BioShares Biotechnology Clinical Trials (BBC): $20.42, +$0.50, +10.9% YTD

BioShares Biotechnology Products (BBP): $36.41, +$0.74, +11.2% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed on the first trading day of the week, after the S&P 500 closed just short of a record high in the previous session. European shares pared early gains to trade lower, while the Asian markets closed up. The dollar gained against the euro. Oil was little changed as investors remained cautious about the tensions between the U.S. and Iran. Gold rose on technical buying.

 

 

MARKET HIGHLIGHTS

 

Advaxis announced that the first patient has been enrolled and dosed in its AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence) trial, the only company-sponsored global phase 3 trial enrolling patients with advanced stage cervical cancer.

 

BioTime announced the acquisition of global rights to ophthalmology-related intellectual property (IP) assets from the University of Pittsburgh’s Medical Center (UPMC), via the school’s Innovation Institute. The technology was developed in part in collaboration with BioTime scientists and includes composition and methodologies to develop 3-D retinal tissue derived from human pluripotent stem cells for implantation in patients with advanced stages of retinal degeneration.

 

Kamada announced today financial results for the three and twelve months ended December 31, 2016.  Net loss for the year was $6.7 million, or $0.18 per share, compared to a net loss of $11.3 million, or $0.31 per share in the same period of 2015.  Adjusted net loss was $5.6 million compared to adjusted net loss of $9.4 million in the same period of 2015.  As of December 31, 2016, Kamada had cash, cash equivalents and short-term investments of $28.6 million, compared with $28.3 million as of December 31, 2015. During 2016, the Company generated $1.9 million in cash from operation operations and used $2.6 million for capital expenditures.  For the year ending December 31, 2017, Kamada expects total revenues to be  $100 million.

 

TiGenix NV announced that the abstract related to the positive results of the ADMIRE-CD pivotal Phase III trial of Cx601 for complex perianal fistulas in Crohn`s disease patients after 52 weeks has been accepted for oral presentation at the upcoming 12th Annual Congress of the European Crohn`s and Colitis Organization (ECCO).

 

Innate Pharma announced top-line results from the randomized, double-blind, placebo-controlled Phase II trial testing the efficacy of lirilumab as a single agent maintenance treatment in elderly patients with acute myeloid leukemia (AML) in first complete remission ("EffiKIR" trial). The study did not meet its primary efficacy endpoint of leukemia-free survival (LFS).  Two arms of the trial tested single agent lirilumab at different doses and treatment intervals (0.1 mg/kg q3months or 1 mg/kg q1month) whereas in the third arm, patients received placebo. There was no statistically significant difference between either lirilumab arms and the placebo arm on the LFS nor on other efficacy endpoints. As announced in March 2015, one arm of the trial was discontinued upon DSMB recommendation. This arm has now been identified as the 1 mg/kg q1month arm of the trial. At the time of its decision, the DSMB assessed that the objective of achieving a superior LFS in this arm compared to placebo could not be reached. There was no concern with tolerance.  The adverse events encountered with lirilumab were consistent with the previously reported safety profile of lirilumab.

 

Addex Therapeutics announced today the publication of a review summarizing the current status of allosteric modulators (AMs) as potential novel treatments for neurodegenerative diseases, such as Parkinson`s and Alzheimer`s disease, in Current Opinion in Pharmacology (http://www.sciencedirect.com/science/article/pii/S1471489217300061).  This review highlights the important contribution Addex has made in the discovery of allosteric modulator compounds.

 

Albireo Pharma is scheduled to present at the 19th Annual BIO CEO & Investor Conference at the Waldorf Astoria New York in New York City on Monday, February 13 @ 9:30 a.m. ET.

 

VBL Therapeutics will provide a corporate overview at the BIO CEO & Investor Conference on Monday, February 13th @ 9:30am ET.

 

Foamix Pharmaceuticals will provide a corporate overview and business update at the BIO-CEO & Investor Conference on Tuesday, February 14th @ 2pm ET.

 

BrainStorm Cell Therapeutics will provide a corporate overview at BIO CEO & Investor Conference on Monday, February 13th @ 1pmET.

 

Rexahn Pharmaceuticals will be presenting at the 2nd Annual Disruptive Growth & Healthcare Conference on Thursday, February 16th @ 11:45am ET.

