Stockwinners Market Radar for December 09, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:59 EST Streamline Health delaying Q3 results to resolve amortization charge - Streamline Health announced it will delay its Q3 earnings release and investor conference call to allow the company time to resolve and make appropriate adjustments to its accounting for amortization expenses related to certain software projects. The company is analyzing the need to amend previously filed financial statements as part of its discovery and review process. The company foresees no impact from this adjustment on its revenue, adjusted EBITDA or cash flow in fiscal year 2019 or prior periods. "Our discovery that software projects were not appropriately amortized is unfortunate, but we do not expect that it will have a material impact on revenue, adjusted EBITDA or cash flow," stated Thomas J. Gibson, CFO. "I want to assure our shareholders that we are working diligently to resolve this issue and believe we will do so in short order. The timing of the discovery prevented us from meeting our scheduled earnings release date and investor conference call for our third quarter performance results, which I'm pleased to report were strong across the board. In the third quarter ended October 31, 2019, we generated approximately $5.7 million in revenues producing improved adjusted EBITDA and $2.5 million in bookings." The Company plans to file its Form 10-Q and report its earnings for its third quarter no later than January 9, 2020.

18:33 EST Fly Intel: After Hours Movers - UP AFTER EARNINGS: Stitch Fix (SFIX) up 11.6%... MongoDB (MDB) up 8.7%... Phreesia (PHR) up 7.9%... Avid Bioservices (CDMO) up 5.8%... Vail Resorts (MTN) up 3.1%... Toll Brothers (TOL) up 0.9%. ALSO HIGHER: Equillium (EQ) up 18.5% after FDA granted Fast Track designation for itolizumab in treatment of lupus nephritis... Supernus Pharma (SUPN) up 10.2% after update on Phase 3 SPN-810 study in ADHD patients... Agilent (A) up 3.8% after disclosing activist stake taken by Pershing Square... Hepion Pharma (HEPA) up 3.0% after disclosing CRV431 data at HEP DART meeting. DOWN AFTER EARNINGS: Construction Partners (ROAD) down 17.4%... Casey's (CASY) down 5.9%... Chewy (CHWY) down 2.4%. ALSO LOWER: Livongo Health (LVGO) down 4.7% after selling stock for holders. Movers as of 18:15ET.

18:21 EST Occidental Petroleum director buys 12.9K shares of common stock - In a regulatory filing, Occidental Petroleum disclosed that its director Jack Moore bought 12.9K shares of common stock on December 6th. The total transaction size was $498K.

18:02 EST Editas Medicine announces in vivo proof-of-concept data for EDIT-301 - Editas Medicine announced in vivo proof-of-concept data supporting the development of EDIT-301 as a potentially best-in-class, durable medicine to treat sickle cell disease and beta-thalassemia. EDIT-301 is the first experimental medicine in development using Cas12a. The company reported these data today at the 61st Annual Meeting and Exposition of the American Society of Hematology in Orlando, Fla. In this study, when EDIT-301 was infused into NBSGW mice, HbF levels in human red blood cells were increased by approximately 50 percentage points above background at 16 weeks post-engraftment with pancellular distribution and no lineage skewing. These elevated HbF levels were observed after editing with Cas12a which created an editing profile that enriched genomic changes that favored high and persistent HbF levels.

17:51 EST First Financial Bancorp chairman Davis sells 25,000 common shares - In a regulatory filing, First Financial Bancorp executive chairman Claude E. Davis disclosed the sale of 25,000 common shares of the company at a price of $24.5238 per share on December 9.

17:43 EST Medtronic director buys 5K shares of common stock - In a regulatory filing, Medtronic disclosed that its director Richard Anderson bought 5K shares of common stock on December 6th. The total transaction size was $566.5K.

17:36 EST Fastly director Sunil Dhaliwal sells almost $576K in company shares - Fastly director Sunil Dhaliwal disclosed in a filing that he had sold 27,526 shares of company stock at an average price of $20.92 per share between December 5 and December 6. The total transaction value of the sale was $575,921.

17:32 EST Ford expects to roughly halve 2018 China EBIT loss - During a meeting with certain analysts and investors in the ordinary course of investor relations activities, management of Ford Motor Company said that in 2019, Ford expects to approximately halve its 2018 China EBIT loss, and, in 2020, to approximately halve its 2019 China EBIT loss, and in 2021, Ford could improve further in China, according to a regulatory filing. Ford has not previously issued such guidance for China, and this should not be construed as guidance for China. Ford's guidance for 2019 was effective as of October 23, 2019, the date Ford released its results for the third quarter of 2019. Ford's practice is to not update guidance intra-quarter. Ford's results for the fourth quarter of 2019 and full-year 2019 will be released on February 4, 2020.

17:25 EST Builders FirstSource acquires assets of Raney Components, Construction - Builders FirstSource announced it has purchased the assets of Raney Components and Raney Construction, located in Groveland, Florida. Founded in 1997, Raney is recognized in the industry for a vertically-integrated manufacturing and installation model which improves labor productivity and reduces cycle times for customers. Raney supplies wall panels, roof trusses, roof decking, interior wall framing and other select building materials and then partners with sub-contractors to install these products in approximately three thousand homes per year to its production builder customers across Florida. Raney has annual revenue of approximately $140M.

17:15 EST StoneCastle trading resumes

17:10 EST Upwork CEO Stephane Kasriel to step down, Hayden Brown to succeed - Upwork (UPWK) announced the initiation of a leadership transition. Stephane Kasriel, President & CEO, has informed the Board of his decision to step down at year end 2019, and the Board has appointed Hayden Brown, current Chief Marketing & Product Officer, to succeed Kasriel as President & CEO, effective January 1, 2020. Kasriel will remain involved with Upwork as an advisor to the company, and will continue to serve on the Board of Directors through the company's 2020 annual meeting of stockholders. Brown will also join the company's Board of Directors. Brown most recently led Upwork's product, design and marketing teams, developing and marketing a platform that enables talented professionals and businesses to seamlessly find each other and work successfully together on projects large and small. Prior to joining Upwork, she was the head of corporate development at LivePerson and previously held several strategy and M&A roles at Microsoft (MSFT).

17:08 EST Wendy's to realign resources in its information technology organization - On December 5, the Board of Directors of The Wendy's Company approved a plan to realign and reinvest resources in its Information Technology organization to strengthen its ability to accelerate growth. The company will be partnering with a third-party global IT consultant on this new structure to leverage their global capabilities, which the company believes will enable a more seamless integration between its digital and corporate IT assets. The company expects that the realignment plan will reduce certain employee compensation and other related costs that the company intends to reinvest back into IT to drive additional capabilities and capacity across all of its technology platforms. The company expects the majority of the impact of the realignment plan to occur at its Restaurant Support Center in Dublin, Ohio. The company expects to incur total costs of approximately $13 to $15 million related to the realignment plan, including approximately $8 to $9 million of severance and related employee costs and approximately $5 to $6M of third-party and other costs. The company expects the costs to be recognized beginning in the fourth quarter of 2019 and continuing into the first half of 2020. The company expects that substantially all of the total costs of the realignment plan will consist of cash expenditures, which are expected to begin in the fourth quarter of 2019 and continue through 2020 and into 2021, with approximately $12M of the total cash expenditures occurring in 2020.

17:04 EST Brown & Brown enters agreement to acquire Special Risk Insurance Managers - J. Scott Penny, Chief Acquisitions Officer of Brown & Brown, and Mark Woodall and Tom Willie, the principals of Special Risk Insurance Managers, announced that Brown & Brown Programs has entered into an agreement to acquire the assets of Special Risk. The transaction is expected to close effective January 1, 2020, subject to certain closing conditions. Founded in 1991, Special Risk has grown to a preeminent player in the MGA industry in Canada, recognized as MGA of the Year in 2018. The acquisition of Special Risk is a strategic step forward for Brown & Brown in establishing a presence in the Canadian insurance brokerage market. Special Risk will operate as a part of Brown & Brown National Programs, which, under the leadership of Chris Walker, consists of over sixty specialty niche programs and collectively represents over $3B in written premium. Special Risk will become a distinct operating division in the National Programs Division alongside specialist operations such as Arrowhead General Insurance Agency and Bellingham Underwriters. Mark Woodall will continue to lead the Special Risk team and will be part of the leadership team of the National Programs Division, reporting to Chris Walker. Tom Willie will continue to the lead the underwriting team of Special Risk.

17:01 EST Tyson Fresh Meats signs agreement with Republic of Kazakhstan - Tyson Fresh Meats, the beef and pork subsidiary of Tyson Foods, signed an agreement with the Republic of Kazakhstan and private holding company Kusto Group to collaborate on a project that, in its initial phase could lead to the construction of a modern beef processing plant in Kazakhstan, with an anticipated harvest capacity of 2,000 head per day. As presently conceived, the investment is projected to help provide an annual agricultural economic benefit to the country well in excess of $1B.

16:59 EST Canadian regulators clear sale of Genworth's stake in Genworth MI Canada - Genworth Financial (GNW) and Brookfield Business Partners (BBU) announced that Brookfield Business Partners together with its institutional partners has received approval under the Insurance Companies Act to purchase Genworth's majority interest in Genworth MI Canada Inc. All regulatory approvals required for the completion of this transaction have now been obtained. The parties expect to complete the Genworth Canada transaction on December 12, 2019.

16:53 EST Horizon Global appoints James Sistek Chief Administrative Officer - Horizon Global Corporation announced that the company's board appointed James Sistek as Chief Administrative Officer. Prior to joining Horizon Global, Sistek served as senior VP Business Operations for Superior Industries International.

