BioShares Biotechnology Clinical Trials (BBC): $21.58, -0.86, -25.7% YTD
BioShares Biotechnology Products (BBP): $32.86, -$0.80, +6.6% YTD
U.S. stock index futures were in the red as investors nervously await minutes from the September Federal Reserve policy meeting for clues on any interest rate hikes this year. JOLTS job openings for August is on the economic calendar, while CSX Corp is scheduled to report third-quarter results later in the day. European stock markets were steady, even as Ericsson led the region’s technology stocks down to a one month-low. Asian markets closed mostly lower, tracking Wall Street after a dour start to the earnings season in the previous session. The recently buoyant dollar came under pressure, as sterling partially rebounded from its dramatic losses in the previous session. Oil prices edged up, supported by record Indian crude imports. Gold prices were steady.
Transgene has entered a collaboration agreement with the science and technology company Merck KGaA, Darmstadt, Germany, and Pfizer under which Transgene will sponsor a Phase 1/2 study evaluating the potential of the therapeutic vaccine candidate TG4001 in combination with avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, for the treatment of human papilloma virus- (HPV-) positive head and neck squamous cell carcinoma (HNSCC), after failure of standard therapy.
MediciNova announced that the U.S. Food and Drug Administration has granted orphan-drug designation to MN-166 (ibudilast) for treatment of Amyotrophic Lateral Sclerosis (ALS).
Intellipharmaceutics International announced that it has entered into a license and commercial supply agreement with Mallinckrodt by which the company has granted Mallinckrodt an exclusive license to market, sell and distribute in the United States the following extended release drug product candidates for which Intellipharmaceutics has ANDAs filed with the FDA: Quetiapine fumarate extended-release tablets (generic Seroquel XR) — ANDA Tentatively Approved by FDA; Desvenlafaxine extended-release tablets (generic Pristiq) — ANDA Under FDA Review; Lamotrigine extended-release tablets (generic Lamictal XR) — ANDA Under FDA Review.
Celgene and Agios Pharmaceuticals announced each company has entered into collaboration agreements with Abbott to develop and commercialize companion diagnostic tests on Abbott’s m2000 RealTime System to identify isocitrate dehydrogenase (IDH) mutations in acute myeloid leukemia (AML) patients. Celgene is currently developing enasidenib (AG-221/CC-90007), an IDH2 mutant inhibitor, for the treatment of patients with relapsed or refractory AML who have an IDH2 mutation. Agios is developing AG-120, an IDH1 mutant inhibitor, for the treatment of patients with relapsed or refractory AML who have an IDH1 mutation.
GTx announced that it has entered into definitive agreements with certain existing shareholders of the Company, including J.R. Hyde, III, its largest shareholder and the Lead Director of GTx’s Board of Directors, Robert J. Wills, the Board’s Executive Chairman, and Marc S. Hanover, the Company’s Chief Executive Officer and a member of the Board, to sell an aggregate of approximately $14.0 million of shares of its common stock in a registered direct offering. The closing of the offering is expected to take place on or about October 14, 2016, subject to the satisfaction of customary closing conditions. Under the terms of the offering, the Company will sell approximately 17.3 million shares of its common stock at a purchase price of $0.81 per share, which was the consolidated closing bid price of the Company’s common stock on October 11, 2016.
RXi Pharmaceuticals announced that it has entered into an exclusive option agreement to acquire all outstanding capital stock of MirImmune, a privately-held company focused on the development of next generation immunotherapies for the treatment of cancer, in consideration for a number of shares equal to 19.99% of the then outstanding shares of common stock of RXi, plus additional potential consideration contingent on MirImmune reaching certain milestones. RXi Pharmaceuticals can exercise the option to acquire MirImmune on the terms set forth in the option agreement at any time prior to April 5, 2017 but has no obligation to do so.
RXi Pharmaceuticals announced that it plans to conduct a securities offering in the near future. RXi plans to use the net proceeds from the offering to enable the smooth integration of MirImmune into RXi in the event that RXi exercises its option to acquire MirImmune Inc. and the timely development of RXi’s current pipeline, as well as sd-rxRNA in cell therapy.
