BioShares Biotechnology Clinical Trials (BBC): $24.00, +$0.47, +30.4% YTD

BioShares Biotechnology Products (BBP): $38.31, +$0.77, +17.0% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures inched higher as concerns over President Donald Trump’s plan to cut taxes and boost the economy taking longer than desired eased. European shares rose as French election worries were soothed by centrist Emmanuel Macron cementing his position as frontrunner in the first televised presidential debate on Monday, while Asian stocks ended mixed. The dollar fell on the prospect of a less hawkish than previously expected Federal Reserve policy trajectory. Oil prices advanced on talk that OPEC could extend supply cuts. Gold slipped after a failure to overcome chart resistance prompted speculative selling.

 

 

MARKET HIGHLIGHTS

 

Transgene announced its financial results for the fiscal year ended December 31, 2016.  The Company had cash and cash equivalents of €56.2 million at December 31, 2016, compared to €31.7 million at the end of 2015. This higher cash balance includes the €10 million draw-down of the EIB loan and the net proceeds of €45.2 million from the rights issue which was concluded in November 2016.  The Company reported a net loss of €25.2 million in 2016, compared to a loss of €46.4 million in 2015.

 

Onconova Therapeutics will present an overview at the Sachs Fifth Annual Cancer Bio Partnering and Investment Forum, and two posters at the American Academy of Cancer Research (AACR) Annual Meeting.

 

CTD Holdings has begun recruiting patients at Salford NHS Trust UK for the Company’s Phase I/II clinical study in Europe that will evaluate the intravenous administration of Trappsol® Cyclo™ in patients with Niemann-Pick Disease Type C (NPC), a rare and fatal genetic disease that impacts the brain, lung, liver, spleen, and other organs. Dr. Reena Sharma, Consultant for Adult Metabolic Medicine and Honorary Senior Lecturer at the Mark Holland Metabolic Unit, is the Principal Investigator for the Salford site, and serves as the Coordinating Investigator for the EU study, which the Company expects will involve additional sites in the UK, Sweden and Italy. The EU clinical study will require 12 patients to be fully enrolled.

 

Aurinia Pharmaceuticals announced the closing of its previously announced underwritten public offering of 25,645,000 common shares, including 3,345,000 common shares pursuant to the full exercise of the underwriters’ option to purchase additional common shares. The shares were sold at a public offering price of US$6.75 per share. The gross offering proceeds to the Company from this Offering are approximately US$173.1 million, before deducting underwriting discounts and commissions and other estimated offering expenses. Leerink Partners and Cantor Fitzgerald & Co. acted as joint book-running managers for the Offering.

 

La Jolla Pharmaceutical announced its intention to offer and sell $100,000,000 of its common stock in an underwritten public offering pursuant to its existing shelf registration statement. J.P. Morgan Securities and Cowen and Company are acting as joint book-running managers for the offering. La Jolla intends to grant the underwriters a 30-day option to purchase additional shares of its common stock. La Jolla intends to use the net proceeds from the underwritten offering for general corporate purposes, including funding its ongoing and future clinical trials of its drug candidates, for expenses relating to the potential regulatory approval of LJPC-501, potential future acquisitions and for general and administrative expenses.

 

Gemphire Therapeutics announced today the results of a Phase 2 trial that investigated insulin sensitization and LDL-C lowering by gemcabene in non-diabetic, obese patients. The results were featured in a poster presentation at the recent American College of Cardiology (ACC) 66th Annual Scientific Session in Washington, D.C.  Gemcabene was associated with a doubling of 13% mean increase in GDR compared to a 6.8% increase for placebo.  Although statistical significance was not observed in the pre-specified analysis, a post-hoc analysis more applicable to the size of this study showed a statistically significant change from baseline to Day 29 in GDR for gemcabene 900 mg (p<0.0178) versus a non-significant effect for placebo.  In addition, gemcabene 900 mg lowered LDL-C by 40% (p<0.0001) and TC by 27% (p<0.0001) consistent with past results in hypercholesterolemic subjects.  Gemcabene was generally well-tolerated.  There were no deaths, serious adverse events, or withdrawals due to adverse events during the study.

 

InVivo Therapeutics Holdings announced that it has submitted its first module containing nonclinical studies to the FDA as part of its Humanitarian Device Exemption (HDE) modular submission and review process for the Neuro-Spinal Scaffold. InVivo’s modular HDE process is based on a submission of three modules to the FDA that constitute a complete HDE submission once all have been submitted: a nonclinical studies module, a manufacturing module, and a clinical data module. This process allows the FDA to review each module separately and provide timely feedback, typically within 90 days of submission, thereby allowing the applicant the opportunity to resolve any deficiencies earlier in the review process compared to a traditional HDE application.