16:49 EST Axcelis CFO sells 24.4K shares of common stock - In a regulatory filing, Axcelis disclosed that its CFO Kevin Brewer sold 24.4 shares of common stock on December 9th. The total transaction size was $550K.

16:46 EST Amerco announces 50c per share special cash dividend - Amerco declared a special cash dividend on its common stock of 50c per share. The dividend will be payable January 6, 2020 to holders of record on December 19, 2019.

16:34 EST First Solar CHRO Chris Bueter to retire, Caroline Stockdale to succeed - First Solar announced that Caroline Stockdale will lead the company's human resources and communications function, or CHRO, overseeing a global workforce of over 6,500 associates. She replaces Chris Bueter, who will continue in an advisory role until his retirement on April 1, 2020. Caroline has more than 20 years of operating experience in finance, human resources, business leadership, and process excellence, ranging from large global companies to entrepreneurial start-ups. She most recently served as the CEO for First Perform, a provider of human resources services for a variety of customers.

16:31 EST Franklin Resources reports preliminary AUM $691.3B as of November 30 - Compared to $693.1B at October 31. The decrease in assets under management was due to net outflows that offset market gains. Preliminary average assets under management for the quarter, through November 30, were $692.3B.

16:28 EST Vail Resorts: Lodging bookings 'largely in-line' with prior year - CEO Katz said, "Overall, lodging bookings for the season ahead are largely in-line with prior year bookings. Based on historical averages, around half of the bookings for the winter season have been made by this time, though it is important to note that our lodging bookings represent a small portion of the overall lodging inventory around our resorts. The early season experience at our resorts has been encouraging, with strong conditions across our Colorado, Tahoe and Northeastern resorts. Both Keystone and Vail have benefited from early snow and our recent snowmaking investments, which allowed Keystone to open on October 12 and Vail to open on November 15 and deliver a much improved experience to guests over Thanksgiving. Our resorts in Tahoe and Utah have opened with typical conditions for this time of year, and our Northeast resorts have started strong with certain resorts opening weeks earlier than in prior years."

16:26 EST Vail Resorts: Season pass sales through December 2 up about 17% in sales dollars - Season pass sales through December 2 for the upcoming 2019/2020 North American ski season increased approximately 17% in sales dollars (22% in units) as compared to the period in the prior year through December 3, 2018, including Military Pass sales and Peak Resorts pass sales in both periods. Pass sales are adjusted to eliminate the impact of foreign currency by applying an exchange rate of 75c between the Canadian dollar and U.S. dollar in both periods for Whistler Blackcomb pass sales.

16:24 EST Hepion Pharmaceuticals presents CRV431 data at HEP DART meeting - Hepion Pharmaceuticals announced that it will present two posters at the HEP DART, Frontiers in Drug Development for Hepatology, Including Viral Hepatitis, NASH and Co-Infections meeting.The presentations will summarize the population pharmacokinetics of CRV431 obtained from a Phase 1 clinical study of healthy human subjects and review CRV431's therapeutic actions in multiple experimental models of liver disease. The findings from the PK presentation will be utilized to establish CRV431 dosing in Phase 2 NASH clinical studies.

16:22 EST Pzena Investment reports $38.6B under management as of November 30 - Pzena Investment reports $38.6B under management as of November 30 versus $35.9B last year.

16:20 EST Supernus provides update on Phase 3 SPN-810 study - Supernus provided an update on the results from the first Phase III study of SPN-810, a novel treatment of Impulsive Aggression, or IA, in patients with ADHD. In early November, the company reported topline results from the Phase III P301 trial in patients six to 11 years. The study was a randomized, double-blind, placebo controlled, multicenter, parallel group clinical trial in patients diagnosed with ADHD. Patients receiving SPN-810 36mg showed a median percent reduction of 58.6% in the average weekly frequency of impulsive aggression episodes from baseline that was not statistically significant compared to placebo. These results are based on the combined analysis of data from stages 1 and 2 in the study. In stage 1, the median percent reduction was 60%, which was statistically significant compared to placebo. However, in stage 2 of the P301 study, post the interim analysis, the increase in variability in the 36mg treatment arm seems to have adversely impacted the results in the combined analysis. After conducting further analysis on the P301 data, the company believes that the high variability in the 36mg treatment arm was primarily due to six patients out of 135 that had a mild IA condition with a baseline score of six episodes or less per week. In the placebo arm, there were seven patients with the same mild IA condition. By excluding these subjects from the placebo and the 36mg treatment arm, the primary analysis of the P301 data on the primary endpoint results in a p value of 0.017 for the treatment arm compared to placebo. This result is also confirmed by the sensitivity analysis on the primary endpoint with a p value of 0.044. The company plans on finalizing the statistical plan, or SAP, for the second Phase III P302 study in patients six to 11 years old taking into consideration the exclusion of patients with six or less episodes of IA per week. The company will be submitting the SAP to the FDA and expects data from the P302 study in Q1. The P503 adolescent Phase III study in patients 12 to 17 years old had been designed from the outset with an exclusion criterion that excludes patients with a baseline score of six or less episodes per week.

16:19 EST Chewy reports Q3 gross margin up 410bps to 23.7% - Reports Q3 active customers up 32.8% to 12.7M and net sales per customer up 11.4% to $360.

16:19 EST Raging Capital urges Popular to take 'aggressive action' to unlock value - Raging Capital announced that it has delivered a letter to the Board of Directors of the company which stated in part: "Raging Capital Management is a long-term shareholder of Popular and currently owns approximately 700,000 shares of common stock of the company. We believe BPOP is significantly undervalued and we call upon you, in your capacities as directors of the company and fiduciaries of all shareholders, to take timely and aggressive action to unlock shareholder value. Specifically, we call upon the Board to: Adopt a $1 billion stock repurchase plan (representing ~20% of the float), at a minimum, to be executed over the next two years; and Double the current dividend payout ratio. These two steps would materially boost BPOP's annual earnings power to over $8 per share and return on equity to more than 15%. Even in this conservative scenario, BPOP would remain one of the most overcapitalized banks in North America with a ~14% CET1 ratio and minimal change to the Company's financial flexibility or significant, ongoing earnings power. We also call upon the Board to engage a nationally-recognized investment banking firm to explore all strategic alternatives. The investment banking firm should be specifically instructed to investigate, among other things, the following potential alternatives: Spin-off to shareholders of BPOP's 16% stake (~$360 million in market value) in EVERTEC, Inc., a publicly traded NASDAQ company; Spin-off and/or stock-based merger of Popular Bank, BPOP's mainland U.S. subsidiary, which operates in attractive markets and accounts for roughly 26% of the company's loan exposure; and sale of the entire company - we believe any reputable investment banking firm retained by BPOP could realistically determine that the value of the company would be best maximized through its acquisition by a larger, more diversified banking organization.Implementing our proposed buyback program and enhancing the dividend payout ratio would be a good first step to confirm that you are serious about unlocking shareholder value. Next, you should hire a nationally recognized investment bank to explore strategic alternatives. We estimate that a more appropriately capitalized BPOP would be valued more in-line with its mainland peers and be worth around $90 per share in the public markets, and perhaps more in various spin-off and/or sale scenarios. The time is now for the Board to be more aggressive. Even Wells Fargo, which is dogged by all sorts of regulatory scrutiny, has been able to buy back shares valued at 100% and 112% of the company's earnings for 2018 and the first 9 months of 2019, respectively. There is no good reason for BPOP to be both as overcapitalized and undervalued as it is today. We call upon the Board to act with urgency and aggressive action."

16:17 EST Harsco makes strategic investment in Carbicrete - Harsco Corporation announced that its Environmental division has made a C$3M investment into Carbicrete, a Canadian technology company developing cement-free, carbon-negative concrete products made with steel slag for the construction industry. The innovation investment will give Harsco Environmental a board seat in Carbicrete and has been made in conjunction with a C$2.1M grant from the Government of Canada's Sustainability Development Technology Canada Foundation and applications to further government grant programs. Harsco's investment will allow for the development of the innovative technology through a demonstration program with support from a commercial concrete block manufacturer as part of a development consortium.

16:16 EST Pershing Square reveals stake in Agilent in amended 13F filing - An amended 13F quarterly filing made by Bill Ackman's Pershing Square Capital Management reveals that the firm held a 2.916M stake in Agilent Technologies as of September 30. Shares of Agilent are up 4% to $85.00 in after-hours trading following the disclosure.

16:16 EST Stitch Fix CFO Paul Yee leaving company - The CEO Katrina Lake said:" We also made some strategic leadership changes this quarter. Elizabeth Spaulding joins us as President starting in January, reporting to me. Elizabeth will help lead us into our next chapter of growth, including the expansion of our customer experience beyond our core Fix offering. I am excited to welcome Elizabeth to Stitch Fix." Lake continued, "Our CFO, Paul Yee, has decided to leave the company to pursue other career opportunities. I want to thank Paul for his dedication to Stitch Fix and for his many contributions to our business. Mike Smith will step in to lead our finance team as we look for Paul's replacement."

16:13 EST Vail Resorts announces key capital investments for 2020/21 N American ski season - Vail Resorts announced a series of major capital improvements across its resorts that are designed to make getting on and around its mountains faster and easier through terrain expansions, new lifts and expanded restaurant experiences. The new projects are part of the company's calendar year 2020 capital plan of approximately $210M-$215M to enhance the guest experience and scale the company's growing business. This investment builds on the approximately $190M-$195M that Vail Resorts is planning to spend on capital improvement projects in calendar year 2019.