Aeterna Zentaris and Specialised Therapeutics Asia ("STA") announced the signing of an exclusive license agreement for the Company’s lead investigational anti-cancer compound, Zoptrex (zoptarelin doxorubicin), for the territories of Australia and New Zealand. Zoptrex, a novel synthetic peptide carrier linked to doxorubicin, is currently undergoing a fully-enrolled Phase III clinical trial to evaluate the compound in endometrial cancer. The Company expects to complete the Phase III clinical trial in 2016 and, if the results of the trial warrant doing so, to submit a new drug application for Zoptrex to the FDA in the first half of 2017. Zoptrex is the Company’s proposed tradename for zoptarelin doxorubicin. The proposed tradename is subject to approval by the FDA. Under the terms of the License Agreement, Aeterna Zentaris will be entitled to receive a non-refundable upfront payment in consideration for the license to STA of the Company’s intellectual property related to Zoptrex and the grant to STA of the right to commercialize Zoptrex in the Territory. STA has also agreed to make additional payments to the Company upon achieving certain pre-established regulatory and commercial milestones, as well as double-digit royalties on future net sales of Zoptrex in the Territory. STA will be responsible for the development, registration, reimbursement and commercialization of the product in the Territory. The Company and STA have also entered into a supply agreement, pursuant to which the Company will supply Zoptrex to STA for the duration of the license agreement.
AMAG Pharmaceuticals announced that it has achieved two key milestones in its next generation development programs. The definitive pharmacokinetic study and the comparative pain study for the Makena (hydroxyprogesterone caproate injection) subcutaneous auto-injector program (Makena SQ) have been initiated with the first patient dosed. The enrollment of patients in the Feraheme Phase III label expansion trial for the treatment of iron deficiency anemia (IDA) has surpassed approximately two-thirds of the total target enrollment of 2,000 patients, resulting in the acceleration of the estimated sNDA filing date to mid-2017.
AzurRx BioPharma announced that its initial public offering of 960,000 shares of common stock has been priced at $5.50 per share. Total gross proceeds from the offering will be $5,280,000. The shares will begin trading on October 11, 2016 on the NASDAQ Capital Market under the ticker symbol "AZRX." The underwriters have a 45-day option to purchase up to 144,000 additional shares of common stock from AzurRx to cover over-allotments, if any. The Company intends to use the net proceeds of the offering to conduct the necessary validation testing on the MS1819 capsules that will be used in future clinical studies, to conduct the Phase IIa trial, and for working capital and general corporate purposes. WallachBeth Capital and Network1 Financial Securities acted as co-book running managers and ViewTrade Securities acted as a co-manager for the offering.
Daiichi Sankyo and the Dana-Farber Cancer Institute announced a preclinical research collaboration focused on lung cancer.
NEOVACS announced a collaboration with Doctor Agnès Lehuen and Professor Christian Boitard, who are leading the laboratory for Research in Immunology of Diabetes at the reputed Cochin Hospital in Paris. The goal of this collaboration is to achieve proof of concept for the use of Neovacs’ IFNa Kinoid in the treatment of Type 1 diabetes.
ProMetic Life Sciences announced that the Drug Safety Monitoring Board recommended that patient enrolment should continue in the Corporation’s ongoing Alström syndrome phase II clinical trial. This recommendation follows the DSMB’s review of the safety data accumulated in the first eight Alström syndrome patients that had received treatment with PBI-4050. The DSMB determined that no safety or tolerability issues had been observed in these patients.
Ablynx announced a second extension of its research collaboration with a subsidiary of Merck & Co., to develop and commercialise Nanobody candidates directed towards an undisclosed voltage gated ion channel. The extension agreement will trigger a €1 million milestone payment to Ablynx, and Merck will extend their funding of the research collaboration at Ablynx to September 2018.
Jefferies analyst Biren Amin increased his price target of Avexis to $58 from $50, citing increased confidence in AVXS-101 based on the motor milestone data presented at World Muscle Society.
RBC analyst Simos Simeonidis increased his price target of Incyte to $113 from $106 following the epacadostat update at ESMO.
Baird analyst Brian Skorney downgraded Theravance Biopharma to “underperform” from “neutral” and increased his price target to $24 from $19, citing current share price.
RBC analyst Douglas Miehm decreased his price target of Valeant Pharmaceuticals to $35 from $36, citing management may lower guidance due to increased operating expenses associated with recovery of the business.
Goldman analyst Stephan Stewart decreased his price target of Horizon Pharma to $26 from $27, citing disappointing guidance.