BioShares Biotechnology Clinical Trials (BBC): $23.12, +$0.24, -20.4% YTD

BioShares Biotechnology Products (BBP): $34.62, +$0.44, +12.3% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures edged lower a day after the S&P enjoyed its biggest 2-day rally in 2 months following the U.S. Federal Reserve’s plan to adopt a less aggressive approach to interest rate hikes next year and in 2018. Markit manufacturing PMI flash data for September is on the economic calendar. European markets were pulled lower by weakness in banking shares. Asian shares closed mixed as investors continued to debate the Bank of Japan’s new policy scheme.  Gold eased from two-week highs as the dollar steadied, but was on track for its biggest weekly gain in two months. Oil futures turned positive after Saudi Arabia said they were ready to reduce output if Iran agreed to freeze output.

 

 

MARKET HIGHLIGHTS

 

Prothena Corporation announced that members of its management team will provide an overview of PRX003, a novel antibody that targets CD146 (or melanoma cell adhesion molecule, MCAM) and discuss its Phase 2 development strategy during a live audio webcast and conference call on September 29, 2016, at 4:30pm EDT.

 

Palatin Technologies announced that a review of the neurobiology and treatment efficacy of bremelanotide for hypoactive sexual desire disorder ("HSDD") was presented at the International Society for Sexual Medicine 20th World Meeting in Beijing, China.

 

The Medicrea Group announced 2016 half-year results to June 30, 2016.  Total revenues were €14.8 million in the first half of 2016, versus €13.8 million in the first half of 2015.  The Company reported a net loss of €2.7 million in the first half of 2016, versus €1.0 million in the first half of 2015.

 

Genticel announced its financial results for the six-month period ending June 30, 2016.  The company reported a net loss for the six-months ended June 30, 2016 of €4.7 million, or €0.31 per share, compared to a net loss of €5.7 million, or €0.37 per share in the same 6 month period of 2015.  As at June 30, 2016, cash and liquid investments amounted to €14.8 million, compared to €18.8 as at March 31, 2016.

 

Catalyst Biosciences will present a corporate overview at the Ladenburg Thalmann 2016 Healthcare Conference on Tuesday, September 27th.

 

ABIVAX will host an R&D Day on Tuesday, October 11, at their research center campus in Montpellier, France.

 

AbbVie announced new data showing high response rates with just eight weeks of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) treatment. In the Phase IIIb GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR12). These data were presented today at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, in Paris, France and included in the newly published ‘EASL Recommendations on Treatment of Hepatitis C.’ VIEKIRAX + EXVIERA is currently approved in the European Union for GT1b patients without cirrhosis or with compensated cirrhosis for 12 weeks.

 

BioLineRx announced that it has signed an exclusive, worldwide agreement with BGN Technologies, the Technology Transfer Company of Ben-Gurion University, and Hadasit, the Technology Transfer Company of Hadassah Medical Organization, for the in-licensing of a novel treatment for various liver failure conditions such as end-stage liver disease (ESLD) and for conditions potentially leading to liver failure such as non-alcoholic steatohepatitis (NASH). This novel treatment, to be named BL-1220, is the second project in-licensed under the framework of the Company’s strategic collaboration with Novartis Pharma AG for the screening and development of novel drug candidates.

 

Endo International announced that its Board of Directors has named Paul V. Campanelli President and CEO, effective immediately. Mr. Campanelli currently serves as President of Endo’s Generic and OTC drugs business, Par Pharmaceutical, which accounts for approximately 60 percent of Endo’s total revenues through the first half of 2016. Campanelli, who will also join Endo’s Board of Directors, succeeds Rajiv De Silva, who has stepped down as President, CEO and a member of the Board. Endo affirmed its third quarter and full year financial guidance.

 

GlaxoSmithKline announced the submission of a BLA to the FDA by Janssen Biotech, seeking approval of a subcutaneous formulation of sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have failed or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). 

 

Intrexon announced it has entered into Exclusive Channel Collaborations (ECC) with two startups backed by the Harvest Intrexon Enterprise Fund, sponsored by Harvest Capital Strategies. Through Intrexon’s proprietary ActoBiotics Lactococcus lactis platform, these companies will pursue new approaches to deliver disease-modifying therapies: Genten Therapeutics, will center efforts on ActoBiotics expression of gluten peptides, alone or in combination with immunomodulatory cytokines, to reestablish immune tolerance for patients with celiac disease; and  CRS Bio will focus on targeted delivery of antibodies for treatment of chronic rhinosinusitis (CRS) with and without nasal polyps, by utilizing ActoBiotics technology to block inflammatory mediators in the nasal passage, leading to improved breathing and, importantly, patients’ quality of life.

 

GlaxoSmithKline announced that it has filed regulatory submissions in the US and Europe for Benlysta (belimumab) for approval as a subcutaneous formulation in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). The submissions comprise: A BLA to the FDA for belimumab administered subcutaneously for the treatment of adult patients with active, autoantibody‑positive SLE who are receiving standard therapy. An extension MAA to the EMA for belimumab administered subcutaneously as add-on therapy in adult patients with active autoantibody-positive SLE with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy.

