Stockwinners Market Radar for January 04, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:05 EDT PG&E down 30% to $17.00 after Reuters reports company may file bankruptcy

17:30 EDT Carlson Capital reports 5.1% passive stake in William Lyon Homes

17:16 EDT Shiloh comments on reorganization of MTD's ownership interest - Shiloh Industries, Inc. commented on a Form 3, Form 4 and Schedule 13D filed today in connection with a reorganization of MTD Holdings Inc ownership of shares of Shiloh Industries' Common Stock. As a result of the internal reorganization at MTD Holdings Inc, the 7,300,866 shares of Common Stock, which represent approximately 31% of Shiloh's shares outstanding, that were previously held indirectly by MTD Holdings Inc are now held indirectly by Oak Tree Holdings LLC, an affiliate of MTD Holdings Inc. "MTD has held a strategic investment in Shiloh since 1998 and I am pleased that this relationship will continue under the new Oak Tree structure," said Ramzi Hermiz, president and chief executive officer of Shiloh Industries. "On behalf Shiloh Industries, I'd like to thank MTD for their continued support of our company."

17:03 EDT Arvinas announces FDA clearance to continue with ARV-110 IND - Arvinas announced that the FDA has cleared the company's investigational new drug application, or IND, for ARV-110, an oral androgen receptor Protac protein degrader, for the treatment of patients with metastatic castration-resistant prostate cancer, or mCRPC. Arvinas expects to begin enrollment of a Phase 1 clinical trial for ARV-110 in Q1. The Phase 1 study will investigate the safety and tolerability of ARV-110 in patients with mCRPC who have progressed on at least two standard of care treatment regimens and includes exploratory measures of efficacy.

16:59 EDT Sens. Warner, Rubio introduce legislation to 'combat' tech threats from China - The Vice Chairman of the Senate Select Committee on Intelligence Sen. Mark R. Warner and Committee member Sen. Marco Rubio introduced bipartisan legislation to help combat tech-specific threats to national security posed by foreign actors like China and ensure U.S. technological supremacy by improving interagency coordination across the U.S. government. To do this, the bill creates an Office of Critical Technologies & Security at the White House responsible for coordinating across agencies and developing a long-term, whole-of-government strategy to protect against state-sponsored technology theft and risks to critical supply chains. "It is clear that China is determined to use every tool in its arsenal to surpass the United States technologically and dominate us economically. We need a whole-of-government technology strategy to protect U.S. competitiveness in emerging and dual-use technologies and address the Chinese threat by combating technology transfer from the United States, " said Sen. Warner, a former technology and telecommunications executive. "We look forward to working with the Executive Branch and others to coordinate and respond to this threat." Reference Link

16:48 EDT Morgan Stanley reports 5% passive stake in DBV Technologies - In a regulatory filing, Morgan Stanley disclosed a 5% stake in DBV Technologies, which represents roughly 1.5M shares. The filing does not allow for activism.

16:43 EDT InVivo Therapeutics sees enrolling first patient in INSPIRE 2.0 study in Q1 - On January 4, the company announced an updated projected clinical timeline, specifically that it anticipates enrolling its first patient in the INSPIRE 2.0 study in the first quarter of 2019.

16:31 EDT Danaos receives NYSE non-compliance notice - Danaos Corporation announced it has received written notice from NYSE that the company is not in compliance with the NYSE continued listing standard with respect to the minimum average share price required by the NYSE because the average closing price of its common stock had fallen below $1.00 per share over a period of 30 consecutive trading days.

16:23 EDT Amarin down 7% after below-consensus FY19 revenue view on Vascepa sNDA timing

16:17 EDT Wintrust Financial acquires branch of PyraMax Bank, FSB - Wintrust Financial announced the acquisition, through its wholly-owned subsidiary Town Bank, of a Milwaukee, Wisconsin branch of PyraMax Bank, FSB. Through this transaction, subject to final adjustments, Town Bank acquired approximately $5M of deposits, the bank facility and property located at 1605 W. Mitchell Street in Milwaukee, and various other assets. The terms of the transaction are not being disclosed at this time.

16:08 EDT GE jumps 2.1% after Bloomberg reports Apollo mulling bid for jet-leasing unit

16:02 EDT Gol Linhas reports preliminary December traffic figures - GOL Linhas Aereas Inteligentes announces today preliminary air traffic figures for the month of December, 2018. Comparisons refer to the same period of 2017. GOL's domestic supply as measured by ASK decreased by 0.5% and demand as measured by RPK increased by 3.0%. GOL's domestic load factor was 84.4%, a 2.8 p.p. increase in comparison to December 2017. The volume of departures decreased by 2.2% and seats increased by 2.5% over December 2017. GOL's international supply and demand increased by 33.7% and 31.8%, respectively, and international load factor was 76.3%, a decrease of 1.1 p.p. in relation to December 2017. GOL's total supply increased 3.2% due to a 2.5% increase in seats and a 1.8% decrease in departures. GOL's total demand increased by 5.9% in comparison to December 2017 and consolidated load factor was 83.3% vs. 81.1% last year.

