Stockwinners Market Radar for January 10, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:50 EST Tejon Ranch issues statement regarding lawsuit filed over planned community - The company said, "The Center for Biological Diversity (CBD), an extremist environmental organization headquartered in Tucson, Arizona, has announced it has filed a new legal challenge over Kern County's December 2019 re-approval of Grapevine at Tejon Ranch, a master planned mixed use residential community. This challenge was entirely expected given the long history of CBD challenging projects statewide that would provide much needed housing and economic development, including projects at Tejon Ranch. Grapevine was first unanimously approved by the Kern County Board of Supervisors in December 2016. CBD subsequently sued and lost on six of the seven issues it raised regarding the sufficiency of the project's environmental impact report. On the seventh issue-the court ruled that there was a deficiency regarding the internal capture rate used in the traffic study-the court ordered the County do additional work and submit a revised environmental impact report reflecting the court-ordered changes to the traffic study. It's important to note that the court said no additional work needed to be done on the rest of the environmental impact report as the issues raised in the original lawsuit had already been litigated and decided. The supplemental re-circulated environmental impact report showing the changes to the internal capture rate analysis was subject to full public review and comment process and was ultimately certified by the Kern County Planning Commission and Board of Supervisors, the later coming on December 10, 2019. Both decisions of the Kern County Planning Commission and Board of Supervisors were unanimous. In this new lawsuit, CBD attempts to re-litigate many of the issues on which it already sued and previously lost. It's important to note that while the lawsuit purports to challenge the supplemental analysis of the internal capture rate that was ordered by the court, CBD did not comment on the internal capture rate, either in writing or at the hearings held by Kern County, prior to raising these issues in its lawsuit. To sue again over issues that previously the court ruled in favor of Tejon Ranch on, and on an issue it did not even raise for consideration by Kern County, is unconscionable and a huge waste of taxpayer dollars. It's clear that this latest lawsuit by CBD is simply another blatant attempt to delay the development of the Grapevine project, which will provide much needed housing and economic development to Kern County and the region. CBD's concerted efforts to likewise delay Tejon Ranch's Centennial and Mountain Village master-planned communities, which together with Grapevine will provide 35,000 new homes for Californians, serve to worsen our housing shortage and drive home costs ever higher. To stand in the way of these locally approved developments that will bring thousands of much-needed price-attainable homes to California families is yet another stark example of CBD's "my-way-or-the-highway" mentality. CBD's intransigence is not surprising. It participated in the negotiations that led to the historic Tejon Ranch Conservation & Land Use Agreement that permanently conserves 240,000 acres of Tejon Ranch-equaling 90% of the Ranch's property, only to, after participating in the negotiations for more than a year, walk away from the table just before the agreement was reached. It's worth noting that the participants in the negotiations which included, in addition to CBD, Audubon California, Endangered Habitats League, Natural Resources Defense Council, Planning and Conservation League, and the Sierra Club, all indicated in advance that the outcome of negotiations would result in some real estate development on Tejon Ranch. In fact, it was actually representatives from CBD who proposed the 90% conservation--10% development ratio - only to later walk away from the negotiations. Now, CBD says it's opposed to conservation agreements. Clearly, CBD would rather retain the opportunity to sue (and presumably collect attorney's fees as their business model to survive on the chance it was to prevail) rather than compromising to achieve a guaranteed positive conservation outcome. The tactics employed by the extremists at CBD and associated organizations to litigate, delay and obstruct, are a significant contributing factor to the housing crisis in California. After all, the co-founder of CBD, Kieran Suckling, has stated that a primary goal of the organization is to inflict severe economic pain. As CBD pursues its agenda, that economic pain is ultimately being felt by countless numbers of Californians who find adequate housing increasingly unavailable and unaffordable."

17:31 EST Jana Partners reports roughly 8% stake in Callaway Golf - In a regulatory filing, Jana Partners disclosed about an 8% stake in Callaway Golf, which represents 7,530,268 shares. The filing allows for activism.

17:14 EST IBM awarded $145.81M Army contract modification - IBM was awarded a $145.81M modification to a contract for the full range of services and solutions necessary to support and maintain the Army's General Fund Enterprise Business System. Work will be performed in Bethesda, Maryland, with an estimated completion date of January 15, 2021. FY20 operations and maintenance, Army; research, development, test and evaluation, Army; and other procurement, Army funds in the amount of $8.92M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.

17:02 EST NeuroBo,Gemphire complete merger - NeuroBo Pharmaceuticals (NRBO) reported that the previously announced merger between it and Gemphire Therapeutics (GEMP) closed on December 31, 2019. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker "NRBO" on December 31, 2019. NeuroBo will focus on advancing the company's clinical-stage pipeline for neurodegenerative diseases. The combined organization will operate under the leadership of NeuroBo's new president and CEO, Richard Kang, and Chief Medical Officer, Mark Versavel.

16:31 EST HCA Healthcare acquires Valify, terms not disclosed - HCA Healthcare announced it has acquired Valify, a technology company focused on helping clients reduce the overall cost of healthcare services. Based in Frisco, Texas, Valify's web-based technology platform is able to provide healthcare systems with in-depth analysis and greater insights across a variety of service categories. The company's proprietary technology, analytics, benchmarking and professional advisory services enables hospitals to better manage resources in ancillary areas. Terms of the agreement were not disclosed.

16:19 EST Kadmon announces acceptance of late-breaking abstract of KD025 for cGVHD - Kadmon Holdings announced that expanded data from the interim analysis of ROCKstar, its ongoing pivotal trial of KD025 in chronic graft-versus-host disease, will be presented in a late-breaking oral presentation at the 2020 Transplantation & Cellular Therapy Meetings to be held February 19-23. The expanded dataset will include response rates across key subgroups and initial safety data for ROCKstar, which is evaluating KD025 in cGVHD in patients who had received at least two prior lines of systemic therapy. In November 2019, Kadmon announced that KD025 met the primary endpoint at the planned interim analysis of ROCKstar, which was conducted as scheduled two months after completion of enrollment. At the interim analysis, KD025 showed clinically and statistically significant Overall Response Rates of 64% with KD025 200 mg once daily and 67% with KD025 200 mg twice daily.

