Stockwinners Market Radar for August 09, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
CPA | Hot Stocks17:50 EDT Copa Holdings reports July traffic down 2.6%, capacity down 0.8% - Load factor was down 1.7 pts to 86.6%.
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LMT | Hot Stocks17:39 EDT Lockheed Martin awarded $176.34M Navy logistics contract - Lockheed Martin has been awarded a $176.34M firm-fixed-priced, performance-based logistics contract for the repair of 1,672 different head-of-family part numbers in support of the AEGIS SPY-1 weapon system. The contract is a five-year contract with no option periods. Work will be performed in Moorestown, New Jersey and is expected to be completed by August 2024. No funds are obligated at the time of award. Working capital funds will be obligated as individual task orders are issued and funds will not expire at the end of the current fiscal year. One company was solicited for this sole-source, non-competitive requirement pursuant to the authority set forth in 10 U.S. Code 2304 and in accordance with Federal Acquisition Regulation 6.302-1, with one offer received. Naval Supply Systems Command is the contracting activity.
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MDRX | Hot Stocks17:30 EDT Allscripts to pay $145M to resolve civil, criminal probes into Practice Fusion - In a regulatory filing, Allscripts said that Practice Fusion, which the company acquired on February 13, 2018, received in March 2017 a request for documents and information from the U.S. Attorney's Office for the District of Vermont pursuant to a CID. Between April 2018 and June 2019, Practice Fusion received from the U.S. Department of Justice seven additional requests for documents and information through four additional CIDs and three Health Insurance Portability and Accountability Act subpoenas. The document and information requests received by Practice Fusion related to both the certification Practice Fusion obtained in connection with the U.S. Department of Health and Human Services' Electronic Health Record Incentive Program and Practice Fusion's compliance with the Anti-Kickback Statute and HIPAA as it relates to certain business practices engaged in by Practice Fusion. In March 2019, Practice Fusion received a grand jury subpoena in connection with a criminal investigation related to Practice Fusion's compliance with the Anti-Kickback Statute. On August 6, 2019, Practice Fusion reached an agreement in principle with the DOJ to resolve all of the DOJ's outstanding civil and criminal investigations, including the investigation by the U.S. Attorney's Office for the District of Vermont. The terms of this agreement in principle, which is subject to final negotiation of settlement documents with the government, contemplate that Practice Fusion will pay $145M and enter into a deferred prosecution agreement and a civil settlement agreement. Other non-financial terms and conditions remain subject to negotiation, and the terms described above may change following further negotiation. The agreement in principle and the final settlement materials are subject to approval of supervisory personnel within the DOJ. The proposed settlement amount is included in Other loss, net within the consolidated statements of operations and Accrued expenses within the consolidated balance sheets as of and for the three months ended June 30, 2019.
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MDRX | Hot Stocks17:29 EDT Allscripts to pay $145 to resolve civil, criminal probes into Practice Fusion - In a regulatory filing, Allscripts said that Practice Fusion, which the company acquired on February 13, 2018, received in March 2017 a request for documents and information from the U.S. Attorney's Office for the District of Vermont pursuant to a CID. Between April 2018 and June 2019, Practice Fusion received from the U.S. Department of Justice seven additional requests for documents and information through four additional CIDs and three Health Insurance Portability and Accountability Act subpoenas. The document and information requests received by Practice Fusion related to both the certification Practice Fusion obtained in connection with the U.S. Department of Health and Human Services' Electronic Health Record Incentive Program and Practice Fusion's compliance with the Anti-Kickback Statute and HIPAA as it relates to certain business practices engaged in by Practice Fusion. In March 2019, Practice Fusion received a grand jury subpoena in connection with a criminal investigation related to Practice Fusion's compliance with the Anti-Kickback Statute. On August 6, 2019, Practice Fusion reached an agreement in principle with the DOJ to resolve all of the DOJ's outstanding civil and criminal investigations, including the investigation by the U.S. Attorney's Office for the District of Vermont. The terms of this agreement in principle, which is subject to final negotiation of settlement documents with the government, contemplate that Practice Fusion will pay $145M and enter into a deferred prosecution agreement and a civil settlement agreement. Other non-financial terms and conditions remain subject to negotiation, and the terms described above may change following further negotiation. The agreement in principle and the final settlement materials are subject to approval of supervisory personnel within the DOJ. The proposed settlement amount is included in Other loss, net within the consolidated statements of operations and Accrued expenses within the consolidated balance sheets as of and for the three months ended June 30, 2019.
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CLDR | Hot Stocks17:24 EDT Icahn raises Cloudera stake to 18.36% from 16.48% - In a regulatory filing, Carl Icahn disclosed a 18.36% stake in Cloudera, which represents over 50M shares. In a filing earlier this week, Icahn reported a 16.48% stake in the company. The filing allows for activism.
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INWK | Hot Stocks17:17 EDT InnerWorkings enters cooperation agreement with Engaged Capital - InnerWorkings announced that it has entered into a cooperation agreement with Engaged Capital. As part of the cooperation agreement, the company has added two new independent directors, Kirt P. Karros and Marc Zenner, to the board effective immediately.
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VCNX | Hot Stocks17:12 EDT MSD Partners reports 8.45% passive stake in Vaccinex - In a regulatory filing, MSD Partners disclosed an 8.45% stake in Vaccinex, which represents about 1.26M shares. The filing does not allow for activism.
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EB | Hot Stocks17:06 EDT Immersion Capital reports 10.91% passive stake in Eventbrite - Immersion Capital disclosed a 10.91% stake in Eventbrite, which represents over 3.95M shares. The filing does not allow for activism.
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ETM | Hot Stocks16:56 EDT Entercom lowers quarterly dividend to 2c from 9c per share - The dividend is payable on September 13, 2019, to shareholders of record as of August 29, 2019. The board authorized the company to reallocate the approximately $39M of capital freed up on an annual basis by this action to repurchase its shares under its existing 2017 share repurchase program authorization and to accelerate deleveraging.
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EXC | Hot Stocks16:39 EDT U.S.DOE awards grant to ComEd, others to advance 'energy internet' - The U.S. Department of Energy's Office of Science has awarded a $1.05M grant to energy company ComEd, the University of Denver, Virginia Tech and software specialist BEM Controls to create an energy internet that will enhance building energy management and benefits to occupants. The award provides funding to commercialize a blockchain-based transactive energy platform developed by BEM Controls with funding from the DOE. Blockchains use multiple servers that operate like decentralized record-keeping and verification systems. They are seen as a promising solution for energy companies bringing more distributed energy resources onto their systems and creating marketplaces offering an array of Internet of Things devices and innovative energy services. The BEM Controls software incorporates time-based energy management and control of interior spaces in buildings to achieve greater energy efficiency, reliability and resiliency. ComEd will use its Grid of the Future Lab to demonstrate the functionality of the system, which will be developed over three years. ComEd is a unit of Exelon Corporation.
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NSPR | Hot Stocks16:33 EDT InspireMD discloses notice of NYSE listing deficiency - InspireMD announced that it has received a letter from the NYSE American on August 7, 2019, indicating that InspireMD does not meet a certain NYSE continued listing standard, due to the fact the company had reported stockholders' equity of less than $6M as of June 30, 2019, and had net losses in its five most recent fiscal years ended December 31, 2018. The company's management is reviewing its options to address the deficiency and expects to submit a compliance plan to the NYSE American on or before September 6, 2019.
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APAM | Hot Stocks16:30 EDT Artisan Partners reports AUM of $114B as of July 31 - Artisan Partners Asset Management Inc. reported that its assets under management as of July 31, 2019 totaled $114B. Separate accounts accounted for $59.8B of total firm AUM, while Artisan Funds and Artisan Global Funds accounted for $54.2B.
