abraxane, gemcitabine plus placebo arm in patients with first-line metastatic pancreatic cancer.

 

Anthera Pharmaceuticals announced the completion of dosing in the randomized, double-blind, placebo controlled, Phase II BRIGHT-SC study of blisibimod in patients with IgA nephropathy (IgAN).  After Week 24, patients were given the opportunity to continue blinded treatment for up to 104 weeks, discontinue treatment but continue to be followed, or discontinue from the study.  Most patients, 42 of 57, completed at least 60 weeks of evaluation and 21 completed assessments through at least 104 weeks.  Anthera anticipates reporting top-line data in Q3.

 

Mast Therapeutics and Savara announced that, pending completion of their proposed merger, the combined company’s common stock has been approved for listing on the Nasdaq Capital Market under the symbol "SVRA."  Trading on the Nasdaq Capital Market is expected to commence on the first business day after completion of the merger.  Mast’s common stock is expected to continue to trade on the NYSE MKT until completion of the merger.  Mast has provided notification to the NYSE MKT of its intent to voluntarily withdraw its common stock from listing and trading on NYSE MKT in connection with the completion of the merger and the move to Nasdaq.

 

Syros Pharmaceuticals announced that the FDA accepted the Company’s IND application to advance SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, into a Phase I clinical trial in patients with advanced solid tumor malignancies, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers. Syros is on track to initiate the Phase I trial in the second quarter of 2017.

 

OncoMed Pharmaceuticals announced that Bayer Pharma has notified OncoMed of its decision not to exercise its option to license the first-in-class Wnt pathway inhibitors vantictumab (anti-Fzd, OMP-18R5) and ipafricept (Fzd8-Fc, OMP-54F28) for strategic reasons.  Effective June 2017, OncoMed will retain worldwide development and commercialization rights to vantictumab, ipafricept and all other Wnt pathway biologics under the collaboration.  The small molecule program under the companies’ collaboration continues without change.

 

Cellular Biomedicine Group announced that they have established a strategic research collaboration to co-develop certain high-quality industrial control processes in Chimeric Antigen Receptor T-cell (CAR-T) and stem cell manufacturing.  In connection with the collaboration, a joint laboratory within CBMG’s new Shanghai Zhangjiang GMP-facility will be established and dedicated to the joint research and development of a functionally integrated and automated immunotherapy cell preparation system.

 

Axovant Sciences announced that David Hung, MD, has been named CEO of Axovant Sciences, effective April 7, 2017. Dr. Hung, who also joined Axovant’s Board of Directors, succeeds founding CEO Vivek Ramaswamy. Mr. Ramaswamy will continue to serve on Axovant’s Board of Directors and will lead parent company and majority owner Roivant Sciences as its full-time CEO.

 

Aptevo Therapeutics announced the presentation of new clinical data evaluating the safety and efficacy of IXINITY [Coagulation Factor IX (Recombinant)] in previously treated patients under 12 years of age with Hemophilia B.  The data suggest that IXINITY appears to be safe and well tolerated in this subject population, and is comparable to the results from the overall patient population studied in the pivotal clinical trial of IXINITY.

 

Chugai Pharmaceutical announced that Alecensa as an initial (first-line) treatment showed that patients lived significantly longer without disease worsening (progression-free survival, PFS) compared to crizotinib in the ALEX Study, a global phase III study targeting ALK fusion gene positive non-small cell lung cancer (NSCLC), conducted by F. Hoffmann-La Roche Ltd. The safety profile of Alecensa was consistent with that observed in previous studies, with no new or unexpected adverse events.

 

Ferring Pharmaceuticals and Alrise Biosystems announced that the companies have entered into a development agreement with exclusive option rights for Ferring to leverage Alrise’s ImSus Technology Platform for the development of an injectable, controlled-release formulation of a peptide therapeutic.

 

Innoviva announced that on May 15, 2017, the next interest payment date under its non-recourse royalty notes due 2029 (the “Royalty Notes”), Innoviva will prepay $50 million in outstanding principal, representing a substantial portion of the Company’s $150 million capital return plan for 2017.

