BioShares Biotechnology Clinical Trials (BBC): $19.30, -$0.18, +4.8% YTD

BioShares Biotechnology Products (BBP): $34.56, -$0.50, +5.5% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed and the dollar edged lower as investors held back ahead of Donald Trump’s inauguration as U.S. president and a speech that could shed some light on his economic policies. European markets were higher, but shares headed for their biggest weekly loss. Asian shares closed down. Oil edged up for a second day on expectations that a weekend meeting of the world’s top oil producers would demonstrate compliance to a global output cut deal. Gold prices held steady and the precious metal was on track for its fourth weekly gain in a row.

 

 

MARKET HIGHLIGHTS

 

Rexahn Pharmaceuticals announced an update on the safety and efficacy of RX-3117 in an ongoing Phase IIa clinical trial in metastatic pancreatic cancer at the American Society for Clinical Oncology (ASCO) 2017 Gastrointestinal Cancer Symposium in San Francisco California. 

 

Minerva Neurosciences announced the results of additional data analyses related to cognitive function from its 12-week, randomized, double-blind, placebo-controlled Phase IIb clinical trial of MIN-101 as monotherapy in patients with negative symptoms of schizophrenia. Data from this trial were reported in May 2016, and data from the 24-week open-label extension period of this trial were reported in October 2016.

 

Mateon Therapeutics announced the presentation of final data from Study OX4218 in patients with neuroendocrine tumors (NETs) at a poster session at the ASCO Gastrointestinal Cancers Symposium being held today in San Francisco.

 

Santhera Pharmaceuticals will announce its preliminary key financial figures for 2016 and provide a corporate update on Thursday, January 26, 2017, at 07:00 hrs CET. An investor conference call with Thomas Meier, PhD, CEO of Santhera, will be held the same day at 13:00 hrs CET.

 

Bristol-Myers Squibb announced that it has decided not to pursue an accelerated regulatory pathway for the combination of Opdivo plus Yervoy in first-line lung cancer in the U.S. based on a review of data available at this time. In order to protect the integrity of ongoing registrational studies, the company will not be providing additional details.

 

Concert Pharmaceuticals announced that the FDA has granted orphan drug designation for CTP-656, Concert’s next generation CFTR potentiator being developed for the treatment of cystic fibrosis. In December 2016, Concert initiated a Phase II trial in the U.S. evaluating CTP-656 in cystic fibrosis patients with gating mutations. Topline results from the Phase II trial are expected by year-end 2017.

 

Gilead announced that the company’s MAA for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients has been fully validated and is now under assessment by the EMA.

 

Novavax announced the initiation of a Phase II clinical trial of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older). The objective of the trial is to assess safety and immunogenicity to one and two dose regimens of the RSV F Vaccine, with and without aluminum phosphate or Novavax’ proprietary Matrix-M adjuvant, in older adults. The trial is a randomized, observer-blinded, placebo-controlled trial designed to enroll up to 300 older adults in the Southern Hemisphere. Participants are being enrolled and vaccinated outside of the RSV season to best assess immunogenicity. Top-line results are expected in the third quarter of 2017.

 

Voyager Therapeutics announced updates regarding the Phase Ib trial of VY-AADC01 for patients with advanced Parkinson’s disease.

 

Minerva Neurosciences announced the results of additional data analyses related to cognitive function from its 12-week, randomized, double-blind, placebo-controlled Phase IIb clinical trial of MIN-101 as monotherapy in patients with negative symptoms of schizophrenia. Data from this trial were reported in May 2016, and data from the 24-week open-label extension period of this trial were reported in October 2016.

 

OncoMed Pharmaceuticals announced dosing of the first patient in a Phase Ib clinical trial of brontictuzumab (anti-Notch1, OMP-52M51) plus chemotherapy in patients with metastatic colorectal cancer.

 

Affimed announced that it has commenced an underwritten public offering of its common shares. The company expects to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of common shares sold in connection with the offering. BMO Capital Markets and Wells Fargo Securities are acting as joint book-running managers, and Trout Capital is acting as co-manager.

 

Stemline Therapeutics announced that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering. In addition, Stemline intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. Jefferies is acting as book-running manager for the offering. Stemline intends to use the net proceeds from the public offering for (i) clinical, regulatory, manufacturing and, if and when approved, potential commercial activities of SL-401; (ii) clinical development of SL-801 and SL-701; (iii) research and development activities; and (iv) other general corporate purposes.

