BioShares Biotechnology Clinical Trials (BBC): $21.70, -$0.26, +17.9% YTD

BioShares Biotechnology Products (BBP): $36.51, -$0.35, +11.5% YTD

 

 

MARKET COMMENTARY

 

Wall Street was set for a modestly higher start, recovering from previous session’s decline, as focus shifted towards fresh batch of corporate earnings. Markets will watch for quarterly results of major companies scheduled to report results later in the day, including Qualcomm, American Express and eBay. Some positive first-quarter results coupled with a bounce in banking shares helped European bourses to trade higher, while Asian stocks closed in lower. The dollar managed to recoup its broader losses and was trading marginally higher against a basket of currencies, while gold futures slipped. Oil prices rose after OPEC said it was committed to eroding a global supply overhang that has dogged markets since 2014.

 

 

MARKET HIGHLIGHTS

 

Advaxis announced that Anthony A. Lombardo, an industry veteran with nearly 30 years’ experience in the field of life sciences, has joined the company as Chief Business Officer. Lombardo is a senior leader with extensive experience in helping global companies achieve significant growth.  Previously, Lombardo was President and CEO of E-Z-EM Inc., a company focusing on oral imaging contrast agents.

 

TherapeuticsMD announced that, based on continued correspondence with the U.S. Food and Drug Administration (FDA), the Company expects that the FDA will finalize an action on the New Drug Application (NDA) for TX-004HR, an investigational bio-identical 17?-estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women, including informing the Company of the deficiencies in the NDA identified by the FDA, on or before the originally scheduled Prescription Drug User Fee Act (PDUFA) target action date of May 7, 2017.  At this time, the Company is not aware of the nature of the deficiencies in the NDA identified by the FDA. The Company continues to communicate with the FDA to understand the nature of the deficiencies and intends to resolve them as quickly as possible.

 

BrainStorm Cell Therapeutics announced that a preclinical study evaluating the use of NurOwn® mesenchymal stem cells in a mouse model of autism was published in the April issue of the journal Behavioural Brain Research [Perets N. et al. Epub ahead of print, PMID: 28392323]. The publication, entitled "Long Term Beneficial Effect of Neurotrophic Factors-Secreting Mesenchymal Stem Cells Transplantation in the BTBR Mouse Model of Autism, was authored by Prof. Daniel Offen, Head of Tel Aviv University’s Translational Neuroscience Laboratory, Sackler School of Medicine, and Brainstorm’s Chief Scientific Advisor.  The publication reported that transplantation of mesenchymal stem cells (MSC) induced to secrete neurotrophic factors (MSC-NTF cells, NurOwn®) in the BTBR mouse model of autism demonstrated significant long-term improvements in autistic behavior in the BTBR mice compared to MSC treated and to untreated BTBR mice.

 

Argos Therapeutics reported interim results from its randomized, active controlled, open-label, multi-center Phase III ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma (mRCC). The Company also provided perspective on its decision to continue the trial.

 

Soligenix announced that results from its ricin toxin vaccine (RiVax) development program will be presented at the 20(th) Annual Conference on Vaccine Research, being held April 24-26 in Bethesda, Md. RiVax is the Company’s proprietary vaccine candidate for the prevention of exposure to ricin toxin that utilizes a unique antigen that is completely devoid of the toxic activity of ricin. When formulated with ThermoVax, Soligenix’s proprietary vaccine heat stabilization technology, RiVax has demonstrated significantly enhanced thermostability and 100% protection in preclinical ricin aerosol challenge models. In collaboration with the New York State Department of Health and the laboratory of Nicholas Mantis, Ph.D., Soligenix has been investigating immune correlates of protection in sera of animals vaccinated with RiVax. The findings demonstrate that: 1) the ThermoVax thermostabilization process significantly enhances the stability of the RiVax antigen; 2) degradation in the antigen can be measured with specific monoclonal antibodies; and 3) these same monoclonal antibodies can be used to probe the immune profile of vaccinated mice and primates and predict their survival to subsequent ricin exposure challenge. These findings are expected to facilitate the potential approval of the RiVax product under the FDA "Animal Rule" and represent a significant step forward in the understanding of ricin toxin immunology.

 

CytRx announced the FDA has reached an agreement with CytRx on preparations for a NDA submission for aldoxorubicin in soft tissue sarcomas (STS). STS remains a high unmet medical need.

