BioShares Biotechnology Clinical Trials (BBC): $21.65, +$0.02, -25.5% YTD

BioShares Biotechnology Products (BBP): $35.42, +$0.16, +14.9% YTD

 

 

MARKET COMMENTARY

 

Tracking gains in global stocks, U.S. stock index futures pointed to a higher start for Wall Street. Existing home sales data for October is expected to be released. An earthquake of magnitude 7.4 and subsequent tsunami warning in northern Japan prompted knee-jerk selling of the U.S. dollar for the safe-haven yen during the Asian hours. Gold extended gains, buoyed by an easing greenback and physical buying in Asia. Hopes that producers will agree to limit output at an OPEC meeting next week, pushed oil prices higher.

 

 

MARKET HIGHLIGHTS

 

BIOPHYTIS has received regulatory authorizations in France and Belgium to conduct the SARA-OBS study in sarcopenia patients.  SARA-OBS is a 6-month clinical observational study in over 300 sarcopenia patients that will monitor multiple parameters of disease severity and progression. Data from SARA-OBS will provide a better characterization of sarcopenia patients that will be later on enrolled in a Phase 2b study, SARA-INT.

 

Ignyta will host a conference call and live webcast on December 1, 2016, at 2:00 p.m. CET (8:00 a.m. ET) to provide highlights related to six presentations at the 2016 EORTC-NCI-AACR (ENA) Molecular Targets and Cancer Therapeutics Symposium. In particular, the conference call will cover a substantial Phase 1b clinical data update of RXDX-105―Ignyta’s VEGFR-sparing, potent RET inhibitor―and the first disclosed preclinical data of RXDX-106―Ignyta’s TYRO3, AXL and MER (or TAM) and c-MET inhibitor.

 

Ignyta will make a presentation at the 28th Annual Piper Jaffray Healthcare Conference on Tuesday, November 29, 2016, at 9:00 a.m. Eastern time (6:00 a.m. Pacific time) in New York City.

 

Pernix Therapeutics Holdings announced the appointment of Gabriel Leung to its Board of Directors, effective immediately. The Board also determined that Mr. Leung is an independent director and appointed him as chairperson of the Nominating Committee and as a member of the Audit and Compensation Committees.

 

Aeglea BioTherapeutics announced results of preclinical studies demonstrating that its product candidate AEB3103 suppressed the growth of tumors in models of prostate and breast cancer and extended survival in a model of chronic lymphocytic leukemia (CLL). The article entitled “Systemic depletion of serum L-Cyst(e)ine with an engineered human enzyme induces production of reactive oxygen species and suppresses tumor growth in mice” was published online today in Nature Medicine.

 

Immune Pharmaceuticals will hold an Immuno-Oncology R&D Update for investors on December 8, 2016 in New York City.

 

Zogenix will participate in the Oppenheimer Life Sciences Summit 2016, being held at the Sofitel New York Hotel on Tuesday, November 29th.

 

Anavex Life Sciences announced a positive 41-week update from its Phase IIa study in mild-to-moderate Alzheimer’s disease (AD) patients for ANAVEX 2-73, which targets cellular homeostasis. At 41 weeks, Alzheimer’s patients taking a daily oral dose of ANAVEX 2-73 in the exploratory, not yet dose optimized Phase IIa clinical trial, showed a stabilization of cognitive and functional measures. This data of stabilization is promising since Alzheimer’s disease is a progressive disease where current therapeutics are only able to temporarily slow the worsening of dementia symptoms and not stop the disease from progressing. At 41 weeks, oral daily dosing between 10mg and 50mg, ANAVEX 2-73 was well tolerated, and no patients discontinued treatment due to adverse events. There were no clinically significant treatment-related adverse events, and no serious adverse events.

 

Janssen Biotech announced the FDA has approved DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Clinical studies have shown that DARZALEX, in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, reduced the risk of disease progression or death by 63 percent, compared to lenalidomide and dexamethasone alone, in patients with multiple myeloma who received a median of one prior therapy (Hazard Ratio


=0.37; 95 percent CI [0.27, 0.52], p<0.0001). In combination with bortezomib (a proteasome inhibitor [PI]) and dexamethasone, DARZALEX reduced the risk of disease progression or death by 61 percent, compared to bortezomib and dexamethasone alone, in patients with multiple myeloma who received a median of two prior lines of therapy (HR=0.39; 95 percent CI [0.28, 0.53], p<0.0001).