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JAX | Hot Stocks16:18 EDT J. Alexander's expands review of strategic alternatives - J. Alexander's Holdings announced that its board of directors is expanding its review of strategic alternatives. The board, in consultation with its financial and legal advisors and the company's executive management team, will explore, review and evaluate a full range of options focused on maximizing shareholder value. These options include, among others, a possible merger or sale of the company; a strategic large investment in the company, accompanied by a significant share repurchase; or the acquisition of complementary concepts to increase the company's revenue base and operating leverage. The board has retained Piper Jaffray & Co. as financial advisor to assist in this process. Lonnie J. Stout II, Executive Chairman of the Board, commented, "Our Board is fully committed to maximizing shareholder value and believes that expanding our ongoing strategic review process is in the best interests of our shareholders. Recent transactions for companies in the upscale casual dining segment make this potential path more attractive now as we contemplate how to best position the Company for the future. In addition to our Board's strategic review process, we will continue to execute our strategic and operational plan to deliver significant value to our shareholders as well as to deliver exceptional food and professional service in a sophisticated and relaxed atmosphere to each of our guests." The company has not set a timetable for completion of the review process or made a decision to pursue any particular strategic alternative. There can be no assurance that the review of strategic alternatives will result in any particular outcome. The company does not intend to provide any updates unless or until it determines that further disclosure is appropriate or necessary. Given the ongoing nature of this process, the company intends to suspend its quarterly conference calls until completion of the review. Shareholders are encouraged to read the company's SEC reports and press releases. This review of strategic alternatives is not expected to have an impact on customers, suppliers or employees of the company, nor on its operations, which are continuing as usual.
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BMI | Hot Stocks16:15 EDT Badger Meter raises quarterly dividend 13% to 17c from 15c per share - The increased dividend is payable September 13 to shareholders of record on August 30.
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WWE | Hot Stocks16:15 EDT WWE's Wilson sells over 158,000 class A common shares - In a regulatory filing, WWE co-president Michelle D. Wilson disclosed the sale of 158,134 class A common shares of the company at a price of $69.30 per share.
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HVT | Hot Stocks16:12 EDT Haverty Furniture raises quarterly dividend to 20c from 18c per share - The dividend is payable on September 11, 2019 to stockholders of record at the close of business on August 26, 2019.
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AMGN NVS | Hot Stocks16:09 EDT Amgen 'pleased' with decision in Sandoz patent case - Amgen (AMGN) announced that the U.S. District Court for the District of New Jersey has ruled in Amgen's favor on validity of the two patents that describe and claim Enbrel and methods for making it. Amgen affiliates Immunex Corporation and Amgen Manufacturing, Limited, along with the owner and licensor of the two patents, Hoffmann-La Roche Inc., brought the patent infringement action in Federal Court against Sandoz Inc., Sandoz International GmbH and Sandoz GmbH. Before trial, Sandoz acknowledged that its biosimilar etanercept infringes seven patent claims in U.S. Patent Nos. 8,063,182 and 8,163,522. Trial proceeded only on Sandoz's challenges to validity of those claims. After careful consideration, the Court found that Sandoz had not met its burden to prove all seven asserted claims invalid. Immunex/Amgen and Sandoz have entered into an agreement with respect to a preliminary injunction regarding Sandoz's etanercept as set out in the Court's order of June 7, 2018. "We are pleased with today's decision recognizing the validity of these patents. Protecting intellectual property is critical to incentivize innovation and the large investments in research and development that are required to bring new medicines to patients and fully develop their therapeutic potential for patients," said Robert A. Bradway, chairman and chief executive officer at Amgen. Sandoz is a division of Novartis (NVS).
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AMGN NVS | Hot Stocks16:09 EDT Correction: Amgen 'pleased' with decision in Sandoz patent case
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AMGN NVS | Hot Stocks16:06 EDT Novartis 'pleased' with decision in Sandoz patent case - Amgen (AMGN) announced that the U.S. District Court for the District of New Jersey has ruled in Amgen's favor on validity of the two patents that describe and claim Enbrel and methods for making it. Amgen affiliates Immunex Corporation and Amgen Manufacturing, Limited, along with the owner and licensor of the two patents, Hoffmann-La Roche Inc., brought the patent infringement action in Federal Court against Sandoz Inc., Sandoz International GmbH and Sandoz GmbH. Before trial, Sandoz acknowledged that its biosimilar etanercept infringes seven patent claims in U.S. Patent Nos. 8,063,182 and 8,163,522. Trial proceeded only on Sandoz's challenges to validity of those claims. After careful consideration, the Court found that Sandoz had not met its burden to prove all seven asserted claims invalid. Immunex/Amgen and Sandoz have entered into an agreement with respect to a preliminary injunction regarding Sandoz's etanercept as set out in the Court's order of June 7, 2018. "We are pleased with today's decision recognizing the validity of these patents. Protecting intellectual property is critical to incentivize innovation and the large investments in research and development that are required to bring new medicines to patients and fully develop their therapeutic potential for patients," said Robert A. Bradway, chairman and chief executive officer at Amgen. Sandoz is a division of Novartis (NVS).
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QUOT | Hot Stocks16:04 EDT Quotient Technology authorizes new $50M share repurchase program - Quotient Technology's board has authorized a stock buyback program of up to $50.0M of the company's common stock, effective August 9, 2019, through a new 10B5-1 plan that expires on August 7, 2020.
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NVS AMGN | Hot Stocks15:53 EDT Novartis' Sandoz to appeal ruling in biosimilar Erelzi U.S. patent case - Sandoz, a Novartis (NVS) division, announced that the United States District Court of New Jersey ruled against Sandoz in patent litigation concerning the Sandoz biosimilar, Erelzi for reference medicine Enbrel. The company will appeal the ruling to the U.S. Court of Appeals for the Federal Circuit, and the parties have agreed to an expedited appeal, Novartis stated. "Sandoz respectfully disagrees with the Court's ruling, which prevents us from launching an additional treatment option for patients with autoimmune and inflammatory diseases. Valid intellectual property should be respected, however, we continue to consider the patents in this case to be invalid. Amgen asserted two patents that it obtained from Roche, in what we believe is an attempt to extend its US compound patent protection for etanercept to 2029. We will appeal this decision, and look forward to presenting our case to the Federal Circuit and bringing Erelzi to US patients as soon as possible," said Carol Lynch, President of Sandoz US and Head of North America. Erelzi has been approved for nearly three years, however Sandoz has been unable to launch the medicine due to the ongoing patent litigation from Amgen (AMGN), Novartis noted.
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AMGN NVS | Hot Stocks15:49 EDT Amgen up over 5% after Enbrel patent upheld by court - Shares of Amgen (AMGN) have risen in afternoon trading after a United States District Court judge in New Jersey ruled in the company's favor in a patent fight with Novartis' (NVS) Sandoz unit over the drug Enbrel. The judge found that the patents-in-suit are not invalid, according to a copy of the ruling posted to the court's website. In afternoon trading following the release of the ruling, shares of Amgen are up over 5% to $195.16.
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AMGN | Hot Stocks15:37 EDT Amgen jumps 6% to $197.16 after court upholds Enbrel patent
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CBLK | Hot Stocks14:55 EDT Carbon Black up 5%, strength attributed to sale exploration report - Shares of Carbon Black are up 5% in afternoon trading. The strength is being attributed to a report from M&A focused publication CTFN, which is saying that the company is exploring a sale and has hired bankers, according to contacts.
