BioShares Biotechnology Clinical Trials (BBC): $20.66, -$0.52

BioShares Biotechnology Products (BBP): $37.03, -$0.58

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed after minutes from Federal Reserve’s meeting failed to give the market much direction, despite its support for interest rate hikes. The dollar traded in tight ranges against the yen and the euro, while gold prices steadied. Gap, Intuit and Baidu.com are among the major companies scheduled to report quarterly results later in the day. European equities were mixed, while Asian stocks closed mostly lower. Decrease in U.S. crude stocks pushed the oil higher.

 

 

MARKET HIGHLIGHTS

 

Pernix Therapeutics Holdings announced that it received a favorable opinion in its litigation with Actavis Laboratories FL, Inc. regarding a proposed generic version of Zohydro ER. Judge Gregory M. Sleet of the United States District Court for the District of Delaware concluded that Actavis’ proposed generic versions of Zohydro ER infringe U.S. Patent Nos. 9,132,096 (which expires on September 12, 2034) and 6,902,742 (which expires on November 1, 2019) following a trial that took place in October 2016. The Judge has entered an order enjoining Actavis from engaging in the commercial manufacture, use, offer to sell, or sale in the United States, or importation into the United States of Actavis’ Abbreviated New Drug Application (ANDA) product prior to expiration of the two patents.  Actavis did not assert invalidity or unenforceability of the patents at trial.

 

CTD Holdings, Inc. has closed a private placement of its securities with a group of accredited investors that included several directors of the Company and members of management. Investors in the private placement purchased 5,754,832 units at a price per unit of $0.35. Each unit consisted of one share of common stock and one seven-year warrant to purchase one share of common stock at an exercise price of $0.35.

 

BioDelivery Sciences International has entered into a senior credit facility with affiliates of CRG LP, a healthcare-focused investment firm, to retire its existing credit facility and provide additional working capital for the company.  The new credit facility consists of $45 million to be drawn at closing and the ability to access additional funding of up to an aggregate of $30 million in two tranches for a total of $75 million based on the achievement of certain revenue and market capitalization milestones through September 30, 2018. The term of the loan is six years with the first three years being interest only.

 

Cellect Biotechnology announced that Dr. Corey Cutler, Senior Physician at the world-renowned U.S. Dana Farber Cancer Institute, and an Associate Professor of Medicine at Harvard Medical School, is joining the Company’s Scientific and Medical Advisory Board. Dr. Cutler is a world leader in the field of Stem Cell Transplantation and Graft Versus Host Disease treatment.

 

Valneva SE published today its unaudited revenues and cash balance, and estimated EBITDA for the fourth quarter and the full year ended December 31, 2016. Audited full year financial results are scheduled to be released on March 23, 2017.  Valneva’s aggregate revenues and grants in the full year 2016 increased to €97.9 million from €83.3 million in 2015.  Liquid funds on December 31, 2016 stood at €42.2 million, compared to €42.6 million on December 31, 2015 and consisted of €35.3 million in cash and cash equivalents and €6.9 million in restricted cash.

 

Achaogen announced that they have achieved a strategic milestone in their ongoing efforts to develop an assay enabling therapeutic drug management (TDM) of plazomicin. Achaogen is developing plazomicin for the potential treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).

 

Rexahn Pharmaceuticals has begun enrolling patients into a Phase IIa clinical study of Supinoxin™ in metastatic triple negative breast cancer (TNBC).  The study will evaluate the safety and efficacy of Supinoxin™ in patients with metastatic TNBC who have failed prior treatments.  The Phase IIa clinical proof-of-concept study is an open-label evaluation of the safety and efficacy of Supinoxin™ monotherapy in patients with metastatic triple negative breast cancer who have failed multiple prior chemotherapeutic regimens.  The study will recruit an initial 10 patients and can be extended up to 50 patients, if warranted, based on the data readout from the initial cohort of patients. The primary endpoint is progression free survival.  Patients will be enrolled at seven study sites in the United States. Based on the initial clinical data, we may conduct additional clinical studies looking at the combination of Supinoxin together with other anti-cancer agents in TNBC.

 

STRATA Skin Sciences will release fiscal year ended December 31, 2016 financial results on Thursday, March 9, after the market close and host a conference call at 4:30 pm Eastern Time to review the Company’s progress and answer questions.