16:11 EST RTW Retailwinds receives continued listing standard notice from NYSE - RTW Retailwinds announced that on January 8, 2020, the company received notice from the New York Stock Exchange that the average closing price of the company's common stock over a consecutive 30 trading-day period had fallen below $1.00 per share, which is the minimum price required by the NYSE under Section 802.01C of the NYSE Listed Company Manual. The company plans to notify the NYSE by January 23, 2020 that it intends to cure the deficiency and return to compliance with NYSE continued listing requirements. Under the NYSE rules, the company can cure this deficiency if, during the six-month period following receipt of the Notice, on the last trading-day of any calendar month, the company's common stock has a closing share price of at least $1.00 and an average closing share price of at least $1.00 over the 30 trading-day period ending on the last trading day of that month. The company intends to consider available alternatives, including but not limited to, a reverse stock split, which would require the approval of a majority of the company's stockholders no later than its next annual shareholders' meeting.

16:08 EST Syndax sees 2020 being a 'transformative year' for the company - Syndax Pharmaceuticals announced a strategic outlook for 2020 outlining key priorities for its broad pipeline. "We expect 2020 to be an exciting and transformative year for the Company, with significant data read outs anticipated for all three of our innovative pipeline programs, each addressing an unmet need for some of today's most underserved patient populations," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Notably, this includes the final overall survival readout for E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we expect in the second quarter of 2020. Based on compelling survival data from the Phase 2b ENCORE 301 trial, we believe that the combination of entinostat and exemestane has strong potential to serve as an effective therapeutic option for the substantial number of patients who have progressed on first line hormone treatment. We are on track to file for regulatory approval in 2020 and to become a fully-integrated oncology company with the launch of entinostat in HR+ breast cancer expected in 2021." Morrison added, "In 2020, we also expect meaningful data readouts from the Phase 1/2 AUGMENT-101 trial of SNDX-5613, our potent, highly selective, oral Menin inhibitor, in adults with relapsed/refractory acute leukemias and the Phase 1 dose escalation trial of SNDX-6352, our anti-CSF-1R monoclonal antibody, in patients with cGVHD."

16:07 EST Brickell Biotech: Kaken Pharma submits NDA for sofpironium bromide in Japan - Brickell Biotech announced that its development partner, Kaken Pharmaceutical Co., submitted a new drug application for approval of manufacturing and marketing for sofpironium bromide in Japan for primary axillary hyperhidrosis. The application for sofpironium bromide in Japan involves data from the Phase 3 study in Japan, targeting patients with primary axillary hyperhidrosis, in which positive results were obtained.

16:06 EST Virtus Investment reports preliminary total AUM $108.9B as of December 31, 2019

16:01 EST Alnylam initiates rolling submission of NDA to FDA for lumasiran - Alnylam announced that the company has initiated a rolling submission of its New Drug Application to the U.S. FDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperoxaluria type 1. The rolling submission allows completed sections of an NDA to be reviewed by the FDA on an ongoing basis. Specifically, Alnylam has submitted the non-clinical components to the FDA and expects to submit the remaining components in early 2020. Alnylam also announced that it has been granted a pediatric rare disease designation from the FDA for lumasiran for the treatment of PH1.

15:43 EST PG&E down after Governor Newsom threatens to take company over - Shares of PG&E (PCG) are lower by 0.7% to $10.19, off earlier highs of $10.49, after Gavin Newsom, the governor of California, said the state will take over the embattled power company if it does not meet mandates, adding that they "have a break the glass scenario," according to a report from Bloomberg.

15:11 EST Charles River rises as Kerrisdale calls long idea, sees shares approaching $200 - Shares of Charles River Laboratories are rising in late day trading ahead of Sahm Adrangi of Kerrisdale Capital Management presenting his investment thesis on at Best Ideas 2020, hosted by MOI Global. A summary of the presentation, scheduled for 4 pm ET, states: "Assuming CRL reaches its target margin in 2021 and adds another $600m of acquisitions (consistent with management targets), Sahm thinks CRL can earn over $9/share in 2021. Well-owned clinical-stage CROs like IQV and ICLR trade for 22-24x forward earnings, and CRL has historically traded at a 2-5x premium to the S&P 500. Using Kerrisdale's $9 earnings estimate and a 22x 2021E P/E, Sahm thinks CRL shares can approach $200/share by the end of the year." About an hour ahead of the presentation, Charles River shares are up $2.28, or 1.5%, to $159.33.

15:01 EST Taro Pharmaceutical issues voluntary recall of Lamotrigine - Taro Pharmaceuticals is voluntarily recalling one lot of Lamotrigine 100 mg Tablets, Lot # 331771 in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot was found to have been cross-contaminated with a small amount of another drug substance, Enalapril Maleate, used to manufacture another product at the same facility. Taro has not received any product complaints or adverse events related to contamination of this product with Enalapril, or any complaints or adverse events that are associated specifically with this recall. Taro will continue to actively monitor for any and all adverse event reports that may be received, in compliance with FDA regulatory requirements.

13:40 EST Alphabet confirms top lawyer David Drummond to retire, effective January 31 - In a regulatory filing, Alphabet confimed that David Drummond has informed the company that he will be retiring from Alphabet, effective as of January 31, 2020.

13:12 EST Baker Hughes reports U.S. rig count down 15 to 781 rigs - Baker Hughes reports that the U.S. rig count is down 15 rigs from last week to 781, with oil rigs down 11 to 659, gas rigs down 4 to 119, and miscellaneous rigs unchanged at 3. The U.S. Rig Count is down 294 rigs from last year's count of 1,075, with oil rigs down 214, gas rigs down 83, and miscellaneous rigs up 3 to 3. The U.S. Offshore Rig Count is down 1 to 21 unchanged year-over-year. The Canada Rig Count is up 118 rigs from last week to 203, with oil rigs up 93 to 120 and gas rigs up 25 to 83. The Canada Rig Count is up 19 rigs from last year's count of 184, with oil rigs up 17 and gas rigs up 2.

12:52 EST Airbus reports 863 commercial aircraft deliveries in 2019 - Airbus said it delivered 863 commercial aircraft to 99 customers in 2019, outpacing its previous output record set in 2018 by 8%. "I am happy to see our commercial aircraft order and delivery numbers reflecting the continuous efforts to better serve our customers and bring our competitive products and services to the market", said Guillaume Faury, Airbus CEO. "I sincerely thank our customers for their loyalty and the Airbus teams and our industry partners who made it possible." Reference Link

12:08 EST ORIX's Peak Utility acquires Riley Brothers - Peak Utility Services Group announced the acquisition of Riley Brothers. ORIX Capital Partners acquired Peak in June 2018.

12:00 EST DRDGold rises 8.6% - DRDGold is up 8.6%, or 47c to $5.95.