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SIEN | Hot Stocks14:39 EDT Breast implant maker Sientra jumps after Q2 results as analysts say buy - Shares of medical aesthetics company Sientra (SIEN) surged after the company reported better than expected revenue for the second quarter and reaffirmed its revenue guidance for fiscal 2019. Following the report, two analysts maintained Buy-equivalent ratings on the stock. EARNINGS/GUIDANCE: After the market close yesterday, Sientra reported Q2 losses per share of ($1.19) on revenue of $20.5M, compared to analysts' estimates of (67c) and $19.04M, respectively. Adjusted EBITDA for the quarter was ($20.4M) while GAAP net loss was ($40.8M). Net sales for the Breast Products segment were $11.2M in Q2, up 19% year-over-year, while miraDry net sales totaled $9.3M, a 15% year-over-year increase. Looking ahead, Sientra backed its FY19 revenue view of $79M-$83M, representing 16%-22% year-over-year growth, and said it expects Breast Products net sales of $44M-$46M and miraDry net sales of $35M-$37M during the fiscal year. Analysts expect the company to report FY19 revenue of $81.13M. MANAGEMENT COMMENTS: Commenting on the quarter, chairman and CEO Jeff Nugent said that the quarterly performance was driven by "strong growth" in both the Breast Products and miraDry segments and represents "solid progress" towards achieving the company's 2019 goals. "Our Breast Products segment grew net sales 19% year over year, strong evidence of market share gains from our targeted new customer conversion programs as well as deeper penetration of existing accounts," Nugent said. "We believe the superior safety profile and industry-leading warranty of our OPUS implants is clearly resonating with board-certified plastic surgeons and their patients." Nugent concluded, "miraDry delivered another strong quarter, achieving record net sales of $9.3M. Our brand awareness and market activation initiatives have positioned miraDry to be a significant growth driver for Sientra in 2019 and beyond." STREET RESEARCH: Following the report, Stifel analyst Jonathan Block maintained a Buy rating and $16 price target on the stock, saying that Sientra's Q2 results were "solid." Block said that, for core breast products, the company is growing in a "flattish" market as share gains continue, and there is a "long runway" in front of the company as supply constraints ease and main competitors stumble. For miraDry, the analyst said that there are early signs that the business, which has "lagged" and underwent management changes about six months ago, is beginning to gain some traction. Meanwhile, Wells Fargo analyst David Maris kept an Outperform rating and $10 price target on Sientra, noting that both the breast products and miraDry segments were above the firm's model for the quarter. Maris said that management's commentary on the breast products trends were "encouraging" and that while he would like to see an acceleration in miraDry growth and an improvement in level of spending, he believes investors own the stock primarily for the growth of the breast products segment. The analyst added that, with the near-term financing overhang gone after the recent financing, he believes the shares should begin to outperform from here. PRICE ACTION: In afternoon trading, Sientra shares are 21% higher at $6.04.
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NGG | Hot Stocks13:42 EDT National Grid says power outages in U.K. areas now resolved - National Grid said via Twitter, "We experienced issues with two power generators causing loss of power in selected UK areas. The issue is now resolved and the system has returned to normal. Anyone continuing to experience a local issue should contact their local Distribution Network Operator for assistance."
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CURLF | Hot Stocks13:19 EDT Curaleaf receives approval for change of ownership and control in Massachusetts - Curaleaf Holdings has been granted approval for its change of ownership and control by the Massachusetts Cannabis Control Commission. Curaleaf said in a statement that it "thanks the Commission and the Commission staff for working collaboratively towards this result. Curaleaf has been proudly serving the Massachusetts medical community and looks forward to working with the Commission to secure approval of its adult-use licenses."
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BHGE | Hot Stocks13:03 EDT Baker Hughes reports U.S. rig count down 8 to 934 rigs - Baker Hughes reports that the U.S. rig count is down 8 rigs from last week to 934, with oil rigs down 6 to 764, gas rigs down 2 to 169, and miscellaneous rigs unchanged at 1. The U.S. Rig Count is down 123 rigs from last year's count of 1,057, with oil rigs down 105, gas rigs down 17, and miscellaneous rigs down 1 to 1. The U.S. Offshore Rig Count is up 1 rig to 25 and up 5 rigs year-over-year. The Canada Rig Count is up 3 rigs from last week to 140, with oil rigs up 3 to 94 and gas rigs unchanged at 46. The Canada Rig Count is down 69 rigs from last year's count of 209, with oil rigs down 46 and gas rigs down 23.
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LLY | Hot Stocks12:19 EDT Eli Lilly announces court ruling in favor of its Alimta patent - Eli Lilly and Company announced that the U.S. Court of Appeals for the Federal Circuit ruled in favor of Lilly, confirming that the Alimta vitamin regimen patent would be infringed by competitors that had stated their intent to market alternative salt forms of pemetrexed prior to the patent's expiration in May 2022. The ruling came in the appeals of U.S. District Court decisions in the cases of Eli Lilly v. Dr. Reddy's Laboratories and Eli Lilly v. Hospira. Previous rulings in Lilly's favor had precluded the generic companies from launching the alternative salt forms until the patent expires. If the patent is ultimately upheld through all remaining challenges, Alimta would maintain U.S. exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force.
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DIS EA | Hot Stocks12:04 EDT ESPN delays 'Apex Legends' event broadcast in response to mass shootings - Esports and gaming consultant Rod "Slasher" Breslau said via Twitter, "ESPN and ABC (DIS) has made the decision not to air the TV broadcast of the XGames Apex Legends (EA) EXP Invitational that was scheduled for this weekend, in response to the recent mass shootings, according to an ABC Affiliate TV station source." Breslau posted an email addressed to "ABC Affiliate" which said that, out of "respect for the victims and all those impacted by the recent shootings, ABC will no longer air "EXP Invitational APEX Legends at X Games" on Sunday, August 11. According to the email, an official booking will be issued shortly. Reference Link
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DXC | Hot Stocks12:00 EDT DXC Technology falls -32.5% - DXC Technology is down -32.5%, or -$16.80 to $34.85.
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CNDT | Hot Stocks12:00 EDT Conduent falls -34.2% - Conduent is down -34.2%, or -$2.96 to $5.70.
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FTCH | Hot Stocks12:00 EDT Farfetch falls -41.4% - Farfetch is down -41.4%, or -$7.56 to $10.69.
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ZN | Hot Stocks11:01 EDT Zion Oil & Gas signs geophysical services agreement with AGS - In a regulatory filing, Zion Oil & Gas disclosed that it has signed a Geophysical Services Agreement For the Acquisition of 3-D Seismic Data on August 8, 2019 with Acoustic Geophysical Services KFT, an international geophysical company based in Budapest, Hungary. AGS has acquired over 8,200 square kilometers of 3-D seismic data along with in excess of 7,500 square kilometers of 2-D seismic data in central and eastern Europe and Turkey over the last eight years. In addition, AGS has logged over 4,828,650 exposure hours to date and 2,197,050 hours without a lost time incident. Shipping arrangements have been made, and the trucks and equipment are expected to arrive at the port of Haifa, Israel by the end of August 2019. The equipment will need to clear customs in Haifa, and barring any unforeseen circumstances, should be on location on the License in early September. Zion's 3-D seismic project is considered to be the largest high-density 3-D seismic acquisition acquired to date in onshore Israel. Pre-approval by the Ministry of Transport in Israel is required before the importation of seismic source vehicles into Israel. The reports that it received that approval from the Ministry on August 2, 2019.
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BPMC | Hot Stocks10:04 EDT Blueprint's fibrodysplasia ossificans progressiva treatment gets orphan status - Blueprint Medicines' treatment of fibrodysplasia ossificans progressive was granted orphan designation by the FDA, according to a post to the agency's website. Reference Link
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MAT | Hot Stocks10:04 EDT Mattel discloses that it received anonymous whistleblower letter - In a regulatory filing, Mattel disclosed that on August 6 it was made aware of an anonymous whistleblower letter. The company added that in order "to provide the company with an opportunity to investigate the matters set forth in the letter, the offering of the company's 6.00% senior notes due 2027 that was scheduled to close on August 8, 2019 has been terminated. The company intends to refinance its 4.350% Senior Notes due October 2020 prior to maturity." In morning trading, shares of Mattel are down over 11% to $11.95.