 

Foamix Pharmaceuticals will participate in a panel discussion entitled "Exciting New Therapeutics: Emerging Public Company Showcase," at the 3rd Annual Dermatology Innovation Forum, being held at the Hyatt Regency Orlando in Orlando, Florida on March 2, 2017.

 

BioTime will release fourth quarter and fiscal 2016 financial and operating results on Thursday, March 16, 2017, after the close of the U.S. financial markets, and host a conference call and webcast on Thursday, March 16, 2017, at 4:30 p.m. Eastern Time to discuss the results and recent corporate developments.

 

Intercept Pharmaceuticals reported 4Q16 GAAP EPS loss of $4.84, which compares to a loss of $3.62 for the same period a year ago. The company missed the GAAP EPS mean estimate loss of $3.68. Total revenue for 4Q16 was $13.8 million, which compares to $0.4 million for the same period a year ago. This compares to a mean estimate of $9.0 million.

 

After yesterday’s close, PRA Health Sciences reported 4Q16 non-GAAP EPS of $0.71, which compares to $0.59 for the same period a year ago. The company beat the non-GAAP EPS mean estimate of $0.64. Total revenue for 4Q16 was $413.6 million, which compares to $362.3 million for the same period a year ago. This compares to a mean estimate of $405.0 million. Following PRA Health Sciences’ earnings, Credit Suisse analyst Erin Wright increased her price target to $69 from $67; Baird analyst Eric Coldwell increased his price target to $68 from $66.

 

After yesterday’s close, Clovis Oncology reported 4Q16 non-GAAP EPS loss of $1.83 which compares to a loss of $2.23 for the same period a year ago. The company missed the non-GAAP EPS mean estimate loss of $1.64. Total revenue for 4Q16 was $0.1 million, which compares to no revenue reported for the same period a year ago. This compares to a mean estimate of $0.1 million. Following Clovis’ earnings, Morgan Stanley analyst Andrew Berens increased his price target to $72 from $68; JP Morgan analyst Cory Kasimov increased his price target to $58 from $49; Credit Suisse analyst Kennen MacKay increased his price target to $70 from $53.

 

After yesterday’s close, bluebird bio reported 4Q16 GAAP EPS loss of $1.88 which compares to a loss of $1.29 for the same period a year ago. The company missed the GAAP EPS mean estimate loss of $1.82. Total revenue for 4Q16 was $1.6 million, which compares to $1.5 million reported for the same period a year ago. This compares to a mean estimate of $1.8 million. Following bluebird’s earnings, JP Morgan analyst Cory Kasimov decreased his price target to $118 from $120.

 

Cyclacel Pharmaceuticals reported top-line results from the pivotal Phase III SEAMLESS study in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML), who are not candidates for or have refused intensive induction chemotherapy.

 

AVEO Oncology announced that its pivotal, Phase III TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), has successfully completed the first safety review by the study’s Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment.

 

Inovio Pharmaceuticals announced that Dr. David B. Weiner, Inovio’s co-founder, presented positive clinical data on Inovio’s DNA-based vaccines against MERS (Middle East Respiratory Syndrome) (GLS-5300) and Zika (GLS-5700) at the Coalition for Epidemic Preparedness Innovation (CEPI)’s 1st Scientific Meeting on “Vaccines Against Emerging Infections – A Global Insurance” in Paris, France.

 

Celgene announced that the FDA has expanded the existing indication for REVLIMID (lenalidomide) 10 mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant (auto-HSCT). The expanded indication makes REVLIMID the first and only treatment to receive FDA approval for maintenance use following auto-HSCT.

 

Shire plc announced the publication of results from the Phase Ib study of lanadelumab (SHP643; formerly DX-2930) in the February 23, 2017 issue of the New England Journal of Medicine (NEJM). In this Phase Ib study, no serious adverse events or discontinuations due to adverse events were observed at all doses studied. Pre-specified efficacy analyses in patients with at least 2 attacks in the 3 months prior to enrolment demonstrated that from day 8 to day 50, the administration of two doses of lanadelumab (300 or 400 mg) 14 days apart, reduced the rate of attacks by 100% and 88% respectively, when compared with placebo.  In addition, all subjects were attack-free in the 300 mg group and 82% were attack-free in the 400 mg group, compared to 27% in the placebo group.

