Stockwinners Market Radar for October 07, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

NHYDY...

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19:44 EDT Hydro says Alunorte receives authorization to utilize press filter - Norsk Hydro (NHYDY) announced over the weekend that its alumina refinery Alunorte was granted an exceptional authorization, on October, 5, by federal environmental agency IBAMA to utilize its press filter technology in its processing of bauxite residues, which will extend the life of its DRS1 bauxite residue disposal area and allow Alunorte to continue operations on safe conditions. Following IBAMA's decision, Alunorte will be working with SEMAS, Secretary of State for Environment and Sustainability, to obtain the authorization to use the press filter on DRS1, the company said. This filter provides stackable residues with less water content than the drum filter, it added. After receiving this authorization, Alunorte will be able to re-start the operation at 50% of capacity. "We are ready to re-start our operations and we thank for all the support that we have received from the authorities and society. We are now making every effort to go back to producing as we maintain our dialog with authorities to resume full production," said John Thuestad, head of Hydro's Bauxite and Alumina business area. Thuestad adds that resuming 50% production at Alunorte would also allow Hydro's bauxite mine Paragominas and its joint-venture primary aluminium smelter Albras to continue operating at half capacity, as opposed to being fully shut down as a consequence of Alunorte being idled. Following news last week that Hydro was preparing for full curtailment of Alunorte operations, shares of Century Aluminum (CENX) fell while Alcoa (AA) rose. Reference Link
PEIX...

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19:31 EDT Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. President Trump is expected to announce the lifting of a federal ban on summer sales of higher-ethanol blends of gasoline on Tuesday ahead of a trip to Iowa the same day, according to Reuters, citing two sources familiar with the matter. The lifting of the summer ban on so-called E15 gasoline is expected to be coupled with restrictions on trading biofuel credits that underpin the program, sources said. Publicly traded companies in the space include Pacific Ethanol (PEIX) and Green Plains (GPRE). 2. Apple's (AAPL) top security officer told Congress that it had found no sign of suspicious transmissions or other evidence that it had been penetrated in a sophisticated attack on its supply chain, according to Reuters. Apple Vice President for Information Security George Stathakopoulos wrote in a letter to the Senate and House commerce committees that the company found no evidence for the main points in a Bloomberg Businessweek article published on Thursday, which said that chips inside servers sold to Apple by Super Micron Computer (SMCI) allowed for backdoor transmissions to China, the report added. 3. Barnes & Noble (BKS) is on the block, which means that investors and potential buyers will be perusing the bookseller more intensely, and should conclude that there are reams of opportunity in a company seen as a casualty of Amazon (AMZN), Andrew Bary wrote in this week's edition of Barron's. Shares of Barnes & Noble jumped 20% after the company announced it would evaluate "strategic alternatives," but even with that jump, there could be more upside in the shares because the company is valued cheaply relative to cash flow and sales, the report added. 4. Sony's (SNE) "Venom" debuted to $80M from 4,250 theaters in the U.S., easily the best showing ever for an October title. Overseas, the comic book movie soared to $125.2M from 58 markets for a global bow of $205.2M. "Venom" earned a B+ and sports 32% Rotten Tomatoes score. 5. MasterCard (MA), Eaton (ETN) and Terex (TEX) saw positive mentions in Barron's, while Western Union (WU) was mentioned cautiously.
T...

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18:02 EDT Box Office Battle: 'Venom' devours $80M in the U.S. - Sony's (SNE) "Venom" debuted to $80M from 4,250 theaters in the U.S., easily the best showing ever for an October title. Overseas, the comic book movie soared to $125.2M from 58 markets for a global bow of $205.2M. "Venom" earned a B+ and sports 32% Rotten Tomatoes score. BOX OFFICE RUNNERS-UP: AT&T (T) subsidiary Warner Bros' "A Start Is Born" opened in second place with $42.6M domestically from 3,686 cinemas. Behind it was Warner Bros' "Smallfoot," finishing the weekend with $14.9M for a domestic total of $42.8M. Comcast (CMCSA) subsidiary Universal's "Night School" placed number four with $12.3M for a 10-day North American cume of $46.8M. Rounding out the top five, Universal's "The House With a Clock in its Walls" grossed $7.3M in its third weekend for a domestic total of $55.1M and $87.4M worldwide. Other publicly traded companies in filmmaking include 21st Century Fox's (FOX, FOXA), Viacom (VIAB), Lionsgate's (LGF.A, LGF.B) and Disney's (DIS).
AAXN...