16:12 EST Astec to sell GEFCO subsidiary - Astec Industries announced that it intends to sell its GEFCO subsidiary, located in Enid, Oklahoma. GEFCO produces drilling equipment for water wells, geothermal wells, and cathodic protection; high-pressure double pumpers for energy services; and King Oil Tools for oil & gas and other applications. The GEFCO businesses contributed approximately $50M in annualized revenue and the divestiture is expected to eliminate related annual operating losses and be accretive to annualized EPS. The divestiture process is in early stages and management expects to conclude the transaction by the end of June 2020. The proceeds of the transaction will be invested in future growth opportunities aligned with the company's capital allocation process.

16:11 EST Equillium says FDA granted Fast Track designation for itolizumab - Equillium announced that the FDA has granted Fast Track designation for itolizumab for the treatment of lupus nephritis. Equillium initiated the EQUALISE Phase 1b study of itolizumab in patients with lupus and lupus nephritis in September 2019. The FDA's Fast Track program is designed to facilitate the development of new treatments for serious or life-threatening conditions for which there is a significant unmet medical need. Companies with investigational drugs that receive Fast Track designation benefit from more frequent meetings or communications with the FDA to discuss the drug's development plan and may be eligible for accelerated approval and priority review.

16:10 EST Oracle names Dr. Vishal Sikka to board of directors - Oracle (ORCL) announced that Dr. Vishal Sikka, founder and CEO of the AI company Vianai Systems, has been named to Oracle's Board of Directors. Before starting Vianai, Vishal was a top executive at SAP (SAP) and the CEO of Infosys (INFY).

16:09 EST Ryman Hospitality to acquire Block 21 from Stratus Properties - Ryman Hospitality Properties (RHP) announced it has reached an agreement with Stratus Properties (STRS) to acquire Block 21, a mixed-use entertainment, lodging, office and retail complex located in the heart of downtown Austin, Texas, for $275M, which includes the assumption of approximately $141M of existing mortgage debt. The acquisition is expected to close in Q1 of 2020, subject to customary closing conditions including, but not limited to, consent to the company's assumption of the existing mortgage loan by the loan servicer and the consent of the property manager, an affiliate of Marriott, to the company's assignment and assumption of the existing management agreement.

16:08 EST Kezar Life Sciences highlights potential of protein secretion inhibitors at ASH - Kezar Life Sciences highlighted work from its research and development platform focusing on Sec61 translocon inhibition during the 61st American Society of Hematology, ASH, Annual Meeting and Exposition taking place in Orlando, FL from December 7-10, 2019. Two oral presentations and one poster presentation focus on novel inhibitors of the Sec61 translocon, which demonstrate high degrees of potency against a large number of therapeutically relevant oncology and immuno-oncology targets that are Sec61 client proteins, translating into broad anti-tumor activity. "Our R&D efforts targeting the protein secretion pathway have progressed significantly, and we are thrilled to highlight this extremely compelling new therapeutic approach in our oral presentations and poster," said Christopher Kirk, President and Chief of Scientific Officer of Kezar. "The preclinical data generated with our first clinical candidate, KZR-261, increases our confidence that inhibiting the Sec61 translocon may prove effective in treating a variety of solid and hematologic tumor types. To that end, we have initiated activities towards an Investigational New Drug filing for an initial study in multiple solid tumor types, which we anticipate in Q1 2021."

16:07 EST Stratus Properties to sell Block 21 to Ryman Hospitality Properties for $275M - Stratus Properties announced that it has agreed to sell Block 21 to Ryman Hospitality Properties, Inc. for $275M, which includes the purchaser's assumption of approximately $142 million of existing mortgage debt. The remainder of the purchase price will be paid in cash. Block 21 is Stratus' wholly owned mixed-use real estate development and entertainment business in downtown Austin, Texas. Stratus is currently considering options for the use of the net proceeds of the sale and for its future real estate development and leasing operations, and expects to engage a nationally recognized financial advisor to assist in its evaluation of its options after the sale of Block 21.

16:06 EST Lululemon COO Stuart Haselden to step down - lululemon announced that Stuart Haselden, Chief Operating Officer and EVP, International, will leave the company, effective January 10, 2020, in order to assume a leadership position outside of the apparel industry. Mr. Haselden joined lululemon in 2015 as CFO and was one of three leaders who guided the company during its CEO search last year. The company announced that Chief Technology Officer, Julie Averill and Chief Supply Chain Officer, Ted Dagnese will join the company's Senior Leadership Team, reporting to Mr. McDonald effective immediately. In support of its long-term growth strategy to quadruple its international business by 2023, the company has begun an external search for the position of EVP, International. While the search is underway, the company's established leaders in APAC and EMEA will report to Mr. McDonald and Celeste Burgoyne, EVP of Americas and Global Guest Innovation, respectively.

16:03 EST Vail Resorts backs FY20 Resort Reported EBITDA guidance - Commenting on fiscal 2020 guidance, CEO Katz said, "Given our first quarter results and the indicators we are seeing for the upcoming season, we are reiterating our Resort Reported EBITDA guidance for fiscal 2020 that was included in our September earnings release, based on the assumptions incorporated at that time, including foreign currency exchange rates. While pass sales results to date have been encouraging, it is important to remember that the North American ski season has just begun, with our primary earnings period still in front of us."

16:01 EST J & J Snack Foods increases quarterly dividend 15% - J & J Snack Foods Corp. announced that its board has declared a regular quarterly cash dividend of 57.5c per share of its common stock payable on January 7, 2020 to shareholders of record as of the close of business on December 20, 2019. The cash dividend represents an increase of 15% from the previous quarterly dividend rate of 50c per share.

15:33 EST Microsoft to shut down Wunderlist on May 6, 2020 - Microsoft said in a blog post that it plans to shut down list app Wunderlist on May 6, 2020. "Why are we doing this now? We've stopped releasing new features and big updates to Wunderlist, so as the app ages it's become more difficult to maintain," the company said. "As technology continues to advance, we can't guarantee that Wunderlist will continue to work as it should, or as we'd like it to. With all our latest updates, we're confident in To Do being the best alternative for Wunderlist now and so we believe it's the right time to make the next move. Now, we want to dedicate all our time to growing that cross-suite experience that transforms how you achieve your goals and dreams." Reference Link

15:09 EST MacroGenics announces updated results from Phase 1/2 study of flotetuzumab - MacroGenics announced updated results from a Phase 1/2 dose expansion study of flotetuzumab, an investigational, bispecific CD123 x CD3 DART molecule in patients with primary induction failure and early relapsed acute myeloid leukemia, or AML. The data were presented in an oral session at the 61st Annual Meeting of the American Society of Hematology, or ASH. In the Phase 1/2 open-label, dose expansion study, 30 patients classified as primary induction failure or early relapsed AML who had received a median of four prior therapies were treated with flotetuzumab at the recommended phase 2 dose of 500 ng/kg/day by continuous infusion. Data were reported as of the cut-off date of November 1, 2019. The study is currently ongoing, with additional patients being enrolled. Responses, including complete remission, CR with partial hematological recovery and CR with incomplete hematological improvement per a modified International Working Group Response Criteria for AML were summarized. Four responders received allogeneic hematopoietic stem cell transplantation as consolidation therapy and remain in remission after 6 to 21 months. The most common treatment-related adverse event (TRAE) was infusion-related reaction/cytokine release syndrome that occurred in all 30 patients. However, most CRS events observed were of short duration and mild to moderate in severity, with only one grade 3 event reported in one patient, the company said. "Based on the encouraging data from this study, and pending anticipated discussions with the FDA in the first half of 2020, we are planning for a potential registration-enabling study of flotetuzumab in this high unmet need population of patients with refractory AML, who have limited treatment options," said Scott Koenig, President and CEO of MacroGenics.

14:53 EST Novartis says Kymriah demonstrates consistent efficacy, safety outcomes - Novartis announced results from two analyses of real-world experience with Kymriah, the only CAR-T cell therapy approved in two distinct indications. These analyses are from a readout of a 15-year post-marketing study that add to and complement the rigor of the Kymriah pivotal trials with evidence of the Kymriah real-world experience in expanded groups of patients. When Kymriah was used in the real-world setting, efficacy and safety were consistent when compared to the pivotal trials, including the 24-month analysis of JULIET in adults with r/r diffuse large B cell lymphoma and ELIANA in children and young adults with r/r B-cell acute lymphoblastic leukemia 1-6. The real-world experience data were presented at the 61st American Society of Hematology, or ASH, annual meeting.

14:49 EST Gamida Cell announces results from Phase 1 clinical study of GDA-201 - Gamida Cell announced updated results from a Phase 1 clinical study of GDA-201, an investigational, natural killer cell-based cancer immunotherapy for the treatment of patients with non-Hodgkin lymphoma, or NHL, and multiple myeloma, or MM, at the 61st Annual Meeting of the American Society of Hematology, ASH, which is being held December 7-10 in Orlando, Florida. Data from 22 patients in the ongoing study showed GDA-201 in combination with monoclonal antibodies was generally well tolerated and demonstrated early evidence of clinical activity in heavily pre-treated patients, including five complete responses observed among nine patients with NHL. Gamida Cell plans to initiate a Phase 1/2 multi-dose, multi-center study of GDA-201 in patients with NHL in 2020.

14:36 EST CBL & Associates closes sale of interest in the Outlet Shoppes at Atlanta - CBL Properties announced that it closed the sale of a 15% interest in The Outlet Shoppes at Atlanta in Atlanta, GA, to an affiliate of its existing joint venture partner, Horizon Group Properties, for total consideration of $20.8 million. The sales price included approximately $11.4 million in related debt. Following the sale, CBL and its joint venture partner both own a 50% interest in the center. Net proceeds from the sale were used to reduce outstanding balances on the company's line of credit. "With the closing of this sale, we've completed gross asset sales of more than $180 million during 2019," said Stephen Lebovitz, CBL's chief executive officer. "Proceeds from dispositions, along with our significant free cash flow, allow us to further transformative redevelopment efforts at our properties as well as improve our balance sheet through debt reduction."