 

Bellicum Pharmaceuticals announced the presentation of updated clinical results from its multicenter BP-004 clinical trial of BPX-501 and rimiducid at the 2017 BMT Tandem Meetings. Results on 73 patients with more than six months of follow-up demonstrated that the use of BPX-501 following an alpha/beta-depleted, haploidentical hematopoietic stem cell transplant (haplo-HSCT) resulted in rapid immune recovery in patients with inherited blood disorders and hematological cancers.   

 

Novartis announced that the FDA accepted the Company’s sNDA for filing, and granted Priority Review for the expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA also granted Breakthrough Therapy designation to Zykadia for the first-line treatment of patients with ALK+ metastatic NSCLC with metastases to the brain.

 

Reata Pharmaceuticals announced the initiation of patient screening in a Phase II/III trial to evaluate bardoxolone methyl (“bard”) in patients with chronic kidney disease (“CKD”) caused by Alport syndrome.  The purpose of this study is to determine the safety and efficacy of bard in Alport syndrome patients, and to determine if Alport syndrome patients experience improvements in kidney function similar to those observed in multiple, previous trials of bard in patients with other forms of CKD.  Reata expects data from the Phase II portion of the trial to be available, and to decide on entering the Phase III portion, by year-end 2017.

 

GlaxoSmithKline and Innoviva announced positive headline results from a non-inferiority lung function study, which demonstrated that patients with well-controlled asthma were able to switch to the once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI) 100/25, an inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) combination, from the twice-daily Seretide Accuhaler (fluticasone propionate /salmeterol, FP/SAL) 250/50, without compromising their lung function.

 

AmpliPhi Biosciences announced the formation of its Scientific Advisory Board (SAB) and the appointment of Timothy K. Lu, M.D., Ph.D., as Chairman of the SAB. Dr. Lu heads the Massachusetts Institute of Technology’s (MIT) Synthetic Biology Group in the Research Laboratory of Electronics, where he applies proprietary engineering techniques to biological systems, including bacteriophages, to address global concerns such as the growing incidence of antibiotic resistance.

 

Resverlogix announced the receipt of the final minutes of an in-person Type B meeting with the Cardiovascular and Renal Products Division of the FDA. The purpose of the meeting was to request written comments, recommendations and feedback on Resverlogix’s proposed protocol for its Phase IIa kidney dialysis trial.  The primary objective of the study will be to evaluate if treatment with apabetalone in combination with standard of care (SoC) decreases alkaline phosphatase in comparison to placebo and SoC.

 

Athersys announced a presentation featuring its MultiStem cell therapy treatment for ischemic stroke at the International Stroke Conference 2017 this week in Houston. Dr. Kiyohiro Houkin, Professor and Chairman at Department of Neurosurgery of Hokkaido University Graduate School of Medicine, and Director of Hokkaido University Hospital, will present an overview of the Treatment Evaluation of Acute Stroke Using Regenerative Cell Elements (TREASURE) study, which is the Phase II/III trial of MultiStem (HLCM051) being conducted by HEALIOS K.K. in Japan.

 

Flexion Therapeutics reported it has enrolled the first patient in a clinical trial to evaluate the safety of repeat administration of its investigational drug candidate Zilretta (also known as FX006) in patients with osteoarthritis (OA) of the knee. The open-label study is expected to enroll approximately 200 patients at up to 20 clinical sites in the United States. A list of participating trial centers is available on ClinicalTrials.gov.

 

KemPharm announced enhancements to its U.S. and global intellectual property estate governing its portfolio of prodrug product candidates.  The USPTO issued two new patents: 1) a “Composition of Matter” patent related to the KP511 family of compounds, and 2) a “Dosage and Formulation” patent protection related to KP201.

 

Abeona Therapeutics announced that on February 14, 2017, the plaintiff voluntarily dismissed the putative securities class action lawsuit he had recently filed against the company and certain members of its management, following the Company’s demand that the case be dismissed because it lacked a valid legal and factual basis. The plaintiff based his Complaint, in its entirety, on allegations that been cut and pasted from an internet blog article. No payment or any other consideration was paid by, or on behalf of, the Company or its management in connection with the lawsuit’s dismissal.

