3:21 am Bluebirdbio signs strategic research and development collaboration and licensing agreement with Medigene for T cell receptor immunotherapies against four targets (BLUE) :
Medigene and bluebird bio announced the signing of a strategic research and development collaboration and licensing agreement encompassing T cell receptor immunotherapies against four targets.
- Medigene will be responsible for the generation and delivery of the TCRs using its TCR isolation and characterization platform. Following the collaborative preclinical development, bluebird bio will assume sole responsibility for the clinical development and commercialization of the TCR product candidates and will receive an exclusive license for the intellectual property covering the resulting TCRs.
- Medigene will receive an upfront payment of $15 million as well as potential preclinical, clinical, regulatory and commercial milestone payments, which together could total over $1 billion in the aggregate for the four potential TCR products across several indications.
- Additionally, Medigene will receive R&D funding for all work performed in the collaboration and is eligible for tiered royalty payments on net sales up to a double-digit percentage.
Galapagos NV (GLPG) and MorphoSys AG (MPSYY) announced that the first patient with atopic dermatitis was dosed in an ongoing clinical phase 1 study with their jointly discovered and developed human monoclonal antibody MOR106 against IL-17C.
- MOR106 is the first publicly disclosed monoclonal antibody targeting IL-17C in clinical development worldwide. IL-17C has been shown to be distinct from other members of the IL-17 cytokine family and to play an important and pro-inflammatory role in certain skin disorders.
- The primary objective of the ongoing randomized, double-blind, placebo-controlled Phase 1 study is to evaluate the safety and tolerability. As secondary endpoints, the study will assess pharmacokinetics and potential immunogenicity of MOR106.
3:12 am ING Groep sells partial stake in Kotak Mahindra Bank (ING) :
Co announced the sale of 46.7 million ordinary shares of Kotak Mahindra Bank.
- The shares were sold at a price of INR 782.32 per share. Gross proceeds to ING from the offering amount to approximately EUR 490 million (at the current exchange rate).
- The sale reduces ING's stake in Kotak from currently 6.4% to 3.9%. ING's remaining stake in Kotak will be subject to a 90 day lock-up following settlement of the transaction which is expected to occur on October 4.
3:10 am Roche Hldg receives FDA approval of a label extension of the cobas EGFR Mutation Test v2 (RHHBY) :
Co announced that the FDA has approved a label extension of the cobas EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca's (AZN) non-small cell lung cancer therapy TAGRISSO.
- Current clinical guidelines, including those from the National Comprehensive Cancer Network in the U.S., and the European Society for Medical Oncology, recommend EGFR mutation testing in patients with advanced NSCLC, prior to administering targeted therapies.
3:06 am On The Wires (:WIRES) :
- Freeport-McMoRan (FCX) announced today the expiration of the previously announced consent solicitations by it and its wholly owned subsidiaries, Freeport-McMoRan Oil & Gas LLC and FCX Oil & Gas Inc. The consent solicitations expired at 5:00 p.m., New York City time, on September 28, 2016.
- Qualcomm (QCOM) announced that its subsidiary, Qualcomm Technologies, and SK Telecom (SKM) announced the first over-the-air technology demonstration of eLAA and LAA that utilizes both licensed and unlicensed spectrum at SK Telecom's Corporate R&D Center in Bundang, Korea.
- NetSuite (N) announced a host of product enhancements to NetSuite OneWorld, delivering deep global financial capabilities designed for Australia and New Zealand-headquartered businesses and multinational companies in both countries. Additionally, co announced that Paycorp, a leading Australian provider of enterprise payment processing solutions, has joined the NetSuite SuitePayments program
- Samsung Electronics (SSNLF) and SAP (SAP) held the opening ceremony for a joint research center where engineers will conduct R&D for memory solutions to be used in next-generation in-memory computing.
- Mitsubishi Electric (MIELY) announced today that it will implement a globally standardized information technology platform across worldwide Mitsubishi Electric Group companies by the end of March 2018. The new platform will provide enhanced security and more efficient communication tools for some 140,000 employees of the Mitsubishi Electric Group worldwide and help to reduce annual operational costs, such as security measures, by up to 20%.
- AbbVie (ABBV) strengthened its manufacturing capabilities by opening the small molecule active pharmaceutical ingredient facility of its Singapore manufacturing site. This facility supports the growth of AbbVie's oncology and women's health pipeline and reflects progress from AbbVie's two previous announcements for manufacturing investment in Asia in 2014.
3:01 am Samson Oil & Gas provides update on North Stockyard closing (SSN) :
As previously advised, Samson has executed a purchase and sale agreement with respect to its interest in the North Stockyard Field and received a $1 million deposit as part of the $15 million consideration.
- The buyer has indicated that it now plans to close on October 20th. Accordingly Samson has accepted an extension request, along with a $50,000 fee to accommodate this extension.
- Mutual of Omaha Bank has accepted our waiver request to allow the current debt facility to be reduced by $11.5 million to $19 million prior to October 31st. Mutual of Omaha Bank has also agreed that a portion of the sale proceeds (in amount to be agreed upon) may be included in the amount needed to complete the $5 million equity required to be raised by Samson. Mutual of Omaha Bank has also agreed that this may be accomplished prior to November 15th, 2016. The equity raised in April this year would be included in the $5 million required to be raised.
- Samson is publishing its June 30th accounts tomorrow and, as of that date, the Company will report that it is in compliance with all other covenants associated with its debt facility.
3:00 am Triumph Bancorp prices offering of $50 mln aggregate principal amount of its Fixed-to-Floating Rate Subordinated Notes due 2026 (TBK) :
2:59 am Aerojet Rocketdyne to redeem its 2% Convertible Subordinated Debentures due 2024 (AJRD) :
2:58 am Mimecast prices secondary public offering by selling shareholders of 4 mln ordinary shares at $16.50 per share (MIME) :
- Mimecast will not receive any proceeds from the sale of these shares
2:57 am Alcobra Pharma receives notice of clinical hold from FDA for co's MDX Phase III MEASURE study (ADHD) :
Co announced that it has received verbal notice from the Division of Psychiatry Products of the FDA that a full clinical hold has been placed on its Investigational New Drug applications for MDX in ADHD and Fragile X Syndrome. The clinical hold affects Alcobra's ongoing Phase III clinical study of MDX in adult patients with ADHD, known as the "MEASURE" study.
- Alcobra has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA indicated that the clinical hold is due to adverse neurological findings in a pre-clinical study.
- The FDA notification was not based on clinical safety data observed in the ongoing MEASURE study, which has enrolled nearly 500 subjects, or previous clinical studies involving MDX. Alcobra plans to work diligently with the FDA to seek the removal of the clinical hold.
2:54 am Cynapsus Therapeutics announces ISS recommendation that shareholders vote in favor of Sunovion Pharmaceuticals' acquisition of Cynapsus (CYNA) :
2:47 am Tabula Rasa HealthCare (Nasdaq) prices 4.3 mln share IPO at $12.00 per share, below the $13-15 expected range (TRHC) :
2:46 am MedEquities (:NYSE) Realty prices 19.9 mln share IPO at $12.00 per share, at the low end of the $12-14 expected range (MRT) :
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