 

Aerie Pharmaceuticals announced the appointments of new employees Gary Menichini as Vice President of Sales, Dale Seibt as Vice President of Market Access, and Gerry McKenzie as Vice President of Commercial Operations. In addition, Michael McCleerey has changed positions within the Company and is now Vice President of Portfolio Development. All four positions are newly established and will report to Judith Robertson, Chief Commercial Officer.

 

Ovid Therapeutics announced that it has initiated a Phase I clinical trial to evaluate the pharmacokinetics (PK), safety and tolerability of OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome. OV101 (gaboxadol), a delta (?)-selective GABA(A) receptor agonist, is believed to be the first investigational drug to target the disruption of tonic inhibition, a key mechanism that allows a healthy human brain to decipher excitatory and inhibitory neurological signals correctly without being overloaded. Tonic inhibition is believed to play a significant role in the neurodevelopmental symptoms characteristic of disorders such as Angelman syndrome and Fragile X syndrome.

 

Portage Biotech announced that Biohaven Pharmaceutical Holding Company, in which Portage holds an equity interest of approximately 28.3%, issued a press release announcing that it filed a registration statement on Form S-1 with the SEC relating to a proposed offering of its common shares.

 

Reuters reported that Stada said it has decided to support an offer from Bain Capital and Cinven for 66 euros per share, valuing the company at about 5.32 billion euros. The private equity consortium is offering 65.28 euros per share and a dividend of 0.72 euro per Stada share, the company said in a statement. Stada, which had received offers from two consortia, said it has signed an investor agreement which would include protection provisions for employees.

 

Genentech, a member of the Roche Group, announced that the global, randomized Phase III ALEX study met its primary endpoint and showed that Alecensa (alectinib) as an initial (first-line) treatment significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared to crizotinib in people with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). This is the second Phase III trial to show that Alecensa was superior as an initial treatment compared to crizotinib in this type of lung cancer. The safety profile of Alecensa was consistent with that observed in previous studies, with no new or unexpected adverse events.

 

Alexo Therapeutics announced that it has initiated dosing in its Phase I clinical program evaluating the safety of ALX148 in patients with advanced solid tumors and lymphoma.

 

 

ANALYST RECOMMENDATIONS

 

Piper Jaffray analyst Joshua Schimmer initiated coverage of Gemphire with an “overweight” rating and $30 price target, citing a minimal ~ $100M mkt cap and a clinically validated and differentiated asset.

 

Janney Capital analyst Debjit Chattopadhyay initiated coverage of TESARO with a “neutral” rating and $141 price target, citing TSRO is relatively well-positioned after Zejula’s broad label unencumbered by a companion diagnostic, although transient myelo-suppression is a concern for some physicians.

 

RBC suspended coverage of the following companies due to the departure of both Adnan Butt and Michael Yee: Acorda Therapeutics, Aerie Pharmaceuticals, Amgen, Arbutus Biopharma, ArQule, Axovant Sciences, Biogen, BioMarin Pharmaceutical, Celgene Corporation, Curis, Endocyte, Esperion Therapeutics, FibroGen, Forward Pharma, Gemphire Therapeutics, Gilead, Intercept Pharmaceuticals, Intra-Cellular Therapies, Kite Pharma, Nabriva Therapeutics, Ocular Therapeutix, PDL BioPharma, Proteostasis, Prothena, Regeneron Pharmaceuticals, SCYNEXIS, Inc. Seattle Genetics, Spark Therapeutics, Spectrum Pharmaceuticals, Synthetic Biologics, TESARO, The Medicines Company, United Therapeutics, and Vertex Pharmaceuticals. 

 

Ladenburg Thalman analyst Kevin DeGeeter increased his price target of Mesoblast to $13.25 from $7.35, citing a positive interim futility analysis from the company’s Phase III program of MPC-150-IM in patients with moderate to advanced chronic heart failure.

 

HC Wainwright analyst Shaunak Deepak increased his price target of Rigel to $6 from $5, citing a reflection of BerGenBio value following Olso IPO.

 

Rodman & Renshaw analyst Joseph Pantginis assumed coverage of Celsion with a “buy” rating and $1.50 price target, citing Celsion’s lead asset is ThermoDox, which is a thermally sensitive liposome containing doxorubicin.