 

Galena Biopharma announced the results from a meeting of the DSMB for the two investigator-sponsored (IST) combination clinical trials with NeuVax (nelipepimut-S) plus trastuzumab.  The trials are being run in breast cancer patients to assess the ability of the combination of trastuzumab and the HER2 vaccine nelipepimut-S (administered with the immunoadjuvant granulocyte macrophage-colony stimulating factor) to prevent recurrence in the adjuvant setting.

 

ARIAD Pharmaceuticals announced the submission of a MAA for its investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the EMA. ARIAD is seeking marketing approval in the European Union of brigatinib in adult patients with anaplastic lymphoma kinase (ALK+) non-small cell lung cancer (NSCLC) who have been previously treated with crizotinib. The FDA is currently reviewing a NDA for brigatinib filed by ARIAD and has set an action date of April 29, 2017 under the PDUFA.

 

AveXis announced that the planned pivotal study of AVXS-101 in spinal muscular atrophy (SMA) Type 1 in the European Union (EU) will reflect a single-arm design, using natural history of the disease as a comparator, and will enroll approximately 30 patients. This update is based on the receipt of the Scientific Advice response from the Scientific Advice Working Party within the CHMP of the EMA.

 

Intarcia Therapeutics announced that the FDA has accepted for active review its NDA for ITCA 650, an investigational therapy for the treatment of Type II diabetes (T2D). Intarcia looks forward to working closely with the FDA through the review process.

 

Kiadis Pharma provides a progress update on the clinical and regulatory status of ATIR101, the Company’s lead product to address the key risks and limitations of hematopoietic stem cell transplantation (HSCT) in blood cancer.

 

Ablynx announced that it has submitted a MAA to the EMA for approval of caplacizumab, its first-in-class anti-von Willebrand factor (vWF) Nanobody for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP), an ultra-rare, acute, life-threatening blood clotting disorder with a high unmet medical need. The MAA includes data from the Phase II TITAN study in patients with aTTP which demonstrated a statistically significant and clinically meaningful benefit of caplacizumab treatment in reducing the time to platelet count normalization and reducing recurrences while on drug treatment. Results of post-hoc analyses of the Phase II TITAN study further demonstrated that caplacizumab dramatically reduced the number of patients experiencing major thromboembolic events, as compared to placebo.  If approved, caplacizumab will be the first therapeutic specifically indicated for the treatment of aTTP.

 

Alimera Sciences announced that its subsidiary, Alimera Sciences Limited, received the pricing and reimbursement decree for ILUVIEN from Agenzia Italiana del Farmaco (AIFA) on January 11, 2017. The decree, published February 2, 2017 in the Gazzetta Ufficiale della Repubblica Italiana, the official journal of record of the Italian government, changed the reimbursement status of ILUVIEN from Class C, in which the patient covers the cost of the treatment, to Class H, with a restriction to patients with an artificial lens implanted. This means that in Italy, ILUVIEN will be hospital-administered and should be fully reimbursed for those patients who have previously undergone cataract surgery. In Europe, ILUVIEN is a sustained release intravitreal implant for the treatment of vision impairment associated with chronic diabetic macular edema (DME).

 

Cytori Therapeutics announced that the FDA Division of Industry and Consumer Education (DICE) has granted Small Business status to Cytori Therapeutics for Fiscal Year 2017. The newly granted Small Business status allows Cytori to receive significant financial incentives, fee reductions, and fee waivers for selective FDA medical device regulatory filings. Such designation makes the company eligible for a substantial reduction in many medical device user fees and a one-time waiver of the user fee for its first premarket approval (PMA) application potentially occurring later in 2017.

 

Veracyte announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), has finalized its coverage policy for the Percepta Bronchial Genomic Classifier. This local coverage determination (LCD) makes Percepta the first genomic test to be covered by Medicare for improved lung cancer screening and diagnosis. Developed through the Medicare MolDx program, the policy will become effective March 13, 2017 and provides a framework for other participating MACs to follow.

 

Selecta Biosciences announced that Selecta Chief Scientific Officer Takashi Kei Kishimoto, Ph.D. is presenting preclinical data from the company’s proprietary peanut allergy and celiac disease programs at GTCbio’s 5th Immunogenicity & Immunotoxicity Conference in San Diego, CA. Entitled "Synthetic Vaccine Particles (SVP) to Treat Food Allergy and Celiac Disease and to Mitigate the Formation of Anti-Drug Antibodies," Dr. Kishimoto’s presentation takes place at 5:45 p.m. ET/2:45 p.m. PT today.

 

Glaukos announced that Joseph E. Gilliam will join the company as Chief Financial Officer and Senior Vice President, Corporate Development in May 2017. Mr. Gilliam will replace the company’s current Chief Financial Officer Richard Harrison, who is retiring later in 2017.