13:46 EST Hoth Therapeutics, NC State iniiate preclinical gene therapy study for asthma - Hoth Therapeutics announced the initiation of a preclinical study for the treatment of asthma and allergic inflammation in collaboration with North Carolina State University beginning on January 1, 2020. The goal of the study is to determine the best approach for targeting allergic inflammation in the airways with Splice-switching oligonucleotides and establish proof of principle by providing preclinical mouse data to inform consequent toxicology, ADME, and Pharmacokinetics study or how an organism affects the drug. The initial set of experiments look to establish the delivery of SSOs targeting the gene encoding the FcRIbeta protein in the lungs of mice by using an ultrasonic nebulizer and assessing its distribution and function in mast cells throughout for a period of one year by using RNA scope technology. During the second phase, the aim will be to determine the efficacy of SSO combinations that target FcRIbeta and other genes that function in the IgE receptor pathway, in airway inflammation using humanized mouse models to establish which target gene(s) to move forward with. The study will determine the efficacy, in vivo, by administering SSOs for the target gene(s) and establishing whether targeting FcRIbeta alone or in combination with other genes provides the best therapeutic approach.

13:17 EST ViacomCBS CEO sees having 'differentiated' streaming strategy for whole company - ViacomCBS CEO Bob Bakish said ViacomCBS is working on one "differentiated" streaming strategy for the entire company, adding that investors can expect to hear more on that plan in the beginning of 2020. Bakish made the comments during an interview on CNBC.

12:10 EST Roper Technologies named a new short idea at Hedgeye - Roper Technologies has been named as a new short idea at Hedgeye, contacts tell The Fly.

12:00 EST Antero Midstream rises 21.8% - Antero Midstream is up 21.8%, or 98c to $5.47.

11:59 EST Jefferies to pay nearly $4M to settle SEC charges over ADRs - The Securities and Exchange Commission announced that Jefferies LLC will pay nearly $4M to settle charges of improper handling of "pre-released" American Depositary Receipts. The SEC's order finds that Jefferies improperly borrowed pre-released ADRs from other brokers when Jefferies should have known that those brokers did not own the foreign shares needed to support those ADRs. Without admitting or denying the SEC's findings, Jefferies agreed to disgorge more than $2.2M in gains and pay over $468,000 in prejudgment interest and a $1.25M penalty for total monetary relief of nearly $4 million. Reference Link

11:12 EST 'Concerned Stockholders' urges Farmer Bros. investors to vote gold proxy card - Jeanne Farmer Grossman, individually and as the sole trustee of certain trusts, Thomas William Mortensen, and Jonathan Michael Waite, the "Concerned Stockholders" group who together beneficially own approximately 4.9% of the outstanding common stock of Farmer Bros. Co., issued an open letter to employees and stockholders of Farmer Bros. Co. In it, Ms. Grossman responds to the company's efforts to exploit estranged members of the company's founding family in a desperate campaign to protect the current entrenched Board of Directors at the upcoming Annual Meeting. Ms. Grossman continues to urge stockholders to vote the GOLD proxy card to elect Mr. Mortensen and Mr. Waite and bring needed change and experience to the Farmer Bros. Board.

11:03 EST Aprea Therapeutics reports 88% ORR in Phase 1b/II APR-246, azacitidine trial - Aprea Therapeutics presented results at the 2019 ASH Annual Meeting from its U.S. Phase Ib/II clinical trial in MDS and AML. The trial is evaluating the safety and efficacy of APR-246 in combination with azacitidine for the treatment of TP53 mutated MDS and AML. The clinical trial is sponsored by the Moffitt Cancer Center with financial support from the MDS Foundation and the Aplastic Anemia and MDS International Foundation as administrator for the Evans MDS Clinical Research Consortium.As of the data cutoff, the overall response rate in 33 evaluable MDS patients was 88%, with a 61% complete remission rate, by International Working Group criteria. With a median duration of follow-up of 10.8 months, the median duration of response was 8.4 months and the median duration of CR was 7.3 months. Seventeen evaluable MDS patients discontinued therapy to pursue stem cell transplant. Median overall survival for all enrolled patients was 10.8 months. Median OS in responding patients versus non-responders was 13.7 vs. 3.9 months. Adverse events, regardless of causality, were mostly grade 1/2. Grade 3+ adverse events occurring in greater than or equal to20% of patients were limited to cytopenias and infection, consistent with underlying hematopoietic malignancies, and no exacerbation of the expected AZA-related safety profile has been observed.

11:02 EST State Street names Brian Franz as chief information officer - State Street Corporation (STT) announced that it has appointed Brian Franz to chief information officer. Franz, who joins the company in January 2020, will report to COO, Lou Maiuri and become a member of State Street's Management Committee, its senior-most strategy and policy making group. Franz comes to State Street from Diageo PLC (DEO), where he most recently served as chief productivity officer leading information technology, enterprise operations and business service functions across the company.

10:20 EST SpringsWorks reports Glaxo presentation of preclinical data on nirogacestat - SpringWorks Therapeutics (SWTX) announced that its collaborator, GlaxoSmithKline (GSK), presented data evaluating SpringWorks' investigational gamma secretase inhibitor, nirogacestat, alone and in combination with GlaxoSmithKline's investigational anti-B-cell maturation antigen antibody-drug conjugate, belantamab mafodotin, in preclinical cell line models of human multiple myeloma and other lymphomas. The data demonstrated that treatment of BCMA-expressing cancer cell lines with nirogacestat led to significantly increased levels of cell surface expression of BCMA and corresponding decreases in shedding of BCMA, as measured by levels of soluble BCMA. Further, the combination of nirogacestat and belantamab mafodotin resulted in synergistic increases in cancer cell killing as compared to belantamab mafodotin alone, with an up to ~3,000-fold improvement in cytotoxicity. The data were presented in a poster presentation at the 61st American Society of Hematology Annual Meeting. As previously announced, GlaxoSmithKline will sponsor and conduct a Phase 1b clinical trial to evaluate the safety, tolerability and preliminary efficacy of nirogacestat in combination with belantamab mafodotin in patients with relapsed or refractory multiple myeloma. This combination will be part of DREAMM-5, a platform trial being conducted by GlaxoSmithKline that is evaluating multiple belantamab mafodotin-containing combinations in separate sub-studies. SpringWorks expects the Phase 1b clinical trial of nirogacestat in combination with belantamab mafodotin to be initiated in the first quarter of 2020. "The data presented at ASH support the potential of nirogacestat to serve as a meaningful potentiator of BCMA-directed therapies. We look forward to further evaluating the combination of nirogacestat and belantamab mafodotin in the clinic as we work to fully explore the role of nirogacestat in multiple myeloma and other BCMA-expressing cancer types," said Saqib Islam, CEO of SpringWorks.

10:15 EST Forty Seven announces preclinical proof-of-concept data for FSI-174 - Forty Seven announced preclinical proof-of-concept data for its novel all antibody conditioning regimen, comprised of FSI-174, its anti-cKIT antibody, and magrolimab, its anti-CD47 antibody. Preclinical studies in a non-human primate model showed that the combination of FSI-174 and magrolimab significantly depleted hematopoietic stem cells from the bone marrow, with no dose limiting toxicities. The data will be presented in a poster session at the 61st American Society of Hematology Annual Meeting. "We are excited to report these preclinical data, which reflect our deep understanding of macrophage biology and our ability to build targeted antibody combinations to better facilitate phagocytosis. These results demonstrate for the first time the utility of our approach in the transplant setting, and the potential of our all antibody-based conditioning regimen to successfully deplete HSCs without relying on chemotherapy or radiation. We are excited to advance FSI-174 into the clinic early next year, and to work internally and with partners to deliver a novel, non-toxic conditioning regimen for patients undergoing transplantation," said Jens-Peter Volkmer, Co-Founder and Vice President of Research and Early Development at Forty Seven.

10:15 EST UPS reports expansion of UPS Worldwide Express, Express Plus across 40 countries - UPS announced an expansion across 40 countries of its UPS Worldwide Express and UPS Express Plus, part of the UPS international suite of shipping services that guarantees time- and day-definite delivery for urgent shipments. UPS express services are now available to businesses across 140 countries and territories, reaching the top 20 countries by GDP with morning delivery. "Cross-border trade continues to present growth opportunities for us and for customers of all sizes," said Nando Cesarone, president of UPS International.

10:14 EST Achillion reports 'positive' data from Phase 2 danicopan, eculizumab study - Achillion Pharmaceuticals reported top-line data from a dose-finding Phase 2 trial assessing the safety and effectiveness of its oral small molecule factor D inhibitor danicopan in combination with intravenous eculizumab in paroxysmal nocturnal hemoglobinuria patients who have an inadequate response to C5 monotherapy. Data from the Phase 2 trial were presented in a poster presentation today at the 61st American Society of Hematology Annual Meeting in Orlando, FL. The primary endpoint of the trial was an increase in hemoglobin from baseline. A mean increase of 2.4 g/dL at 24 weeks of treatment was achieved in this proof-of-concept trial. Danicopan, in combination with eculizumab, resulted in a significant reduction in blood transfusions with 10 patients receiving 34 transfusions in the 6 months prior to screening to 1 patient receiving 1 transfusion during the 24-week trial. In addition to improvements in hemoglobin and transfusions, there were also meaningful improvements in markers of hemolysis including bilirubin, reticulocytes, and PNH red blood clone size. "The increase in PNH specific red blood cell clone size, and reduction of reticulocytes, is likely due to the prevention of C3-mediated extravascular hemolysis, a result of targeting upstream in the Alternative Pathway, while retaining the control of MAC-mediated intravascular hemolysis," said Dr. Steven Zelenkofske, Chief Medical Officer of Achillion. "The mean increase of 11 points on the FACIT Fatigue scale, relative to the baseline on eculizumab monotherapy, demonstrates the potential impact the addition of danicopan can have on a patient's quality of life." In this clinical trial, danicopan was generally well tolerated. All treatment emergent adverse events were considered mild to moderate in severity except for Grade 3 severe adverse events that occurred in two patients. Both patients had resolution of their events, remained on danicopan, and completed the study. The company was granted Breakthrough Therapy designation by the FDA in September and PRIME designation by the European Medicines Agency in November for danicopan for the treatment of PNH in combination with a C5 monoclonal antibody for patients who are suboptimal responders to a C5 inhibitor therapy alone. In addition, the company met with the FDA during an End of Phase 2 Meeting in the fourth quarter and is progressing to Phase 3. The company plans to initiate a global Phase 3 trial in early 2020.

