Stockwinners Market Radar for June 21, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:22 EDT Edwards Lifesciences 'commends' CMS on approach toward updating TAVR policy - Edwards Lifesciences commented on the final updated U.S. Centers for Medicare and Medicaid Services national coverage determination pertaining to transcatheter aortic valve replacement programs: "We commend CMS on its thoughtful approach toward updating the TAVR policy. Throughout the NCD process, Edwards emphasized that the priority must be ensuring timely patient access to high-quality care, so that clinicians can provide all people with heart valve disease with the therapy that is right for them. Often, the primary risk facing severe aortic stenosis patients is not treatment complications, but the risk of not receiving treatment at all. Many of the core elements of the updated NCD better reflect today's practices in the treatment of patients with severe AS, the needs of those patients and the robust evidence and technology enhancements that have occurred in the last several years. We believe the modernized requirements and more streamlined patient evaluation process are meaningful enhancements that may help ensure equitable access for more patients suffering from severe AS. We are encouraged that CMS is open to moving toward a quality measure focused on patient outcomes, not procedural volume, in evaluating hospitals eligible to provide TAVR in the U.S., which Edwards believes could reasonably coincide in the future with discontinuation of Coverage with Evidence Development. We look forward to continuing to engage with all of the stakeholders around the best way to ensure high quality and appropriate access for all Medicare beneficiaries in need of treatment for structural heart disease."

17:37 EDT SPDR Gold Shares holdings rise to 799.03MT from 764.10MT - This is the highest level of holdings since February 11th.

17:07 EDT Davidson Kempner reports 7.88% passive stake in Lincoln Heritage - Davidson Kempner disclosed a 7.88% stake in Lincoln Heritage, which represents over 1.57M shares. The filing does not allow for activism.

16:40 EDT Nautilus CFO Sidharth Nayar to step down - In a regulatory filing, Nautilus disclosed that its board accepted the resignation of Sidharth Nayar, the company's CFO, effective July 12, 2019. The board expects to engage an executive search firm to assist in identifying and evaluating candidates for the CFO position.

16:16 EDT Yuma Energy announces one-for-fifteen reverse stock split - Yuma Energy announced that its Board of Directors has approved a one-for-fifteen reverse stock split of its issued and outstanding shares of common stock. The reverse split will be effective at 12:01 a.m. Eastern Time on July 3, and shares of the company's common stock will begin trading on a split-adjusted basis when the NYSE American market opens on that date. The company's common stock will continue to trade on the NYSE American under the trading symbol "YUMA," but will trade under the following new CUSIP number starting July 3: 98872F 204. As a result of the reverse split, each fifteen pre-split shares of common stock outstanding will automatically combine into one new share of common stock without any action on the part of the stockholder. The number of outstanding common shares will be reduced from approximately 23.2M to approximately 1.5M shares. The authorized number of shares of common stock will not be reduced and will remain at 100M. All fractional shares will be rounded up to the nearest whole share.

16:06 EDT Avinger to effect one-for-ten reverse stock split - Avinger announced that the company will effect a 1-for-10 reverse stock split of its common stock, which will be effective at 5:00 p.m. Eastern time on Friday, June 21, 2019. As of that date, each 10 shares of issued and outstanding common stock and equivalents will be converted into one share of common stock.

16:04 EDT Marriott Vacations CMO sells 7K shares of common stock - In a regulatory filing, Marriott Vacations disclosed that its Chief Marketing Officer Brian Miller sold 7K shares of common stock on June 20th. The total transaction size was $689K.

14:13 EDT Sycamore reiterates request for Chico's due diligence access, calls for meeting - In a regulatory filing, Sycamore Partners disclosed that on June 21 it sent a letter to the Chair of the Board of Chico's reiterating its request for due diligence access to the company and indicating that, in connection with the June 19 proposal, the firm was formally requesting that the company call a special meeting of shareholders pursuant to Section 607.0902 of the Florida Business Corporation Act.