15:31 EDT ACT Capital reports 8% passive stake in HyreCar - In a regulatory filing, ACT Capital disclosed an 8% stake in HyreCar, which represents 935,000 shares. The filing does not allow for activism.

15:07 EDT Engaged Capital reports 5.1% stake in Benchmark Electronics - In a regulatory filing, Engaged Capital reported a 5.1% stake in Benchmark Electronics, calling the stock "undervalued" and "an attractive investment opportunity." The filing further states Engaged has held, and "intends to continue to engage in communications" with the board and management team regarding means to create shareholder value. Engaged "previously ran a successful proxy contest at the Issuer's 2016 annual meeting of shareholders at which two of its director nominees were elected to the Board," the filing noted.

15:00 EDT SJW 'disappointed' in Connecticut Public Utilities Regulatory Authority ruling - SJW Group (SJW) issued a statement in response to the ruling by the Connecticut Public Utilities Regulatory Authority to deny the request of it and Connecticut Water Service (CTWS) to reopen the record and grant an extension of time to submit the additional evidence for PURA's review of SJW's proposed merger with Connecticut Water. SJW said, "We are disappointed that our motion to reopen the record to consider additional evidence was denied by PURA. We continue to believe that the transaction is in the public interest and will provide significant benefits to all stakeholders, including employees, customers and local service area communities throughout Connecticut. We are reviewing all of our options and we will provide a public update about our next steps in a timely manner."

14:23 EDT Achaogen reports license confirmation, redemption pacts with Gates Foundation - In a regulatory filing earlier, Achaogen reported that on December 27, 2018, the company entered into a License Confirmation Agreement and a Redemption Agreement with the Bill & Melinda Gates Foundation in connection with the amendment of certain provisions of the Grant Agreement and the Letter Agreement each previously entered into between the company and the Gates Foundation and dated as of May 4, 2017. The 2018 agreements were entered into following the de-prioritization of antibody work by the company, which was the focus of the company's collaboration with the Gates Foundation. Among other things, the 2018 agreements terminated the company's obligations to conduct mutually agreed upon work, including work related the company's platform technology to develop and launch a product intended to prevent neonatal sepsis, terminated the obligations of the company to discover drug candidates intended to prevent neonatal sepsis and the obligation of the Gates Foundation to fund approximately $7.1M in grants not yet received by the company and granted the Gates Foundation a non-exclusive license to intellectual property developed by the company pursuant to the grant agreement and letter agreement in specified developing countries. The redemption agreement also provided for the redemption by the company of the 407,331 shares of the company's common stock purchased by the Gates Foundation pursuant to a common stock purchase agreement between the company and the Gates Foundation dated as of May 4, 2017 for an aggregate redemption price of $5,737,082. The company paid for the redemption of the Gates Shares with the unused portion of the restricted cash received by the company pursuant to the original purchase of the Gates Shares under the purchase agreement and no unrestricted company cash was used to fund the redemption, the filing stated.

14:02 EDT FOD Capital reports 9% passive stake in Arcimoto - In a regulatory filing, FOD Capital disclosed a 9% stake in Arcimoto, which represents 1.44M shares. The filing does not allow for activism.

12:17 EDT Generex plans breast cancer vaccine spinout and dividend - Generex President & CEO Joe Moscato stated, "NuGenerex Immuno-Oncology is being established to not only advance the NuGenerex Immuno-Oncology core technology, but also to expand the Company's portfolio in the field of immunotherapy and personalized medicine through partnerships and acquisitions. As part of our strategy, we are exploring opportunities to spin-out NuGenerex Immuno-Oncology as a separate DTC-eligible SEC registered company." Moscato stated that following the spin-out, NuGenerex Immuno-Oncology is expected to seek to list its common stock on a national stock exchange. "The spin-out of NuGenerex Immuno-Oncology into a separate, publicly traded entity has been the focus of the Generex strategic development plan in cancer drug development," Moscato indicated. "The Ii-Key technology has been underappreciated for too long, as we have advanced the immunotherapy field with the largest breast cancer vaccine study ever conducted, and now the results of that trial have led to an exciting combination Phase II trial with AE37 plus Ketruda in triple negative breast cancer. We believe this spin-out will help to unlock the true value of the Ii-Key technology for our stockholders as it creates a pure play in immunotherapy, which will foster investment and collaboration." The spin-out will be accomplished by the issuance of one or more dividends of NuGenerex Immuno-Oncology stock to Generex stockholders. Following the issuance of stock dividends, Generex expects to retain a controlling interest in NuGenerex Immuno-Oncology, but the exact proportion of the shares to be held by Generex has not yet been determined. Subject to market conditions and the satisfaction of regulatory requirements, it is expected that the NuGenerex Immuno-Oncology spin-out will occur sometime following the upcoming Annual Meeting of the Generex stockholders.