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15:59 EDT Axon launches TASER 7, Axon Body 3 - Axon (AAXN) announced its seventh generation TASER conducted energy weapon, TASER 7, and its first connected body camera, Axon Body 3 with LTE. The Axon Body 3 will be wirelessly connected via FirstNet, Built with AT&T (T), and Verizon (VZ). Axon also announced that it is offering Axon Records, a revolutionary records management system, free for five years to any agency that purchases the TASER 7 and the Axon Body 3 on the Officer Safety Plan through 2019.
VCYT

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13:24 EDT Veracyte announces new data from multiple studies in thyroid cancer diagnosis - Veracyte announced that new findings from six studies reinforcing the "real world" performance of the next-generation Afirma Genomic Sequencing Classifier and the Afirma Xpression Atlas in thyroid cancer diagnosis were presented at the 88th Annual Meeting of the American Thyroid Association. Researchers from leading institutions presented posters showing that use of the Afirma GSC at their respective centers significantly increased the identification of benign thyroid nodules among those deemed indeterminate - not clearly benign or malignant - following cytopathology review, compared to the original Afirma test. The Ohio State University - Researchers compared results of 113 indeterminate samples that were tested with the Afirma GSC to those of 403 samples using the earlier version of the test. The Afirma GSC identified 74.1% of the nodules as benign, compared to 48.4% with the GEC, an increase of 53%. The overall surgery rate among all patients who underwent genomic testing decreased by more than half - from 42.2% with the GEC to 20.2% with the GSC. Cleveland Clinic - Comparing results of 46 samples tested with the Afirma GSC between July 2017 and December 2017 with 182 samples tested with the original test between December 2011 and July 2017, researchers found that the GSC identified 67.4% as benign, compared to 41.8% with the GEC - an increase of 61%. The overall surgery rate for nodules tested with the GSC was 32.6%, compared to 47.3% with the original test, a decrease of 31%. Brigham and Women's Hospital - Researchers evaluated results for 583 thyroid nodules tested with either the Afirma GSC or GEC between 2011 and 2018. They found that the Afirma GSC identified 64.9% of nodules as benign, compared to 47.9% with the GEC, an increase of 35%. Additionally, in two oral presentations, researchers shared the first "real world" Afirma Xpression Atlas data, providing insights into the distribution of a wide range of gene variants and fusions across key categories of indeterminate thyroid nodules and Afirma GSC results.
LOXO

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13:20 EDT Loxo Oncology announces LOXO-292 durability update in RET-Mutant MTC - Loxo Oncology announced updated interim clinical data for LOXO-292 from the global Phase 1/2 LIBRETTO-001 trial in patients with RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer who were initially included in the LOXO-292 presentation at the 2018 ASCO Annual Meeting. In these 38 patients, approximately 3.5 months of additional patient follow-up were available, as were first follow-up scans for the nine patients most recently enrolled. Sixteen of 17 responding RET-mutant MTC patients remained on therapy, with median follow-up of 8.4 months. Seven of seven responding RET fusion-positive thyroid cancer patients remained on therapy, with median follow-up of 8.5 months. Inclusion of new restaging data for the most recently enrolled patients resulted in a 59% overall response rate in the presented subset of RET-mutant MTC patients, and a 78% confirmed overall response rate in the presented subset of RET fusion-positive thyroid cancer patients. These data were presented at the 88th Annual Meeting of the American Thyroid Association. The data presented were based on a July 19, 2018 data cut-off date and included the 29 patients with RET-mutant MTC and the nine patients with RET fusion-positive thyroid cancer who were initially included in the LOXO-292 presentation at the 2018 ASCO Annual Meeting. Patients were heavily pretreated, having received a median of three prior systemic treatment regimens. Of the patients with RET-mutant MTC, 79% had previously received cabozantinib or vandetanib and 45% had received prior treatment with both agents. Of the patients with RET fusion-positive thyroid cancer, 78% had previously received radioactive iodine and 78% had previously received sorafenib or lenvatinib. Anti-tumor activity was observed regardless of RET mutation, RET fusion partner, and prior multikinase inhibitor treatment. One patient, with RET fusion-positive thyroid cancer, had RECIST target lesions in the central nervous system and exhibited an intracranial partial response by RECIST 1.1, pending confirmation. Of the 82 patients in the safety analysis, most treatment-emergent adverse events were Grade 1 in severity and judged by the investigator as not related to LOXO-292.
BPMC