 

Novo Nordisk announced that the FDA has approved the NDA for Xultophy 100/3.6. Xultophy 100/3.6 is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with Type II diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).

 

Sanofi announced that the FDA approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with Type II diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide. Soliqua 100/33 is the combination of Lantus (insulin glargine 100 Units/mL) and lixisenatide, a GLP-1 receptor agonist, in a once-daily injection, studied in a Phase III program of more than 1,900 patients.

 

AstraZeneca announced that the U.S FDA has lifted the partial clinical hold on the enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) for clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines. The Phase III KESTREL trial has already re-opened for new patient enrolment at some clinical study sites and the EAGLE trial is expected to resume recruitment shortly, without amendments to either protocol. AstraZeneca will progressively resume enrolment for all HNSCC trials across the participating sites in the U.S and globally, subject to national health authority and ethics committee approval where required.

 

Immunovaccine announced that the EMA has granted ‘Orphan Drug Designation’ status to the Company’s lead immuno-oncology product candidate, DPX-Survivac for the treatment of ovarian cancer in the EU.

 

TG Therapeutics announced that the independent Data Safety Monitoring Board (DSMB) providing oversight for the UNITY-CLL Phase III trial reviewed the cumulative safety data from the ongoing clinical study and informed the Company that it has identified no safety concerns, and recommended the continuation of the study with no modifications. Per the protocol’s pre-specified DSMB charter, the DSMB is scheduled to meet approximately every 6-9 months to review cumulative safety data.

 

CTI BioPharma announced that data from the randomized Phase III PERSIST-2 clinical trial comparing the investigational agent pacritinib, an oral multikinase inhibitor, with physician-specified best available therapy (BAT), including ruxolitinib, for treatment of patients with myelofibrosis whose baseline platelet counts are less than 100,000 per microliter will be presented in a late-breaking oral presentation at the upcoming 58(th) American Society of Hematology (ASH) Annual Meeting, being held December 3-6 in San Diego, CA.

 

Arog Pharmaceuticals announced that the EMA Committee for Orphan Medicinal Products (COMP) has granted orphan drug designation for its lead product candidate, crenolanib, for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma. Crenolanib also recently received Fast Track designation from the FDA for the treatment of patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRα) D842V mutation.

 

Reuters reported that a U.S. appeals court upheld AstraZeneca and Ranbaxy Laboratories’ victory in a lawsuit accusing them of reaching an illegal deal to delay the launch of a generic version of AstraZeneca’s heartburn drug Nexium. A panel of the 1st U.S. Circuit Court of Appeals in Boston refused to throw out a December 2014 jury verdict in favor of AstraZeneca and Ranbaxy, which was acquired in March 2015 by Sun Pharmaceutical Industries.

 

Medigene AG announced that its Supervisory Board has appointed Dr. Thomas Taapken as Chief Financial Officer (CFO) as of 1 January 2017. As a member of Executive Management working at the Munich headquarters of Medigene, Dr. Taapken will assume the CFO responsibilities which were temporarily taken over by the Company’s Chief Operating Officer (COO). Additional administrational tasks taken over from the Chief Executive Officer (CEO) will also be of part his duties.

 

Caladrius Biosciences announced that PCT, its cell therapy contract development and manufacturing subsidiary, has earned re-accreditation by the Foundation for the Accreditation of Cellular Therapy ("FACT"). This accreditation confirms that PCT operates in compliance with the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration at both its Allendale, New Jersey and Mountain View, California sites.

 

KalVista Pharmaceuticals announced the closing of the previously announced merger with Carbylan Therapeutics. As a result of the completion of this transaction, Carbylan changed its name to KalVista Pharmaceuticals, Inc. The Company will commence trading on November 22, 2016 on the NASDAQ Stock Market under the symbol "KALV".

 

Allergan announced the FDA has cleared the XEN Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector) for use in the U.S. The XEN Glaucoma Treatment System reduces intraocular pressure (IOP) in patients and is indicated for the management of refractory glaucomas, where previous surgical treatment has failed or in patients with primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. XEN is implanted through an ab interno approach and reduces IOP by creating a new drainage channel with a permanent implant that becomes flexible. This provides a new treatment option for the millions of Americans with refractory glaucoma.