10:12 EST Constellation Pharmaceuticals provides update on MANIFEST clinical trial - Constellation Pharmaceuticals provided an update of preliminary data from the MANIFEST clinical trial in oral and poster presentations at the annual meeting of the American Society of Hematology. The updated preliminary data presented showed signs of clinical activity for CPI-0610 similar to that previously reported at the annual meetings of the American Society for Clinical Oncology and the European Hematology Association and in the ASH abstracts. The preliminary data included data on additional patients and showed evidence of activity across a broad range of myelofibrosis parameters in both JAK-inhibitor-naive and ruxolitinib-resistant or -intolerant patients. The company said, "Preliminary data showed continuing signs of activity across a broad range of parameters, suggesting possible disease-modifying effects of CPI-0610;In the first-line treatment arm, 12 out of 15 (80%) evaluable JAK-inhibitor-naive patients treated with a CPI-0610 / ruxolitinib combination achieved at least a 35% spleen volume response (SVR35) at 12 weeks;Clinical activity, including SVR35 responses, TSS50 responses, and conversion from transfusion dependence to transfusion independence, was seen at 24 weeks in patients in the second-line treatment arm who added CPI-0610 to ruxolitinib, suggesting that treatment with CPI-0610 may have durable effects."

10:10 EST Molecular Templates announces presentations of two posters at ASH - Molecular Templates announced the presentations of two posters on its pipeline programs at the American Society of Hematology Annual Meeting. One of thee posters includes final results from the Phase 1/1b study of MT-3724, in subjects with relapsed/refractory diffuse large b-cell lymphoma. The expansion cohort mandated negative serum RTX levels for enrolled subjects. Of the 13 serum rituximab negative DLBCL or mixed DLBCL/FL subjects, 5 responded across the range of 5 to 100 mug/kg doses. Of the 5 responses, 2 were complete responses and 3 were partial responses. Three patients had stable disease and 5 patients had progressive disease. Of the 5 serum RTX-neg subjects with DLBCL who received MT-3724 at 50 mug/kg, the maximum tolerated dose, 3 responded. Of all 25 subjects evaluable for efficacy, 13 developed anti-drug antibodies or neutralizing antibodies; the development of ADAs or NAbs did not preclude benefit of MT-3724, consistent with what has been seen with other immunotoxins, the company said. Safety events were mostly mild to moderate, and dose limiting toxicities were indicative of innate immune response, including grade 2 capillary leak syndrome and grades 1-3 arthralgias and myalgias, it added. No life-threatening toxicities were attributed to MT-3724.

10:08 EST Seattle Genetics, Takeda announce additional analyses of Adcetris - Seattle Genetics (SGEN) and Takeda Pharmaceutical (TAK) announced additional analyses of results from the Echelon-1 and Echelon-2 frontline Phase 3 trials of Adcetris. These analyses were presented at the Annual Meeting of the American Society of Hematology. The Echelon-1 analysis highlighted a four-year update of the Phase 3 clinical trial in a poster presentation. Echelon-1 is evaluating Adcetris in combination with AVD compared to ABVD in patients with Stage III or IV frontline classical Hodgkin lymphoma. The Echelon-2 Phase 3 clinical trial data were presented in an oral session at ASH and focused on the outcomes of the subset of patients who underwent consolidative stem cell transplant. Echelon-2 is evaluating Adcetris in combination with CHP compared to CHOP in frontline CD30-expressing PTCL. "Updated data from the ECHELON-1 trial and further insights from ECHELON-2 build upon our continued understanding of the potential ADCETRIS offers patients with CD30-positive lymphomas," said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. "We're especially encouraged by the promising four-year follow-up ECHELON-1 results being presented at ASH, as approximately one in three patients with advanced Hodgkin lymphoma do not achieve long-term remission after standard frontline therapy."

10:04 EST Intel reveals what it believes to be a first-of-its-kind cryogenic control chip - Intel Labs unveiled what it believes to be a first-of-its-kind cryogenic control chip - code-named "Horse Ridge" - that will speed up development of full-stack quantum computing systems. "Horse Ridge will enable control of multiple quantum bits and set a clear path toward scaling larger systems - a major milestone on the path to quantum practicality. Developed together with Intel's research collaborators at QuTech, a partnership between TU Delft and TNO, Horse Ridge is fabricated using Intel's 22nm FinFET technology. In-house fabrication of these control chips at Intel will dramatically accelerate the company's ability to design, test and optimize a commercially viable quantum computer," the company stated.

10:00 EST Stage Stores rises 11.5% - Stage Stores is up 11.5%, or 65c to $6.30.

10:00 EST VelocityShares 3x Inv Natural Gas ETN rises 17.0% - VelocityShares 3x Inv Natural Gas ETN is up 17.0%, or $26.47 to $182.26.

09:48 EST Forty Seven trading halted, volatility trading pause

09:47 EST VelocityShares 3x Long Natural Gas ETN falls -15.2% - VelocityShares 3x Long Natural Gas ETN is down -15.2%, or -$1.42 to $7.94.

09:47 EST Virgin Galactic rises 10.4% - Virgin Galactic is up 10.4%, or 76c to $8.02.

09:47 EST VelocityShares 3x Inv Natural Gas ETN rises 16.0% - VelocityShares 3x Inv Natural Gas ETN is up 16.0%, or $24.90 to $180.69.

09:40 EST Alpine Immune Sciences presents ALPN-101 Phase 1 healthy volunteer study data - Alpine Immune Sciences announced earlier that it presented Phase 1 data yesterday from the healthy volunteer study of ALPN-101, a first-in-class dual CD28/ICOS antagonist, and details on its upcoming Phase 1/2 BALANCE study of ALPN-101 in steroid-resistant or steroid-refractory acute graft-versus-host disease at the 61st American Society of Hematology, or ASH, Annual Meeting. "Despite decades of intense research, GVHD remains a major cause of morbidity and mortality after hematopoietic stem cell transplantation. Current therapies are associated with significant toxicities or are simply insufficient to control the disease. CD28 and ICOS appear to be key pathways in the pathogenesis of GVHD, and the presented data with ALPN-101 appear uniquely strong. I look forward to the BALANCE study, which may demonstrate the therapeutic potential of ALPN-101," said Sophie Paczesny, MD, PhD, Professor of Immunology and Pediatrics at Indiana University School of Medicine and lead of the Biomarkers Stem Cell Transplantation Program and one of Alpine's research collaborators.

09:19 EST Broadwind Energy announces CEO succession - Broadwind Energy announced that its board has named Eric Blashford as the company's incoming CEO and President, following the retirement of Stephanie Kushner. The leadership transition is effective March 1, 2020, at which time Mr. Blashford will also be named to the company's board. Ms. Kushner will continue to serve as a member of the board following her retirement from the company.

09:15 EST Biolase Epic Hygiene laser receives FDA clearance - Biolase announced the launch of their new Epic Hygiene laser at the Greater New York Dental Meeting. The laser has officially been granted FDA clearance. Epic Hygiene is the latest innovation in Epic laser technology, designed by dental hygienists. This new laser system gives dental professionals a solution to manage non-surgical periodontitis and increase clinical production. The system includes step-by-step clinical protocols, including pocket therapy and perio debridement.

09:13 EST QuickLogic announces board approval for 1-for-14 reverse stock split - QuickLogic announced that its board has approved a reverse stock split of the company's common stock at a ratio of 1-for-14. The reverse stock split was previously approved by stockholders at a special meeting of stockholders held on November 26. QuickLogic's common stock will begin trading on a split-adjusted basis on Nasdaq at the market open on or about December 24. Once effective, the reverse stock split will reduce the number of shares of common stock issued and outstanding from approximately 116.6M to approximately 8.3M. No fractional shares will be issued as a result of the reverse stock split. In lieu thereof, the company's transfer agent will aggregate all fractional shares and sell them as soon as practicable after the effective time at the then-prevailing prices on the open market. After the transfer agent's completion of such sale, stockholders who would have been entitled to a fractional share as a result of the reverse stock split will instead receive a cash payment from the transfer agent in an amount equal to their respective pro rata share of the total proceeds of that sale. The objective of the reverse stock split is to ensure that QuickLogic regains full compliance with the Nasdaq share price listing rule and maintains its listing on the Nasdaq. As previously noted in the proxy statement filed with the Securities and Exchange Commission on October 17, QuickLogic will regain compliance with the Nasdaq per share price listing rule if QuickLogic has a closing bid price of its common stock of at least $1.00 per share for a minimum of 10 consecutive business days during the additional 180-day period, or before January 13, 2020, the end of the 180-day period.