 

Osiris Therapeutics announced that the study “A Comparative Outcomes Analysis Evaluating Clinical Effectiveness in Two Different Human Placental Membrane Products for Wound Management” has been published in the peer-reviewed journal Wound Repair and Regeneration and is available online. This is the first comparative effectiveness study to report on the clinical outcomes associated with the use of different placental wound care products once broadly implemented in the clinical setting.

 

Prima BioMed announced the first patient has been dosed as part of the enlarged randomized phase of its AIPAC Phase IIb clinical trial for IMP321 in metastatic breast cancer. The randomized phase of AIPAC (Active Immunotherapy PAClitaxel) will see half of the 226 patients receiving paclitaxel plus a placebo and half receiving paclitaxel in conjunction with IMP321. This follows the Dose Escalation Committee approval of the 30 mg dosage level for IMP321 and commencement of the randomized study on December 30, 2016.

 

Synergy Pharmaceuticals announced that the FDA has approved TRULANCE (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC). TRULANCE is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function.

 

Amarin Corporation announced that it and its wholly owned subsidiary, Corsicanto II Designated Activity, have entered into separate, privately negotiated purchase agreements with certain investors pursuant to which the Issuer will issue and sell $30.0 million in aggregate principal amount of 3.50% Exchangeable Senior Notes due 2047 (the “2017 Notes”), which will be guaranteed by Amarin, at an issue price of 100%. The purchase agreements were entered into in contemplation of the surrender for purchase of approximately $15.0 million aggregate principal amount of 3.50% Exchangeable Senior Notes due 2032, which were issued in January 2012 by a subsidiary of Amarin (the “2012 Notes”). As detailed in an Amarin press release issued on December 16, 2016, Amarin was required by the terms of the indenture governing the 2012 Notes to purchase all 2012 Notes surrendered to it on January 19, 2017. As of today, approximately $0.1 million aggregate principal amount of 2012 Notes remain outstanding.

 

Pluristem Therapeutics announced that due to increased demand, it has entered into an amended and restated underwriting agreement (as amended and restated, the “Underwriting Agreement”) with H.C. Wainwright & Co., LLC, acting as the sole book-running manager, to increase the size of the previously announced bought deal to $15,000,000. Pursuant to the Underwriting Agreement, the underwriter has agreed to buy, on a firm commitment basis, 12,244,898 shares of common stock of the Company, at a price to the public of US$1.225 per share (the “Public Price”) together with warrants to purchase up to 7,346,939 shares of common stock of the Company with an exercise price of US$1.40 per share of common stock, for gross proceeds of $15,000,000.

 

 

ANALYST RECOMMENDATIONS

 

H.C. Wainwright analyst Andrew Fein initiated coverage of Bellerophon Therapeutics with a “buy” rating and a $5 price target, citing the value of INOpulse in PAH is underappreciated.

 

JP Morgan analyst Chris Schott revised his rating and price target of the following companies, citing the current fundamental environment: Endo International downgraded to “neutral” from “overweight” and decreased his price target to $20 from $30; Teva downgraded to “neutral” from “overweight” and decreased his price target to $40 from $45.

 

Needham analyst Alan Carr downgraded Intercept Pharmaceuticals to “hold” from “buy,” citing lack of catalysts in 2017.

 

Cowen analyst Doug Schenkel increased his price target of Illumina to $175 from $150, citing a model update to reflect 2017 guidance and initial channel checks subsequent to the NovaSeq announcement.

 

The following analysts revised their price target and rating of Bristol-Myers: Cowen analyst Steve Scala downgraded the stock to “market perform” from “outperform” and decreased his price target to $65 from $85; SunTrust analyst John Boris decreased his price target to $57 from $62.

 

Jefferies analyst Jeffery Holford revised his price target on the following Pharma companies: Abbott increased to $48 from $47; Bayer AG increased to €125 from €115; Eli Lilly increased to $93 from $90; GlaxoSmithKline increased to 1,780.00p from 1,750.00p; Johnson & Johnson increased to $120 from $110; Sanofi increased to €80 from €76; Zoetis increased to $64 from $62.

 

Oppenheimer analyst Jay Olson initiated coverage of Portola Pharmaceuticals with a “perform” rating and $28 price target based on the view that the shares are approaching full valuation at this point although significant upside may be achieved in the longer term.