 

Sarepta Therapeutics priced an underwritten public offering of an aggregate of 5.02 million shares of its common stock at a price to the public of $59.75 per share. In addition, Sarepta has granted the underwriters a 30-day option to purchase up to an additional 753,138 shares of common stock on the same terms and conditions as the initial shares sold to the underwriters. Sarepta anticipates the gross proceeds from the offering, before deducting the underwriter discounts and commissions and other offering expenses, to be approximately $300 million, excluding any exercise of the underwriters’ option to purchase additional shares. J.P. Morgan and Goldman Sachs are acting as joint book-running managers of the proposed offering. Credit Suisse is also acting as a joint book-runner. In addition, Baird, Needham & Company, Oppenheimer & Co., Wedbush PacGrow and WBB Securities, are acting as co-managers for the offering. Sarepta intends to use the net proceeds from the offering principally for the continuation and initiation of further clinical trials, commercialization, manufacturing, business development activities including the potential licensing or acquisition of complementary products and technologies and other general corporate purposes.

 

AC Immune SA announced the pricing of its IPO of 6,000,000 of its common shares at the initial public offering price of $11.00 per common share. This represents a 32% increase in the offering size relative to the originally announced amount of 4,545,456 common shares. In addition, AC Immune has granted the underwriters for the offering an option to purchase up to 900,000 additional common shares to cover over-allotments. After deducting the underwriting discounts and other estimated offering expenses, the net proceeds of the initial public offering are expected to be approximately $57.8 million. AC Immune’s common shares have been approved for listing on the NASDAQ and are expected to begin trading under the ticker symbol "ACIU" on September 23, 2016. Credit Suisse Securities, Jefferies and Leerink Partners are acting as joint book-running managers for the proposed offering.

 

Reuters reported that Novartis’ cancer drug Zykadia showed positive results in a Phase III clinical trial in treating patients with a form of lung cancer, the Swiss drugmaker said. Zykadia, whose generic name is ceritinib, displayed significant improvement in progression-free survival compared to standard chemotherapy in previously untreated patients with advanced anaplastic lymphoma kinase-positive non-small cell lung cancer, it said.

 

Faraday Pharmaceuticals announced the start of a Phase I clinical trial evaluating its lead compound FDY-5301.

 

Pfizer announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended has expired with respect to Pfizer’s pending acquisition of Medivation.

 

Mallinckrodt Pharmaceuticals announced that the USPTO has upheld the validity of commercially significant claims related to five patents covering gas delivery systems as well as methods of using such systems related to INOMAX (nitric oxide) gas, for inhalation.

 

Catabasis Pharmaceuticals announced the pricing of an underwritten offering of 2,500,000 shares of its common stock at a price of $4.00 per share. The gross proceeds to Catabasis from this offering are expected to be $10.0 million. Catabasis has granted the underwriter a 30-day option to purchase up to an additional 375,000 shares of common stock. Catabasis intends to use the net proceeds from the sale of the offered securities to fund our ongoing and planned clinical trials of edasalonexent (CAT-1004), to fund market development activities for edasalonexent, to fund research and development to advance its pipeline of preclinical product candidates and expand its product platform, and for working capital and general corporate purposes. All of the shares in the offering are to be sold by Catabasis. The offering is expected to close on September 28, 2016. Cowen and Company is acting as sole book-running manager for the offering.

 

Apricus Biosciences entered into a definitive agreement with institutional investors for an offering of shares of common stock with gross proceeds of approximately $4.6 million in a registered direct offering. The closing of the offering is expected to take place on or about September 27, 2016. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. Rodman & Renshaw, a unit of H.C. Wainwright & Co., acted as the exclusive placement agent in connection with this offering.

 

 

ANALYST RECOMMENDATIONS

 

Janney analyst Ken Trbovich upgraded BioDelivery Sciences International to “buy” from “neutral,” citing  an improved financial outlook for 2017 on Endo’s (ENDP) Belbuca  winning preferred status over competitor Butrans on UNH’s formulary list, as well as the recent Bunavail contract awards.

 

Ladenburg Thalman analyst Kevin DeGeeter initiated coverage of Biotime with a “buy” rating and $6 price target, citing BTX is roughly halfway through a restructuring designed to unlock shareholder value through separation of non-core assets and accelerated development of the company’s cell therapy programs in ophthalmetry, aesthetics and orthopedics.

 

Wedbush analyst Heather Behanna initiated coverage of the following companies: Achillion Pharmaceuticals with an “outperform” rating and $13 price target; Alexion Pharmaceuticals with a “neutral” rating and $132 price target.

 

Jefferies analyst Eun Yang decreased her price target of Alexion to $120 from $140, citing reduced Soliris estimates due to potential biosimilar impact.

 

Suntrust analyst Peter Lawson increased his price target of Clovis to $50 from $38, citing rucuparib has a clear competitive advantage over the approved competitor Lynparza — in an earlier line, a broader label, better response rate, better side-effect profile and lower pill burden, Clovis is retaining greater economics by going direct in Europe, and unlikely to see an equity raise until after approval.

 

Credit Suisse analyst Erin Wilson assumed coverage of Lantheus with a “neutral” rating and $8 price target, citing LNTH’s market leadership in its flagship DEFINITY/Xenon franchises, strong industry fundamentals, pipeline opportunities, and global expansion initiatives.

 

HC Wainwright analyst Shaunak Deepak downgraded Mirna Therapeutics to “neutral” from “buy” and decreased his price target to $2 from $6, citing reduced visibility regarding the company’s clinical development plans following the MRX34 trial halt.

 

HC Wainwright analyst Carol Ann Werther increased her price target of Ultragenyx to $109 from $104, citing increased confidence in KRN23 success.

 

Piper Jaffray analyst Richard Purkiss initiated Novo Nordisk with a “neutral” rating and DKK320 price target, citing resilient top-line growth story albeit with structurally lower revenue growth prospects than the last few decades.