09:11 EST Cardlytics appoints Michael Akkerman as Chief Product & Strategy Officer - Cardlytics (CDLX) announced the appointment of Michael Akkerman as the company's Chief Product and Strategy Officer. "Akkerman will lead Cardlytics' overall product strategy, including the development of a multi-year high-impact, growth-driving strategic roadmap. He will oversee the delivery of all enhancements and innovations for marketers, financial institutions, and consumers, as well as the ongoing evolution of the Cardlytics platform." Akkerman joins Cardlytics from Pinterest (PINS), where he served as Global Head of Strategic Partnerships.

09:04 EST Amgen signs lease for new R&D facility in San Francisco - Amgen announced the signing of a lease with BioMed Realty for a new 240,000-square-foot leadership in energy and environmental design, or LEED, candidate facility in the Gateway of Pacific campus development in South San Francisco. The new location, currently under construction at Oyster Point, will house Amgen's Bay Area employees focused on cardiometabolic, inflammation and oncology, research. In addition to enhanced R&D laboratory and office space at the new nine-story facility, which is scheduled to open in early 2022, the new campus will house a variety of meeting spaces, an amenity center that includes a number of dining options, a health club and a variety of outdoor recreation areas.

09:03 EST SG Blocks awarded new contract for food and beverage venue - SG Blocks announced it has been awarded a new contract for the design and construction of a 1,920 square foot fully-modular space for a food and beverage provider located in Detroit, Michigan. "This project is indicative of the quality and scope of our commercial backlog of business, which totaled $17.8 million at the end of the last quarter," commented Paul Galvin, CEO of SG Blocks. "Commercial development is seeing a resurgence in Detroit. By using our modular structures, the developer of this project will be able to deliver a quality product more quickly and at a lower cost than more traditional construction." The project, valued at nearly $560,000, began this month and is expected to be completed and delivered to the owner/developer within the next six to eight months. The project has been fully funded by the developer.

08:38 EST Sanofi vaccines unit enters agreement with HHS to increase production capability - Sanofi Pasteur, the vaccines global business unit of Sanofi, has entered into an agreement with the U.S. Department of Health and Human Services, or HHS, to increase the company's domestic pandemic influenza vaccine production capabilities based in Swiftwater, Pennsylvania. The contract is supported by federal funds from the Biomedical Advance Research and Development Authority, or BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at HHS. The contract will support the clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine to help enhance U.S. and global pandemic preparedness. This investigational pandemic vaccine will utilize the same recombinant technology as Sanofi's Flublok Quadrivalent. In addition, the contract will expand the site's role as a center of excellence for pandemic preparedness by adding both recombinant and adjuvant manufacturing alongside current egg-based manufacturing. Flublok Quadrivalent is indicated for adults 18 years of age and older and proven in a randomized controlled trial to help prevent 30%-43% more cases of laboratory-confirmed influenza in people 50 years of age and older compared to a standard-dose quadrivalent inactivated influenza vaccine.

08:36 EST AptarGroup Unidose Liquid System approved by FDA - AptarGroup announced that its patented Unidose Liquid System is the device delivering the first and only nasal rescue treatment approved by the FDA, which has recently launched in the U.S. to treat acute repetitive seizures in people living with epilepsy. This ready-to-use rescue treatment can be used when and where a seizure cluster occurs thanks to Aptar's proven, intuitive and convenient Unidose Liquid System.

08:25 EST Hoth Therapeutics initiates asthma, allergic inflammation preclinical study - Hoth Therapeutics announced the initiation of a preclinical study for the treatment of asthma and allergic inflammation in collaboration with North Carolina State University beginning on January 1, 2020. The goal of the study is to determine the best approach for targeting allergic inflammation in the airways with splice-switching oligonucleotides, or SSOs, and establish proof of principle by providing preclinical mouse data to inform consequent toxicology, ADME and Pharmacokinetics study or how an organism affects the drug. The initial set of experiments look to establish the delivery of SSOs targeting the gene encoding the FceRIss protein in the lungs of mice by using an ultrasonic nebulizer and assessing its distribution and function in mast cells throughout for a period of one year by using RNA scope technology. Once effective delivery of SSOs to the lungs has been established and determined that delivery of a target gene SSO reduces allergic airway inflammation in a standard asthma mouse model, Hoth and NC State plan to move on to the second phase of the study. During the second phase, the aim will be to determine the efficacy of SSO combinations that target FceRIss and other genes that function in the IgE receptor pathway, in airway inflammation using humanized mouse models to establish which target genes to move forward with. The study will determine the efficacy, in vivo, by administering SSOs for the target genes and establishing whether targeting FceRIss alone or in combination with other genes provides the best therapeutic approach.

08:18 EST Lantheus enters into collaboration with CarThera for use of microbubbles - Lantheus Holdings announced it has entered into a strategic commercial supply agreement with CarThera for the use of Lantheus' microbubbles in combination with SonoCloud, a proprietary implantable device in development for the treatment of recurrent glioblastoma. Under the commercial supply agreement, Lantheus' microbubbles will be used as a component in CarThera's SonoCloud System, which uses low-intensity pulsed ultrasound specifically designed to open the blood-brain barrier to facilitate more effective delivery of chemotherapy to tumors. As part of the agreement, CarThera will be responsible for regulatory filings and approvals in the U.S., Europe and rest of world as well as commercialization of SonoCloud. Lantheus will supply its microbubble vials and activation devices at a predetermined transfer price. Additionally, Lantheus will receive royalties on the SonoCloud kit product sales upon regulatory approval.

08:17 EST Spire appoints Steve Lindsey as COO - Steve Lindsey has been appointed executive VP, COO of Spire, effective January 1, 2020. In this role, Lindsey retains oversight of Spire's gas utilities while assuming management oversight for the company's midstream operations, which include Spire Storage and Spire STL Pipeline. Lindsey joined Spire as president of its gas utility in 2012 and is currently the executive VP, CEO of gas utilities and distribution operations, leading 3,000 employees to deliver energy to more than 1.7M homes and businesses in Alabama, Mississippi and Missouri.

08:16 EST Replimune Group appoints Jean Franchi as CFO - Replimune Group announced the expansion of its executive team with the appointment of Jean Franchi as CFO. Franchi will lead the company's financial strategy as Replimune continues to advance its pipeline of next-generation oncolytic immuno-gene therapies for the treatment of cancer. Franchi spent 16 years at Genzyme.

08:13 EST Chesapeake Utilities to acquire South Jersey Industries subsidiary Elkton Gas - Chesapeake Utilities (CPK) and South Jersey Industries (SJI) announced they have entered into an agreement, under which Chesapeake Utilities will acquire SJI subsidiary Elkton Gas, which operates in Cecil County, Maryland. Upon completion of the transaction, Elkton Gas will become a wholly-owned subsidiary of Chesapeake Utilities. The transaction was approved by the SJI board and by Chesapeake Utilities' Investment Committee, which is comprised of five of the company's board members. The acquisition, which is expected to close in the first half of 2020, is subject to approval by the Maryland Public Service Commission. Elkton Gas delivers natural gas to approximately 7,000 residential and commercial customers within a franchised area of Cecil County, Maryland. Elkton Gas will continue to operate out of its existing office with the same local personnel. Customers can expect to continue to receive the same hservice that they have experienced with the local office and its team members. Elkton Gas has also been a long-term customer of Eastern Shore Natural Gas, an interstate transmission pipeline company that is a wholly-owned subsidiary of Chesapeake Utilities Corporation. Chesapeake Utilities currently serves another franchised area of Cecil County, Maryland with natural gas service and has been managing its expansion into this area largely from its Delaware operations. The specific terms of the transaction were not publicly disclosed. The transaction is expected to close in the first half of 2020.

08:10 EST Trovagene presents final results from Phase 1b onvansertib study at ASH - Trovagene announced the presentation of final results from the company's Phase 1b study of onvansertib in patients with relapsed/refractory acute myeloid leukemia, or AML, in an oral session at the American Society of Hematology, or ASH, annual conference. The presentation highlighted the efficacy, durability of response, favorable safety and tolerability profile, as well as correlative biomarker data from the recently completed Phase 1b trial. Onvansertib is an oral, highly-selective Polo-like Kinase 1, or PLK1, inhibitor with a half-life of about 24 hours. PLK1 inhibition by onvansertib, assessed via a simple blood test and shown as changes in the phosphorylation of its direct substrate, the translational controlled tumor protein, TCTP, is a biomarker for identifying patients most likely to respond to treatment. Patients eligible for enrollment in the Phase 1b trial were treatment naive and not candidates for induction therapy or had relapsed/refractory disease to up to 3 prior regimens. Treatment was well tolerated through the first 5 dose escalation cohorts. Nine of the 71 SAEs were considered as possibly related to onvansertib and occurred at the higher dose levels: 40 mg/m2, 60 mg/m2 and 90 mg/m2. The maximum tolerated dose or recommended Phase 2 dose was established at 60 mg/m2. Six patients had a complete response; 9 had an ORR across LDAC and decitabine arms and doses. At the four higher dose levels, CR/CRi was observed in five of the 16 patients in the decitabine Arm and one of the nine patients in the LDAC Arm. Median time to achieve CR/CRi was 4 cycles. Median duration of response was five months. Four of six patients remain on treatment and in remission; duration of CR/CRi is respectively 1.5, 7, 8 and 11.5 months. Of the 24 evaluable patients, eight were biomarker positive across both arms. Among patients with at least 1 BM biopsy, biomarker positivity was associated with higher response to treatment: 67% of biomarker positive patients had a 20% decrease in blasts versus 18% in biomarker negative patients.CR/CRi was achieved in two biomarker positive patients but in none of the biomarker negative patients.