13:09 EDT PG&E resumes trading after volatility halt, shares up $1.29 to $24.86

13:05 EDT PG&E jumps 4% to $24.60 after Bloomberg report of restructuring plan

13:02 EDT Baker Hughes reports U.S. rig count down 2 to 967 rigs - Baker Hughes reports that the U.S. rig count is down 2 rigs from last week to 967, with oil rigs up 1 to 789, gas rigs down 4 to 177, and miscellaneous rigs up 1 to 1. The U.S. Rig Count is down 85 rigs from last year's count of 1,052, with oil rigs down 73, gas rigs down 11, and miscellaneous rigs down 1. The U.S. Offshore Rig Count is unchanged at 24 and up 6 rigs year-over-year. The Canada Rig Count is up 12 rigs from last week to 119, with oil rigs up 11 to 80 and gas rigs up 1 to 39. The Canada Rig Count is down 41 rigs from last year's count of 160, with oil rigs down 23 and gas rigs down 18.

12:20 EDT Owens Corning rallies after amending bylaws over director nominations - Owens Corning disclosed earlier in a regulatory filing that on June 19, its board adopted, effective immediately, the company's Second Amended and Restated Bylaws. The bylaws include amendments "providing enhanced advance notice disclosure requirements for shareholder proposals of business or director nominations for an annual meeting of shareholders," the company said. The amendments expand the information that shareholder proponents and others must disclose to the company, and clarify that the shareholder "must appear at the applicable meeting to present its nomination or proposed business to avoid the nomination or proposed business being disregarded." Shares of Owens Corning are up 4.5% to $51.40 in midday trading.

11:56 EDT AMD drops 2% to $29.41 after China joint venture partner added to blacklist

11:35 EDT Harris, L3 Technologies expect to close all-stock merger on June 29 - Harris Corporation (HRS) and L3 Technologies (LLL) announced that they have received the necessary regulatory approvals for their all-stock merger and have set a closing date of June 29, 2019. Upon closing, Harris will be renamed L3Harris Technologies, Inc., and shares of L3Harris common stock will trade on the NYSE under ticker symbol "LHX". L3 shares will cease trading upon market close on June 28 and convert into 1.3 L3Harris shares for each L3 share."Receiving these approvals marks the successful completion of a thorough regulatory review process - clearing the way for one of the largest mergers in defense industry history," said William M. Brown, Chairman, CEO and President of Harris. "Today's announcement positions us to close the merger and establish L3Harris as an agile aerospace and defense technology innovator that delivers value for all of our stakeholders," said Christopher E. Kubasik, Chairman, CEO and President of L3. The regulatory process requires the divestiture of Harris' Night Vision business, which is expected to be completed following the merger, pursuant to Harris' previously announced sale agreement with Elbit Systems (ESLT).

11:16 EDT European Commission approves acquisition of L3 by Harris, subject to conditions - The European Commission announced that it has approved, under the EU Merger Regulation, the proposed acquisition of L3 Technologies (LLL) by Harris Corporation (HRS), conditional on the divestiture of Harris Corporation's global night vision business. As regards night vision devices, the Commission found that Harris Corporation and L3 Technologies compete head-to-head in the markets for image intensification night vision devices and image intensification tubes in the EEA. The proposed transaction, as initially notified, would have significantly reduced competition in these markets. As a result, the Commission was concerned that the transaction would lead to higher prices and less choice for governmental defense departments, commercial customers and other customers of the companies' night vision products in the EEA. As regards hand held video data links, the Commission concluded that the proposed merger would raise no competition concerns, given that the merged entity would continue to face a number of credible competitors in the EEA. To address the Commission's competition concerns, the companies offered to divest Harris Corporation's global night vision business. These commitments fully address the Commission's concerns as they remove the global overlap between L3 Technologies' and Harris Corporation's activities related to night vision devices. Therefore, the Commission concluded that the proposed transaction, as modified by the commitments, would no longer raise competition concerns in the EEA or any substantial part of it. The Commission's decision is conditional upon Harris Corporation's full compliance with the commitments.

10:50 EDT Pfizer announces European Commission approval for TALZENNA - Pfizer announced that the European Commission approved TALZENNA, an oral poly polymerase inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene 1/2-mutations, who have human epidermal growth factor receptor 2-negative-locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.1 This approval follows the medicine's approval by the U.S. Food and Drug Administration in October 2018. The European Commission's approval of TALZENNA, which was acquired as part of Pfizer's acquisition of Medivation, is based on results from the EMBRACA trial. The global trial evaluated once-daily TALZENNA compared to physician's choice standard chemotherapy in patients with an inherited BRCA1/2 mutation in triple-negative or HR+/HER2- LA or MBC who may have received up to three prior cytotoxic chemotherapy regimens for their advanced disease. The primary endpoint was progression-free survival, as assessed by blinded independent central review.