12:00 EST OneConnect rises 14.5% - OneConnect is up 14.5%, or $1.96 to $15.50.

11:18 EST Nielsen completes acquisition of Precima from Alliance Data - Nielsen (NLSN) announced that it has completed its acquisition of Precima, an SaaS-based provider of retail and customer data applications and analytics, from Alliance Data Systems (ADS). "The addition of Precima into Nielsen Global Connect's portfolio will allow Nielsen to accelerate its new product capabilities while also strengthening existing products within its analytic suite. By bringing Precima into its measurement framework, Nielsen Global Connect will achieve a heightened advantage in the loyalty and personalization space, furthering its ability to help brands plan and measure the impact and success of personalized consumer offerings," the company stated.

11:03 EST DXC Technology's Luxoft, LG Electronics form joint venture - Luxoft, a DXC Technology Company (DXC), and LG Electronics announced that they will form an automotive joint venture to advance the deployment of production-ready digital cockpit, in-vehicle infotainment, rear-seat entertainment and ride-hailing systems based on the webOS Auto platform. The announcement said the "JV will bring together one of the industry's most innovative automotive software engineering providers with one of the world's leading innovators in technology and home entertainment."

11:01 EST CBAK Energy Technology announces supply agreement with Viessmann - CBAK Power Battery announced that the company and Viessmann Faulquemont SAS have entered into a Supply Agreement. Under the agreement, Viessmann undertakes to purchase lithium battery cells and other further products from CBAK Battery.

10:09 EST FDA discusses abuse potential for Nektar's NKTR-181 in briefing docs - The FDA released background information prepared by the Food and Drug Administration for the panel members of the advisory committee being convened to advise on the new drug application 211802 for oxycodegol for management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. The document states in part: "The results of human abuse potential Study 15-181-15 and the occurrence of adverse events are indicative of abuse potential in the clinical development program. NKTR-181 demonstrates an oral abuse potential comparable to oxycodone following oral administration. Results from Study 15-181-15 indicate that oxycodone, as a metabolite of NKTR-181, contributes in part to the subjective effects seen following oral administration of NKTR-181." Reference Link

10:00 EST Kimbell Royalty Partners falls -9.1% - Kimbell Royalty Partners is down -9.1%, or -$1.58 to $15.79.

10:00 EST Six Flags falls -18.1% - Six Flags is down -18.1%, or -$7.93 to $35.83.

10:00 EST Lithium Americas rises 8.3% - Lithium Americas is up 8.3%, or 31c to $4.04.

09:50 EST PhaseBio Pharmaceuticals Inc trading resumes

09:47 EST GrubHub falls -7.0% - GrubHub is down -7.0%, or -$3.89 to $51.84.

09:47 EST Six Flags falls -16.1% - Six Flags is down -16.1%, or -$7.03 to $36.73.

09:47 EST Kadmon rises 5.4% - Kadmon is up 5.4%, or 25c to $4.85.

09:40 EST Six Flags reports continued challenges in China, lower North America attendance - In a regulatory filing earlier, Six Flags stated: "The development of the Six Flags-branded parks in China has encountered continued challenges and has not progressed as Six Flags Entertainment had expected. The company's partner in China, Riverside Investment Group, continues to face severe challenges due to the macroeconomic environment and the declining real estate market in China. This has led Riverside to default on its payment obligations to the company and, as such, the company has delivered formal notices of default under its agreements. While the company continues to work with Riverside and each of Riverside's governmental partners, the eventual outcome is unknown and could range from the continuation of one or more projects to the termination of all the Six Flags-branded projects in China. In the fourth quarter of 2019, the company will realize no revenue from the China international agreements and expects a negative $1M revenue adjustment related to the China international agreements that will offset a portion of the revenue from the company's remaining international agreements. In addition, the company expects aggregate one-time charges of approximately $10M related to the China international agreements and certain unrelated litigation matters in the fourth quarter. For 2020, while the company does not foresee any significant additional one-time costs or expenses irrespective of the outcome of the Six Flags-branded projects in China, the loss of all the China projects would result in no revenue for that market if Riverside does not cure the default and the company is not able to engage other partners to complete any of the projects. Separately, the company's North America parks experienced lower attendance in the fourth quarter of 2019 versus the same period in 2018 due to softer than expected season pass and membership sales, primarily during the holiday sales periods. As a result, the Company expects total revenue in the fourth quarter of 2019 to be less than prior year by $8M-$10M. The company will provide additional details about the results for the fourth quarter of 2019 in the company's year-end earnings release and investor call."

09:29 EST Blue Ridge Bankshares names Jim McCarty as Chief Administrative Officer - Blue Ridge Bankshares is pleased to welcome Jim McCarty to its team as Chief Administrative Officer. Blue Ridge recently completed its merger with Virginia Community Bankshares and listed on the NYSE American. McCarty brings broad financial and operational experience in executive management to Blue Ridge developed over a twenty-five-year banking career, including over twenty in executive roles as CFO and Chief Administrative Officer.

09:04 EST Illumina files patent infringement suits against BGI in Sweden, UK - Illumina announced that it has filed two additional patent infringement suits relating to BGI's sequencing products, including the DNBSeq-400, DNBSeq-T7, and related chemistry reagents. The first complaint was filed against MGI Tech Co., Ltd. and Latvia MGI Tech SIA in the High Court of Justice, Chancery Division, Patents Court in the United Kingdom alleging infringement of four patents: EP 1 530 578 B1, EP 1 828 412 B2, EP 2 021 415 B1, and EP 3 002 289 B1. The second complaint was filed against Latvia MGI Tech SIA in the Patent and Market Court in Sweden alleging infringement of EP 3 002 289 B1. The patents cover Illumina's proprietary sequencing-by-synthesis chemistry. Related patent suits are pending in Denmark, Germany, Switzerland, Turkey and the United States.

09:02 EST China XD Plastics regains Nasdaq compliance for independent director requirement - China XD Plastics announced that it has received the formal notification from the Listing Qualifications Department of The NASDAQ Stock Market, informing the company that it has regained compliance with Listing Rule 5605, the independent director requirement for continued listing on The NASDAQ Stock Market, with the appointment of two independent directors, Guanbao Huang and Huiyi Chen.