 

Pain Therapeutics announced positive regulatory guidance from a recent meeting with the FDA regarding REMOXY (extended-release oxycodone capsules CII), its lead drug candidate.

 

Heat Biologics announced the latest results of its ongoing Phase II clinical trial of HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), for the treatment of non-small cell lung cancer (NSCLC). Fifteen patients have completed the HS-110/nivolumab combination treatment to-date and 12 of these 15 patients were evaluable for ELISPOT analysis. Researchers reported a strong correlation between T cell activation, tumor reductions and increased overall survival in these 12 patients.  These data reinforce preliminary results seen in the first eight patients as reported last December at the International Association for the Study of Lung Cancer Annual Meeting.

 

Neurocrine Biosciences announced that positive results from the Kinect 3 Phase III study of INGREZZA (valbenazine) for the treatment of tardive dyskinesia (TD) were published online by the American Journal of Psychiatry. Once-daily INGREZZA, a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, demonstrated a significant and meaningful reduction in TD symptoms compared with placebo in participants with underlying schizophrenia, schizoaffective disorder or mood disorder. INGREZZA was found to be generally well tolerated with adverse events consistent with those of prior studies.

 

RedHill Biopharma announced dosing of the first patient in the open-label extension study to the Phase III study with RHB-104 for the treatment of Crohn’s Disease (the MAP US study).

 

Sanofi Consumer Healthcare – the makers of new Xyzal Allergy 24HR, which is now available on retail shelves nationwide – revealed the results of a social experiment in which 160 participants (80 allergy sufferers and 80 non-sufferers) wore a wearable device for 30 days to track their sleep and activity. The first-of-its-kind experiment found allergy symptoms can impact various elements of sufferers’ lives, including both the quality of their sleep and their daytime activities. Xyzal is partnering with renowned allergist Dr. Neeta Ogden to encourage allergy sufferers to Wise Up about the importance of managing their allergies this spring, so they can have a better night’s sleep and Rise Up in the morning to take on the day.

 

Crescita Therapeutics announced it has signed an exclusive license agreement with a U.S.-based, major dermatological CRO (the Licensee) to develop prescription treatments of skin diseases utilizing Crescita’s patented Multiplexed Molecular Penetration Enhancer technology.

 

Cellceutix announced additional favorable topline findings as part of interim analysis from its ongoing Phase IIa Proof-of-Concept (PoC) study of Brilacidin for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease.

 

argenx announced that it has entered into a new collaboration with Broteio Pharma B.V. to develop an antibody against a novel target in the complement cascade with therapeutic potential in autoantibody- and complement-mediated indications including autoimmune haemolytic anaemia (AIHA) and antibody mediated rejection (AMR) following organ transplantation.

 

Novartis announced new data suggesting, for the first time, that Cosentyx (secukinumab) may modify the course of moderate-to-severe psoriasis leading to long-term, treatment-free skin clearance. Cosentyx is the first and only IL-17A inhibitor to have reported this potential of disease modification. These data were presented at the 13th Annual Maui Derm for Dermatologists 2017.

 

Dermira presented new information about the Axillary Sweating Daily Diary (ASDD), a proprietary patient-reported outcome (PRO) instrument designed to measure the sweating severity of axillary hyperhidrosis and its impact on daily activities and bothersomeness for patients. The presentation took place at the 13th Annual Maui Derm for Dermatologists 2017 meeting in Maui, Hawaii.

 

Blueprint Medicines announced that it has dosed the first patient in a Phase I clinical trial of BLU-667, an investigational RET inhibitor for patients with non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other advanced solid tumors that harbor a RET alteration.

 

Valeant Pharmaceuticals wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. announced that the FDA has set a PDUFA date of August 24, 2017 for its decision on the NDA for latanoprostene bunod ophthalmic solution, 0.024%. Latanoprostene bunod is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT).  If approved, latanoprostene bunod would be the first nitric-oxide donating prostaglandin F2α analog for ophthalmic use.

 

Apexigen announced the initiation of patient enrollment in a Phase I/II clinical trial at The University of Texas MD Anderson Cancer Center.  This trial is designed to evaluate Apexigen’s CD40 agonistic antibody APX005M in combination with pembrolizumab (Keytruda) in patients with metastatic melanoma.

 

EnGeneIC Limited announced that it has begun dosing patients in a USA-based open-label Phase I clinical trial evaluating its proprietary EDV nanocells to treat recurrent glioblastoma multiforme (GBM) in adults.

 

OncoCyte has submitted its application for CLIA certification of its laboratory, the next step towards its objective of launching the Company’s first commercial product, a lung cancer diagnostic test, in the second half of 2017.  The Company expects to receive the certification during the second quarter of 2017.