 

Incyte announced a multi-year research collaboration with the Abramson Cancer Center at the University of Pennsylvania. Through this collaboration, Incyte and Abramson have agreed to bring together the knowledge and expertise of their leading drug discovery and development scientists to conduct collaborative research aimed at advancing the understanding of cancer biology and fostering innovative science in immunotherapy. Under the collaboration, Penn investigators will leverage their expertise in preclinical biology and translational science to investigate the novel therapeutics being discovered at Incyte and better understand their mechanisms of action–further developing the clinical rationales for combination therapy and patient selection. Additionally, in a combined effort to better define the relationships between human tumor characteristics and immune cell infiltration and function, Incyte and Penn will work together to develop a bioinformatics program in clinical immunotherapy aimed at fostering the advancement of novel therapeutics.

 

Fibrocell Science announced that the first patient has been dosed in the Phase I portion of the Phase I/II clinical trial of FCX-007, the Company’s gene therapy candidate for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)–a devastating, progressive genetic skin disease with a high mortality rate.

 

Corbus Pharmaceuticals Holdings announced that Michael Knowles, M.D., a member of the Company’s Scientific Advisory Board and Professor of Pulmonary and Critical Care Medicine, University of North Carolina Chapel Hill will present findings demonstrating positive effects of JBT-101 on reducing inflammatory mediators in alveolar macrophages isolated from excised lungs of cystic fibrosis (CF) patients. The presentation will be on March 13, 2017, in New York City, at the Research and Development Day hosted by Corbus.

 

Madrigal Pharmaceuticals announced that the first patient has been dosed in its Phase II study of MGL-3196 for the treatment of heterozygous familial hypercholesterolemia (HeFH), a severe genetic dyslipidemia that causes early onset cardiovascular disease. MGL-3196 is a first-in-class, oral, once-daily, liver-directed, thyroid hormone receptor (THR) <BETA>-selective agonist medication. MGL-3196 is also in a Phase II clinical trial for the treatment of non-alcoholic steatohepatitis (NASH).

 

MabVax Therapeutics Holdings announced that it has received notice from the FDA authorizing the initiation a Phase I clinical trial with MVT-1075 as a therapeutic treatment for pancreatic cancer. MVT-1075 ((177) Lu-CHX-A"-DTPA-HuMab5B1) is the Company’s novel fully human antibody radioimmunotherapy (RIT). MabVax plans to initiate the Phase I clinical trial in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies the first half in 2017. This is the third IND authorized by FDA in the last fourteen months by MabVax that builds on the tumor targeting characteristics of the HuMab-5B1 antibody discovered from immune responses of cancer patients vaccinated with the Company’s proprietary cancer vaccines.

 

Bristol-Myers Squibb announced that it has agreed to sell $1.5 billion of senior unsecured notes: $750 million in aggregate principal amount of 1.600% notes due 2019 and $750 million in aggregate principal amount of 3.250% notes due 2027, in an underwritten public offering. Goldman Sachs, Morgan Stanley, Merrill Lynch, Pierce, Fenner & Smith, Citigroup Global Markets and J.P. Morgan Securities are acting as joint book-running managers for the offering. Bristol-Myers Squibb intends to use the proceeds from the offering to fund its share repurchase program and for general corporate purposes.

 

 

ANALYST RECOMMENDATIONS

 

LifeSci Capital analyst Jerry Isaacson initiated research coverage of Bellerophon Therapeutics.

 

Following Endologix’s earnings, Canaccord analyst Jason Mills decreased his price target to $5.75 from $6.30.

 

Chardan analyst Keay Nakae initiated coverage of OncoCyte with a “buy” rating and $6.50 price target, citing OncoCyte has the potential to become a successful competitor in the emerging field of non-invasive liquid biopsy diagnostics.

 

HC Wainwright analyst Ed Arce decreased his price target of Trevana to $8 from $11, citing the implications of the mixed data set and the likely/probable clinical settings for use that best match OLINVO’s (new brand name for oliceridine) overall therapeutic profile.

 

Following Esperion’s earnings, Chardan analyst Gbola Amusa increased his price target to $20 from $10; RBC analyst Michael Yee increased his price target to $30 from $20.

 

Evercore ISI analyst Umer Raffat initiated coverage of Jazz Pharmaceuticals with a “buy” rating and $160 price target, citing JZP-110 fits in very nicely with Xyrem franchise.

 

Stifel analyst Adam Walsh initiated coverage of Reata with a “buy” rating and $38 price target, citing blockbuster potential for lead asset bardoxolone methyl (BARD) in chronic kidney disease (CKD) caused by Alport syndrome.