09:00 EST PhaseBio Pharmaceuticals Inc trading halted, news pending

08:45 EST NeoGenomics acquires Oncology Division assets of Human Longevity for $37M - NeoGenomics announced that the company has acquired the Oncology Division assets of Human Longevity for $37M. The transaction closed and was financed via available cash on hand. The Oncology Division of Human Longevity performs Next Generation Sequencing services for pharmaceutical customers. The Division generated approximately $10M in revenues in 2019 and ended the year with a backlog of approximately $15M of signed contracts. NeoGenomics expects acquired assets to be slightly dilutive to 2020 adjusted EBITDA before becoming accretive in 2021 and beyond.

08:37 EST Guidewire announces CFO transition - Guidewire Software announced that CFO Curtis Smith is resigning for personal reasons. Smith is transitioning into a consulting role with the company effective in March, following the release of the company's Q2 financial results and the filing of Guidewire's quarterly report on Form 10-Q for the quarter ending January 31. The company will initiate a search to identify a successor.

08:34 EST Auris Medical announces notice of allowance for European patent application - Auris Medical Holding announced that the European Patent Office has issued a notice of "Intention to Grant" for its patent application entitled "Treatment of Tinnitus Through Modulation of Chloride Co-Transporter NKCC1 in the Auditory System". The allowed claims cover compounds modulating the sodium potassium chloride co-transporter 1 for use in the oral treatment or prevention of tinnitus. As demonstrated in an animal model of acute noise trauma, administration of an NKCC1 inhibitor resulted in a significant reduction of a biomarker for the presence of tinnitus. Inhibition of NKCC1 reduces trauma-induced excessive intracellular chloride ion levels in inner hair cells and the resulting neural hyperexcitability in the auditory system, which underlies the perception of tinnitus. A corresponding patent application is currently pending before the US Patent and Trademark Office and was already granted in Japan.

08:26 EST Meet Group, Microsoft collaborate on tech to help detect child sex predators - Meet Group (MEET) welcomed Microsoft's (MSFT) announcement that it was sharing a new tool, created in collaboration with The Meet Group and others, to help better detect on-line behaviors aimed at child exploitation. The new algorithm-based technology helps to better detect, address and report online predators attempting to lure children for sexual purposes.

08:21 EST Diffusion Pharmaceuticals appoints Robert Cobuzzi to board of directors - Diffusion Pharmaceuticals (DFFN) announces the appointment of Robert Cobuzzi, Jr., to the Company's board of directors, effective immediately. From 2005 until 2018 he was with Endo International (ENDP), a specialty branded and generic pharmaceutical manufacturer, holding positions of increasing responsibility including most recently President, Endo Ventures Limited in Dublin, Ireland from 2015 until 2018.

08:19 EST ViiV Healthcare submits regulatory application to EMA for fostemsavir - ViiV Healthcare, the HIV company majority owned by GSK (GSK), with Pfizer (PFE), and Shionogi as shareholders, announced the submission of a marketing authorisation application, or MAA, to the European Medicines Agency seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection. This application seeks approval of fostemsavir, used in combination with other antiretrovirals, for the treatment of adults with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen due to resistance, intolerance or safety considerations. The EMA's Committee for Medicinal Products for Human Use, or CHMP, has granted an accelerated assessment for the fostemsavir MAA. Accelerated assessment reduces the timeframe for review of a MAA and is awarded if the CHMP determines the product is of major interest for public health and therapeutic innovation.

08:17 EST Forty Seven expects updated data from Phase 1b trial of magrolimab mid-year - Forty Seven will expand enrollment in its ongoing Phase 1b clinical trial evaluating the combination of magrolimab and azacitidine to include additional untreated TP53 mutant AML patients who are ineligible for induction chemotherapy to inform a potential registrational path. Updated data from this trial will be presented mid-year. Additionally, Forty Seven is evaluating magrolimab for the treatment of colorectal and ovarian cancer. Clinical data in patients with CRC and ovarian cancer will be presented at the ASCO Gastrointestinal Cancers Symposium, held January 23-25, 2020 in San Francisco, and the ASCO-SITC Clinical Immuno-Oncology Symposium, held February 6-8, 2020 in Orlando, respectively. While data from these studies do not support a path to registration, Forty Seven intends to use these results and learnings to identify its next steps in solid tumors.

08:16 EST Forty Seven expects to initiate Phase 3 ENHANCE trial in 2020 - Forty Seven is focused on advancing magrolimab in registration-enabling programs for the treatment of patients with untreated, higher-risk myelodysplastic syndrome and heavily-pretreated, relapsed or refractory diffuse large B-cell lymphoma. Magrolimab has previously been granted Fast Track designation by the FDA for the treatment of MDS and acute myeloid leukemia, and for the treatment of relapsed or refractory DLBCL and follicular lymphoma, as well as Orphan Drug designation by the U.S. Food and Drug Administration and European Medicines Agency for the treatment of AML. In December 2019, the FDA granted Orphan Drug designation to magrolimab for the treatment of MDS. The company expects to achieve the following milestones in 2020: Myelodysplastic Syndrome: Initiate Phase 3 ENHANCE trial evaluating the combination of magrolimab and azacitidine compared to azacitidine alone in patients with untreated, higher risk-MDS in the second quarter; Present updated data from the ongoing Phase 1b clinical trial evaluating the combination of magrolimab and azacitidine in untreated patients with higher risk MDS mid-year; Complete enrollment in the ongoing Phase 1b clinical trial in the third quarter. Diffuse Large B-Cell Lymphoma: Initiate single-arm, registration-enabling trial evaluating the combination of magrolimab and rituximab in heavily pre-treated relapsed or refractory DLBCL patients who have failed at least two prior lines of therapy in the first quarter; Present initial data from the registration-enabling trial in the fourth quarter.

08:13 EST Mersana says Immunosynthen platform on track for development candidate in 2020 - Immunosynthen platform on track to deliver a STING agonist ADC development candidate in 2020. The Company has developed a novel STING agonist ADC platform and has generated preclinical data across multiple targets and models showing complete regression of tumors in vivo with a single, well-tolerated dose, consistent with increased cytokine expression and immune cell infiltration within the tumor. The Company expects to finalize the platform design and target evaluation and select its first STING agonist ADC development candidate in the second half of 2020. The Company also expects to disclose additional preclinical data at scientific meetings throughout 2020.