 

QuintilesIMS announced that it will lead a collaborative initiative involving founding partners Bristol-Myers Squibb, Eli Lilly, Merck KGaA and Pfizer, which aims to provide clearer and more proactive insight into how anti-cancer treatments are used in a real-world setting across key European markets.

 

Fate Therapeutics announced that it has entered into a definitive securities purchase agreement with certain institutional and other accredited investors. The private placement is being led by Redmile Group with participation from BVF Partners L.P., EcoR1 Capital LLC and Franklin Advisers, Inc. as well as certain individual investors including members of the Company’s Board of Directors. Gross proceeds from the private placement are expected to be approximately $57 million dollars. Redmile has agreed to purchase 2,819,549 shares of non-voting Class A Preferred Stock at $13.30 per share, each of which is convertible into five shares of common stock upon certain conditions. The remaining investors have agreed to purchase 7,236,837 shares of common stock at $2.66 per share. The purchase and sale is expected to close on or about November 23, 2016, subject to customary closing conditions. The Company expects to use the proceeds from the transaction primarily to advance its pipeline of programmed cellular immunotherapies and for general corporate purposes. Leerink Partners LLC acted as the exclusive placement agent to the Company in connection with the private financing.

 

Nabriva Therapeutics announced that it has changed the record date for its previously announced planned rights offering from November 22, 2016 to November 29, 2016. Holders of common shares on the new record date will be entitled to exercise non-transferable statutory pre-emptive rights to subscribe for new common shares to maintain their proportionate ownership interest in Nabriva in accordance with the relevant provisions of the Austrian Stock Corporation Act. In addition, holders of American Depositary Shares (ADSs) as of 5:00 pm (New York City time) on the new record date will also receive non-transferable subscription rights to purchase new common shares, in the form of new ADSs, to maintain their proportionate ownership interest. Each ADS represents one tenth (1/10) of a common share.

 

Taro Pharmaceutical Industries announced the appointment of Mr. Uday Baldota as CEO and as a nominee to Taro’s Board of Directors. He is expected to begin his role as CEO on or about April 1, 2017, and will focus solely on the Taro business.

 

The American College of Surgeons (ACS) announced a new multifaceted initiative to improve the knowledge and management of pain in surgical patients with a focus on opioid risk and non-opioid alternatives. With an educational grant from Pacira Pharmaceuticals, ACS will develop Opioids and Surgery: Use, Abuse and Alternatives (Opioids and Surgery) professional and patient education materials.

 

BioPharmX announced the pricing of an underwritten public offering comprised of Class A Units and Class B Units.  The Class A Units, priced at a public offering price of $0.35 per unit, consist of one share of common stock and one seven-year warrant to purchase 0.75 of a share of common stock with an exercise price of $0.35 per share.  The Class B units consist of one share of Series A preferred stock, with a stated value of $1,000 convertible into shares of common stock at a ratio of $1000 divided by $0.35, and one seven-year warrant to purchase the same number of shares of common stock at an exercise price of $0.35 per share.  The conversion price of the preferred stock as well as the exercise price of the warrants are fixed price and do not contain any variable pricing features nor any price based anti-dilutive features.  The preferred stock and warrants include a beneficial ownership blocker but have no dividend rights (except to the extent dividends are also paid on common stock), liquidation preference or other preferences over common stock and the preferred stock is non-voting.  The Company will need to obtain stockholder approval of an amendment to its charter to increase the number of authorized shares of common stock before the warrants can become exercisable. The warrants will become exercisable upon the later of the one-year anniversary from issuance and following such stockholder approval.  The securities comprising the units are immediately separable and will be issued separately.  All securities to be sold in the offering are being offered by BioPharmX. The offering is expected to close on or about November 28, 2016, subject to customary closing conditions. A total of 31,489,429 shares of common stock, 1,515 shares of Series A preferred stock convertible into 4,328,571 shares of common stock, and warrants to purchase 26,863,501 shares of common stock will be issued in the offering.  The net proceeds to BioPharmX from this offering are expected to be approximately $11.7 million, after deducting discounts and commissions and before deducting other offering expenses payable by BioPharmX, and excluding any proceeds that may be received upon exercise of the warrants.  BioPharmX anticipates using the net proceeds from the offering to fund further clinical development of BPX-01, as well as the ongoing expenses of its operations during such development and for working capital and general corporate purposes. In addition, BioPharmX has granted the underwriters a 30-day option to purchase up to 4,723,414 additional shares of common stock and/or additional warrants to purchase up to 3,542,560 shares of common stock to cover over-allotments, if any, at the public offering price per share and warrants less the underwriting discounts and commissions.  Roth Capital Partners, LLC is acting as sole book-running manager for the offering.