11:23 EDT 111, Inc. signs online healthcare project strategic framework agreement - 111, Inc. announced the signing of a strategic framework agreement with the Kunshan Health Commission of Kunshan City, Jiangsu Province in China, to co-develop an online healthcare and pharmaceutical operations service platform. Under the terms of the agreement, 111 will establish offline medical outlets in Kunshan and leverage them to launch its online hospital business, integrating its nationwide network of 2,000 medical professionals and rapidly expanding its team of online doctors. Concurrently, 111 will leverage its strong pharmaceutical supply chain management system which consists of 1 Drug Mall, 1 Clinic, and over 130,000 pharmacies, to build an innovative integrated healthcare and pharmaceutical services ecosystem, and to launch the Operations Service Platform pilot initiative in conjunction with the Kunshan Health Commission.In addition, 111 will leverage its core strengths of smart supply chain management, cloud-based solutions, big data analytics, healthcare expertise and pharmaceutical supply service infrastructure to deliver online services through the Operations Service Platform to healthcare institutions and pharmaceutical wholesalers and retailers within Kunshan.

11:04 EDT RegeneRx says partner GtreeBNT moving forward with trials after 'some delay' - RegeneRx Biopharmaceuticals is updating the status of the U.S. phase 3 dry eye clinical trial, ARISE-3, and the U.S. trial in patients with epidermolysis bullosa based on a letter to stockholders issued by its partner, GtreeBNT. GtreeBNT is the sponsor of the EB trial while a U.S. joint venture between GtreeBNT and RegeneRx, ReGenTree, is the sponsor of the dry eye trial. GtreeBNT stated that it is planning to sign the contract for management of the clinical trial in February and that the trial will start thereafter. The company went on to say that manufacturing of the investigational drug has been completed and confirmed that the FDA had previously agreed on the protocol. The company also clarified that while the FDA requires multiple pivotal studies and reproducibility for NDA approval, due to the multi-factorial nature of dry eye syndrome and heterogeneity of the patient population, Gtree is not designing ARISE-3 to do more than the FDA requires for products currently on the market. The company also stated that it intends to keep its stockholders informed on the progress with ARISE-3 after the contract is signed. GtreeBNT stated that it has selected the clinical trial sites that specialize in EB and one of the sites has begun patient recruitment. Since most of the clinical trial sites selected are university hospitals, the approval procedures from the institutional review boards is required and will take several months to complete in some cases, most of which are expected to come in February. Therefore, it is expected that several hospitals will begin enrolling and administering the investigational drug simultaneously and that GtreeBNT expects fairly rapid progress. "We are pleased our partner, GtreeBNT, is now moving forward with these two important clinical trials after some delay and that they will be keeping us informed of the progress on a regular basis, which we will relay to our stockholders. We look forward to success with both of our product candidates over the next twelve months and hope that 2019-2020 will be the most productive period in the history of RegeneRx," said RegeneRx president and CEO J.J. Finkelstein.

10:31 EDT Borqs Technologies Inc trading resumes

10:06 EDT Borqs Technologies Inc trading halted, volatility trading pause

10:00 EDT Kosmos rises 8.1% - Kosmos is up 8.1%, or 34c to $4.56.

10:00 EDT American Midstream Partners rises 27.0% - American Midstream Partners is up 27.0%, or 85c to $4.00.

09:47 EDT VelocityShares 3x Inv Natural Gas ETN falls -6.5% - VelocityShares 3x Inv Natural Gas ETN is down -6.5%, or -$8.25 to $118.05.

09:47 EDT Talos Energy rises 3.9% - Talos Energy is up 3.9%, or 67c to $18.05.

09:47 EDT American Midstream Partners rises 27.0% - American Midstream Partners is up 27.0%, or 85c to $4.00.

09:07 EDT InnerWorkings appoints Donald Pearson as CFO - InnerWorkings announced that Donald Pearson has been appointed EVP and CFO, effective January 10, 2019. In this role, Pearson will oversee the financial operations and partner with the company's business leaders to ensure InnerWorkings' business strategy and operational plans drive significant shareholder value. Most recently, Mr. Pearson served as Chief Financial Officer of private-equity owned global packaging company BWAY Corporation, before its sale to Stone Canyon Industries. Pearson will replace interim CFO Chip Hodgkins, who is leaving the company effective January 15, 2019 to launch a new commercial litigation investment firm, Statera Capital.

09:03 EDT OrthoPediatrics updates sales agency agreement with Hospithera - OrthoPediatrics announced their recently updated and signed agreement with Hospithera to act as OrthoPediatrics' exclusive sales agency in Belgium and the Netherlands. Since 2015, Hospithera has been OrthoPediatrics' stocking distributor, developing sales in these regions. Going forward, OrthoPediatrics will sell direct to hospitals in Belgium and the Netherlands with Hospithera as the company's exclusive sales agency.

08:37 EDT Arcus Biosciences' chief financial and operating officer Jarrett steps down - Arcus Biosciences announced that Jennifer Jarrett will step down as the company's Chief Financial and Operating Officer, effective January 11, 2019, to pursue an opportunity at a privately-held transportation and technology company. Jarrett will remain actively engaged with the company and has been appointed to Arcus's Board of Directors commencing January 12, 2019. Jarrett and the company have also entered into a consulting agreement that will ensure a seamless transition.