10:27 EDT Aspen Group announces uplisting to Nasdaq Global Market - Aspen Group announced that its common stock, which has been traded on The Nasdaq Capital Market, has been approved for listing on The Nasdaq Global Market. Trading on The Nasdaq Global Market is expected to commence on June 24 and ASPU will continue to be the trading symbol. "We believe this move is important for the growth of our Company. The Nasdaq Global Market sets certain financial requirements that we have met, and we believe the Global Market will increase our visibility in the institutional marketplace and enhance our ability to attract new investors," said Chairman and CEO, Michael Mathews.

10:03 EDT Mesoblast granted FDA orphan status for rexlemestrocel-L - The FDA granted Mesoblast orphan status for rexlemestrocel-L, its prevention of post-left ventricular assist device implantation mucosal bleeding. Reference Link

10:00 EDT Canopy Growth falls -7.9% - Canopy Growth is down -7.9%, or -$3.46 to $40.25.

10:00 EDT LSC Communications falls -24.4% - LSC Communications is down -24.4%, or -$1.42 to $4.41.

10:00 EDT Seadrill rises 8.4% - Seadrill is up 8.4%, or 32c to $4.13.

09:50 EDT Catabasis Pharmaceuticals presents preclinical data on edasalonexent in DMD - Catabasis Pharmaceuticals presented new preclinical data showing preserved bone health with edasalonexent in contrast to negative effects of the corticosteroid prednisolone in a mouse model of Duchenne muscular dystrophy. Edasalonexent is a novel NF-kB inhibitor in Phase 3 development for the treatment of DMD. The data were presented at the Symposium on Muscle-Bone Interaction in Duchenne Muscular Dystrophy. In the preclinical study sponsored by Catabasis, prednisolone treatment negatively impacted bone health in mdx mice compared to control, whereas edasalonexent treatment showed bone sparing effects compared to the bone loss seen with prednisolone. Mice treated with prednisolone had significantly weaker bones and also grew less as assessed by femur length compared to control mdx mice. These results were seen following 6 months of treatment of clinically relevant doses of prednisolone or edasalonexent. The mice receiving 6 months of edasalonexent had preserved cortical density, cortical thickness and femur length, similar to the control mice. Corticosteroids, such as prednisolone, can negatively impact bone health by increasing osteoclast apoptosis, reducing ossification and leading to increased bone resorption and osteoporosis. Catabasis believes that the treatment of DMD by inhibiting NF-kB with edasalonexent has the potential to reduce bone loss and enhance new bone growth in those affected by DMD by increasing osteoblast maturation and decreasing osteoclast differentiation and function. Boys with DMD typically have decreased height compared to boys that do not have DMD and the adverse effects of corticosteroids include decreased vertical growth. In the Phase 2 MoveDMD trial and open-label extension, over a 72-week period, boys receiving edasalonexent grew taller by an average of 2.1 inches per year, increases that were consistent with the growth curves of unaffected boys. The effects of edasalonexent on bone health are being further studied in DMD in the ongoing global Phase 3 PolarisDMD trial, which includes dual-energy X-ray absorptiometry to assess bone density and body composition and standardized lumbosacral spine films to assess for fractures at baseline and following 1 year of treatment. The Phase 3 PolarisDMD trial is a one-year, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of edasalonexent in patients with DMD. Catabasis plans to enroll approximately 125 patients ages 4 to 7 regardless of mutation type who have not been on steroids for at least 6 months. Boys on a stable dose of eteplirsen may be eligible to enroll. The primary efficacy endpoint is change in the North Star Ambulatory Assessment score after 12 months of treatment with edasalonexent compared to placebo. Key secondary endpoints include the age-appropriate timed function tests: time to stand, 4-stair climb and 10-meter walk/run. Assessments of growth, cardiac and bone health are also included as important potential areas of differentiation. Two boys are receiving 100 mg/kg/day of edasalonexent for each boy that receives placebo, and, after 12 months, all boys are expected to receive edasalonexent in the open-label extension study GalaxyDMD. Top-line results from the Phase 3 PolarisDMD trial are expected in the second half of 2020.

09:47 EDT PBF Energy rises 8.2% - PBF Energy is up 8.2%, or $2.10 to $27.70.