 

Flex Pharma announced that human efficacy data from its study in nocturnal leg cramps (NLC) will be presented at the upcoming American Academy of Neurology (AAN) 69(th) Annual Meeting in Boston, MA. When a neurologist evaluated, in a blinded manner, subjects likely to have NLC based upon a questionnaire administered after the study was completed, the data from first treatment exposure of these 26 subjects showed a statistically significant effect in the reduction in cramp frequency when compared to placebo (p=0.03).

 

Ultragenyx PharmaceuticalKyowa Hakko Kirin Co. and Kyowa Kirin International, a wholly owned subsidiary of Kyowa Hakko Kirin, announced positive 24-week data from the randomized, double-blind, placebo-controlled Phase III study of burosumab (KRN23) in adults with X-linked hypophosphatemia (XLH). Patients treated with burosumab demonstrated a statistically significant improvement in serum phosphorus levels, with 94% of patients achieving normal levels compared to 8% on placebo (p <0.0001). Patients treated with burosumab also achieved a statistically significant improvement in stiffness and strong trends in improvements in physical function and pain. Adverse events were consistent with what has been previously observed in open label studies in adults and children. Ultragenyx is conducting the study under a collaboration and license agreement with Kyowa Hakko Kirin.  Burosumab is being developed by Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International. Following the news, Wedbush analyst David Nierengarten downgraded Ultragenyx to “neutral” from “outperform” and decreased his price target to $75 from $80; HC Wainwright analyst Carol Ann Werther downgraded the stock to “neutral” from “buy” and decreased her price target to $72 from $88; SunTrust analyst Ed Nash increased his price target to $105 from $100; Leerink analyst Joseph Schwartz increased his price target to $93 from $90.

 

Nivalis Therapeutics and Alpine Immune Sciences jointly announced they have entered into a definitive merger agreement under which Alpine will merge with a wholly-owned subsidiary of Nivalis in an all-stock transaction. The merger will result in a combined company with a novel protein-based discovery platform focused on inflammation and immuno-oncology.

 

Enanta Pharmaceuticals announced new data from its lead FXR agonist candidate EDP-305 for NASH and PBC. This new data is being presented during The International Liver Congress (ILC) 2017, April 19-23, in Amsterdam. Data from three poster presentations being presented at the Congress will demonstrate that EDP-305 is a potent Farnesoid X Receptor (FXR) agonist that has been shown to reduce expression of fibrogenic genes, reduce fibrosis progression and improve non-alcoholic fatty liver disease (NAFLD) activity scores (NAS) in a variety of preclinical models.

 

Vical announced that it has completed the target enrollment of 225 subjects in a Phase II trial of its therapeutic bivalent vaccine for herpes simplex virus type 2 (HSV-2), the leading cause of recurrent genital herpes.

 

TherapeuticsMD announced that, based on continued correspondence with the FDA, the Company expects that the FDA will finalize an action on the NDA for TX-004HR, an investigational bio-identical 17?-estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women, including informing the Company of the deficiencies in the NDA identified by the FDA, on or before the originally scheduled PDUFA target action date of May 7, 2017.

 

Kura Oncology announced issuance of a U.S. patent for KO-947, its drug candidate targeting extracellular-signal-regulated kinases (ERK). The new patent, U.S. 9,624,228, entitled “Inhibitors of ERK and Methods of Use,” covers KO-947 and structurally-related compounds as well as methods of using the compounds for the treatment of diseases including cancer.

 

Lion Biotechnologies and The University of Texas MD Anderson Cancer Centerannounced a multi-year strategic alliance agreement involving multi-arm clinical trials to evaluate the safety and efficacy of TIL therapy in ovarian cancer, various sarcomas, and pancreatic cancer. In addition, preclinical research will explore the expansion of TIL in other rare tumor types.

 

Synthetic Biologics announced positive data for SYN-005, the Company’s orphan drug program for the prevention and treatment of pertussis (whooping cough). SYN-005 combines two highly synergistic humanized monoclonal antibodies (hu1B7 and hu11E6) to target and potentially inactivate the life-threatening pertussis toxin that causes disease symptoms.