08:33 EDT Ultragenyx announces safety, efficacy data from cohort of DTX401 study - Ultragenyx announced topline safety and efficacy data from the first, lowest dose cohort of the ongoing Phase 1/2 study of DTX401, an adeno-associated virus based gene therapy for the treatment of glycogen storage disease type Ia, or GSDIa. A biologic response, reflected by improved glucose control and increased time to hypoglycemia during fasting, was observed in all three patients, with two patients demonstrating a clinically meaningful improvement in time to hypoglycemia during a controlled fasting challenge. "Two of three patients in this first dose cohort experienced a sufficient increase in time to hypoglycemia such that they may be able to sleep through the night without taking supplemental cornstarch," said Eric Crombez, CMO of the Ultragenyx gene therapy development unit. "In addition to the promising results observed with the controlled fasting challenge, all three patients have demonstrated improvement in glucose control throughout the day, and all three patients have been able to decrease their daily cornstarch intake by approximately half. We are extremely encouraged by these results and look forward to beginning enrollment in the second cohort this month, with results expected in mid-2019."

08:32 EDT Cesca Therapeutics acquires remaining ownership stake in ThermoGenesis - Cesca Therapeutics announced that, under the terms of a reorganization and share exchange agreement approved by the Board of Directors, it has acquired from Bay City Capital the remaining 20% equity share of its device subsidiary, ThermoGenesis Corp. In exchange, BCC has taken 20% ownership in a newly created subsidiary of ThermoGenesis called CARTXpress Bio. the remaining 80% of which is owned by ThermoGenesis. The reorganization and share exchange took effect on January 1, 2019. As a result, ThermoGenesis is now a wholly owned subsidiary of Cesca with a focus on the development and commercialization of automated medical devices and technologies for cell-based therapies, including stem cell banking, point-of-care applications, and large-scale cell manufacturing of immunotherapy drugs, such as chimeric antigen receptor T cells. In connection with the reorganization, Haihong Zhu, president of ThermoGenesis, has also been appointed president of its newly formed subsidiary, CARTXpress Bio. Additionally, beginning with the filing of company's first quarter 2019 financial results, Cesca will report ThermoGenesis as a 100% owned device division, according to business segment accounting requirements.

08:24 EDT Catalyst Pharmaceuticals announces publication of Firdapse trial data - Catalyst Pharmaceuticals announced the online publication in Sage Open Medicine of the results of an investigator-sponsored Phase IIb clinical trial evaluating Firdapse for the treatment of MuSK antibody positive Myasthenia Gravis, or MuSK-MG. The positive topline results from this trial were previously announced, but the full results of safety, efficacy and other clinical data are now available. The MSK-001 trial was a randomized, double-blind, placebo-controlled, double crossover design. The co-primary endpoints were statistically met as well as the secondary endpoints. The study provided evidence that amifampridine phosphate was safe and effective in treating MuSK-MG patients. The study was conducted in Milan, Italy.

08:21 EDT Vertex, X-Chem expand existing partnership - X-Chem, a privately held biotechnology company, announced the expansion of its collaboration with Vertex Pharmaceuticals. Under the terms of the expanded agreement, X-Chem will apply its growing collection of next-generation DEX libraries toward the discovery of novel lead compounds against multiple targets across Vertex's drug development portfolio. Vertex will be responsible for further development and commercialization of licensed programs. X-Chem will receive an upfront payment, and stands to receive additional payments linked to the achievement of R&D and regulatory milestones. X-Chem is also eligible for royalties on revenues from medicines originating from the collaboration. The expanded partnership now comprises 14 targets, increasing the scope of the original agreement two-fold.

08:16 EDT Nielsen names George Callard Chief Legal Officer, effective January 22 - David Kenny, Nielsen's CEO announced the appointment of George Callard as Chief Legal Officer, effective January 22, 2019. Callard succeeds Eric Dale, who has served in the role since 2015 and resigned to pursue an opportunity outside of the company. Callard joins Nielsen from The Weather Channel television network, where he was President.

08:10 EDT AmpliPhi, C3J Therapeutics announce merger agreement - AmpliPhi Biosciences and C3J Therapeutics announced that the companies have entered into a definitive agreement under which a wholly owned subsidiary of AmpliPhi will merge with C3J in an all-stock transaction, subject to shareholder approval. The consummation of the merger transaction will result in a combined company that has a diverse clinical-stage pipeline, including a Phase 1/2-ready natural phage candidate targeting bacteremia, as well as a synthetic phage candidate targeting respiratory infections poised to enter Phase 1 development later this year. In addition, the combined company will have an extensive natural phage library and the capability to develop synthetic phage against a wide range of microbial agents. Certain existing C3J shareholders have committed to invest $10M in the combined company, subject to customary conditions. The financing will help fund the further development of the combined company's preclinical and clinical programs and is expected to close immediately following with the completion of the merger. The combined company's total cash balance following the closing of the merger and contemplated financing is expected to be approximately $18M. Under the terms of the merger agreement, on a pro-forma basis and after closing of the merger but prior to the closing of the financing, the current C3J securityholders will own approximately 70% of the combined company, while current AmpliPhi securityholders will own approximately 30% of the combined company. The pre-financing ownership split was determined by the exchange ratio in the merger agreement, which was based on a $28M valuation for C3J and a $12M valuation for AmpliPhi, a premium to the 30-day volume weighted average share price of AmpliPhi. On a proforma basis, after giving effect to the contemplated $10M financing, current C3J securityholders will own approximately 76% of the combined company and current AmpliPhi securityholders will own approximately 24% of the combined company. The transaction has been unanimously approved by the boards of directors of both companies, and is expected to close in the first quarter of 2019, subject to approval by AmpliPhi shareholders. The transaction is also subject to customary conditions, including the execution of stock purchase agreements by certain existing C3J shareholders who have agreed to invest an additional $10M into the combined company, subject to customary closing conditions. The investment is expected to close immediately following with the closing of the merger. Mr. Patrick of C3J will be the CEO of the combined company and Dr. Brian Varnum of C3J will be appointed president and Chief Development Officer. Steve Martin, AmpliPhi's CFO, will continue to act as the CFO of the combined company. Dr. Grint has agreed to act as a clinical consultant for the combined company. Prior to closing, AmpliPhi will seek stockholder approval to conduct a reverse split of its outstanding shares to satisfy listing requirements of the NYSE American. The combined company is expected to trade on the NYSE American under a new ticker symbol.