09:39 EDT FDA panel to discuss Aimmune's AR101 on September 13 - The FDA said its Allergenic Products Advisory Committee will hold a meeting on September 13 to discuss and make recommendations on the safety and efficacy of the peanut allergen powder manufactured by Aimmune Therapeutics (AIMT). The company is developing AR101, which is indicated for treatment to reduce the risk of anaphylaxis after accidental exposure to peanut in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. Shares of Aimmune are down 22c to $20.02 in early trading. DBV Technologies (DBVT) is also developing a treatment for peanut allergy. Reference Link

09:29 EDT Geo, CoreCivic fall after Elizabeth Warren says she'll ban private prisons - Senator and presidential hopeful Elizabeth Warren this morning laid out her plan to end the private contracting of prisons. Publicly traded companies that operate prisons include Geo Group (GEO) and CoreCivic (CXW). Warren, in a piece posted on Medium, explained, "The government has also stood silently by while private contractors providing services in both public and private centers come up with extortive schemes to make millions off of the backs of incarcerated people...While contractors getting paid taxpayer dollars cut corners to maximize margins, the government has turned a blind eye...The government has a basic responsibility to keep the people in its care safe - not to use their punishment as an opportunity for profit. That's why today, I'm proposing my plan to root out once and for all the profit incentives perverting our criminal and immigration systems." Warren says she'll ban private prisons and detention facilities, stop contractors from charging service fees for essential services, and "hold contractors accountable by expanding oversight, transparency and enforcement." Shares of Geo Group are down 30c to $23.39 and CoreCivic is down 76c to $23.04 heading into today's market open. Reference Link

09:25 EDT On The Fly: Pre-market Movers - HIGHER: CarMax (KMX), up 3.6% after reporting Q1 results... SeaWorld (SEAS), up 4.1% after being upgraded to Buy from Neutral at Goldman Sachs... Fastly (FSLY), up 2% after being initiated with a Buy at Craig-Hallum... LOWER: Paypal (PYPL), down 2.1% after announcing planned departure of COO Bill Ready... Caterpillar (CAT), down 1.1% after being downgraded to Underweight from Neutral at Atlantic Equities.

09:05 EDT U.K.'s CMA asks Facebook, eBay to tackle sale of fake reviews - The Competition and Markets Authority said in a statement that it has found "troubling evidence that there is a thriving marketplace for fake and misleading online reviews. After web sweeps performed in the period November 2018 to June 2019, the CMA was concerned about over 100 eBay (EBAY) listings offering fake reviews for sale. It also identified - during the same period - 26 Facebook (FB) groups in total where people offered to write fake reviews or businesses recruited people to write fake and misleading reviews on popular shopping and review sites." The CMA is not alleging that Facebook or eBay are intentionally allowing this content to appear on their websites. Since the CMA wrote to the sites, both have indicated that they will cooperate and Facebook has informed the CMA that most of the 26 groups have been removed. The CMA welcomes this, and said it expects the sites to put measures in place to ensure that all the identified content is removed and to stop it from reappearing. Reference Link

09:02 EDT Fred's to close an additional 49 underperforming stores - Fred's announced it will close an additional 49 underperforming stores as part of an ongoing effort to optimize store footprint. Pharmacies will remain open at all locations listed below - customers can continue to fill their prescriptions, receive vaccinations, and purchase over the counter medications. Fred's decision to close additional underperforming stores follows a continued evaluation of the company's store portfolio, including historical and recent store performance and the timing of lease expirations, among other factors. Fred's will continue its partnership with Malfitano Advisors and SB360 Capital Partners to help manage the process.

08:48 EDT Lamb Weston agrees to acquire Ready Meals, terms not disclosed - Lamb Weston announced that it has entered into an agreement to acquire Ready Meals, a frozen potato processor in Australia. Terms were not disclosed. Ready Meals sells frozen potato products under the Harvest Choice brand and operates frozen potato processing and storage facilities in Hallam, Victoria.

