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BioShares Biotechnology Clinical Trials (BBC): $21.57, -$0.07, +17.2% YTD

BioShares Biotechnology Products (BBP): $36.44, -$0.03, +11.3% YTD

 

 

MARKET COMMENTARY

 

The dollar slid against a basket of currencies, while gold rose, after U.S. President Donald Trump’s comments that he would like to see interest rates stay low and that the greenback was too strong. U.S. stock index futures indicated a lower start on Wall Street as focus shifted to quarterly results of major banks such as Wells Fargo and Citigroup. Weekly jobless claims and producer prices data occupies the day’s economic calendar. The University of Michigan will also release its consumer sentiment data for April. Asian bourses fell, and financial shares dragged European markets lower. Oil was little changed on concerns about rising U.S. output.

 

 

MARKET HIGHLIGHTS

 

Transgene announced that the first patient with soft tissue sarcoma (STS) has been treated in the Phase 2 part of the METROmaJX clinical trial at Institut Bergonié (Bordeaux, France). METROmaJX is a Phase 1/2 clinical trial evaluating the tolerability and efficacy of the co-administration of Pexa-Vec with metronomic cyclophosphamide (low doses given with high frequency) in patients with advanced solid tumors such as breast cancer and STS (NCT02630368).

 

Rexahn Pharmaceuticals announced that it will implement a 1-for-10 reverse stock split of outstanding shares of the Company’s common stock, together with a corresponding proportional reduction in the number of authorized shares of the Company’s capital stock. The Company expects that the reverse stock split will be effective on May 5, 2017 upon the filing and effectiveness of a Certificate of Amendment to the Company’s Certificate of Incorporation, and that trading of the Company’s common stock on the NYSE MKT will begin on a split-adjusted basis at the opening of trading on May 5, 2017. The authorized share reduction will be effective concurrently with the reverse stock split. As a result of the reverse stock split, each 10 shares of issued common stock will be converted into one share of common stock. Shareholders will receive cash in lieu of any fraction of a share that they would otherwise be entitled to receive as a result of the reverse stock split.

 

DelMar Pharmaceuticals announced that it has priced a 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. The offering is expected to close on or about April 18, 2017, subject to the satisfaction of customary closing conditions.

 

CymaBay Therapeutics announced that data from its Phase 2 proof-of-concept study of seladelpar in patients with primary biliary cholangitis (PBC) will be presented at the International Liver Congress™  2017 sponsored by the European Association for the Study of Liver Diseases (EASL), in Amsterdam, The Netherlands, April 19-23 2017. Seladelpar is an orally administered potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist.

 

Achaogen announced seven upcoming presentations on plazomicin at the 27th European Congress of Clinical Microbiology and Infectious Disease (ECCMID). The company and its collaborators will deliver two oral presentations and five poster presentations at the event, which will be held in Vienna, Austria from April 22 to 25, 2017. Achaogen is developing plazomicin, its lead product candidate, to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).

 

Aimmune Therapeutics announced the appointment of Eric Bjerkholt as Chief Financial Officer.  Mr. Bjerkholt joins Aimmune from Sunesis Pharmaceuticals, Inc., where, over 13 years with the company, his role as CFO expanded to oversee multiple aspects of governance, corporate relations, and other functions.  Mr. Bjerkholt holds a Cand. Oecon. (master’s) degree in economics from the University of Oslo and an M.B.A. from Harvard Business School. He has served on the boards of directors of several publicly traded companies and is currently a member of the board of directors and chair of the audit committee for Corium International, Inc.

 

Ocera Therapeutics announced that data from an investigator-sponsored preclinical study of Ocera’s validated ammonia scavenger, ornithine phenylacetate (OCR-002), will be presented in a poster session at The International Liver Congress™ of the European Association for the Study of the Liver (EASL 2017) in Amsterdam, The Netherlands, on Thursday, April 20, 2017.

 

Catalyst Biosciences announced the closing of an underwritten public offering of units for gross proceeds of $20.7 million, which includes the full exercise of the underwriters’ over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses payable by Catalyst.