08:07 EDT Natera obtains two Z-codes for company's Signatera test - Natera announced the assignment of two Z-codes for the company's Signatera test, in preparation for its planned clinical launch in Q2 2019. Signatera, when clinically available, is intended for use by oncologists to detect molecular residual disease and monitor treatment response in cancer patients. Two Z-codes were awarded, ZB8DC and ZB8DD, representing the initial and subsequent test orders for each patient. These codes will cover multiple cancer types, as the Signatera technology has shown consistent performance across multiple cancers, including lung, breast, colorectal, and bladder.

08:06 EDT Allena Pharmaceuticals CEO to transition to chairman, Louis Brenner to succeed - Allena Pharmaceuticals announced that Louis Brenner, president and COO at Allena, will be promoted to CEO and appointed to the board effective February 1. Brenner will succeed Alexey Margolin as CEO. Margolin, who co-founded Allena in 2011, will transition to chairman of the board effective February 1. He will continue advising the company in this new role. Brenner has served as COO of Allena since April 2015 and as president since February 2017. Brenner has more than a decade of industry experience, including pharmaceutical development strategy, regulatory affairs, business development and commercialization.

08:04 EDT Blueprint Medicines announces '2020 Blueprint' global business strategy - Blueprint Medicines announced "2020 Blueprint," a two-year strategy to launch Blueprint Medicines' global commercial business. Under this strategy, by the end of 2020, the company expects to have two marketed products and at least four additional marketing applications pending in the United States and Europe. In addition, Blueprint Medicines today announced recent milestones and key goals through 2020 across its differentiated portfolio of investigational precision therapies. The "2020 Blueprint" strategy establishes a path to transform Blueprint Medicines into a global commercial enterprise focused on delivering a portfolio of precision therapies to patients with cancer and rare diseases. Under this strategy, Blueprint Medicines anticipates achieving the following by the end of 2020: 2 marketed products in the United States and 1 marketed product in Europe; 4 additional marketing applications pending in the United States and Europe; 6 therapeutic candidates in global clinical development; 8 research programs that leverage strategic areas of focus.

07:48 EDT Celgene, Bristol-Myers deal has $2.2B termination fee - In a regulatory filing, Celgene (CELG) and Bristol-Myers Squibb (BMY) disclosed additional information about their merger plan, including details on the agreement's termination clauses. "Either Celgene or BMS may terminate the Merger Agreement in certain circumstances, including if the Merger is not completed by January 2, 2020, subject to extension by either party in certain circumstances in the event that any required regulatory approval is not obtained, Celgene's stockholders fail to adopt the Merger Agreement, BMS's stockholders fail to approve the share issuance in connection with the Merger, a governmental authority of competent jurisdiction has issued a final non-appealable governmental order prohibiting the Merger, the other party breaches its representations, warranties or covenants in the Merger Agreement in a way that would entitle the party seeking to terminate the Merger Agreement not to consummate the Merger, subject to the right of the breaching party to cure the breach, subject to compliance with specified process and notice requirements, such party terminates the Merger Agreement in order to enter into an agreement providing for, in the case of Celgene, a "Company Superior Proposal" or, in the case of BMS a "Parent Superior Proposal", or the other party's board of directors has changed its recommendation in favor of the Merger. In the event of a termination of the Merger Agreement under certain specified circumstances, including termination by Celgene to enter into an agreement providing for a Company Superior Proposal, or a termination by BMS following a change in recommendation by Celgene's board of directors, Celgene may be required to pay BMS a termination fee equal to $2.2B. In the event of a termination of the Merger Agreement under certain specified circumstances, including termination by BMS to enter into an agreement providing for a Parent Superior Proposal, or a termination by Celgene following a change in recommendation by BMS's board of directors, BMS may be required to pay Celgene a termination fee equal to $2.2B," the filing states.