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CNDT | Hot Stocks10:00 EDT Conduent falls -26.9% - Conduent is down -26.9%, or -$2.33 to $6.33.
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DXC | Hot Stocks10:00 EDT DXC Technology falls -30.7% - DXC Technology is down -30.7%, or -$15.88 to $35.77.
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FTCH | Hot Stocks10:00 EDT Farfetch falls -42.0% - Farfetch is down -42.0%, or -$7.67 to $10.58.
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YELP | Hot Stocks10:00 EDT Yelp rises 11.6% - Yelp is up 11.6%, or $4.04 to $38.99.
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CBB | Hot Stocks10:00 EDT Cincinnati Bell rises 14.8% - Cincinnati Bell is up 14.8%, or 59c to $4.59.
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NVRO | Hot Stocks10:00 EDT Nevro rises 18.9% - Nevro is up 18.9%, or $11.96 to $75.30.
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TRCB | Hot Stocks09:50 EDT Two River Bancorp trading resumes
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NVRO | Hot Stocks09:47 EDT Nevro rises 9.1% - Nevro is up 9.1%, or $5.74 to $69.08.
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ERF | Hot Stocks09:47 EDT Enerplus rises 10.3% - Enerplus is up 10.3%, or 61c to $6.52.
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ELY | Hot Stocks09:47 EDT Callaway Golf rises 12.2% - Callaway Golf is up 12.2%, or $2.14 to $19.68.
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KLDO | Hot Stocks09:35 EDT Kaleido Biosciences Inc trading resumes
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KLDO | Hot Stocks09:30 EDT Kaleido Biosciences Inc trading halted, volatility trading pause
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UBER | Hot Stocks09:23 EDT Uber CEO says looking forward to moving past lock-up expiration - Uber CEO Dara Khosrowshani said he "doesn't know" how many insiders may sell when the stock's IPO lock-up expires, but he looks forward to moving past the expiration, which he thinks gets talked about "too much." Khosrowshani added that Uber's underlying trends are healthy and that the company's interests are aligned with Softbank (SFTBY), which is the company's biggest investors but also invests in competitors. Khosrowshani is being interviewed on CNBC.
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APVO | Hot Stocks09:19 EDT Aptevo Therapeutics to file CTA in Q4 for ALG.APV-527 - The company said, "Continued preparations to file a Clinical Trial Authorization in Q4 2019 for ALG.APV-527, Aptevo's 4-1BB x 5T4 bispecific antibody candidate partnered with Alligator Bioscience."
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APVO | Hot Stocks09:18 EDT Aptevo Therapeutics expects preliminary data from APVO436 Phase 1/1b study in Q4 - The company said, "Continued enrollment in a dose escalation Phase 1/1b open-label clinical study of APVO436 in patients with Acute Myeloid Leukemia and High-Grade Myelodysplastic Syndrome; dosing in Cohort 4 currently underway; anticipate reporting preliminary Phase 1 safety data in the fourth quarter of 2019."
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APVO | Hot Stocks09:16 EDT Aptevo Therapeutics expects preliminary data from APVO210 MAD study in 1Q20 - The company said, "Commenced a multiple ascending dose Phase 1 clinical study of APVO210 evaluating repeat administrations of APVO210 administered by intravenous injection; anticipate preliminary data read-out from the MAD study in Q1 2020."
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APVO | Hot Stocks09:15 EDT Aptevo Therapeutics expects more data from APVO210 SAD study in Q4 - The company said, "Announced preliminary top-line safety data from the APVO210 SAD study showing that APVO210 did not cause any adverse events of concern or dose-limiting toxicities in doses up to 320 mcg/kg; no evidence of anti-drug antibodies were observed based on patient samples obtained to date; anticipate reporting more comprehensive data from the SAD study in Q4 2019."
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APVO | Hot Stocks09:11 EDT Aptevo Therapeutics reaffirms 2019 cash burn guidance $36M-$40M - Jeff Lamothe, CFO, said, "We are also pleased to reaffirm our 2019 cash burn guidance of $36-40 million. The first half of the year included planned significant expenditure related to a multi-batch IXINITY manufacturing campaign and clinical trial initiation costs, including preparatory work for the upcoming IXINITY pediatric trial. The second half of the year will see our burn rate moderate significantly."
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UBER... | Hot Stocks09:09 EDT Fly Intel: Pre-market Movers - UP AFTER EARNINGS: Yelp (YELP), up 7%... Tecnoglass (TGLS), up 14%... Leap Therapeutics (LPTX), up 2%... Voyager Therapeutics (VYGR), up 4%. ALSO HIGHER: Symantec (SYMC), up 2% following the company's announcement that it will sell its enterprise security business to Broadcom (AVGO) for $10.7B... Lexicon (LXRX), up 5% after announcing 52-week cardiorenal results from a pooled analysis from the inTandem1 and inTandem2 studies of Zynquista in adults with type 1 diabetes. DOWN AFTER EARNINGS: Uber (UBER), down 7%... Activision-Blizzard (ATVI), down 1%... Diplomat Pharmacy (DPLO), down 2%... U.S. Concrete (USCR), down 2%. ALSO LOWER: Nektar (NKTR), down 37% after management disclosed that the scope of collaboration with partner Bristol-Myers (BMY) is now narrowed and that there were some issues pertaining to the manufacturing of bempegaldesleukin that potentially led to the drastic difference in response rate between the November 2017 and June 2018 data announcement of the Phase II PIVOT-02 results... Amarin (AMRN), down 21% after announcing that that it received notice from the FDA that the agency plans to hold an advisory committee meeting, tentatively scheduled for November 14, in connection with its review of the pending supplemental new drug application for expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study.
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EBMT | Hot Stocks09:08 EDT Eagle Bancorp Montana to acquire Western Holding Company of Wolf Point - Eagle Bancorp Montana announced that it has reached an agreement to acquire Western Holding Company of Wolf Point, and its wholly owned subsidiary, Western Bank of Wolf Point. Opportunity Bank's acquisition of the $100 million in assets Western, which is structured as a 50% cash and 50% stock deal, will further solidify its position as the fourth largest Montana based bank with approximately $1.10 billion in assets. Western currently operates one branch in Wolf Point and the acquisition will provide Opportunity with an additional $100 million in assets, $77 million in deposits, and $41 million in gross loans, based on June 30, 2019 information. Opportunity Bank will have, upon completion of the transaction, 22 retail branches in Montana. The board of directors for both companies unanimously approved the transaction, which is subject to the approvals of bank regulatory agencies, the shareholders of Western Holding Company of Wolf Point, and other customary closing conditions. Upon completion of the transaction, Duane Kurokawa, currently President of Western Holding Company of Wolf Point, will lead the new branch efforts in northeastern Montana. Under the terms of the definitive agreement signed by the parties, Western Holding Company of Wolf Point shareholders will receive an aggregate of 395,859 shares of Eagle common stock and $6.5 million in cash, for a total transaction value of approximately $13.0 million. The deal is expected to close during the fourth quarter of 2019. Eagle was represented by Nixon Peabody LLP and Panoramic Capital Advisors, Inc. while Western Holding Company of Wolf Point was represented by Ballard Spahr LLP and Vining Sparks, IBG, LP.