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13:11 EDT Blueprint Medicines announces updated data from Phase 1 ARROW clinical trial - Blueprint Medicines announced the presentation of updated data from the ongoing Phase 1 ARROW clinical trial of BLU-667, an investigational precision therapy targeting RET alterations, including resistance mutations. The new results showed that BLU-667 was highly active and well-tolerated in patients with advanced RET-altered medullary thyroid cancer and papillary thyroid cancer, with increased activity observed with higher dose levels and longer treatment durations. The reported data showed 90% of evaluable patients with MTC and PTC had radiographic tumor reductions, regardless of RET alteration type or prior multi-kinase inhibitor therapy. In addition, the response rate was 62% in patients with MTC treated once daily with BLU-667 at doses of 300 to 400 mg for at least 24 weeks. In the MTC and PTC populations, all responders across dose levels and all patients treated at 400 mg QD remain on study. Safety results were consistent with prior data, and the majority of adverse events were Grade 1. These results were as of a data cutoff date of September 14, 2018 and were reported in an oral presentation at The 88th Annual Meeting of the American Thyroid Association. Based on the encouraging data reported to date, Blueprint Medicines has expanded enrollment targets for the ARROW trial to further evaluate the safety and efficacy of BLU-667 in a broader patient population and, ultimately, to support potential registration. The data presented included all patients enrolled in the Phase 1 ARROW clinical trial as of May 9, 2018 and included follow-up on these patients through the data cutoff date of September 14, 2018. Of the 69 patients who had been treated with BLU-667 in the dose escalation and expansion portions of the trial, 42 had RET-altered thyroid cancer, including 37 with MTC and five with PTC. In the dose escalation portion, patients were treated at dose levels ranging from 30 mg to 600 mg QD or up to 300 mg twice daily. In the expansion portion, patients were treated at the recommended phase 2 dose of 400 mg QD. As of the data cutoff date, 35 patients with MTC and four patients with PTC were evaluable for response assessment by Response Evaluation Criteria in Solid Tumors version 1.1. Overall, 90% of MTC and PTC patients with measurable target lesions had radiographic tumor reductions. In patients with MTC, response assessments showed increased clinical activity with higher dose levels and longer treatment durations. Across all evaluable MTC patients, the overall response rate was 49%, including one patient with a confirmed complete response and 16 patients with a partial response. In patients with MTC treated with 300 to 400 mg QD for at least 24 weeks, the response rate was 62%, including one patient with a confirmed CR and seven patients with a confirmed PR. In patients with PTC, two of four evaluable patients had a confirmed PR, and all evaluable patients with PTC had radiographic tumor shrinkage. The data also showed encouraging evidence of durable activity. All patients with MTC and PTC who responded to BLU-667 remain on treatment as of the data cutoff date. In addition, all patients treated at 400 mg QD are continuing on therapy. Patients with the longest treatment durations remain on therapy for more than 15 months. Anti-tumor activity was observed regardless of prior MKI therapy or RET alteration. The reported data showed that across 69 patients, BLU-667 was well-tolerated as of the data cutoff date. Most AEs were Grade 1, and only two patients discontinued therapy due to a treatment-related AE - Grade 3 increased alanine aminotransferase in a patient with liver metastases and Grade 2 pneumonitis.
PTCT