07:39 EDT Biogen, Skyhawk enter strategic collaboration for neurological disease treatment - Biogen and Skyhawk Therapeutics announced a strategic collaboration in which the companies will leverage Skyhawk's SkySTAR technology platform with the goal of discovering innovative small molecule treatments for patients with neurological diseases. Biogen will have the option to license therapies resulting from the collaboration and will be responsible for their development and potential commercialization. The agreement grants Biogen an exclusive license to worldwide intellectual property rights on research-stage therapeutic candidates for the treatment of multiple sclerosis, spinal muscular atrophy and additional neurological disorders. As part of the agreement, Skyhawk received an upfront payment of $74M from Biogen and may receive potential future milestone payments and royalties. A portion of the upfront payment will be allocated to future research services, with the remainder expensed in Q1 as research and development.

07:35 EDT Biogen, Skyhawk Therapeutics announce strategic collaboration - Biogen announced a strategic collaboration in which the companies will leverage Skyhawk's SkySTAR technology platform with the goal of discovering innovative small molecule treatments for patients with neurological diseases. Biogen will have the option to license therapies resulting from the collaboration and will be responsible for their development and potential commercialization. The agreement grants Biogen an exclusive license to worldwide intellectual property rights on research-stage therapeutic candidates for the treatment of multiple sclerosis, spinal muscular atrophy and additional neurological disorders. As part of the agreement, Skyhawk received an upfront payment of $74M from Biogen and may receive potential future milestone payments and royalties. A portion of the upfront payment will be allocated to future research services, with the remainder expensed in the first quarter of 2019 as research and development.

07:33 EDT Marriott provides update on Starwood database security incident - Marriott is providing an update on the number of guests whose passport numbers and payment card numbers were involved in the Starwood reservations database security incident announced by the company on November 30, 2018. Working closely with its internal and external forensics and analytics investigation team, Marriott determined that the total number of guest records involved in this incident is less than the initial disclosure. Also, the number of payment cards and passport numbers involved is a relatively small percentage of the overall total records involved. "We want to provide our customers and partners with updates based on our ongoing work to address this incident as we try to understand as much as we possibly can about what happened," said Arne Sorenson, Marriott's President and CEO. "As we near the end of the cyber forensics and data analytics work, we will continue to work hard to address our customers' concerns and meet the standard of excellence our customers deserve and expect from Marriott." Marriott is updating its press release of November 30, 2018, which announced that the company determined on November 19, 2018 that there was unauthorized access to a Starwood guest reservations database. In that release, the company said that it believed the incident involved information about up to approximately 500 million guests who made a reservation at a Starwood property* on or before September 10, 2018, although at that point the company had not completed the analytics work to identify duplicative information. Marriott now believes that the number of potentially involved guests is lower than the 500 million the company had originally estimated. Marriott has identified approximately 383 million records as the upper limit for the total number of guest records that were involved in the incident. This does not, however, mean that information about 383 million unique guests was involved, as in many instances, there appear to be multiple records for the same guest. The company has concluded with a fair degree of certainty that information for fewer than 383 million unique guests was involved, although the company is not able to quantify that lower number because of the nature of the data in the database. Marriott now believes that approximately 5.25 million unencrypted passport numbers were included in the information accessed by an unauthorized third party. The information accessed also includes approximately 20.3 million encrypted passport numbers. There is no evidence that the unauthorized third party accessed the master encryption key needed to decrypt the encrypted passport numbers. Marriott is putting in place a mechanism to enable its designated call center representatives to refer guests to the appropriate resources to enable a look up of individual passport numbers to see if they were included in this set of unencrypted passport numbers. Marriott will update its designated website for this incident (https://info.starwoodhotels.com) when it has this capability in place. The website lists phone numbers to reach the company's dedicated call center and includes information about the process to be followed if guests believe that they have experienced fraud as a result of their passport numbers being involved in this incident.

07:30 EDT Mersana Therapeutics trading resumes

07:24 EDT Nabriva Therapeutics announces FDA acceptance of Contepo NDA - Nabriva Therapeutics announced that the FDA has accepted the new drug application, or NDA, and granted a priority review for Contepo to treat complicated urinary tract infections, or cUTIs, including acute pyelonephritis. The acceptance of the NDA indicates that the FDA has deemed the application sufficiently complete to allow a substantive review. The PDUFA goal date for the completion of the FDA's review of the Contepo NDA is June 30. In addition to priority review, Contepo has been granted qualified infectious disease product and fast track designations by the FDA for the treatment of several serious infections, including cUTI. The NDA submission is utilizing the 505 regulatory pathway and is supported by a data package, including a pivotal Phase 2/3 clinical trial, which met its primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with cUTI, including acute pyelonephritis.

07:18 EDT Crispr Therapeutics, Vertex announce fast track designation for CTX001 - Crispr Therapeutics (CRSP) and Vertex (VRTX) announced that the FDA has granted fast track designation for CTX001 for the treatment of sickle cell disease, or SCD. CTX001 is an investigational, autologous, gene-edited hematopoietic stem cell therapy for patients suffering from severe hemoglobinopathies. CTX001 is being developed under a co-development and co-commercialization agreement between Crispr Therapeutics and Vertex.