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OCFC TRCB | Hot Stocks09:06 EDT OceanFirst Financial to merge with Two River Bancorp for $20.79 per share - Two River Bancorp (TRCB) announced the signing of a definitive merger agreement with OceanFirst Financial Corp. (OCFC). Under the agreement, Two River Bancorp will merge into OceanFirst. Upon completion of the merger, Two River Community Bank will merge into OceanFirst Bank. The transaction is valued at approximately $20.79 per Two River common share or approximately $182.8M in the aggregate based on OceanFirst's closing stock price of $23.14 as of August 8, 2019. OceanFirst was founded in 1902 and is an $8.0 billion regional bank operating throughout New Jersey, metropolitan Philadelphia and metropolitan New York City. OceanFirst Bank delivers commercial and residential financing solutions, trust and asset management and deposit services and is one of the largest and oldest community-based financial institutions headquartered in New Jersey. Under the terms of the merger agreement, upon completion of the merger, shareholders of Two River will be entitled to receive 0.6663 shares of OceanFirst common stock and $5.375 in cash for each outstanding share of Two River common stock. The merger agreement has been unanimously approved by the Two River and OceanFirst Board of Directors. The completion of the merger is expected to close in the first quarter of 2020, subject to Two River receiving the requisite approval of its shareholders, receipt of all required regulatory approvals, and fulfillment of other customary closing conditions.
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GPS | Hot Stocks09:06 EDT Gap announces 12-year VPPA agreement to reduce emissions - Gap announced that it has signed a 90 Megawatt, or MW, virtual power purchase agreement, or VPPA, for the Aurora Wind Project with Enel Green Power North America. The 12-year agreement is Gap's latest renewable energy deal and will enable the company to reach its 2020 goal to reduce absolute Scope 1 and 2 greenhouse gas, or GHG, emissions for its owned and operated facilities by 50% compared to 2015. The company also announced it has set a goal to reach 100% renewable energy across its global owned and operated facilities by 2030. Gap operates more than 3,300 stores worldwide, however the vast majority of its distributed store fleet are leased sites located in buildings and malls owned by landlords, limiting the company's ability to implement onsite renewable energy assets. The agreement with Enel Green Power allows Gap to meet its renewable energy goal by aggregating its distributed electricity load in the U.S. and purchasing wind energy equivalent to the energy needs of over 1,500 retail stores in its global real estate portfolio. The agreement provides benefits both to the local grid by adding new clean generation, while also stabilizing operating costs for Gap in the face of fluctuating energy prices. The wind electricity output purchased by Gap from the 90 MW portion of Enel Green Power's 299 MW Aurora project is expected to total approximately 374 gigawatt hours, or GWh, each year. It will reduce GHG emissions equivalent to the carbon reduction of removing 60,000 passenger cars from the road annually. In addition to meeting its 2020 Scope 1 and 2 GHG emissions-reduction goal, Gap is also establishing a Scope 3 goal to reduce upstream and downstream emissions, including in its supply chain. The company has committed to setting a science based target, including addressing Scope 3 emissions, which will be announced later this year. This announcement is the third renewable energy contract signed by Gap.
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OCFC | Hot Stocks09:04 EDT OceanFirst Financial to merge with Country Bank Holding for $102.2M - Country Bank Holding Company announced the signing of a definitive merger agreement with OceanFirst Financial. Under the agreement, OceanFirst will acquire CYHC and upon completion of the merger, Country Bank will merge into OceanFirst Bank. The transaction is valued at approximately $46,280 per CYHC common share or approximately $102.2 million in the aggregate based on OceanFirst's closing stock price of $23.14 as of August 8, 2019. OceanFirst was founded in 1902 and is an $8.0 billion regional bank operating throughout New Jersey, metropolitan Philadelphia and metropolitan New York City. OceanFirst Bank delivers commercial and residential financing solutions, trust and asset management and deposit services and is one of the largest and oldest community-based financial institutions headquartered in New Jersey. Under the terms of the merger agreement, upon completion of the merger, shareholders of CYHC will be entitled to receive 2,000 shares of OceanFirst common stock for each outstanding share of CYHC common stock. The merger agreement has been unanimously approved by the CYHC and OceanFirst Boards of Directors. The completion of the merger is expected to close in the first quarter of 2020, subject to CYHC receiving the requisite approval of its shareholders, receipt of all required regulatory approvals, and fulfillment of other customary closing conditions.
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OCFC TRCB | Hot Stocks09:03 EDT OceanFirst announces merger agreements with Two River, Country Bank Holding - OceanFirst Financial (OCFC) announced the concurrent signing of two separate definitive merger agreements. Under one agreement, Two River Bancorp (TRCB), parent company of Two River Community Bank, headquartered in Tinton Falls, New Jersey, will merge into OceanFirst. Upon completion of the Two River merger, Two River Community Bank will merge into OceanFirst Bank. Under the other agreement, Country Bank Holding Company, parent company of Country Bank, headquartered in New York, New York, will merge into OceanFirst. Upon completion of the CYHC merger, Country Bank will merge into OceanFirst Bank. Based on June 30, 2019 results and the impact of purchase accounting, the combined company is expected to have pro forma approximately $9.9 billion in assets, $7.5 billion in loans and $7.7 billion in deposits. The proposed acquisition of CYHC would expand OceanFirst's retail branch footprint into metropolitan New York. The two transactions combined are expected to result in approximately 8% earnings per share accretion in 2021, the first full year of fully phased-in synergies, and approximately 5% tangible book value per share dilution at closing with a projected earnback period of less than 4 years using the cross-over method. Founded in 2000, Two River is a full-service community bank operating 14 branch locations and 2 loan production offices in Monmouth, Ocean, Union and Essex Counties. At June 30, 2019, Two River had $1.2 billion in assets, $953.1 million in loans, $972.6 million in deposits and $121.4 million in shareholders' equity. Under the terms of the Two River merger agreement, upon completion of the merger, shareholders of Two River will be entitled to receive 0.6663 shares of OceanFirst common stock and $5.375 in cash for each outstanding share of Two River common stock. Based on OceanFirst's closing stock price on August 8 of $23.14, the Two River transaction is valued at approximately $20.79 per Two River common share or approximately $182.8 million in the aggregate.CYHC was founded in 1988 and provides banking services to small businesses and individuals through its network of five Country Bank branches located in the metropolitan New York market. At June 30, 2019, CYHC had $783.4 million in assets, $592.4 million in loans, $649.7 million in deposits and $67.5 million in shareholders' equity. Under the terms of the CYHC merger agreement, upon completion of the merger, shareholders of CYHC will be entitled to receive 2,000 shares of OceanFirst common stock for each outstanding share of CYHC common stock. Based on OceanFirst's closing stock price on August 8 of $23.14, the CYHC transaction is valued at approximately $46,280.00 per CYHC common share or approximately $102.2 million in the aggregate. Each of the Two River and CYHC merger agreements have been unanimously approved by the OceanFirst Board of Directors. The Two River Board of Directors has unanimously approved the Two River merger agreement. The Two River merger is expected to close in the first quarter of 2020, subject to Two River receiving the requisite approval of its shareholders, receipt of all required regulatory approvals, and fulfillment of other customary closing conditions. The CYHC Board of Directors has unanimously approved the CYHC merger agreement. The CYHC merger is expected to close in the first quarter of 2020, subject to CYHC receiving the requisite approval of its shareholders, receipt of all required regulatory approvals
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COCP | Hot Stocks08:59 EDT Cocrystal Pharma expects cash to fund operations through 1Q20 - The company said, "As of June 30, 2019, Cocrystal had approximately $7,474,000 cash on hand. Based on management's current projections, the Company expects to have sufficient cash to fund operations through the first quarter of 2020."
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COCP | Hot Stocks08:58 EDT Cocrystal expects to report interim results for Phase 2a study of CC-31244 in Q4 - The company said, "Expected Near-Term CC-31244 Clinical Program Milestones Report interim safety results for Hong Kong Phase 2a study in Q4 2019. Complete patient enrollment in Hong Kong Phase 2a study and report topline results in Q1 2020. Advance discussions with potential strategic partners to secure development and commercialization licensing agreement."