08:11 EST Mersana expects to initiate dose escalation in XMT-1592 in 1H20 - XMT-1592, a NaPi2b-targeting Dolasynthen ADC, selected as next clinical candidate, further extending Mersana's leadership position in NaPi2b and ADC innovation. Mersana's Dolasynthen platform retains the proprietary auristatin DolaLock payload with controlled bystander effect plus the added benefits of site-specific conjugation, precise drug-to-antibody ratio, and even greater hydrophilicity for further enhanced drug-like properties and tumor exposure. In preclinical studies, Dolasynthen has shown four times greater efficacy in a lung tumor model in comparison to Dolaflexin, a platform that has already shown success when targeted to NaPi2b. The Company plans to evaluate the clinical differentiation of Dolasynthen by leveraging its experience in NaPi2b to rapidly and efficiently progress XMT-1592 through dose escalation, which it expects to initiate in the first half of 2020.

08:09 EST Relmada Therapeutics names Maged Shenouda as CFO - Relmada Therapeutics (RLMD) announced that Maged Shenouda has been appointed the company's new CFO. Shenouda, who has nearly 30 years of biotechnology and equity research experience, has also stepped down from the Company's Board of Directors in order to join the executive management team. Relmada's current CFO, Charles Ence, will assume a new role in the expanded financial team as the company's Chief Accounting and Compliance Officer. Most recently, Shenouda served as CFO and Executive Vice President of Corporate Development for AzurRx BioPharma (AZRX).

08:08 EST Mersana Therapeutics CEO says 2020 has 'potential to be transformational year' - Mersana Therapeutics provided a pipeline update and announced its strategic priorities and anticipated milestones for 2020. Anna Protopapas, President and CEO of Mersana Therapeutics, will review these business updates in a presentation at the upcoming 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020. "XMT-1536, a first-in-class NaPi2b-targeting Dolaflexin ADC, is nearing proof of concept and we expect to report important data from both the dose escalation and expansion portions of the study throughout 2020," said Anna Protopapas. "XMT-1536 has shown confirmed responses and durable stable disease in biomarker unselected and heavily pretreated patients. XMT-1536 continues to be both active and well-tolerated at higher doses, and we have increased the dose in both the expansion and dose escalation portions of the study. We have also made significant progress in leveraging our differentiated ADC platforms to build an exciting pipeline of candidates. XMT-1592, a NaPi2b-targeted ADC based on our new Dolasynthen platform, aims to extend our leadership in NaPi2b-directed therapies while also clinically validating the differentiated profile that our Dolasynthen platform has shown preclinically. In addition, we are advancing a first-in-class ADC candidate targeting B7-H4, an antigen with a unique expression profile in the tumor and its microenvironment. Finally, we have developed a STING agonist ADC platform, Immunosynthen, with encouraging preclinical efficacy and tolerability data across multiple targets and anticipate selection of a development candidate later this year. 2020 has the potential to be a transformational year for Mersana as we progress in our efforts to develop novel therapeutics for patients with high unmet need."

08:06 EST Harsco sells IKG business to KPS Capital Partners for $85M - Harsco Corporation announced that it has sold its Houston-based IKG business to KPS Capital Partners for $85M in cash and notes, subject to post-closing adjustments. Harsco expects to use the net cash proceeds from the transaction to reduce debt to further strengthen its balance sheet to pursue growth, while the $40M note is expected to be paid over a number of years. KPS is a global private equity firm with over $11.5B under management that makes investments in manufacturing and industrial companies. With the completion of this transaction, the Company will have sold for a total of approximately $745M all three businesses that composed its Industrial segment. The Company announced the sale of its Patterson-Kelley and Air-X-Changers businesses last year.

08:03 EST Yirendai, Principal Financial enter agreement to expand into retirement market - Yiren Digital (YRD) announced that its wealth management platform Yiren Wealth has entered into a strategic cooperation agreement with Principal Global Investors Limited., a subsidiary of Principal Financial Group (PFG). The partnership will open up a comprehensive strategic business deployment in China's retirement financial service market, helping China's mass affluent population better prepare for retirement.

07:50 EST Profound Medical to begin patient recruitment for TULSA-PRO trials in 1H20 - In November 2019, Profound submitted its application for a Healthcare Common Procedure Coding System C-Code from the Centers for Medicare & Medicaid Services for the TULSA-PRO procedure. A C-Code is a unique temporary product code established by CMS for the Hospital Outpatient Prospective Payment System to promote the adoption of new medical technology that otherwise had no codes to facilitate payment. C-Codes are used on Medicare OPPS claims, but may also be recognized on claims from other providers or by other payment systems. "We are accelerating our reimbursement strategy for TULSA-PRO by pursuing both temporary and permanent CMS codes," said CEO Arun Menawat. "If and when Profound receives a C-Code for TULSA-PRO, it would provide for a 3-year period of coding and billing methodology for facility costs, where patients may only be required to personally cover the related physician fees. As for the longer term, we expect patient recruitment to begin in the first half of 2020 for planned additional trials designed to expand the body of clinical publications and enable TULSA-PRO to qualify for a specific CPT code."

07:41 EST Scholar Rock expects to intiate Phase 1 SRK-181 trial in 1Q20 - Initiation of SRK-181 Phase 1 Dose Escalation and Dose Expansion Clinical Trial in Patients with Solid Tumors Planned for the First Quarter of 2020. TGFbeta signaling has been implicated in driving immune exclusion, a key culprit of primary resistance to checkpoint inhibitor therapies as described by multiple academic and industrial groups. Scholar Rock is developing SRK-181 as a potential therapy in cancer immunotherapy to broaden responses to anti-PD-(L)1 therapies. In an aim to reduce toxicities associated with non-selective TGFbeta inhibition that have historically limited the ability to dose at clinically meaningful levels, SRK-181 has been designed to selectively block the TGFbeta1 isoform. An IND application for SRK-181 has been submitted to the FDA and Scholar Rock plans to initiate a Phase 1 proof-of-concept trial in the first quarter of 2020 in patients with locally advanced or metastatic solid tumors. The two-part trial will consist of a dose escalation portion for SRK-181 as both a single-agent and in combination with an approved anti-PD-(L)1 antibody, followed by a dose expansion portion evaluating SRK-181 in combination with an approved anti-PD-(L)1 antibody in multiple tumor-specific cohorts, such as urothelial carcinoma, melanoma, non-small cell lung cancer, and other solid tumors. Key objectives of the study include evaluating the safety and pharmacokinetics of SRK-181 and the efficacy of SRK-181 in combination with anti-PD-(L)1 therapy in the treatment of solid tumors exhibiting primary resistance to anti-PD-(L)1 therapy. Initial clinical data from the Phase 1 trial are expected in the second half of 2020 with clinical response and safety data anticipated in 2021.