08:21 EDT Winnebago forms new Advanced Technology Group - Winnebago Industries announced updates related to key leadership positions within the organization. In addition, the company is announcing the creation of a new Advanced Technology Group to enable stronger levels of product innovation in the future. Don Clark, President and CEO of Grand Design RV and VP of Winnebago Industries, has committed to a multi-year agreement to continue leading Grand Design RV and serving as an Executive Officer at Winnebago Industries. Clark will continue to report directly to Michael Happe, President and CEO, and have responsibility for Grand Design RV's business operations. As a member of Winnebago's Executive Leadership Team, Clark will also support and contribute to the execution of the Company's overall outdoor lifestyle strategies and long-term enterprise goals. Bryan Hughes, VP and CFO of Winnebago Industries, will have his role expanded to include oversight for the company's Information Technology function and responsibility for annual and long-term strategic planning processes within Winnebago. Jeff Kubacki, CIO, who will continue to serve on the WGO Executive Leadership Team and lead IT to deliver strategic value for the whole of the Winnebago enterprise, will report directly to Hughes. Already responsible for the Company's financial functions, including Accounting, Treasury, Tax, Reporting, Financial Planning and Investor Relations, Hughes will ensure that Winnebago's strategic, financial, and technical processes and systems are working in synergy for the benefit of the firm's end customers, channel partners, and shareholders. Hughes will continue reporting directly to Happe. Winnebago Industries is also announcing the formation of a new Advanced Technology Group. Under the leadership of Ashis Bhattacharya, VP of Business Development, Specialty Vehicles, and Advanced Technology, the new ATG function will work closely with each of the company's business units to identify, develop, and commercialize emerging technologies as applied to and within future products. Jamie Sorenson, Director of Advanced Technology, will report to Bhattacharya and lead ATG on a day-to-day basis. The initial areas of focus within the Advanced Technology Group will be the increasing electrification and connectivity of the organization's products, delivering value via data acquisition from customer use of products, and improving the user interface experience for our end customers. Bhattacharya reports directly to Happe and will continue to lead the expansion of Winnebago's Specialty Vehicles business and its overall Business Development activities. Russ Garfin has been promoted to Director, Product Management for Winnebago-branded Class B vans and Class C Diesel products in the Winnebago Motorhome business and will continue to report to Brian Hazelton, VP, Winnebago Motorhomes. Lastly, Winnebago Industries announced this past April the addition of Joel Eberlein as the new GM of Winnebago Towables, overseeing sales, marketing, product development, and engineering.

08:15 EDT Mogo Finance, Difference Capital complete business combination - Mogo Finance Technology and Difference Capital Financial announced the completion of Mogo's previously announced arrangement under the Business Corporations Act pursuant to which Mogo combined its business with the business of Difference. The Arrangement became effective at 12:01 a.m. on June 21, 2019. Prior to the consummation of the Arrangement, Difference completed the Continuance and changed its name to "Mogo Inc.". Under the Arrangement, Mogo was amalgamated with a wholly-owned subsidiary of Difference and each Mogo common share outstanding immediately prior to the Arrangement, other than Mogo Shares held by Difference, was exchanged for one common share of the Combined Entity. Prior to the commencement of the Arrangement, Difference continued from a corporation existing under the Canada Business Corporations Act to a corporation existing under the BCBCA. On completion of the Arrangement, former Mogo shareholders own approximately 80% of the Combined Entity, on a fully diluted basis. In connection with the Arrangement, all of Mogo's outstanding convertible securities became exercisable or convertible, as the case may be, for shares of the Combined Entity in accordance with the provisions thereof. It is anticipated that the Mogo Shares will be delisted from the Toronto Stock Exchange on or about the close of trading on June 24, 2019. Shares of the Combined Entity will begin trading on the TSX under the ticker symbol "MOGO" in place of the Difference common shares at the open of trading on June 25, 2019. In addition the Combined Entity will be treated as a successor in interest to Mogo and, as such, the Combined Entity will be listed on the Nasdaq Capital Market under the ticker symbol "MOGO". Shares of Mogo and Difference traded between June 21st and June 25th will automatically settle for shares of the Combined Entity. Following the completion of the Arrangement, the board of directors of the Combined Entity was reconstituted and now consists of David Feller, Chairman and CEO, Gregory Feller, President and CFO, Michael Wekerle, Minhas Mohamed and Kees Van Winters. The Combined Entity will continue to execute on Mogo's vision of building the leading fintech platform in Canada. The Arrangement provides Mogo with immediate access to cash and Difference's portfolio of investments which includes some of the premier private technology companies in Canada, which collectively had an estimated fair market value of approximately $24M as of December 31, 2018.