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COCP | Hot Stocks08:57 EDT Cocrystal Pharma expects to file regulatory submission for CC-42344 in 4Q20 - The company said, "Expected Near-Term CC-42344 Clinical Program Milestones: Complete preclinical IND-enabling studies in Q1 2020. File a regulatory submission in Q4 2020. Initiate Phase 1 study evaluating CC-42344 for the treatment of influenza in Q4 2020."
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TRCB | Hot Stocks08:55 EDT Two River Bancorp trading halted, news pending
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ZAGG AAPL | Hot Stocks08:53 EDT mophie introduces multi-device wireless charging pads at Apple stores - mophie, a ZAGG Inc (ZAGG) brand, introduced two multi-device wireless charging pads and two car chargers designed to work with a variety of Apple (AAPL) products. The sleek, dual wireless charging pad, and 3-in-1 wireless charging pad easily keep everyday-carry Apple accessories powered with fast wireless charging. The new products are available now at apple.com and will be available next week at select Apple Stores, and mophie.com.
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CANN | Hot Stocks08:51 EDT General Cannabis enters into term sheet for acquisition of cultivator, retailer - General Cannabis announced that it has entered into a non-binding term sheet to acquire substantially all of the assets of a licensed recreational cannabis cultivator and retailer in Denver, Colorado. The seller of the Business operates two indoor cultivation facilities and a retail cannabis dispensary in central Denver to manage the Business. This potential transaction follows the Company's recent announcements of its entry into non-binding term sheets to acquire other licensed cannabis entities in Colorado. The Company is taking these actions based on the signing of Colorado House Bill 1090, a recently approved law allowing public companies to own Colorado-licensed cannabis companies. Once the regulations surrounding the implementation of the law are finalized, the Company plans to enter into a binding transaction for the Business. It is anticipated that General Cannabis will pay consideration consisting of sixty percent cash and 40% in shares of the Company's common stock for virtually all of the tangible and intangible assets of the Business. The number of common shares issued at closing will be determined based on the 30-day volume weighted average price. The term sheet also provides that the Company will enter into a five-year lease for the retail and cultivation co-located facility with options for renewal and purchase.
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EXTR HIVE | Hot Stocks08:47 EDT Extreme Networks completes acquisition of Aerohive - Extreme Networks (EXTR) announced that it has completed its acquisition of Aerohive Networks (HIVE). Extreme intends to cause Aerohive's common stock to be delisted from the NYSE MKT and deregistered under the Exchange Act.
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PCG | Hot Stocks08:46 EDT PG&E says not providing guidance due to uncertainty related to wildfires - At this time, PG&E is not providing guidance for 2019 GAAP earnings and non-GAAP earnings from operations due to the continuing uncertainty related to the 2018 Camp fire, the 2017 Northern California wildfires, the Chapter 11 proceedings, and legislative and regulatory reforms. PG&E Corporation is providing 2019 IIC guidance of $3.8B-$4.1B after-tax for costs related to the 2017 Northern California wildfires, the 2018 Camp fire, enhanced and accelerated electric asset inspections, and Chapter 11-related matters.
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GEMP | Hot Stocks08:46 EDT Gemphire expects to submit additional information on gemcabene to FDA in Q4 - The company said, "In Q3 2018, Gemphire's request to the FDA to lift the partial clinical hold on gemcabene was denied and the FDA requested additional information in order to resubmit. Gemphire is currently collecting and collating additional information including a subchronic study of gemcabene in PPARalpha knockout mice and a study of gemcabene in in vitro PPAR transactivation assays using monkey and canine PPAR isoforms. Gemphire expects to submit additional information to the FDA in the fourth quarter of 2019 to request that it lift the partial clinical hold, assuming the proposed merger is consummated in a timely fashion."
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GEMP | Hot Stocks08:44 EDT Gemphire Therapeutics expects NeuroBo merger to close in 2H19 - The company said, "Immediately following the merger, Gemphire security holders are expected to own 4.06% of the post-merger company and NeuroBo security holders are expected to own 95.94% of the post-merger company on a fully-diluted basis. Pre-closing financing by NeuroBo with approximately $24 million of gross proceeds already received. The merger includes contingent value rights for existing Gemphire stockholders entitling them to receive certain cash payments in the event the gemcabene assets are sold or licensed during the CVR period. The post-merger company will be led by John L. Brooks, III, President & CEO of NeuroBo, and the post-merger Board of Directors will be 6 directors, including Steven Gullans, Ph.D., Gemphire's current President & CEO. The merger is expected to close in the second half of 2019, subject to the approval of the stockholders of each company, as well as other closing conditions."
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ARLP | Hot Stocks08:43 EDT Alliance Resource Partners announces coal production ceasing at Dotiki Mine - Alliance Resource Partners reported that it will cease coal production effective August 16 at the Dotiki Mine operated by its subsidiary, Webster County Coal, in order to focus on maximizing production at its lower-cost mines in the Illinois Basin. After production ceases, the operation will engage in reclamation of equipment and infrastructure for an indeterminate time. "Unfortunately, weak market conditions made this action necessary," said Joseph W. Craft III, Chairman, President and Chief Executive Officer. "We are saddened that production will be ending at the Dotiki Mine, which was opened in 1969 and is the oldest mine operated by ARLP." ARLP does not expect this action to have any impact on its previously announced earnings guidance provided in its July 26 Press Release, including 2019 full-year ranges for coal production of 40.8 to 42.3 million tons and coal sales volumes of 40.8 to 42.4 million tons.
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GEMP | Hot Stocks08:43 EDT Gemphire Therapeutics expects resources to fund operations into 3Q19 - The company said, "At June 30, 2019, the company had cash and cash equivalents of approximately $3.6 million. Based on current projections, the Company believes it has sufficient resources to fund operations into the third quarter of 2019. Management believes, if the proposed merger is not consummated in a timely fashion, Gemphire would need to raise additional capital to continue its operations thereafter, including submission of the additional information requested by the FDA to make a decision regarding lifting the partial clinical hold. Additional financing may not be available in a timely manner, on favorable terms or at all."
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EGBN | Hot Stocks08:41 EDT Eagle Bancorp announces share repurchase program up to 5% of shares - Eagle Bancorp announced that its Board of Directors had adopted its first share repurchase program. Under the repurchase program, the Company may repurchase up to 1,715,547 shares of its common stock, or approximately 5% of its outstanding shares of common stock at June 30, 2019. The repurchase program will expire on December 31, 2019, subject to earlier termination of the program by the Board of Directors. As of June 30, 2019, the Company had approximately 34,539,853 shares outstanding.
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GURE | Hot Stocks08:40 EDT Gulf Resources says Subdivision of Factory #1 has not yet re-opened - On April 2 and April 11, 2019, Gulf Resources inadvertently announced that Subdivision of Factory #1 was approved to re-open and begun operation respectively. This announcement should have reflected that Factory #1 was back online and begun production. Factory #1 is one of the primary drivers of operations for Company in the area and has 6,442 acres, compared to 0.79 acres used by the Subdivision of Factory #1, and annual capacity of 6,681 tonnes, compared to the 3,186 tonnes of annual capacity that the Subdivision of Factory #1 has. The Subdivision of Factory #1 utilizes the resources of the land of Factory #1, however as of today's date, it has not yet re-opened. The Company believes it will receive approval to begin production at this factory in the relatively near future. Below are details about each factory.