07:12 EDT Boehringer Ingelheim exercises option in research collaboration with Dicerna - Boehringer Ingelheim and Dicerna Pharmaceuticals announced that Boehringer Ingelheim has exercised an option to receive exclusive rights to a second hepatic disease target emerging from its research collaboration and license agreement with Dicerna. The collaboration, established in October 2017, aims to discover and develop novel GalXC RNAi therapeutics for the treatment of chronic liver diseases, with an initial focus on nonalcoholic steatohepatitis, a devastating disease for which there is no approved treatment. The option is the second target under the two companies' research collaboration and license agreement. Under the terms of the agreement, Boehringer Ingelheim will be responsible for future clinical development and commercialization of the therapeutic target. Dicerna is eligible to receive development and commercial milestone payments, and royalties on worldwide net sales. Dicerna and Boehringer Ingelheim selected the target based on its ability to be drugged using Dicerna's proprietary GalXC technology platform. The GalXC platform uses RNAi to inhibit the expression of disease-causing genes by destroying the messenger RNAs of those genes. The approach has the potential to treat diseases by silencing previously inaccessible drug targets.

07:07 EDT Flex Pharma, Salarius Pharmaceuticals announce merger agreement - Flex Pharma and Salarius Pharmaceuticals announced that the companies have entered into a definitive merger agreement under which privately-held Salarius will merge with a wholly-owned subsidiary of Flex Pharma. Management believes that the proposed transaction will position the combined company to recognize multiple value inflection points based on Salarius' clinical pipeline, which targets rare, orphan cancers with no targeted treatments and cancers that have a high unmet need. Salarius recently completed a $6.4M private placement, which combined with cash from Flex Pharma is expected to fund the combined company to mid-2020, allowing it to report early cohort data from an ongoing Phase 1 Ewing sarcoma trial. Upon the closing of the transaction, Flex Pharma stockholders will own approximately 19.9% of the combined company and current Salarius investors will own approximately 80.1% of the combined company. Flex Pharma stockholders will also receive a right to receive warrants, six months and one day following the closing date of the transaction, allowing them to purchase additional shares. The total value of these warrants will be calculated such that upon exercise Flex Pharma stockholders would own an additional 2.4%, or a total of 22.3%, of the value of the combined entity, subject to adjustment based on Flex Pharma's net cash at closing. Upon closing of the transaction, Flex Pharma is expected to be renamed Salarius Pharmaceuticals and be under the leadership of Salarius' current management team, led by CEO David Arthur. The Salarius clinical pipeline will become the lead assets of the company following the transaction. Flex Pharma President and CEO William McVicar, Ph.D., is expected to join the Board of Directors of the combined company following the closing of the transaction. Salarius' lead compound, Seclidemstat, targets the epigenetic dysregulation underlying Ewing sarcoma, a devastating pediatric, adolescent and young adult bone cancer for which no targeted therapies currently exist. Seclidemstat is a differentiated, reversible inhibitor of the lysine-specific demethylase 1 enzyme, or LSD1, which is a widely studied epigenetic enzyme and a validated drug target for clinical development. The company is currently enrolling patients in an open-label Phase 1 dose escalation/dose expansion study, which is expected to conclude in 2020. Salarius is also preparing to initiate additional studies in advanced solid tumors, including prostate, breast and ovarian cancers. The transaction has been approved unanimously by the Board of Director of Flex Pharma and Board of Managers of Salarius. The proposed transaction is expected to close in the first half of 2019, subject to the approval of Flex Pharma stockholders at a special stockholder meeting and other customary conditions, including approval by Salarius' members.

07:03 EDT Callaway Golf sees Jack Wolfskin acquisition 11c per share dilutive for 2019 - Callaway Golf announced that it has completed the previously announced acquisition of Jack Wolfskin for EUR418M, or approximately $476M assuming a 1.140 Euro to US Dollar conversion rate, subject to a working capital adjustment. Callaway financed the transaction with a $480M Term Loan B facility, which was led by BofA Merrill Lynch and JP Morgan Securities LLC. The facility has a seven-year term, subject to certain prepayment rights, and bears interest at a rate of LIBOR plus 4.50%. The Term Loan B market weakened during the period the Company marketed the loan to investors and therefore the estimated annual financing costs will be approximately 5c per share higher than previously estimated. As a result, Callaway currently estimates that this transaction is expected to be approximately 11c per share dilutive for full year 2019 and slightly accretive in 2020, both on a non-GAAP basis, which excludes non-recurring transaction costs and non-cash purchase accounting adjustments. The company intends to provide further guidance on a GAAP basis once it has completed its purchase accounting adjustments. Full year 2019 adjusted EBITDA, which excludes transaction costs and non-cash purchase accounting adjustments, is still estimated to be approximately $33M for the Jack Wolfskin business. The company remains excited about adding this premium brand to its portfolio and the strategic benefits and long-term potential this acquisition provides.