08:10 EDT ILJIN Chairman issues open letter to Aurinia shareholders - ILJIN SNT, a founding shareholder of Aurinia Pharmaceuticals, which together with certain affiliates holds an approximate 14% ownership interest in Aurinia, issued an open letter to Aurinia shareholders from ILJIN Group Chairman, Mr. Chin Kyu Huh. The letter said in part:On June 3, "we, ILJIN SNT and its affiliated companies filed an information circular seeking to replace three incumbent directors with more capable and independent directors at the upcoming Annual General Meeting of Shareholders of Aurinia Pharmaceuticals to be held on June 26. ILJIN Group is a long-term investor and the largest shareholder of Aurinia, holding 14.94% of the issued and outstanding shares of Aurinia, as of May 9. We have strongly believed in the potential of Voclosporin and have consistently supported Aurinia by serving as an anchor investor in all major financings. To my disappointment, despite our good faith efforts, the former CEO and Chairman of the Board, Mr. Glickman, failed to take any meaningful action in response to our good faith suggestions for improvement. Even following Mr. Glickman's departure (notwithstanding his continued service as an advisor) the incumbent board has failed to take any adequate steps to address the concerns of shareholders...Fortunately, Mr. Glickman has retired and Aurinia has a more experienced CEO. We fully support Mr. Greenleaf as a new CEO and have high expectations that he will drive the Company in the right direction and maximize its true value. ...Nevertheless, we are quite concerned about potential interference by the former CEO and Chairman and his close relationship with the majority of the other incumbent directors. This is crystal clear in the board and Mr. Glickman's attempt to install Mr. Glickman's close friend, Mr. MacKay-Dunn, as a new director. This is even more concerning given the actions of Mr. Glickman to threaten one of our director candidates using improperly obtained confidential Company information regarding our nominations. Aurinia is not owned by the former CEO and Chairman of the Board, Mr. Glickman. We, the shareholders, control the destiny of Aurinia...If we want to improve Aurinia and maximize our investment return, we have to change the Board - now - before it is too late. We need your support to bring the change necessary to make Aurinia a great company. Please vote for the three independent directors nominated by us: Dr. Robert Foster, the inventor of Voclosporin and a co- founder of the Company; Mr. Soon-Yub (Samuel) Kwon, a US attorney with 30 years of international legal and corporate experience; and Dr. Myeong-Hee Yu, a renowned scientist with over 30 years of proven international leadership experience.

08:07 EDT Allena to present on reloxaliase development program at OHF workshop - Allena Pharmaceuticals announced that it will present on its reloxaliase development program and the unmet need in patients with enteric hyperoxaluria in four sessions at the Oxalosis & Hyperoxaluria Foundation International Hyperoxaluria Workshop. In the session on enteric hyperoxaluria, Allena's CMO Annamaria Kausz, will present data on the burden of disease and the significant unmet need in this under-recognized patient population. In addition to recurrent kidney stones, EH patients can also suffer from progressive loss of kidney function and end stage renal disease. A recent review on clinical outcomes in EH patients with oxalate nephropathy found that renal replacement therapy was required in greater than 50% of patients. Additionally, there is increasing awareness of the association between excess urinary oxalate excretion and the risk of chronic kidney disease progression. In the session on the industry pipeline, Allena's President and CEO Louis Brenner, will present an overview of the development program for reloxaliase, including the ongoing URIROX Phase 3 program and Study 206. Allena's URIROX program consists of two pivotal Phase 3 trials, URIROX-1 and URIROX-2, which are designed to evaluate the safety and efficacy of reloxaliase in patients with EH. These trials represent the largest studies conducted to-date in patients with EH. In the poster session, a case series of the first four subjects with EH and advanced CKD treated with reloxaliase in Study 206 will be presented. Study 206 is a multi-center, open-label, single-arm Phase 2 basket study, designed to evaluate reloxaliase in adult and pediatric patients suffering from the progression of enteric hyperoxaluria with advanced chronic kidney disease or primary hyperoxaluria, both of which can lead to systemic oxalosis. In the family and patient advocacy panel, Allena will join other biotechnology companies developing potential therapies that target the common enemy of excess oxalate, which can lead to severe disease in high risk patient populations.