 

Aerie Pharmaceuticals reported the successful six-month topline safety and efficacy results of its Rocket 4 Phase III clinical trial for product candidate Rhopressa, a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The Rocket 4 trial was designed to provide six-month safety data adequate for European regulatory filing purposes. Rocket 4 was not necessary for U.S. NDA filing purposes, although data from the 90-day efficacy component of the trial was included in the February 2017 Rhopressa NDA submission as supportive.   Rocket 4 enrollment totaled approximately 700 patients and was a two-arm six-month trial, which included a 90-day efficacy readout evaluating once-daily Rhopressa for non-inferiority to twice-daily timolol. The 90-day efficacy readout, which took place in October 2016, demonstrated successful achievement of the 90-day primary efficacy endpoint. This final readout from Rocket 4 includes six-month safety data and diurnal efficacy measurements at months four, five and six, which do not constitute a primary efficacy endpoint.

 

AVEO Oncology announced that its European licensee for tivozanib, EUSA Pharma, has submitted responses to the EMA Day 180 List of Outstanding Issues (LOI) related to the MAA for tivozanib as a first-line treatment for renal cell carcinoma. With submission of the response complete, EUSA remains tentatively scheduled to provide an oral explanation to the EMA’s CHMP at its May 2017 meeting.

 

Relmada Therapeutics announced that the FDA has granted Fast Track designation for d-Methadone (REL-1017 dextromethadone), the company’s novel N-methyl-D-aspartate (NMDA) receptor antagonist in development for the adjunctive treatment of major depressive disorder.

 

RedHill Biopharma together with IntelGenx announced that the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT(5 mg and 10 mg), a proprietary oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.

 

Bristol-Myers Squibb announced that it has entered into two separate agreements to license BMS-986168, an anti-eTau compound in development for Progressive Supranuclear Palsy (PSP), to Biogen, and BMS-986089, an anti-myostatin adnectin in development for Duchenne Muscular Dystrophy (DMD), to Roche. Under the agreement to license BMS-986168, Biogen will pay to Bristol-Myers Squibb an upfront payment of $300 million with potential milestone payments of up to $410 million. Biogen also will assume all remaining obligations to the former stockholders of iPierianrelated to Bristol-Myers Squibb’s acquisition of the company in 2014. Under the agreement to license BMS-986089, Roche will pay to Bristol-Myers Squibb an upfront payment of $170 million with potential milestone payments of up to $205 million. Bristol-Myers Squibb will receive tiered double-digit royalties if either asset is approved and commercialized. These agreements are subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and are expected to close in the second quarter of 2017.

 

Arbutus Biopharma announced that a justice of the Court of Appeal for British Columbia denied an attempt by Acuitas Therapeutics to appeal the injunction issued by the Supreme Court of British Columbia, which prevents Acuitas from any further licensing of Arbutus’ lipid nanoparticle (LNP) technology.

 

Celsion announced publication of the article, “Lyso-Thermosensitive Liposomal Doxorubicin for Treatment of Bladder Cancer,” in the International Journal of Hyperthermia. The article describes the results of porcine in vivo studies to evaluate ThermoDox in combination with loco-regional mild hyperthermia for targeted drug delivery to the bladder wall as a potential treatment for bladder cancer.  Swine bladder walls are similar in proportion and composition to human bladders.  Doxorubicin accumulation and distribution within the bladder wall with ThermoDox plus mild bladder hyperthermia was achieved at concentrations nearly ten times higher than with free intravenous doxorubicin combined with mild bladder hyperthermia. The study was conducted under a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH) to evaluate whether ThermoDox combined with mild heating of the bladder can target drug delivery in the bladder.

 

BioMarin Pharmaceutical announced that it has entered into a settlement agreement with Par Pharmaceutical that resolves patent litigation in the U.S. related to BioMarin’s Kuvan (sapropterin dihydrochloride) 100mg oral tablets and powder for oral solution in 100mg packets.