06:55 EDT Mersana Therapeutics trading halted, news pending

06:50 EDT RPM CEO: 'Bottom line was impacted by continued rise in costs for raw materials' - "We achieved solid top-line improvement with sales growth of 3.6%, despite the unfavorable foreign currency translation effect of 2.0%," stated Frank Sullivan, RPM chairman and CEO. "Like many manufacturers, our bottom line was impacted by a continued rise in costs for raw materials, freight, labor and energy, as well as adverse foreign exchange translation. SG&A improved by 30 basis points, and adjusted SG&A, excluding restructuring expenses, improved by 100 basis points versus last year's second quarter. Restructuring activities related to our MAP to Growth operating improvement plan, the details of which we shared at an investor day on November 28, are well under way. Our plan is focused on driving greater efficiency and long-term profitability of the business to enhance shareholder value."

06:39 EDT LyondellBasell subsidiary declares $15.00 per share special stock dividend - LyondellBasell announced that its wholly owned subsidiary, A. Schulman has declared a quarterly dividend of $15.00 per share for A. Schulman's convertible special stock. The dividend is payable on February 1 to shareholders of record as of January 15.

06:36 EDT Epizyme announces registration path for tazemetostat for follicular lymphoma - Epizyme announced a comprehensive set of pipeline updates, including that the company has identified a path to submission for accelerated approval of tazemetostat for patients with relapsed and/or refractory follicular lymphoma, both with and without EZH2 activating mutations. The company recently conducted a productive meeting with the U.S. FDA to discuss the FL registration strategy based on the current patient population in its ongoing Phase 2 clinical trial. Following the discussion, Epizyme has defined a registration strategy for tazemetostat in both EZH2 mutant and wild type FL patient populations, where patients' disease has progressed following two or more lines of therapy. Based on this, the company anticipates submitting a New Drug Application for this indication in the fourth quarter of 2019. In addition, the company provided an update on its clinical and preclinical pipeline and anticipated milestones for 2019.

06:34 EDT Aerie: 'Positive' results from Phase 2 study of netarsudil ophthalmic solution - Aerie Pharmaceuticals announced the topline results of its pilot Phase 2 study of netarsudil ophthalmic solution in a Japanese-American population. The study was designed in accordance with the requirements of Japan's PMDA to support the potential regulatory submission of netarsudil ophthalmic solution in Japan. Netarsudil ophthalmic solution 0.02% is known by the name Rhopressa in the United States, where it is currently marketed. This pilot study was initially designed as a larger Phase 2 trial to be conducted in the United States, enrolling Japanese subjects and Japanese-American subjects that are within second generation. Due to scarcity of qualified subjects in the United States, the enrollment of this study was limited to approximately 40 subjects across three study arms. The primary objectives of the study were to evaluate (1) the ocular hypotensive activity of two different dose concentrations of netarsudil ophthalmic solution (0.02% and 0.04%) relative to placebo over a 28-day period, for a total of three arms all dosed in the evening, and (2) the ocular and systemic safety of netarsudil ophthalmic solution relative to placebo over that period. The ranges of unmedicated baseline IOP at 8am in the study were greater than or equal to 15 mmHg to less than 35 mmHg for subjects with open-angle glaucoma, and greater than or equal to 22 mmHg to less than 35 mmHg for subjects with ocular hypertension. The results, which are outlined in the supporting slide presentation to this press release, demonstrated that netarsudil ophthalmic solution 0.02% lowered IOP in mean diurnal IOP by a range of 5.0 to 5.3 mmHg for subjects with an average baseline IOP of 18.3 mmHg. The netarsudil ophthalmic solution 0.04% arm lowered IOP in mean diurnal IOP by a range of 5.2 mmHg to 6.6 mmHg for subjects with average baseline IOP of 20.2 mmHg. The placebo arm lowered IOP in mean diurnal IOP by a range of 2.0 to 2.5 mmHg for subjects with an average baseline pressure of 19.6 mmHg. Both netarsudil arms showed higher levels of IOP reduction as compared to placebo to a statistically significant degree at Day 28. The safety findings were consistent with previous netarsudil trials. Aerie expects to initiate a Phase 2 clinical trial in Japan in the first quarter of 2019 structured, as agreed with the PMDA, consistently with this pilot study with the addition of a 0.01% concentration of netarsudil.

06:05 EDT QuickLogic acquires SensiML - QuickLogic announced that it has acquired SensiML. Under the terms of the agreement, the details of which are not disclosed, QuickLogic will fund the acquisition in shares of common stock. SensiML will operate as a division of QuickLogic and continue to develop, expand and optimize its platform-independent software solutions to support SoCs from other semiconductor companies as well as QuickLogic SoCs, QuickAI platforms and licensees of QuickLogic's ArcticPro embedded FPGA IP. SensiML has developed strategic and ongoing software as a service, or SaaS, contracts with customers in its targeted IoT and consumer markets.

06:01 EDT Tesla says Model 3 configurator now open to countries in Europe - Tesla tweeted: "Model 3 configurator is now open to left-hand drive countries in Europe. Design your Model 3. Now open to: Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden and Switzerland." Reference Link

05:23 EDT Axalta Coating, Plenham form three-year global alliance - Axalta and Plenham, parent company of bodyshop and IBIS Worldwide brands, announced a multi-year global partnership to help the worldwide collision repair industry share ideas for business improvement, drive best practices in innovation, and establish new processes and know-how through dynamic media and social interactions. The agreement will leverage Axalta's global refinish expertise and experience to enhance Plenham's worldwide media platforms and networks.