 

venBio Select Advisor LLC, venBio’s New York-based investment manager focused principally on publicly traded biotechnology companies, and the largest beneficial owner of Immunomedics with approximately 9.5 million shares, or 9.0%, announced that it has nominated four highly-qualified candidates — Scott Canute, Peter Barton Hutt, Dr. Khalid Islam, and Dr. Behzad Aghazadeh — for election to the Company’s Board of Directors at the upcoming 2016 Annual Meeting of stockholders, to be held on December 14, 2016.

 

Primex Pharmaceuticals announced the acquisition of OGNA. The acquisition expands the company’s product portfolio to the full dental surgery range, from local anaesthetics to dental products.

 

Elanix Biotechnologies announced that the company has entered into a non-binding letter of intent (LOI) with Oxford MEStar. The LOI contains broad terms of a potential transaction whereby the two companies, together with UniNova, might establish a Chinese JV. In the first instance this would market Elanix’s GynRepair, used for the treatment of vulvodynia, in the domestic market in China (PRC). The transaction is necessarily subject to entering into a definitive agreement between the parties, containing specific signing and closing terms and conditions yet to be finalised, negotiated and agreed up.

 

Mayne Pharma Group announced the U.S. launch of IDT’s generic temozolomide 5mg, 20mg, 100mg, 140mg, 180mg and 250mg capsules, which is a generic version of branded Temodar. Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed cancerous brain tumors known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.

 

Actinium Pharmaceuticals announced that it has issued a letter to shareholders highlighting the Company’s accomplishments in 2016 and anticipated milestones for 2017.

 

Biostage announced that it has received a continued listing deficiency notice from The NASDAQ Stock Market LLC because its share price has not met the $1.00 minimum closing bid price requirement for 30 consecutive business days [Nasdaq Listing Rule 5450(a)(1)]. This notice has no immediate effect on the Company’s Nasdaq listing or the trading of its common stock. Nasdaq has provided Biostage with a 180-day compliance period, until May 17, 2017, in which to regain compliance with the minimum bid price requirement [Nasdaq Listing Rule 5500(a)(2)]. If at any time during the compliance period, the closing bid price of Biostage’s common stock is at least $1.00 per share for at least ten consecutive business days, Nasdaq will provide the Company a written confirmation of compliance and the matter will be closed.

 

Shire announced that it will expand its operations in Cambridge, Massachusetts, establishing a rare disease innovation hub and increasing its footprint in the heart of Kendall Square. Shire and BioMed Realty have signed a lease for a 343,000-square-foot building at 500 Kendall Street. Shire’s lease begins in Q3, 2018, with occupancy anticipated for Q1, 2019.

 

 

ANALYST RECOMMENDATIONS

 

Jefferies analyst Matthew Andrews assumed coverage of TherapeuticsMD with a “buy” rating and $18, citing its bioidentical hormone replacement therapies for moderate/severe menopausal symptoms due to VMS and VVA offer innovation and clinical differentiation from existing HRTs and have blockbuster sales potential with combined peak sales of $4.5B.

 

Aegis analyst Difei Yang initiated coverage of Momenta with a “hold” rating and $15 price target, citing uncertain market opportunities and/or being early in development cycle.

 

Jefferies analyst Eun Yang downgraded uniQure to “hold” from “buy” and decreased her price target to $8 from $28, citing lack of progress, competition & poor execution.

 

Leerink analyst Jason Gerberry increased his price target of Corium International to $16 from $14, citing positive pilot study data on donepezil to serve as a key catalyst for the company.

 

Oppenheimer analyst Jay Olson initiated coverage of the following companies: TherapeuticsMD with an “outperform” rating and $12 price target; Neurocrine with a “perform” rating and $55 price target.

 

JP Morgan analyst Jessica Fye increased her price target of Enanta Pharmaceuticals to $32 from $29, citing the company’s wholly owned assets should become increasingly important drivers of valuation over time.