Stockwinners Market Radar for December 16, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:52 EDT Innovent, Incyte announce agreement for three clinical-stage candidates in China - Incyte and Innovent Biologics announced that the companies, through their respective subsidiaries, have entered into a strategic collaboration agreement for three clinical-stage product candidates discovered and developed by Incyte-pemigatinib, itacitinib and parsaclisib. Under the terms of the agreement, Innovent will pay Incyte $40M in cash up front, and Incyte shall be eligible to receive an additional $20M in consideration in connection with the first investigational new drug application by Innovent in China, which is expected to be achieved in 2019. Innovent will receive the rights to develop and commercialize the three assets in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. In addition, Incyte will be eligible to receive up to $129M in potential development and regulatory milestones, and up to $202.5M in potential commercial milestones. Incyte will also be eligible to receive tiered royalties from the high teens to the low twenties on future sales of products resulting from the collaboration. Incyte retains an option to assist in the promotion of the three product candidates in China. The transaction is effective immediately upon the execution of the strategic collaboration agreement. Further financial details were not disclosed.

13:02 EDT Jeld-Wen announces final ruling in Steves & Sons litigation, to appeal decision - Jeld-Wen announced that the U.S. District Court for the Eastern District of Virginia, Richmond Division, has issued a final judgment in the company's ongoing antitrust and trade secrets litigation with Steves & Sons. Jeld-Wen believes that the District Court's ruling is in numerous respects both unprecedented and fundamentally incorrect as a matter of law, and results from a flawed trial process that improperly limited the Company's defenses. "Jeld-Wen firmly maintains that it has not violated any antitrust laws and that it has not damaged Steves," stated Gary Michel, President and Chief Executive Officer. "Rather than resolving a simple contractual dispute between two parties, the District Court has now delivered an erroneous ruling that improperly interferes with our company and the broader commercial marketplace." Consistent with the preliminary ruling previously announced on October 6, 2018, the final judgment orders the company to divest its 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. The ruling requires Jeld-Wen to divest the Towanda facility to a third party, and gives Jeld-Wen and Steves the option, but not the obligation, to purchase doorskins from the acquiring company. The judgment anticipates that the divestiture will not be required until some time after the appeal process is complete. The initial appeal process is expected to take approximately 9 to 18 months. Should an appeal to the U.S. Supreme Court be necessary, the appeal process would be extended by an additional 6 to 18 months. The District Court's judgment also denied Steves' request for an injunction to extend the existing supply agreement between Jeld-Wen and Steves, which is scheduled to terminate in September 2021. As a result, should the appeal process extend beyond September 2021, Jeld-Wen will no longer be contractually obligated to supply doorskins to Steves. The company continues to believe that requiring a divestiture of the Towanda facility is both unprecedented and fundamentally incorrect as a matter of law and intends to appeal the judgment. No U.S. court has ever permitted divestiture as a remedy in private litigation for a merger that has already closed, such as Jeld-Wen's acquisition of CMI. Not only is there no precedent for a remedy of divestiture, the District Court's ruling disregards the significant passage of time since the CMI acquisition, which was completed more than six years ago. Furthermore, the judgment is contrary to established legal and equitable principles due to Steves' own misconduct in misappropriating Jeld-Wen's trade secrets and the District Court's acknowledgement of the availability of monetary remedies. The company also believes that the findings of violations of the antitrust laws and resulting damages award are legally and factually incorrect and the result of significant 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. Jeld-Wen also believes that the District Court improperly bifurcated the trial involving Steves' contract claims from the trial involving Jeld-Wen's claims regarding Steves' misappropriation of trade secrets, allowing Steves to present contradictory evidence in the two different trials. The company is unable to estimate the ultimate timing of, transaction terms, or estimated potential proceeds from any divestiture of the Towanda facility. Regardless of the outcome of the appeal process, the company expects to meet its internal requirements for doorskins currently supplied by the Towanda facility through other existing internal sources of supply or from a supply agreement with the acquiring company. 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 majority of Towanda's doorskin manufacturing capacity is used by the company in its own door assembly operations.

12:41 EDT BeiGene announces updated Phase 1A/1B data on tislelizumab - BeiGene announced that updated clinical data from an ongoing Phase 1A/1B trial of tislelizumab, an investigational anti-PD-1 antibody, were presented in an oral session and a poster at the European Society for Medical Oncology Immuno-Oncology Congress, being held December 13-16 in Geneva, Switzerland. The multi-center, open-label Phase 1A/1B trial of tislelizumab as monotherapy in advanced solid tumors is being conducted in Australia, New Zealand, the U.S., Taiwan and South Korea and consists of dose-escalation and dose-expansion phases in disease-specific cohorts. Data presented at ESMO-IO included updated results from an analysis of tislelizumab in 17 patients with UC. At the time of the data cutoff on August 31, 2018, median treatment duration was 4.1 months, with two patients still on treatment. Treatment-related adverse events as assessed by the investigator occurred in 15 patients. Of those, fatigue, infusion-related reactions, rash, nausea, pain in extremity, peripheral adema, and proteinuria occurred in two or more patients. Three treatment-related Grade 3 or 4 AEs occurred in two patients, fatigue, and hyperglycemia and latent autoimmune diabetes. One patient discontinued treatment due to recurrent infusion-related reactions considered related to tislelizumab. At the time of the data cutoff, all 17 patients were evaluable for response, defined as having a baseline tumor assessment with at least one post-baseline tumor response assessment, or progression or death. The confirmed response rate was 29.4%, with one complete response and four partial responses. Three additional patients achieved stable disease as their best response. There was one CR, one PR and one SD among the eight patients with PD-L1 high tumors and two PRs and two SDs among the eight patients with PD-L1 low or negative tumors. The median duration of response was 18.7 months. In an oral presentation at ESMO-IO, data on patients with esophageal, gastric, hepatocellular and non-small cell lung cancers were reported. TRAEs occurring in at least 5% of patients across all cohorts included fatigue, pruritis, hypothyroidism, decreased appetite, rash and nausea. Ten patients experienced one or more serious adverse events considered related to tislelizumab. Grade 3 or 4 TRAEs occurring in more than one patient included increased AST, increased ALT and pneumonitis. There were two fatal TRAEs reported, including acute hepatitis in a patient with HCC confounded by rapidly progressive disease, and pneumonitis in a patient with NSCLC with compromised pulmonary capacity at baseline. Confirmed response rates and disease control rates in patients with EC were 11.1% and 37.0%, respectively; 13.0% and 29.6% in patients with GC, respectively; 12.2% and 51.0% in patients with HCC, respectively, and 13.0% and 63.0% in patients with NSCLC, respectively. For patients with EC and NSCLC, the median duration of response had not been reached. The mDOR in patients with GC was 8.5 months and for patients with HCC it was 15.7 months.