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CLSN | Hot Stocks08:37 EDT Celsion says GEN-1 immunotherapy highlighted in Oppenheimer expert call - Celsion Corporation announces that Premal H. Thaker, M.D., MSc., Professor of Obstetrics and Gynecology-Division of Gynecologic Oncology at Washington University School of Medicine in St. Louis, led an expert call on the ovarian cancer treatment landscape and emerging opportunities hosted by Oppenheimer & Co. Inc. on August 8th. Dr. Thaker is active in the development of GEN-1, Celsion's DNA-based, IL-12 immunotherapy for the treatment of ovarian cancer. "Ovarian cancer is typically diagnosed in its later stages and, as such, is very difficult to treat. The prognosis for patients with advanced ovarian cancer is poor, and treatment options are limited," said Dr. Thaker. "As Principal Investigator for the Phase Ib dose-escalation OVATION 1 study evaluating patients newly diagnosed with Stage III/IV ovarian cancer and treated with four different doses of GEN-1, in combination with neoadjuvant chemotherapy, I was encouraged by this promising data. Those data showed that of the 14 evaluable patients, 100% administered NAC plus the two higher doses of GEN-1 experienced an objective tumor response, defined as a partial or complete response. Only 60% of patients given the two lower doses had such a response. In addition, patients in the higher-dose cohorts had a high surgery success rate, with 88% achieving the optimal outcome of a complete resection. Pre- and post-treatment levels of key ovarian cancer biomarkers showed a marked reduction in immunosuppressive response across multiple biomarkers post-treatment, indicating GEN-1 may alter the tumor microenvironment and may improve ovarian cancer outcomes in combination with NAC. As Study Chair of the OVATION 2 study, I am eager to see if these results can be duplicated in a larger patient population." "We appreciate the attention Oppenheimer and Hartaj Singh have given the topic of ovarian cancer treatment," said Michael Tardugno, Celsion's chairman, president and CEO. "Celsion is dedicated to the goal of providing an efficacious option to women suffering from this deadly disease. We expect to report data from the Phase I dose-escalation run-in portion of the OVATION 2 study during the second half of 2019."
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GILD | Hot Stocks08:35 EDT Gilead announces China NMPA approval for Biktarvy - Gilead announced that the China National Medical Products Administration, or NMPA, has approved Biktarvy, a once-daily single tablet regimen, or STR, for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor, or INSTI, bictegravir with the demonstrated safety and efficacy profile of the Descovy dual nucleoside reverse transcriptase inhibitor, or NRTI, backbone and is the smallest INSTI-based triple-therapy STR available. In China, Biktarvy is indicated for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir. The approval of Biktarvy is supported by data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naive HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a diverse population of 2,414 participants on Biktarvy or an active comparator regimen, including a wide range of adult age groups and races/ethnicities. Biktarvy met its primary efficacy objective of non-inferiority at 48 weeks across all four studies. Through 48 weeks, no participants in any of the four studies developed treatment-emergent virologic resistance while taking Biktarvy, and no patients discontinued Biktarvy due to renal, bone or hepatic adverse events. The most common adverse reactions in patients taking Biktarvy through 48 weeks were diarrhea, nausea and headache.
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AKTX | Hot Stocks08:35 EDT Akari Therapeutics says data shows benefits of C5, LTB4 pathways by nomacopan - Akari Therapeutics announced new preclinical and human data demonstrating the potential benefits of the dual inhibition of complement and leukotriene pathways by nomacopan for the treatment of pemphigoid disease. In a murine model of pemphigoid diseases, nomacopan, which inhibits both C5 and LTB4, and L-nomacopan, which inhibits only LTB4, were shown to both significantly attenuate disease. However, nomacopan was shown to reduce disease more effectively than L-nomacopan highlighted by a reduction in peak disease activity of 75% and 60%, respectively. The results demonstrate the synergistic inhibition of C5 and LTB4 in the therapeutic efficacy of nomacopan in this model. The joint role of C5 and LTB4 in BP is further supported by data from BP patients which highlight the role of both inflammatory mediators in disease progression. C5a and LTB4 are present in patients' blister fluid in quantities that induce in vitro recruitment of granulocytes which are considered necessary for disease progression. Furthermore, the number of cells expressing C5 and LTB4 G-protein coupled receptors is significantly increased in perilesional skin compared to healthy control skin supporting the view that selectively disrupting the recruitment of granulocytes into the skin by inhibiting both C5 and LTB4 may be key to treating pemphigoid diseases. Initial data from the first three BP patients in Akari's ongoing Phase II clinical trial in patients with BP demonstrated a rapid reduction in BP Disease Area Index score and blistering. There were no reported drug related serious adverse events for the BP patients, which is comparable to treatment data from other patients systemically treated with nomacopan for a total of approximately 20 cumulative patient-years.
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GCAP | Hot Stocks08:33 EDT GAIN Capital reports July operating metrics - In the retail segment in July, OTC Trading Volume was down 1.4% sequentially and down 25.5% y/y. OTC Average Daily Volume was down 14.5% sequentially and down 28.9% y/y. 12 Month Trailing Active OTC Accounts were down 0.6% sequentially and were down 10.2% y/y. 3 Month Trailing Active OTC Accounts were up 1.4% sequentially and down 8.9% y/y.
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VBIV | Hot Stocks08:32 EDT VBI Vaccines expects to submit IND for Phase 2 study of VBI-1501 around year end - The company said, "In July 2019, VBI received positive feedback from the FDA on the design of the proposed Phase 2 dose-ranging study that is expected to assess the safety and immunogenicity of dosages of VBI-1501 up to 20 microg with alum. Submission of the Investigational New Drug application for this study is expected around the end of 2019."
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VBIV | Hot Stocks08:30 EDT VBI Vaccines expects initiation of enrollment in Phase 2 study in Q4 - The company said, "As part of the collaboration with Brii Biosciences, work is underway to prepare regulatory filings to enable the expected initiation of enrollment in the Phase 2 study in subjects with chronic hepatitis B in the fourth quarter of 2019, which would thus provide an expected initial human proof-of-concept readout in the second half of 2020."
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VBIV | Hot Stocks08:28 EDT VBI Vaccines expects data from CONSTANT Phase 3 study around year end - The company said, "Top-line data from the CONSTANT Phase 3 study, a 4-arm lot-to-lot consistency study in approximately 2,850 subjects, is expected around year-end 2019."
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SOFO | Hot Stocks08:26 EDT Sonic Foundry CFO Ken Minor to retire - Sonic Foundry announced CFO Ken Minor will retire effective Oct. 1 after 22 years with the company. Minor will continue to serve as a consultant for Sonic Foundry as Interim Chief Financial Officer until a transition of his duties are complete and will continue as a Senior Financial Advisor through Sept. 30, 2020. Minor joined Sonic Foundry in 1997 and prior to that was VP and Treasurer for Fruehauf Trailer Corporation. Sonic Foundry has no current plans to directly replace Minor. His responsibilities will be absorbed in-house by the company's accounting and finance teams, allowing for the reduction of operating expenses.
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VRAY | Hot Stocks08:22 EDT ViewRay announces departure of CFO Ajay Bansal - ViewRay last night announced that its Chief Financial Officer Ajay Bansal will be leaving the company effective September 30. Scott Drake, President and CEO, said in the earnings release, "We are disappointed to take down guidance for the year, but we believe it is prudent given the timing of installations around year-end. We remain focused on the long-term opportunity versus short term variability and are confident that we will demonstrate the momentum of our growing pipeline and end-user demand moving forward. Today we are also announcing the departure of our Chief Financial Officer, Ajay Bansal. We thank him for his service over the last three years and wish him well. We are in the midst of a retained search to find his replacement."