07:39 EST Scholar Rock expects interim data from TOPAZ Phase 2 PoC trial in mid-2020 - Interim Safety and Efficacy Data from TOPAZ Phase 2 Proof-of-Concept Trial Expected in Mid-2020. Scholar Rock plans to report interim safety and efficacy results at six months of treatment exposure for all three fully enrolled cohorts in mid-2020. Top-line data for the full 12-month treatment period are expected beginning in the fourth quarter of 2020 and into the first quarter of 2021.

07:36 EST LogicBio Therapeutics to move into new headquarters in spring 2020 - The company said, "Doubling available lab and office space to support GeneRide platform development and capabilities expansion. LogicBio expects to move into new headquarters in Lexington, Mass. in the spring of 2020. LogicBio will be adding vivarium space, internal development capabilities, and will increase its capacity for in-house manufacturing of preclinical material. The expanded lab space will support the continued advancement of a robust pipeline that builds on the modular GeneRide construct. The new facilities will also support continued growth of the capsid program, which aims to develop and license new state-of-the-art viral vectors."

07:33 EST Seelos Therapeutics announces interim data from Phase 1 study of SLS-002 - Seelos Therapeutics announced interim data from its Phase I study of Intranasal Racemic Ketamine. Interim data from study SLS-002-101 demonstrated that 60mg of SLS-002, when administered as a monotherapy and in combination with an oral antidepressant, was generally safe and well-tolerated. All adverse events, except for one, were deemed mild or moderate. All AEs were transient in nature, consistent with the known profile of the drugs, and all resolved without medical intervention. The interim results from the study have not revealed any new or unique safety signals, there were no serious adverse events, and only one of 42 subjects discontinued the trial prematurely. Study SLS-002-101 is a single-center, open-label study which enrolled 42 healthy volunteers, studied over 14 days, randomized into two treatment arms and dosed with a combination of 60mg of SLS-002 and either, venlafaxine ER or sertraline. The primary objective of this study was to evaluate the pharmacokinetic profile, drug-drug interaction, and safety measures of SLS-002. Additional data from the ongoing Phase I studies of SLS-002 to evaluate the pharmacokinetics, pharmacodynamics and safety of multiple, repeated, single doses of SLS-002 as well as IV ketamine is expected throughout the first quarter of 2020.

07:29 EST Chiasma expects cash, cash equivalents to fund operations through 2020 - As of December 31, 2019, Chiasma had approximately $92M in cash, cash equivalents and marketable securities, which is expected to fund its operations, as currently planned, through at least 2020, including key milestones such as the planned FDA approval of MYCAPSSA, the anticipated U.S. commercial launch, and the release of top-line MPOWERED Phase 3 results.

07:28 EST Chiasma expects top-line results from MPOWERED Phase 3 trial in 4Q20 - Top-line MPOWERED Phase 3 Results: Chiasma expects to report top-line results from the MPOWERED Phase 3 open-label trial of MYCAPSSA in the fourth quarter of 2020.

07:27 EST Chiasma expects six-month review of MYCAPSSA NDA resubmission in mid-2020 - MYCAPSSA PDUFA Decision: Chiasma expects a six-month review of the MYCAPSSA NDA resubmission and a PDUFA decision from the FDA in mid-2020.

07:25 EST Chiasma to present OPTIMAL Phase 3 results at Endo 2020 conference - ENDO 2020 Conference: Chiasma has been selected to present the CHIASMA OPTIMAL Global Phase 3 results in an oral presentation at the Endo 2020 conference. Additional abstracts have been submitted to the conference which is being held March 28-31, 2020 in San Francisco, CA.

07:24 EST Chiasma CEO says 2019 was a 'successful year' - Chiasma reviewed its 2019 highlights and previewed its anticipated 2020 corporate milestones. On December 26, Chiasma resubmitted its NDA to the U.S. Food and Drug Administration for its investigational octreotide capsules product candidate, MYCAPSSA, for the maintenance treatment of adults with acromegaly. The positive results from the CHIASMA OPTIMAL trial, which was conducted under a Special Protocol Assessment agreement with the FDA, support the NDA resubmission. Chiasma expects a six-month review of the NDA resubmission. The NDA resubmission marks an important milestone in the company's effort to bring an oral somatostatin analog to patients. Following anticipated NDA approval, and in order to have commercial supply of MYCAPSSA product for launch, Chiasma expects to submit two manufacturing supplements to provide for an additional active pharmaceutical ingredient manufacturer and an additional commercial-scale manufacturing site affiliated with the API manufacturer currently referenced in the NDA. Chiasma is currently procuring API from both sources in anticipation of NDA approval. Chiasma expects to have adequate product available to support its planned commercial launch in the fourth quarter of 2020, subject to FDA's timely approval of the NDA and either of the manufacturing supplements. In July, Chiasma announced that the primary endpoint of the CHIASMA OPTIMAL trial, the proportion of patients biochemically controlled at the end of the trial, was achieved. Additionally, all four secondary endpoints were met. The CHIASMA OPTIMAL trial was conducted under an SPA agreement with the FDA and evaluated MYCAPSSA for the maintenance treatment of adults with acromegaly. Three Posters Presented at ENDO 2019 Highlighted Significant Unmet Needs in U.S. Acromegaly Patients: Data presented concluded that patients currently treated on injectable somatostatin analog therapies experience a significant disease burden and treatment dissatisfaction even when biochemically-controlled using existing therapies. The MPOWERED trial, designed to support approval of MYCAPSSA in the European Union for acromegaly, completed enrollment in June 2019. As of January 2020, the randomization was completed. Responders to the octreotide capsules were randomized per the protocol into the nine-month randomized controlled phase. Chiasma began its transformation into a commercial-ready organization with the appointment of a commercially-experienced chief executive officer and the addition of experienced leaders in marketing, market access and patient services. Chiasma has also expanded its medical affairs function, including hiring a leader with strategic medical and scientific expertise. "2019 was a successful year for Chiasma, highlighted by the positive results from the Phase 3 CHIASMA OPTIMAL trial and the NDA resubmission," said CEO Raj Kannan. "Looking ahead, 2020 has the potential to be a transformational year for our company as we focus on executing a successful launch of the first oral somatostatin analog for the treatment of acromegaly."

07:20 EST Evelo expects further data from EDP1503 Phase 1/2 trial in 1H20 - EDP1503 - Phase 1/2 in oncology- Further data from the ongoing Phase 1/2 clinical trial evaluating EDP1503 in combination with Merck's anti-PD-1, KEYTRUDA, in individuals with microsatellite colorectal cancer, triple-negative breast cancer or other tumor types who have relapsed on prior PD-1/L1 inhibitor treatment, in the first half of 2020.