08:08 EST Galectin NASH-CX Phase 2 clinical trial results published in Gastroenterology - Galectin Therapeutics announced that a paper highlighting the results of its NASH-CX Phase 2 clinical trial in NASH cirrhosis have been published in the peer-reviewed journal Gastroenterology. The paper, titled "Effects of Belapectin, an Inhibitor of Galectin-3, in Patients with Nonalcoholic Steatohepatitis with Cirrhosis and Portal Hypertension," was authored primarily by Naga Chalasani, M.D., of the Indiana University School of Medicine with the extensive support and assistance of many others. "The paper outlines that in a phase 2b study of 162 patients with NASH, cirrhosis, and portal hypertension, one year of biweekly infusion of belapectin was safe but not associated with significant reduction in HVPG or fibrosis, compared with placebo. However, in a subgroup analysis of patients without esophageal varices, 2 mg/kg belapectin (GR-MD-02) did reduce HVPG and development of varices. This subgroup analysis suggests that there may be benefits from belapectin in patients with NASH cirrhosis without esophageal varices. Further, if this observation can be reproduced in subsequent studies, belapectin may have a role in the management of patients with NASH cirrhosis and portal hypertension but no varices. Galectin Therapeutics is planning an adaptively-designed Phase 3 trial of belapectin in NASH cirrhosis patients as previously disclosed."

08:04 EST South Jersey Industries announces sale of Elkton Gas to Chesapeake Utilities - SJI (SJI) has entered into an agreement to sell Elkton Gas to Chesapeake Utilities (CPK) for approximately $15M. Elkton Gas serves roughly 7,000 residential and commercial customers in Cecil County, Maryland and was acquired by SJI in July 2018. Completion of the transaction is estimated in the second quarter of 2020, following Maryland Public Service Commission Approval. Both SJI and Chesapeake Utilities are focused on ensuring the continued delivery of safe, reliable, affordable natural gas service during this transition. "Chesapeake Utilities is committed to providing the same level of service Elkton Gas customers expect and deserve. The company will also maintain commitments to Elkton Gas employees."

07:43 EST Antero Midstream to purchase $100M of shares from Antero Resources - Antero Midstream (AM) announced that it has agreed to repurchase $100M of Antero Midstream shares from Antero Resources (AR). In addition, Antero Midstream and Antero Resources have agreed to a growth incentive fee program where Antero Midstream will provide a reduction in low pressure gathering fees for volumes gathered from January 1, 2020 through December 31, 2023 subject to achieving increasing volumetric targets. The growth incentive fee program aligns with Antero Resources' current 8%-10% compound annual net production growth plan in 2020 and 2021. The share repurchase and growth incentive fee reduction transactions have been negotiated and recommended by the Conflicts Committees of Antero Midstream and Antero Resources and approved by both boards. Due to additional optimization of the midstream infrastructure buildout, Antero Midstream is now targeting a 2020 capital program of approximately $300M-$325M. This represents a $75M-$100M, or 22% reduction, compared to the previous target of $375M- $425M. Antero Resources' previously announced preliminary 2020 target of 110 to 120 completions in 2020, with an average lateral length of 12,100 feet is unchanged. Both Antero Resources and Antero Midstream expect to finalize their respective capital budgets early in Q1 of 2020 following board approval. Formal guidance is expected to be released following board approval. Antero Midstream and Antero Resources have agreed to a growth incentive fee program where Antero Midstream will provide fee reductions to Antero Resources from January 1, 2020 through December 31, 2023, contingent upon Antero Resources achieving volumetric growth targets on low pressure gathering. Antero Midstream's compression, high pressure gathering, and fresh water delivery fees remain unchanged. In addition, Antero Midstream and Antero Resources agreed to extend the gathering and compression contract term for four additional years. The decision to provide a fee reduction on low pressure gathering services was driven by the strong rates of return on low pressure gathering projects. These returns have improved materially relative to expectations at the time the gathering and compression agreement was signed in 2014 due to more wells per pad, longer laterals and higher estimated ultimate recoveries per foot. In addition, Antero Midstream believes that the growth incentive fee program will drive continued throughput growth from Antero Resources supporting Antero Midstream's gathering, compression, processing, fractionation and fresh water delivery businesses. Antero Resources' plans to grow net production 8%-10% through 2021 in order to fill its premium firm transportation portfolio. The initial threshold approximates Antero Midstream's Q3 low pressure volumes. If actual low pressure volumes are below the lowest tier for the respective calendar years, Antero Resources will not receive a reduction in low pressure gathering fees.

07:41 EST BridgeBio appoints Eli Wallace as chief scientific officer for oncology - BridgeBio Pharma announced it has appointed Eli Wallace, Ph.D., as its chief scientific officer in residence for oncology effective immediately. In this new role, Dr. Wallace will oversee BridgeBio's ongoing discovery efforts in targeted oncology while driving the identification and adoption of new oncology programs.

07:37 EST Sesen Bio initiates rolling submission of BLA for Vicinium to FDA - Sesen Bio announced that on December 6, the company initiated the submission of its Biologics License Application, or BLA, for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer, or NMIBC, under Rolling Review to the FDA. Vicinium was granted Fast-Track Designation by the FDA in 2018. The company has submitted completed non-clinical and clinical modules, and a partially completed Chemistry, Manufacturing and Controls, or CMC, module. The company anticipates completing the BLA submission with the finalization of the CMC module in 2020. If the FDA accepts the BLA filing, the company plans to request a Priority Review.

07:31 EST SL Green Realty signs Amazon to 335,000 sq. ft. lease at 410 Tenth Ave., NY - SL Green Realty (SLG) announced that Amazon (AMZN) has signed a new 335,408-square-foot lease at 410 Tenth Avenue, previously known as 460 West 34th Street. In May, SL Green acquired a majority and controlling interest in the building located along the full block front of Tenth Avenue, between 33rd and 34th Streets, at the intersection of Manhattan West and Hudson Yards. In April, First Republic Bank, a leading private bank and wealth management company, signed a new 211,521-square-foot lease.

07:17 EST Independent Bank, Texas Capital Bancshares enter $5.5B all-stock merger - Texas Capital Bancshares (TCBI) and Independent Bank Group (IBTX) announced that they have entered into a definitive agreement under which the companies will combine in an all-stock merger of equals with a total market value of approximately $5.5 billion to create the premier, Texas-based super regional bank. The name of the combined holding company will be Independent Bank Group and the name of the combined bank will be Texas Capital. Retail locations in Colorado will continue to operate and retain the Independent Financial branding. The corporate headquarters of the combined company will be located in McKinney, Texas. The combined company will trade under the Independent Bank Group ticker symbol "IBTX" on The Nasdaq Stock Market. Under the terms of the merger agreement, which was unanimously approved by the Boards of Directors of both companies, Texas Capital shareholders will receive 1.0311 shares of Independent Bank Group for each Texas Capital share they own. Former Texas Capital shareholders will own 55% and Independent Bank Group shareholders will own 45% of the combined company. Upon consummation of the transaction, the combined company expects to offer an annualized dividend on its common stock of $1.00 per share, subject to approval by the Board of Directors. The merger is expected to close in mid-2020, subject to satisfaction of customary closing conditions, including receipt of customary regulatory approvals and approval by the shareholders of each company.

07:10 EST Kamada enters into binding term sheet, sees product adding $8M-$10M in revenue - Kamada announced that it has entered into a binding term sheet for a 12-year contract manufacturing agreement with an undisclosed partner to manufacture a FDA approved and commercialized specialty hyper-immune globulin product. Following the execution of the required technology transfer from the current manufacturer, and pending obtaining all required FDA approvals, Kamada is expected to commence commercial manufacturing of the product in early 2023. "This binding term sheet supports our strategy to leverage our experience and available manufacturing capacity at our FDA-approved manufacturing facility to initiate the production of additional plasma-derived products following the transition of GLASSIA manufacturing to Takeda during 2021," said Amir London, CEO of Kamada. "Based on the current market sales volume of this specialty hyper-immune globulin product, we estimate that its manufacturing will add approximately $8M-$10M to our annual revenues, with estimated gross margin level similar to the average gross margins of our proprietary products segment. In addition to this new product, we will continue to manufacture and sell KEDRAB, our anti-rabies immunoglobulin, which is experiencing growing demand in the U.S. market, as well as our other proprietary products, which are sold in international markets. Moreover, we continue to proactively explore additional new product opportunities for our manufacturing plant."

07:07 EST KalVista says KVD001 does not meet primary endpoint - KalVista Pharmaceuticals (KALV) announced results of the Phase 2 clinical trial evaluating the use of KVD001 in patients with diabetic macular edema, or DME. The KVD001 Phase 2 clinical trial study was designed to evaluate patients who were poor responders to previous treatment with anti-VEGF therapy. The primary efficacy endpoint in the trial was change in best corrected visual acuity, or BCVA, at 16 weeks compared to sham. The 6mug dose showed a difference of +2.6 letters versus sham, which was not statistically significant, and the 3mug dose showed a difference of +1.5 letters. No significant differences were observed in the secondary endpoints of central subfield thickness, or CST, or the diabetic retinopathy severity scale, or DRSS. KVD001 was generally safe and well tolerated with no drug-related serious adverse events. "This was the first study to evaluate the efficacy of a plasma kallikrein inhibitor in DME," said Andrew Crockett, CEO of KalVista. "There is a significant population of DME patients who do not respond sufficiently to anti-VEGF therapies, and we want to express our gratitude to these patients as well as the healthcare providers and others who participated. Although the study did not meet the primary endpoint, KVD001 demonstrated what we believe is an important dose responsive clinical benefit on vision in the overall population. In addition, we identified a substantial proportion of patients who experienced a more robust response to treatment, that we believe warrants further study. These data and the safety profile also support continued evaluation of oral plasma kallikrein inhibitors as a treatment for DME." KVD001 is subject to an option agreement with Merck (MRK), signed in 2017. Under the terms of the agreement, KalVista will provide to Merck a package of clinical and other data, after which Merck will have a specified period of time to determine whether to exercise the option. Exercise of the option by Merck will result in a payment due to KalVista, as well as future potential milestone and royalty payments. KalVista will provide further public updates once Merck has notified KalVista of its decision or the option exercise period has expired.