 

Nuvox Pharma announced that the FDA has allowed an IND application to initiate a Phase II clinical trial for its oxygen therapeutic, NVX-108, in patients with the hypoxic solid brain tumor, glioblastoma multiforme (GBM). NVX-108 is an injectable drug that travels through the bloodstream arriving first at the lungs to pick up oxygen and finally to hypoxic tissue where it passively delivers the oxygen. It is designed to reduce tumor hypoxia in order to make tumors more sensitive to radiation therapy and chemotherapy.

 

CRISPR TherapeuticsIntellia TherapeuticsCaribou Biosciences and ERS Genomicsannounced that The Regents of the University of California, the University of Vienna, and Dr. Emmanuelle Charpentier (collectively “UC”), co-owners of foundational intellectual property relating to CRISPR/Cas9 genome engineering, have appealed to the U.S. Court of Appeals for the Federal Circuit (the “Federal Circuit”) the decision by the Patent Trial and Appeal Board (“PTAB”) to terminate the interference between certain CRISPR/Cas9 patent claims owned by UC and patents and patent applications owned by the Broad Institute, Harvard University and the Massachusetts Institute of Technology.

 

resTORbio, a subsidiary of PureTech Health announced the appointment of Joan Mannick, M.D., as Chief Medical Officer.

 

Medicenna BioPharma, a wholly owned subsidiary of Medicenna Therapeutics, announced that it has treated the first patient in its Phase IIb clinical trial of MDNA55, the Company’s lead candidate. MDNA55 is being developed for the treatment of recurrent glioblastoma (rGB), the most common and uniformly fatal form of brain cancer.

 

Cellectis announced that it is exploring the possibility of an IPO of a minority interest in its plant sciences business, Calyxt. No decisions have been taken at this point on the structure or timing of any IPO, and no assurance can be given that an IPO will be pursued.

 

Tocagen announced the pricing of its initial public offering of 8,500,000 shares of common stock at a public offering price of $10.00 per share. The shares are expected to begin trading on the NASDAQ Global Select Market on April 13, 2017 under the ticker symbol "TOCA." In addition, Tocagen has granted the underwriters a 30-day option to purchase up to an additional 1,275,000 shares of common stock at the initial public offering price. Leerink Partners LLCEvercore Group L.L.C. and Stifel, Nicolaus & Company, Incorporated are acting as joint bookrunning managers for the offering.

 

Sorrento Therapeutics announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. Sorrento will grant the underwriter an option exercisable, in whole or in part, in the sole discretion of the underwriter, to purchase additional shares, for a period of up to 30 days. Cantor Fitzgerald & Co. is acting as the lead book-running manager for the offering. FBR & Co. is also acting as a joint book-running manager. 

 

Endo International announced that Endo Designated Activity Company, Endo Finance LLC and Endo Finco Inc., its wholly-owned subsidiaries, priced $300 million aggregate principal amount of 5.875% senior secured notes due 2024 at an issue price of $1000 per $1000 principal amount in connection with their previously announced private offering. The notes will be senior obligations of the Issuers and will be guaranteed by Endo and certain of Endo’s subsidiaries and will be secured by first priority liens on the same collateral that secures Endo’s obligations under its previously announced newly proposed senior secured credit facilities. Endo intends to use the net proceeds from the offering, together with approximately $3.4 billion of borrowings under its new term loan facility and cash on hand, to repay all outstanding loans and all other obligations under its existing credit facilities and to pay related fees and expenses.

 

 

ANALYST RECOMMENDATIONS

 

Ladenburg Thalmann analyst Matthew Kaplan initiated coverage of Reata with a “buy” rating and $55 price target, citing the development of novel small molecule drugs for the treatment of orphan diseases driven by mitochondrial dysfunction and inflammation.

 

RBC Capital analyst Randall Stanicky initiated coverage of Pacira Pharmaceuticals with a “buy” rating and $58 price target, citing the combination of a focused selling strategy on the back of the DPS deal and accelerating data reads will set EXPAREL sales up for an inflection that could come as early as 2H2017.

 

Oppenheimer analyst Leah Rush Cann initiated coverage of the following companies:Epizyme with an “outperform” rating and $26 price target; Verastem with an “outperform” rating and $6 price target.