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13:03 EDT PTC Therapeutics announces initial data from patient registry - PTC Therapeutics announced preliminary data from the first international drug registry for Duchenne patients receiving Translarna, underscoring the long-term clinical benefit of Translarna when used in routine clinical practice in delaying irreversible muscle loss in children with Duchenne caused by a nonsense mutation, when compared with published natural history. The data show that children and adolescents receiving Translarna in the real-world setting are continuing to walk years longer than untreated children, and are staying more physically able. A time-to-event analysis for loss of ambulation has shown that patients on Translarna had a median age of loss of ambulation of 16.5 years of age - up to 5 years later than seen with natural disease progression in untreated children. The data were presented as a late breaker at the 23rd International Annual Congress of the World Muscle Society in Argentina. Patients who received Translarna in routine clinical practice also experienced a slower decline in their physical function compared with the placebo arm of Phase 3 Study 020, as measured by a series of timed function tests. Safety outcomes for patients in the STRIDE Registry were consistent with the known safety profile of Translarna. The analysis was based on data captured from 216 patients, the majority of whom had not been previously enrolled in an ataluren clinical trial, across 11 European countries and Israel. Patients had a mean age of 9.8 years at first assessment and had been diagnosed with Duchenne caused by a nonsense mutation at approximately five years of age. Almost 90% had previously or were still receiving corticosteroids.
BIIB IONS

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12:58 EDT Biogen presents new Spinraza data in Spinal Muscular Atrophy - Biogen (BIIB) announced new interim results from NURTURE, an ongoing open-label, single-arm efficacy and safety study of Spinraza in 25 presymptomatic infants with SMA. The interim analysis evaluated survival and respiratory intervention rates in infants who were genetically diagnosed with SMA and began treatment in the presymptomatic stage of the disease. As of May 2018 all patients in the study were alive and none required tracheostomy or permanent ventilation. Additionally, 22 of the 25 participants were able to walk either with assistance or independently according to the motor milestone standard of the World Health Organization and all 25 were able to sit without support. The motor skills of study participants were also evaluated using the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders, an assessment which considers 16 different types of movement to create an overall score between zero and 64. The mean CHOP INTEND scores were 62.6 for study participants with three copies of the SMN2 gene and 61.0 for those with two copies of the gene. All NURTURE study participants were 14 months or older at the time of the analysis. Participants included infants with two copies of the SMN2 gene who are likely to develop a fatal, early-onset form of SMA known as Type 1, and infants with three copies of the SMN2 gene who typically develop SMA Type 2 or 3. People living with SMA Types 2 and 3 may never be able to walk or will lose that ability over time. No new safety concerns were identified. Additional research presented compared levels of phosphorylated neurofilament heavy chain in plasma in more than 300 patients from Spinraza clinical trials, including those in the NURTURE study, and a control group of people without SMA. The data demonstrated that treatment with Spinraza is associated with a rapid decline followed by stabilization of pNF-H in plasma at levels close to those of healthy controls. The results are part of Biogen's ongoing work to identify and validate biomarkers that could provide insight on the disease progression of SMA. Biogen licensed the global rights to develop, manufacture and commercialize Spinraza from Ionis Pharmaceuticals (IONS). Biogen and Ionis conducted an innovative clinical development program, the largest of its kind in SMA, that moved Spinraza from its first dose in humans in 2011 to its first regulatory approval in five years.
JELD