 

Argentum Pharmaceuticals announced that it has reached a settlement and license agreement with Allergan related to Argentum’s generic version of RESTASIS (0.05% cyclosporine ophthalmic emulsion). The agreement generally provides that Argentum may commence marketing its generic equivalent product sometime prior to the expiration of the patents covering RESTASIS. The specific date on which Argentum may launch its generic product and other details concerning the settlement have not been disclosed. RESTASIS is a registered trademark of Allergan.

 

Prima BioMed announced that approval has been granted for the third cohort of its Phase I clinical trial for IMP321 in combination with KEYTRUDA being conducted in Australia. The third cohort will recruit six patients with unresectable or metastatic melanoma. Interim data results from the first patient cohort released in December 2016 indicate IMP321 at the 1mg dose level is safe and well tolerated. Out of the six patients in the first cohort (all with suboptimal response to KEYTRUDA monotherapy) two patients had a partial or complete radiological tumour response according to immune related response criteria (irRC).

 

Boehringer Ingelheim Pharmaceuticals announced that the first patient has been enrolled in the PF-ILD (progressive fibrosing interstitial lung disease) trial. This study investigates the efficacy and safety of nintedanib in a range of progressive fibrosing lung conditions other than idiopathic pulmonary fibrosis (IPF).

 

Pluristem Therapeutics announced that it has been issued its 100(th) patent, an important milestone attesting to the significant accomplishments of its scientists and engineers, and its enduring commitment to innovative research and development.

 

ANI Pharmaceuticals announced launch of Indapamide Tablets, 1.25mg and 2.5mg, which is used in the treatment of hypertension and swelling associated with congestive heart failure.

 

Advaxis announced that Anthony A. Lombardo, an industry veteran with nearly 30 years’ experience in the field of life sciences, has joined the company as Chief Business Officer.

 

Audentes Therapeutics announced the pricing of its underwritten public offering of 5,200,000 shares of its common stock at a price to the public of $14.50 per share before underwriting discounts and commission. The gross proceeds to Audentes from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by Audentes, are expected to be approximately $75.4 million. In addition, Audentes has granted the underwriters a 30-day option to purchase up to an additional 780,000 shares of common stock. BofA Merrill LynchCowen and Company and Piper Jaffray are acting as joint book-running managers for the offering.Wedbush PacGrow is acting as a co-manager.

 

Agios Pharmaceuticals announced that it has priced an underwritten a public offering of 5,050,505 shares of common stock at a price to the public of $49.50 per share, before underwriting discounts, which would result in aggregate gross proceeds of approximately $250 million. Agios has also granted the underwriters a 30-day option to purchase from it up to an additional 15% of the shares of common stock offered in the public offering on the same terms and conditions. J.P. Morgan Securities and Goldman Sachs & Co. are acting as joint book-running managers for the offering. Cowen and Company is serving as lead manager.

 

Edge Therapeutics announced that Edge has entered into a subscription agreement for the sale of shares of its common stock in a registered direct offering with Satter Medical Technology Partners and certain of its affiliated parties. Pursuant to the agreement, Edge has agreed to sell to the investors 1,800,000 shares at a purchase price of $10.00 per share with gross proceeds of $18 million.

 

ANALYST RECOMMENDATIONS

 

LifeSci Capital analyst David Sherman initiated research coverage of Minerva Neurosciences, citing the unmet need in the treatment of central nervous system disorders.

 

Oddo BHF analyst Pierre Corby upgraded Transgene to a Buy from Reduce, citing the company’s restructuring is now complete and the company is focused on therapeutic vaccines and oncolytic viruses with checkpoint inhibitors.

 

Credit Suisse analyst Alethia Young decreased her price target of Incyte to $167 from $174, citing baricitinib’s U.S. launch moves to 2019 and a lower probability of success on U.S. revenues to 80%.

 

Goldman Sachs analyst Robert Jones made price target changes to the following companies: Icon to $90 from $93; Quintiles to $84 from $83; Parexel to $57 from $59.

 

Leerink analyst Michael Schmidt upgraded Immunogen to “outperform” from “market perform,” citing a higher level of conviction on IMGN’s lead asset mirvetuximab soravtansine.

 

Cantor analyst Bryan Brokmeier downgraded PerkinElmer to “neutral” from “overweight,” citing there may be risk from a moderation of newborn screening growth in China, the uncertain geopolitical environment, and an over-reliance on a contribution from new products.