07:19 EST Evelo expects initial data from EDP1066 Phase 1b trial in 1Q20 - EDP1066 - Phase 1b new formulation in mild to moderate atopic dermatitis- Initial data from the Phase 1b clinical trial evaluating a new formulation of EDP1066 in a cohort of individuals with mild to moderate atopic dermatitis in the first quarter of 2020.

07:17 EST Evelo expects initial data from cohort in EDP1815 Phase 1b trial in 2Q20 - EDP1815 - Phase 1b new formulation in mild to moderate psoriasis: Initial data from an additional cohort in the EDP1815 Phase 1b trial to evaluate a new formulation in up to 24 individuals with mild to moderate psoriasis in the second quarter of 2020.

07:14 EST ContraFect announces first patient dosed in Phase 3 DISRUPT study of Exebacase - ContraFect Corporation announced the first patient has been dosed in the Phase 3 DISRUPT study of exebacase in patients with Staph aureus bacteremia, including right-sided endocarditis. The Phase 3 DISRUPT study of exebacase is a randomized, double-blind, placebo-controlled clinical study conducted in the U.S. to assess the efficacy and safety of exebacase in approximately 350 patients with complicated Staph aureus bacteremia, including right-sided endocarditis. Patients entering the Phase 3 study will be randomized 2:1 to either exebacase or placebo, with all patients receiving standard-of-care antibiotics. The primary efficacy endpoint will be clinical response at Day 14 in patients with MRSA bacteremia, including right-sided endocarditis. Secondary endpoints will include clinical response at Day 14 in the All Staph aureus patients (MRSA and methicillin-sensitive Staph aureus, 30-day all-cause mortality in MRSA patients, and clinical response at later timepoints. The company plans to conduct an interim futility analysis following the enrollment of approximately 60% of the study population.

07:11 EST Akcea, Ionis announce initiation of CARDIO-TTRansform Phase 3 clinical trial - Akcea Therapeutics, Inc. (AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (IONS), announced the initiation of the CARDIO-TTRansform Phase 3 cardiovascular outcomes study for AKCEA-TTR-LRx in patients with transthyretin-mediated amyloid cardiomyopathy. AKCEA-TTR-LRx is an antisense drug developed using Ionis' proprietary LIgand Conjugated Antisense technology platform and is designed to inhibit production of TTR. It was discovered by Ionis and is being co-developed by Ionis and Akcea. In a Phase 1 clinical trial, patients treated with AKCEA-TTR-LRx experienced reductions in TTR of up to 94 percent at the highest dose.

07:08 EST LogicBio, Takeda announce collaboration to develop LB-301 - LogicBio Therapeutics (LOGC) announced a research collaboration with Takeda Pharmaceutical Company Limited (TAK) to further develop LB-301, an investigational therapy using LogicBio's proprietary, promoterless, nuclease-free genome editing technology, GeneRide, for the treatment of Crigler-Najjar syndrome. LB-301 is a recombinant adeno-associated viral (AAV) vector with a uridine disphosphate-glucuronosyltransferase-1 gene. The collaboration will bring together LogicBio's propriety platform for genome editing and Takeda's expertise in researching and developing gene therapies. Under the agreement, LogicBio and Takeda will collaborate to further research and develop LB-301. Takeda will provide funding for the research program under the collaboration agreement and will have an exclusive option to negotiate an exclusive, worldwide license to LogicBio's LB-301 program.

07:06 EST Biogen collaborates with CAMP4 to treat neurodegenerative, neurological diseases - CAMP4 Therapeutics announced a collaboration with Biogen aimed at addressing neurodegenerative and neurological diseases. The collaboration will leverage CAMP4's Gene Circuitry Platform with the aim of identifying how to dial up or down the expression of disease-associated genes within microglial cells, which are implicated in many serious neurological and neurodegenerative diseases. Under the terms of the agreement, CAMP4 will receive a $15M upfront payment from Biogen. Biogen will reimburse CAMP4 for research activities, and Biogen will have the option to select resulting targets to advance to discovery, development and commercialization. CAMP4 will be eligible to receive development and milestone payments of up to $96M, plus future royalties, for each of the initial selected targets and up to $173M, plus future royalties, for each additional target. As part of the collaboration, the companies will also explore other cell types of the central nervous system beyond microglial cells to potentially expand the number of neurological diseases that could be addressed. Using insights generated by its Gene Circuitry Platform, CAMP4 is creating tissue-specific circuitry maps, with each map serving as its own therapeutic area discovery engine. CAMP4 began by generating a liver cell map and is currently underway with mapping multiple additional tissue-based cell types. CAMP4's collaboration with Biogen will leverage the company's signaling map of the brain. Other maps in development include the kidney, heart, immune cells and muscle.

07:04 EST Sorrento receives non-binding acquisition proposal for up to $7.00 per share - Sorrento Therapeutics announced that on January 9, 2020, it received a non-binding proposal from a private equity fund to acquire a majority or all of the issued and outstanding shares of the Company for up to $7.00 per share. Consistent with its fiduciary responsibilities, the Company's Board of Directors is carefully reviewing the proposal with the assistance of its advisors to determine the course of action it believes is in the best interests of the Company and its stockholders. There is no assurance that any transaction will occur. Sorrento stockholders are not required to take any action at this time.

07:01 EST Nektar, Bristol-Myers amend strategic pact for bempegaldesleukin plus Opdivo - Nektar Therapeutics (NKTR) and Bristol-Myers Squibb (BMY) announced the companies have agreed to a new joint development plan to advance bempegaldesleukin plus Opdivo into multiple new registrational trials. The revision to the strategic collaboration agreement includes a new joint development plan under which Nektar and Bristol-Myers Squibb will expand the active clinical development program for bempeg plus nivolumab from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma to include two additional registrational trials in adjuvant melanoma and in muscle-invasive bladder cancer. In addition, a Phase 1/2 dose escalation and expansion study will be initiated to evaluate bempeg plus nivolumab in combination with axitinib in first-line RCC in order to support a future registrational trial. The costs for these studies will be shared based upon the cost-sharing outlined in the terms of the original collaboration agreement. Also as part of the new strategic collaboration agreement, Bristol-Myers Squibb will independently conduct and fund a Phase 1/2 dose optimization and expansion study in first-line non-small-cell lung cancer with bempeg and nivolumab.