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12:52 EDT Jeld-Wen announces rulings in Steves & Sons litigation - Jeld-Wen announced that the U.S. District Court for the Eastern District of Virginia, Richmond Division, has recently issued a number of rulings in the company's ongoing antitrust and trade secrets litigation with Steves & Sons. First, the District Court entered judgment against Steves in the amount of $1.2M, in accordance with the previously announced jury verdict in Jeld-Wen's favor on its claims that Steves misappropriated Jeld-Wen's trade secrets. Second, the District Court granted Jeld-Wen's motion to vacate the jury verdict on Steves' breach of contract claims related to the quality of the company's doorskins. This ruling eliminates $2.2M of damages under the previously announced jury verdict on Steves' breach of contract claims against Jeld-Wen. Lastly, the District Court ruled that divestiture of the company's facility in Towanda, Pennsylvania, the primary asset acquired in Jeld-Wen's 2012 acquisition of CraftMaster and one of the company's four domestic doorskin manufacturing facilities, is an appropriate remedy in the antitrust litigation. A final judgment on the antitrust claims and the breach of contract claims has not yet been entered in the case, and the company does not expect a final judgment until later this year. Jeld-Wen intends to vigorously oppose entry of an adverse judgment and to appeal any judgment that may be entered awarding damages to the Steves. The company expects that the next procedural step in the case will be a final determination of remedies, following which the Court will enter judgment. Under the ruling, if divestiture of the Towanda facility is included in the final judgment, such a divestiture would not be required until sometime after the appeal process is complete. The initial appeal process is expected to take approximately 9-18 months following entry of a final judgment. Should an appeal to the U.S. Supreme Court be necessary, the appeal process would be extended by an additional 6-18 months. The company continues to believe that any remedy requiring the company to sell the Towanda facility is both unprecedented and fundamentally incorrect as a matter of law. Jeld-Wen believes that both the jury verdict on Steves' breach of contract and antitrust claims and the rulings on those claims are incorrect due to multiple flawed rulings during the trial process. These rulings improperly limited the company's defenses in the trial by excluding key evidence and other relevant matters from the jury's consideration. Evidence that the company was prevented from presenting to the jury included the favorable results of the two previous DOJ antitrust enforcement reviews, the significant profitability growth and expansion of Steves' own business since the 2012 acquisition, and other benefits to the market resulting from the combination of Jeld-Wen and CMI. Finally, the company maintains that a potential remedy of divestiture in this matter is contrary to established legal and equitable principles due to the significant passage of time since the acquisition, Steves' own misconduct in misappropriating Jeld-Wen's trade secrets and the availability of monetary remedies. For the fiscal year ended 2017, the Towanda facility generated external revenues of approximately $120M from Steves and other third-party customers related to doorskins and other building products. The company continues to supply doorskins to Steves in the ordinary course of business pursuant to a long-term agreement that is currently set to terminate in September 2021. The company is unable to predict the ultimate timing of, transaction terms, or proceeds from any divestiture of the Towanda facility. In the event that a divestiture is ultimately required, Jeld-Wen expects the Towanda facility to be sold to an independent third-party buyer, in which case the company expects to meet its internal requirements for doorskins currently supplied by the Towanda facility through other existing internal sources of supply and from a supply agreement with the new owner.
JELD

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12:44 EDT Federal judge orders Jeld-Wen to divest Towanda plant to restore competition - In a major antitrust decision, San Antonio-based door manufacturer Steves & Sons won an order of divestiture against Jeld-Wen in the U.S. District Court for the Eastern District of Virginia, Richmond Division. Jeld-Wen will be required to sell its doorskin plant in Towanda, Pennsylvania, under terms and conditions established by the Court. Judge Robert E. Payne's decision is designed to restore competition in the marketplace.
WTI

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12:41 EDT W&T Offshore announces pricing of $625M offering of senior second lien notes - W&T Offshore announced the pricing of its previously announced private offering of $625M in aggregate principal amount of senior second lien notes due 2023. The notes, which priced at par, will mature on November 1, 2023, and will pay interest at an annual rate of 9.75%. The closing of the offering of the Notes is expected to occur on October 18, 2018, subject to customary closing conditions. W&T Offshore intends to use the net proceeds of the offering, together with borrowings from a proposed amended revolving bank credit facility and cash on hand, to repay and retire its outstanding 11.00% 1.5 Lien Term Loan and 9.00% Second Lien Term Loan and redeem or repurchase in full all of its outstanding 8.500% Senior Unsecured Notes due 2019, 9.00%/10.75%, Second Lien PIK Toggle Notes due 2020 and 8.50%/10.00%, Third Lien PIK Toggle Notes due 2021. In connection with the offering, W&T Offshore has obtained a commitment letter from three commercial banks for a proposed amended revolving bank credit facility with initial bank lending commitments and borrowing base of $250M that is expected to close concurrently with the closing of the offering of the notes.
ALSK

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12:35 EDT Alaska Communications comments on letter from 22NW Fund - Alaska Communications commented on the open letter issued by 22NW Fund. In a statement, the company said: "Alaska Communications strives to maintain constructive, ongoing communications with its shareholders and welcomes and values their input toward the shared goal of enhancing value. In this spirit, our Board will carefully evaluate 22NW's letter and looks forward to further constructive dialogue with 22NW. We remain committed to running a quality business that allows us to retain our talent, fosters trust with our customers, and enables us to win in the market. We have also been very clear and consistent that we are open to considering all opportunities to create and unlock shareholder value. Our Board of Directors is committed to acting in the best interests of Alaska Communications shareholders. They are well-advised and regularly consider strategic and value creation alternatives with the assistance of nationally-recognized financial and legal advisors."