 

Opiant Pharmaceuticals announced the appointment of Phil Skolnick, Ph.D., D.Sc. (hon.) as Chief Scientific Officer, effective immediately. In his new position, Dr. Skolnick will lead Opiant’s research and development activities.   

 

MediWound announced that the EMA has endorsed the extension of the Children Innovative Debridement Study (CIDS) population to include patients age one to 18. Based on the recommendation of the study’s Data Safety Monitoring Board (DSMB), after blindly reviewing the accumulated CIDS data, and the EMA endorsement, MediWound will initiate the second stage of the study that allows inclusion of younger pediatric burn patients beginning at the minimum age of one instead of four years of age.

 

Strata Oncology announced an agreement with Epizyme to support patient identification and enrollment for Epizyme’s ongoing Phase II clinical trial of tazemetostat in patients with relapsed or refractory non-Hodgkins lymphoma (NHL).

 

Immunovaccine announced that the UHN’s Princess Margaret Cancer Centre (PM) will conduct a Phase II clinical trial to evaluate the use of a combination of immunotherapies from Immunovaccine and Merck.

 

Rosetta Genomics announced that the USPTO has granted two patent allowances for patent applications US 14/756,185 (‘185) and US 14/999,879 (‘879), both divisional patents of the parent application titled "microRNAs and uses thereof."

 

Edenbridge Pharmaceuticals announced that the CHMP has adopted a positive opinion for Yargesa (100mg miglustat capsules). The total market for miglustat capsules in the EU is estimated to be €50 million and Edenbridge is exploring partnering, licensing and divestiture opportunities.

 

MiMedx Group announced the decision of its Board of Directors to authorize an increase in the Company’s Share Repurchase Program.

 

ProMetic Life Sciences announced that California Capital Equity has exercised 44,791,488 share purchase warrants at a price of $0.47 per share for total proceeds of $21,051,999.36 to the Corporation.

 

Foresee Pharmaceuticals announced that it has successfully concluded its scientific advice discussions with German BfArM on key regulatory and development issues relating to a MAA submission of FP-001, Leuprolide Mesylate Injectable Suspension (LMIS) 50 mg, a 6-month depot of leuprolide mesylate for subcutaneous injection.  Foresee has very recently completed a global registration study with FP-001 LMIS 50 mg and plans to seek regulatory approvals in the US and several major EU countries.

 

Rigel Pharmaceuticals announced the closing of its previously announced underwritten public offering of 23,000,000 shares of its common stock at a price to the public of $2.00 per share, which includes 3,000,000 additional shares of common stock issued upon the exercise in full of the underwriters’ option to purchase additional shares. The gross proceeds to Rigel from this offering are $46,000,000, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Rigel. Jefferies, Piper Jaffray & Co. and BMO Capital Markets acted as joint book-running managers for the offering. H.C. Wainwright & Co. acted as lead manager for the offering.

 

 

ANALYST RECOMMENDATIONS

 

FBR analyst Vernon Bernardino downgraded Galena Biopharma to “market perform” from “outperform” and decreased his price target to $4 from $11, citing the CEO departure.

 

Roth Capital analyst Mark Breidenbach downgraded bluebird bio to “neutral” from “buy”, citing LentiGlobin won’t be commercialized quickly.

 

Needham analyst Chad Messer upgraded the following companies: Progenics to “strong buy” from “buy and increased his price target to $14 from $11; Cytokinetics to “strong buy” from “buy” and increased his price target to $22 from $17.

 

Rodman & Renshaw analyst Raghuram Selvaraju increased his price target of Abeona Therapeutics to $20 from $17, citing over the course of the past several months, Abeona has reported various positive achievements for multiple programs in its pipeline.

 

Rodman & Renshaw analyst Raghuram Selvaraju initiated coverage of NovaBay Pharmaceuticals with a “buy” rating and $6 price target, citing a risk-mitigated firm with a high-growth lead franchise.

 

Cowen analyst Boris Peaker initiated coverage of Tesaro with a “market perform” rating and $155 price target, citing TSRO has a high probability of being acquired, but the acquisition premium to be small at current valuation offset by significant risk from competitor data in 2017.

 

Goldman Sachs analyst Terence Flynn decreased his price target of Regeneron to $446 from $448, citing lower sales.

 

Barclays analyst Douglas Tsao made price target revisions to the following companies, citing estimate revisions: Endo International to $15 from $22; Perrigo to $100 from $110.