06:58 EST MGIC Investment issues November operating statistics - MGIC Investment issued an operational summary of its insurance subsidiaries for the month of November for their primary mortgage insurance. The beginning primary delinquent inventory was 30,366 in November with ending primary delinquent Inventory of 30,123. November insurance in force was $220.7B. The information concerning new delinquency notices and cures is compiled from reports received from loan servicers. The level of new notice and cure activity reported in a particular month can be influenced by, among other things, the date on which a servicer generates its report, the accuracy of the data provided by servicers, the number of business days in a month, transfers of servicing between loan servicers and whether all servicers have provided the reports in a given month.

06:49 EST Merck to acquire ArQule for $20 per share, or approximately $2.7B - Merck (MRK) and ArQule (ARQL) announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire ArQule for $20 per share in cash for an approximate total equity value of $2.7B. ArQule's lead investigational candidate, ARQ 531, is a novel, oral Bruton's tyrosine kinase, or BTK, inhibitor currently in a Phase 2 dose expansion study for the treatment of B-cell malignancies. BTK inhibition has been shown to prevent B-cell receptor signaling that is critical for the survival and proliferation of leukemic cells in many B-cell malignancies. ARQ 531 is a selective, reversible inhibitor that blocks both wild-type BTK and the C481S mutant form of the enzyme that is commonly associated with resistance to other BTK inhibitors. In early clinical trials, ARQ 531 demonstrated a manageable safety profile and early signs of anti-tumor activity for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia, or CLL, and Richter's Transformation. Final data from the Phase 1 study of ARQ 531 will be presented on December 9 at the 61st American Society of Hematology, or ASH. Under the terms of the acquisition agreement announced, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of ArQule. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of ArQule's outstanding shares, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Upon the successful completion of the tender offer, Merck's acquisition subsidiary will be merged into ArQule, and any remaining shares of common stock of ArQule will be canceled and converted into the right to receive the same $20 per share price payable in the tender offer. The transaction is expected to close early in Q1 of 2020.

06:39 EST Constellation Brands appoints Garth Hankinson as CFO - Constellation Brands (STZ) announced that Garth Hankinson has been promoted to Executive Vice President and CFO, effective January 13, 2020. Hankinson succeeds David Klein, who will leave his role with Constellation Brands on January 13 to become CEO at Canopy Growth (CGC), which is anticipated to be effective January 14. Hankinson joined Constellation Brands in 2001.

06:34 EST Owens Corning chairman Mike Thaman to retire, CEO Brian Chambers to succeed - Owens Corning announced that executive chairman of the board of directors Mike Thaman has decided to retire from the company as of the date of the annual meeting of stockholders, currently scheduled in April 2020. Brian Chambers, president and CEO, has been elected by the board to succeed Thaman as chairman effective at the same time. Chambers became CEO and was elected to the board in April. He has been with the company for over 15 years, and throughout his career, has held a number of senior operating roles across a range of businesses and geographies.

06:14 EST Actinium Pharmaceuticals presents new findings from Phase 3 SIERRA trial at ASH - Actinium Pharmaceuticals presented new findings from its pivotal Phase 3 SIERRA trial for Iomab-B at the American Society of Hematology, or ASH, annual meeting in a poster presentation. Actinium is advancing the development of low dose Iodine-131 apamistamab, a CD45 targeting antibody radiation-conjugate, or ARC, as an alternative to standard practice of chemotherapy-based lymphodepletion regimens like fludarabine/cyclophosphamide, which have been implicated in CAR-T toxicities including cytokine release syndrome, or CRS, and neurotoxicity. The analysis of dosimetric results with Iomab-B in the pivotal Phase 3 SIERRA trial was conducted to model a non-myeloablative dose level to be used for lymphodepletion prior to CAR-T, as well as the time frame in which an adoptive cell therapy such as CAR-T could be administered. Based on the results from 56 evaluable patients that received a dosimetric dose of Iodine-131 apamistamab, including patients initially randomized to receive Iomab-B and those that received Iomab-B upon crossover from the control arm, it was determined that a single 75 mCi dosage of Iodine-131 apamistamab would deliver approximately 200 cGy to the bone marrow, the threshold that is considered non-myeloablative. At this dose level, it expected that an adoptive cell therapy could be administered approximately six days following Iomab-ACT lymphodepletion. Actinium intends to advance its Iomab-ACT program into human proof-of-concept clinical trials in conjunction with an adoptive cell therapy. At fractional dose levels of Iodine-131 apamistamab used for dosimetry analysis in the SIERRA trial, approximately 1/10 of the targeted lymphodepletion dose, a significant but transient reduction in lymphocytes and white blood cells was observed compared to pre-dosimetry infusion levels.Overall, 85% reduction in lymphocytes was observed at the post-dosimetry infusion time point, a 67% decrease at day 1 post-dosimetric infusion, and a 43% decrease one week later just prior to the Iomab-B therapeutic infusion, demonstrating potent yet reversible lymphodepletion at this dose level. Also, 35% reduction in peripheral leukemic blasts was observed at the post-dosimetry infusion time point, suggesting a rapid anti-leukemic effect with single-agent Iodine-131 apamistamab consistent with findings from SIERRA presented at ASCO. The levels of platelets, red blood cells, and neutrophils did not significantly change between pre-infusion and post-dosimetry infusion. Based on the analysis of the 56 treated patients, a non-myeloablative dosage of 75 mCi has been proposed as a starting dose for human clinical testing in combination with a CAR-T. Analysis of the dosimetry data establishes that the proposed 75 mCi dosage of Iodine-131 apamistamab would be sufficiently cleared in approximately 147 hours to allow for CAR-T administration.

06:08 EST Ideaya Biosciences announces update on IDE196 clinical trial - Ideaya Biosciences announced further progress on elements of its ongoing Phase 1/2 clinical trial entitled "A Phase 1/2 Study in Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions". This clinical trial is evaluating the tolerability and preliminary clinical activity of IDE196 for the treatment of Metastatic Uveal Melanoma, or MUM, and other solid tumors harboring GNAQ or GNA11 mutations activating the PKC signaling pathway. Initiated 13-week GLP-compliant toxicology studies in two species in November, in support of registration-enabling FDA requirement to submit study results prior to enrollment of more than approximately 50 patients in the investigational arm of the clinical trial that will support a marketing application. Pharmacokinetic Phase 1 clinical sub-study with immediate release tablet formulation of IDE196 scheduled to initiate in January 2020, in support of potential introduction of the tablet in the Phase 2 clinical trial in Q1 2020 Targeting initiation of Phase 2 single-arm potentially registration-enabling clinical trial in MUM in Q1 2020, which the company anticipates may coincide with introduction of tablet formulation. Targeting initiation of combination clinical trial of IDE196 plus a MEK inhibitor in H1 2020, accelerated from earlier guidance. Preclinical evaluation of potential additional combinations ongoing. Total of 40 patients enrolled in the Phase 1 portion of the Phase 1/2 GNAQ/11 basket trial as of as of December 6, including 38 MUM patients, for which dose escalation is complete, and 2 non-MUM patients, for which enrollment is ongoing. Launching the Ideaya Genomics Profiling Initiative. IDEAYA GPI is a company initiative leveraging various next generation sequencing platforms, including in partnership, to identify patients having tumors with specific mutations, such as tumors with activating GNAQ/11 mutations for potential enrollment in our IDE196 basket trial. The company is on track to present interim clinical data from the GNAQ/11 Phase 1/2 monotherapy basket trial in Q2/Q3 2020.

05:16 EST Sanofi to acquire Synthorx for $68 per share in cash - Sanofi (SNY) and Synthorx (THOR) entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Synthorx for $68 per share in cash, which represents an aggregate equity value of approximately $2.5B, on a fully diluted basis. The transaction was unanimously approved by both the Sanofi and Synthorx boards. Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all of the outstanding shares of Synthorx common stock for $68 per share in cash. The $68 per share acquisition price represents a 172% premium to Synthorx's closing price on December 6. Following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with Synthorx and the outstanding Synthorx shares not tendered in the tender offer will be converted into the right to receive the same $68 per share in cash paid in the tender offer. The tender offer is expected to commence in December. Sanofi plans to finance the transaction with cash on hand. Subject to the satisfaction or waiver of customary closing conditions, Sanofi expects to complete the acquisition in the first quarter of 2020. "Synthorx's Expanded Genetic Alphabet platform is expected to be a source for developing a differentiated therapeutic pipeline. Alone and in combination with other existing Sanofi platforms, including the Nanobody technology, it will enable the company to develop a wide range of novel biologics, including drug conjugates, protein fusions, and multi-specific biologics, with applications beyond oncology and extending to other therapeutic areas... The addition of THOR-707 and Synthorx's other earlier-stage cytokine programs to Sanofi's pipeline will enhance Sanofi's position in oncology, and in immuno-oncology. We expect IL-2 to become a foundation of future IO-IO combinations as well as offering multiple combination opportunities with Sanofi's clinical and pre-clinical oncology assets, including with PD-1, CD-38, and molecules that modulate effector T-cells and natural killer cells."