 

Actinium Pharmaceuticals has received positive Scientific Advice from the CHMP of the EMA related to the EU approval pathway for Iomab-B. In its correspondence to Actinium, the EMA commented that the trial design, primary endpoint and planned statistical analysis of the U.S. pivotal Phase III SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial are acceptable and can serve as the basis for submission of a Marketing Authorization Application. In addition, the EMA commented that it does not anticipate the need for further standalone preclinical toxicology or safety studies. The EMA requested supporting data and information that is already being collected as part of the U.S. pivotal Phase III SIERRA trial. The SIERRA trial is a 150 patient, randomized controlled study of Iomab-B that is currently enrolling patients in the U.S. Upon approval, Iomab-B is intended to be an induction and conditioning agent prior to a bone marrow transplant (BMT), often referred to as a hematopoietic stem cell transplant (HSCT) with an initial indication in patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above.

 

Asterias Biotherapeutics reported that including the sixth and final patient in the AIS-A 10 million cell cohort in the company’s ongoing SCiStar Phase I/IIa clinical trial has further confirmed previously-announced motor function improvements at 6-months following administration of AST-OPC1.

 

Eagle Pharmaceuticals announced that three additional patents have been issued related to Bendeka by the USPTO. Patent numbers 9,579,397 and 9,579,398 and 9,579,399 will expire March 2033. The USPTO has now issued or allowed a total of 14 patents in the Bendeka family of patents expiring from 2026 to 2033.

 

Calithera Biosciences announced that it intends to offer and sell, subject to market and other conditions, 4,500,000 shares of its common stock in an underwritten public offering. In connection with this offering, Calithera expects to grant the underwriters a 30-day option to purchase up to 675,000 additional shares of common stock. Leerink Partners is acting as sole book-running manager for the offering. Wells Fargo Securities is acting as a lead manager and JMP Securities is acting as a co-manager for the offering.

 

Axsome Therapeutics announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Axsome intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. Ladenburg Thalmann is acting as sole book-running manager for the offering. Axsome intends to use the net proceeds from the offering to fund its ongoing clinical programs, including its clinical trials with AXS-05 and AXS-02, Axsome’s two late-stage product candidates, as well as for working capital and other general corporate purposes.

 

Valeant Pharmaceuticals announced that as of 5:00 p.m. New York City time on March 20, 2017, holders of its outstanding 6.75% Senior Notes due 2018 had validly tendered $1,552,046,000 in aggregate principal amount of the Notes in connection with the Company’s offer to purchase for cash up to $1,100,000,000 aggregate principal amount of the Notes, which the Company commenced on March 7, 2017.  As a result of the oversubscription of the Tender Offer, the Company has accepted for purchase tendered Notes on a prorated basis in the manner described in the Company’s Offer to Purchase dated March 7, 2017.

 

Cipher Pharmaceuticals announced that veteran pharmaceutical industry executive Robert D. Tessarolo has been appointed President and CEO of Cipher, effective April 17, 2017.  Mr. Tessarolo will also be nominated for election as a director at the Company’s next annual general meeting in May 2017.

 

Five Prime Therapeutics announced the appointment of Helen Collins, M.D., as Senior Vice President and Chief Medical Officer following the transition of Robert Sikorski, M.D., Ph.D., to Senior Vice President, Special Projects, effective immediately.

 

 

ANALYST RECOMMENDATIONS

 

Following Nektar’s Phase III results with NKTR-181, Janney analyst Debjit Chattopadhyay increased his fair value estimate to $23 from $17; Aegis analyst Difei Yang increased her price target to $24 from $21.

 

Ladenburg Thalman analyst Christopher James assumed coverage of Intra-Cellular Therapies with a “buy” rating and decreased his price target to $36 from $61, citing in late March 2017, the company has a scheduled FDA meeting to discuss the potential submission of its NDA in schizophrenia; clinical development with lumateperone in bipolar depression is progressing well with the Phase III monotherapy and adjunctive study enrollments expected to complete in 1H18 and 2H18, respectively; in 2Q17, the company plans to initiate a Phase I/II study with ITI-214, the lead molecule in the PDE1 program, in patients with Parkinson’s disease.

 

Following Aevi Genomic Medicine’s announcement the Phase II/III SAGA adolescent ADHD data didn’t achieve significance on its primary endpoint, Jefferies analyst Matthew Andrews downgraded the stock to “hold” from “buy” and decreased his price target to $2.50 from $10; HC Wainwright analyst Carol Ann Werther decreased her price target to $10 from $14.

 

Citi analyst Yigal Nochomovitz downgraded Merus to “neutral” from “buy” and increased his price target to $31 from $26, citing the recent strength and in the absence of new data, these developments now point to fair value.

 

Following Esperion’s announcement they had received written confirmation from the FDA that they can pursue approval for bempedoic acid for an LDL-C lowering indication; JP Morgan analyst Jessica Fye increased her price target to $50 from $22; Citi analyst Joel Beatty increased his price target to $77 from $39.