08:04 EDT Ocular Therapeutix announces FDA approval of sNDA for Dextanza - Ocular Therapeutix announced the FDA approved a Supplemental New Drug Application, or sNDA, for Dextanza to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication. With the approval of the sNDA, Dextanza is now approved for the treatment of both ocular inflammation and pain following ophthalmic surgery. "Dextanza is the first FDA-approved intracanalicular insert, a novel route of administration that delivers drug to the surface of the eye without the need for eye drops. Dextanza is a preservative-free, resorbable hydrogel insert that delivers 0.4mg of dexamethasone to treat post-surgical ocular inflammation and pain for up to 30 days with a single administration. Dextanza originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery."

08:00 EDT Epizyme reports updated data from tazemetostat Phase 2 trial - Epizyme reported positive interim data from an ongoing Phase 2 trial of its lead candidate, tazemetostat, as a monotherapy for patients with relapsed or refractory follicular lymphoma, or FL, who have received at least two prior lines of systemic therapy. The data show that tazemetostat demonstrated meaningful clinical activity and was generally well tolerated in both patients with EZH2 activating mutations and those with wild-type EZH2. The data will be presented today in an oral presentation entitled "Interim update from a Phase 2 multicenter study of tazemetostat, an EZH2 inhibitor, in patients with relapsed or refractory follicular lymphoma" at the International Conference on Malignant Lymphoma, or ICML, by Franck Morschhauser, M.D., Ph.D., Centre Hospitalier Regional Universitaire de Lille, France, an investigator in the Phase 2 trial.

07:31 EDT Allergan: FDA approves sBLA for botox to treat pediatric patients - Allergan announced that the U.S. FDA approved the company's supplemental biologics application for BOTOX for the treatment of pediatric patients with upper limb spasticity. BOTOX was granted a six-month Priority Review by the FDA, which is typically granted to therapies that if approved, could offer significant improvements in safety and effectiveness when compared to current standard of care. The FDA is also reviewing an additional sBLA for the use of BOTOX to treat pediatric patients with lower limb spasticity, with a decision expected in the fourth quarter of this year.

07:05 EDT Innovative Industrial Properties acquires Michigan property for $6.9M - Innovative Industrial Properties announced that it closed on the acquisition of a property in Harrison, Michigan, which comprises approximately 45,000 square feet of industrial space. The purchase price for the Michigan property was approximately $6.9M. Concurrent with the closing of the purchase, IIP entered into a long-term, triple-net lease agreement with an affiliate of Emerald Growth Partners, or EGP, which intends to operate the property as a licensed medical-use cannabis cultivation and processing facility upon completion of redevelopment. EGP is expected to complete tenant improvements for the building, for which IIP has agreed to provide reimbursement of up to approximately $3.1M. Assuming full reimbursement for the tenant improvements, IIP's total investment in the property will be approximately $10M. As the pioneering real estate investment trust, or REIT, for the medical-use cannabis industry, IIP partners with experienced medical-use cannabis operators and serves as a source of capital by acquiring and leasing back their real estate assets, in addition to offering other creative real estate-based capital solutions.

06:46 EDT Medtronic raises quarterly dividend 8% to 54c per share - The dividend is payable on July 25 to shareholders of record at the close of business on July 8.

06:33 EDT Nuance accelerates exit of non-core subscriber revenue services business - Nuance announced it has accelerated the exit of its non-core Subscription Revenue Services business, which provides services to mobile consumers in emerging markets, primarily Brazil and India. The company has completed the sale of its Brazil SRS operations and has signed a definitive agreement for the sale of its India SRS operations. The latter is expected to close in July. The terms of both deals were not disclosed.

06:31 EDT Thomson Reuters to acquire Confirmation, terms not disclosed - Thomson Reuters announced that it has signed a definitive agreement to acquire Confirmation, a provider of secure audit confirmation services. The completion of the acquisition is subject to specified regulatory approvals and customary closing conditions, including the expiration or termination of applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act. Financial terms of the transaction were not disclosed.

06:03 EDT China Yuchai announces dissolution of Venture Lewis Limited subsidiary - China Yuchai announced that its wholly owned subsidiary, Venture Lewis Limited, has been dissolved. No further information was disclosed.

05:20 EDT Biofrontera board intend to accept partial tender offer from Maruho Deutschland - Biofrontera announces that the members of the management board, Prof. Dr. Hermann Lubbert, Thomas Schaffer and Christoph Dunwald, intend to tender all of their personally held Biofrontera AG shares to the partial tender offer by Maruho Deutschland GmbH. The management board would like to help Maruho Deutschland GmbH to successfully complete its offer and serve as an example for other shareholders.