BioShares Biotechnology Clinical Trials (BBC): $20.70, -$0.26

BioShares Biotechnology Products (BBP): 34.36, -$0.26

 

 

MARKET COMMENTARY

 

A day after the Dow index broke the 19,000 mark, U.S. stock index futures were little changed ahead of a flurry of economic data. Durable goods, weekly jobless claims, new home sales, home price index, Markit manufacturing PMI and consumer sentiment are on the economic calendar. Major European stocks lost ground, struggling to match the exuberance in Asia, where shares traded mostly higher. The dollar took a breather ahead of the U.S. Thanksgiving holiday. Oil prices turned lower. Gold stuck to a narrow range as investors awaited the Federal Reserve policy meeting minutes amid expectations of an interest rate hike in December. 

 

 

MARKET HIGHLIGHTS

 

Zealand Pharma announced that Sanofi has received U.S. Food and Drug Administration approval for Soliqua™ 100/33 (insulin glargline and lixisenatide injection) 100 Units/mL and 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide (Adlyxin™).  FDA approval triggers a $25 million milestone payment and double-digit percentage royalties of net sales of Soliqua to Zealand.  Sanofi plans to make Soliqua available in U.S. retail pharmacies in January 2017.

 

TRACON Pharmaceuticals will host a Key Opinion Leader luncheon for investors focused on the treatment of angiosarcoma and metastatic castration-resistant prostate cancer (mCRPC) at 12:00pm Eastern Time on Thursday, December 1, 2016.

 

TRACON Pharmaceuticals announced the pricing of an underwritten public offering of 2,625,000 shares of its common stock at a price to the public of $5.75 per share. The gross proceeds to TRACON from the offering are expected to be approximately $15.1 million. The offering is expected to close on or about November 29, 2016, subject to customary closing conditions. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 393,750 shares of common stock at the public offering price, less the underwriting discounts and commissions. TRACON intends to use the net proceeds from this offering to fund its ongoing and planned development of TRC105, including the planned global Phase III trial in angiosarcoma, to continue development of other pipeline assets such as TRC205, and for working capital and general corporate purposes. Jefferies and Stifel are acting as joint book-running managers for the offering. BTIG is acting as co-manager.

 

Zogenix announced the presentation of four clinical and scientific posters, and the hosting of a scientific exhibit room at the 70th Annual American Epilepsy Society (AES) meeting, which will take place at the George R. Brown Convention Center in Houston, Texas, from December 2 – 6, 2016.

 

Achaogen announced that on November 18, 2016, the compensation committee of the Company’s board of directors granted its recently appointed General Counsel, Gary Loeb, an option to purchase 71,000 shares of the Company’s common stock and 15,000 Restricted Stock Units (RSUs) and eight new non-executive employees the option to purchase an aggregate of 64,500 shares of the Company’s common stock and 32,225 RSUs. Each stock option has an exercise price per share equal to $4.86, which was the closing trading price on November 18, 2016, the date of the grant. The stock options were granted pursuant to the Company’s 2014 Employment Commencement Incentive Plan, which was approved by the Company’s board of directors in December 2014 under Rule 5635(c)(4) of The Nasdaq Global Market for equity grants to induce new employees to enter into employment with the Company.

 

ABIVAX will host a Key Opinion Leader luncheon for investors focused on novel approaches to HIV therapy at 12:00pm Eastern Time on Monday, November 28, 2016.

 

BioDelivery Sciences International will present at the 28th Annual Piper Jaffray Healthcare Conference on Wednesday, November 30th @ 2pm Eastern Time.

 

Eli Lilly and Company announced that solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a Phase III study of solanezumab in people with mild dementia due to Alzheimer’s disease. Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo, as measured by the ADAS-Cog(14). While the study results, including many secondary clinical endpoints, directionally favored solanezumab, the magnitudes of treatment differences were small. There were no new safety signals identified in the study. Lilly will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer’s disease.

 

Juno Therapeutics announced that it has voluntarily placed on hold the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia, known as the "ROCKET" trial. The clinical hold was initiated after two patients suffered cerebral edema earlier this week. One patient died and as of last night the other is not expected to recover.

 

Galapagos reported the first dosing of a patient in the DIVERSITY Phase III study with filgotinib in Crohn’s disease (CD). The start of the DIVERSITY study triggers a $50 million milestone payment from Gilead. The worldwide DIVERSITY Phase III study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 patients with moderately to severely active Crohn’s disease, including those with prior biological therapy failure.

 

Allergan announced that it has completed the acquisition of Chase Pharmaceuticals Corporation. Allergan acquired Chase for an upfront payment of $125 million (subject to certain adjustments) and additional potential regulatory and sales milestone payments related to Chase’s lead compound, CPC-201, and certain backup compounds.

 

Green Cross announced that it has received a CRL from the FDA regarding its BLA for IVIG-SN (human normal immunoglobulin G for intravenous administration) intended for the treatment of primary immunodeficiency diseases. The requests raised by the FDA pertain only to Chemistry, Manufacturing and Controls (CMC). As the CRL did not cite efficacy or safety issues, Green Cross believes that these items can be addressed and is working for a timely response to the FDA.

 

Approval has been obtained for the manufacturing of Enoxaparin Sodium pre-filled syringes in Poland and elsewhere in the European Union, as part of a strategic collaboration with Adimmune and Techdow Pharmaceutical for the European market. Separately, the company has also begun its Quadrivalent Influenza Vaccine Phase III trial in Europe.

 

Verona Pharma announced that it plans to conduct a registered initial public offering in the United States. The number of shares and price of the proposed offering have not yet been determined. The proposed offering is expected to commence in the first half of 2017, after the U.S. Securities and Exchange Commission completes its review process of the registration statement relating to the proposed offering and subject to market and other conditions.

 

Takeda Canada announced that ENTYVIO (vedolizumab), a gut-selective biologic treatment to treat the two most common types of inflammatory bowel disease (IBD), has been named the 2016 winner of the prestigious Prix Galien Canada Innovative Product Award.

 

Bellerophon Therapeutics announced the pricing of a public offering with expected total gross proceeds of approximately $12 million. The offering is expected to close on or about November 29, 2016, subject to satisfaction of customary closing conditions.

 

Cellectar Biosciences announced the pricing of an underwritten public offering of shares of its common stock, or in lieu thereof, shares of its preferred stock convertible into 66,667 shares of common stock per share of preferred stock, at an effective price of $1.50 per share of common stock, and in both cases, associated warrants, for gross proceeds of approximately $8.0 million, prior to deducting underwriting discounts, commissions and offering expenses payable by the company. The net proceeds of the offering are estimated to be approximately $7.2 million. Ladenburg Thalmann is acting as sole bookrunner for the offering, and Aegis Capital is acting as co-manager.

 

 

Analyst Recommendations

 

Evercore analyst John Scotti decreased his price target of Pfizer to $37 from $38, citing disconsolation of bococizumab development program as well as other new information disclosed by the company during Q3’16 earnings call, including guidance updates, progress with Ibrance launch, and acquisition of MDVN.

 

Wells Fargo analyst David Maris decreased his valuation range of Teva to $53-$55 from $60-$61, citing weakness in Generics.

 

Mizuho analyst Irina Koffler downgraded Valeant to “underperform” from “neutral” and decreased her price target to $11 from $25, citing growth challenges, 2017 guidance risk, legal overhangs, and weaker asset divestitures.