06:49 EST Aquestive Therapeutics CEO says entering 2020 'with a strong cash position' - "In addition to exceeding the top end of our revenue guidance, we achieved significant milestones, as promised, in 2019. First, we completed our rolling submission of the New Drug Application for our therapeutic candidate Libervant Buccal Film for the management of seizure clusters to the U.S. Food and Drug Administration in November 2019. Next, we successfully completed a number of early stage clinical trials regarding AQST-108, advancing toward our February 2020 Pre-IND meeting with the FDA to clarify the clinical and regulatory path forward. These milestones establish a path forward in 2020 to advance our pipeline and commercial opportunities," said Keith Kendall, CEO of Aquestive. "Sympazan continued to extend its reach in the prescribing community that will ultimately be vital to the successful launch of Libervant, subject to approval by the FDA. We entered 2020 with a strong cash position of approximately $49 million and, with the announcement by Sunovion of a May 2020 PDUFA date for APL-130277, we believe that we have a clear timetable to work toward securing substantial additional non-dilutive capital in mid-2020. We anticipate current capital and revenues from monetization of our rights in APL-130277, subject to approval by the FDA, to fully support our commercial activities, the expected launch of Libervant, the continued development of AQST-108 and the identification, investigation and development of additional product candidates."

06:46 EST Entegris acquires Sinmat for approximately $75M in cash - Entegris announced it has acquired Sinmat, a CMP slurry manufacturer. Located in Gainesville, Florida, Sinmat is now part of the Specialty Chemicals and Engineered Materials Division of Entegris. Entegris acquired Sinmat for approximately $75M in cash, subject to customary purchase price adjustments.

06:39 EST Elanco says FY20 guidance for stand-alone Elanco only - The company said, "The 2020 guidance presented is for stand-alone Elanco only, including full year revenues for products that may be divested, and does not include any expected revenues or expenses from the Bayer animal health business or impact of transactions related to the acquisition, such as potential issuance of additional shares."

06:33 EST Eli Lilly agrees to acquire Dermira for $18.75 per share, or about $1.1B in cash - Eli Lilly (LLY) and Dermira (DERM) announced a definitive agreement for Lilly to acquire Dermira for $18.75 per share, or approximately $1.1B, in an all-cash transaction. Dermira is a biopharmaceutical company dedicated to developing new therapies for chronic skin conditions. The acquisition will expand Lilly's immunology pipeline with the addition of lebrikizumab, a novel, investigational, monoclonal antibody designed to bind IL-13 with high affinity that is being evaluated in a Phase 3 clinical development program for the treatment of moderate-to-severe atopic dermatitis in adolescent and adult patients, ages 12 years and older. Lebrikizumab was granted Fast Track designation from the FDA in December 2019. The acquisition of Dermira will also expand Lilly's portfolio of marketed dermatology medicines with the addition of QBREXZA cloth, a medicated cloth approved by the FDA for the topical treatment of primary axillary hyperhidrosis. Under the terms of the agreement, Lilly will commence a tender offer to acquire all outstanding shares of Dermira, Inc. for a purchase price of $18.75 per share in cash, or approximately $1.1B. The transaction is not subject to any financing condition and is expected to close by the end of the first quarter of 2020, subject to customary closing conditions, including receipt of required regulatory approvals and the tender of a majority of the outstanding shares of Dermira's common stock. Following the successful closing of the tender offer, Lilly will acquire any shares of Dermira that are not tendered into the tender offer through a second-step merger at the tender offer price. The purchase price represents a premium of approximately 86% to the 60-day volume-weighted average trading price of Dermira's stock ending on January 9, the last trading day before the announcement of the transaction. Dermira's board unanimously recommends that Dermira's stockholders tender their shares in the tender offer. Additionally, certain Dermira stockholders, beneficially owning approximately 13% of Dermira's outstanding common stock, have agreed to tender their shares in the tender offer. This transaction will be reflected in Lilly's financial results and financial guidance according to GAAP. Lilly will provide an update to its 2020 financial guidance, including the expected impact from the acquisition of Dermira, as part of its fourth-quarter and full-year 2019 financial results announcement on January 30.

06:09 EST TSMC reports December revenue NT$103.31B, a decrease of 4.2% from November - TSMC announced its net revenues for December: On a consolidated basis, revenues for December were approximately NT$103.31B, a decrease of 4.2% from November and an increase of 15% from December 2018. Revenues for January through December totaled NT$1,069.99 billion, an increase of 3.7 percent compared to the same period in 2018.

06:05 EST Profound Medical, RadNet sign U.S. multi-center pact for TULSA-PRO - Profound Medical (PROF) announced the signing of its first-ever U.S. multi-site imaging center agreement for TULSA-PRO with RadNet (RDNT). TULSA-PRO is a transurethral prostate tissue ablation system that combines real-time MRI with robotically-driven directional thermal ultrasound and closed-loop temperature feedback control software to deliver predictable physician prescribed ablation of whole-gland or partial prostate tissue. Pursuant to the agreement, Profound will install TULSA-PRO systems at three RadNet imaging centers in the greater Los Angeles area, with one such installation anticipated in each of Q1-, Q2- and Q3-2020. Profound will rent the systems to RadNet on a per-use basis, in addition to selling it per-use consumables. Based upon the success of these installations, the two companies hope to expand their partnership in the future to include additional RadNet centers in other U.S. markets.

05:28 EST Boeing says internal Max communications raise questions about FAA interactions - Boeing released a statement last night addressing employee messages provided to Congress and the Federal Aviation Administration. The documents have been released publicly at the encouragement of Chairman DeFazio and Chairman Wicker. Boeing said, "Some of these communications relate to the development and qualification of Boeing's MAX simulators in 2017 and 2018. These communications contain provocative language, and, in certain instances, raise questions about Boeing's interactions with the FAA in connection with the simulator qualification process. Having carefully reviewed the issue, we are confident that all of Boeing's MAX simulators are functioning effectively. The qualification activities referenced in these communications occurred early in the service life of these simulators. Since that time, both internal and external subject matter experts have repeatedly tested and qualified the simulators at issue...We regret the content of these communications, and apologize to the FAA, Congress, our airline customers, and to the flying public for them. We have made significant changes as a company to enhance our safety processes, organizations, and culture. The language used in these communications, and some of the sentiments they express, are inconsistent with Boeing values, and the company is taking appropriate action in response. This will ultimately include disciplinary or other personnel action, once the necessary reviews are completed." Reference Link