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HIVE | Hot Stocks08:21 EDT Aerohive trading halted, news dissemination
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GALT | Hot Stocks08:21 EDT Galectin Therapeutics expects cash to fund operations through December 2020 - The company said, "As of June 30, 2019, the Company had $52.0 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date, and potential additional capital under its At the Market common stock issuance agreement. The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations at least through December 31, 2020. The Company expects that it will require more cash to fund operations after December 31, 2020 and believes it will be able to obtain additional financing as needed. The currently planned operations include estimated costs related to a planned Phase 3 clinical trial through December 31, 2020. While the costs of the trial and general overhead during the Phase 3 trial are expected to be approximately $100 million, the costs and timing of such trial is not yet completely finalized. "
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UBNT | Hot Stocks08:11 EDT Ubiquiti announces name change, transfer to NYSE from Nasdaq - Ubiquiti will change its corporate name to Ubiquiti Inc. and transfer its common stock to the New York Stock Exchange, or NYSE, from the Nasdaq. The company's common stock has been authorized for listing and is scheduled to begin trading on the NYSE on August 20, under the new trading symbol (UI). At the close of business on August 19, the company will legally change its name to Ubiquiti Inc. The last trading day on Nasdaq under the name Ubiquiti Networks and the (UBNT) symbol is expected to be August 19.
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KTOS | Hot Stocks08:06 EDT Kratos Defense receives $4.8M in sole source awards for jet drone systems - Kratos Defense & Security Solutions announced that its Unmanned Systems Division has recently received approximately $4.8M of awards for high performance jet drones, spares for Kratos jet drones, support equipment for Kratos jet drones, and specialty composite components. Kratos is a provider of high performance unmanned aerial drone systems for threat representative target missions to exercise weapon, radar, and other systems; and tactical aerial drone systems for strike/ISR and force multiplication missions. Work under these recent contract awards will be performed at secure Kratos manufacturing facilities and customer locations.
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AQXP | Hot Stocks08:05 EDT Aquinox Pharmaceuticals, Neoleukin Therapeutics complete merger transaction - Neoleukin Therapeutics announced the completion of the previously disclosed merger transaction with Aquinox Pharmaceuticals. Aquinox Pharmaceuticals, Inc. will be renamed Neoleukin Therapeutics, Inc. and will trade under the new ticker symbol "NLTX" beginning on Monday, August 12, 2019, on the Nasdaq Global Market. Following the close of the transaction, and after giving effect to conversion of preferred shares into common subject to a stockholder vote, there are expected to be 38.3 million total shares of common stock outstanding. The corporate headquarters are now located in Seattle, Washington at Neoleukin's existing facility. As of June 30, 2019, after giving effect to the merger, including merger-related expenses, the company has approximately $65M in cash and cash equivalents, which it believes will be sufficient to fund operations through 2021.
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URGN | Hot Stocks08:03 EDT UroGen Pharma says UGN-101 rolling NDA submission on track for Q4 - UroGen Pharma says the UGN-101 rolling NDA submission is on track for Q4 with a planned launch in the first half of FY20.
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WAIR CG | Hot Stocks08:03 EDT Wesco Aircraft to be acquired by Platinum Equity affiliate for $1.9B - Wesco Aircraft Holdings (WAIR) announced that it has entered into a definitive merger agreement to be acquired by an affiliate of Platinum Equity in a transaction valued at approximately $1.9B. Upon closing, Wesco will be combined with Platinum Equity portfolio company Pattonair, a provider of supply chain management services for the aerospace and defense industries based in the United Kingdom. Under the agreement, which has been unanimously approved by Wesco's Board of Directors, Wesco shareholders would receive $11.05 per share in cash. The cash purchase price represents a premium of approximately 27.5 percent to the 90-day volume weighted average share price for the period ended May 24, 2019, the last trading day prior to media speculation regarding a potential transaction involving Wesco Aircraft.Wesco's three largest shareholders, affiliates of The Carlyle Group (CG) and Makaira Partners, as well as the Snyder Family Trusts, support the transaction and have entered into voting and support agreements to vote their shares in favor of the transaction. The transaction will be financed through a combination of committed equity financing provided by affiliates of Platinum Equity Capital Partners IV, L.P., as well as debt financing that has been committed to by Bank of America Merrill Lynch. The transaction is expected to be completed by the end of calendar 2019 and is subject to Wesco shareholder approval, regulatory clearances and other customary closing conditions. Upon the completion of the transaction, Wesco will become a privately held company, and shares of its common stock no longer will be listed on any public market.
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PGNX | Hot Stocks08:00 EDT Progenics plans to evaluate initiating pivotal trial of 1095 in 2020 - The company said, "The Company announced that the first patient was dosed in the ongoing Phase 2 trial of 1095 in combination with enzalutamide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer. 1095 is a small molecule radiotherapeutic designed to selectively bind to the extracellular domain of prostate specific membrane antigen, a protein that is highly expressed on prostate cancer cells. Based on the early data emerging from this open-label trial and dialogue with the FDA, the Company plans to evaluate initiating a pivotal trial of 1095 in 2020."
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PGNX | Hot Stocks07:58 EDT Progenics expects data from Phase 3 CONDOR trial by year end - The company said, "Patient enrollment for the Phase 3 CONDOR trial, evaluating the diagnostic performance and clinical impact of PyL was completed five months ahead of schedule. The Phase 3 CONDOR trial is a multi-center, open label trial that enrolled 208 male patients with biochemical recurrence of prostate cancer at 14 sites in the U.S. and Canada. Based on discussions with the FDA, Progenics believes that positive data from the CONDOR study and the previously reported OSPREY study could serve as the basis for a New Drug Application for PyL."
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PGNX | Hot Stocks07:57 EDT Progenics to begin basket study of AZEDRA by end of the year - The company said, "The Company reached alignment with the U.S. Food and Drug Administration on a clinical development plan to potentially support an expanded label for AZEDRA for the treatment of patients with advanced neuroendocrine tumors who have MIBG-avid tumors. Progenics plans to conduct a tissue agnostic, basket study that will evaluate AZEDRA in patients with NETs that are MIBG-avid, including gastroenteropancreatic neuroendocrine tumors, as well as other NETs, and utilize a dosing regimen that enables outpatient administration. The basket study is expected to begin by the end of the year and enroll approximately 150 patients at sites in the U.S and Canada."
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TGTX | Hot Stocks07:54 EDT TG Therapeutics to initiate rolling NDA submission for patients with treated MZL - The company noted remaining 2019 and early 2020 milestones, "Initiate a rolling New Drug Application submission for patients with previously treated MZL; Present final data from the MZL cohort of the UNITY-NHL registration directed trial evaluating umbralisib in MZL; Potential top-line progression free survival results from the Phase 3 UNITY-CLL trial evaluating U2 in patients with CLL; Present updated data from our pipeline products and combination studies at upcoming major medical conferences."
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AVDL | Hot Stocks07:44 EDT Avadel Pharmaceuticals on track to realize $80M-$90M in annualized cost savings - The company said, "Cost reductions and restructuring actions to date have resulted in approximately $40 million of lower SG&A and R&D spending; the Company is on track to realize the full $80 to $90 million of cost reductions before December 31, 2019, as previously announced."
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AVDL | Hot Stocks07:43 EDT Avadel Pharmaceuticals on track to complete REST-ON enrollment in 2H20 - The company said, "The REST-ON clinical trial has enrolled 183 patients, which is 69% of the total 264 target enrollment for the study; based on current trends, the Company remains on-track to complete enrollment in the second half of 2020."
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TGTX | Hot Stocks07:40 EDT TG Therapeutics expects cash to fund operations through 3Q20 - The company said, "Cash, cash equivalents and investment securities were $85M as of June 30, 2019. Pro forma cash, cash equivalents and investment securities as of June 30, 2019 are approximately $96.6M, after giving effect to $11.6M of net proceeds from the utilization of the Company's at-the-market sales facility during the third quarter of 2019. The Company believes its cash, cash equivalents and investment securities on hand as of June 30, 2019, inclusive of the proceeds raised from the ATM facility subsequent to the second quarter, as well as future availability under the ATM facility, will be sufficient to fund the Company's planned operations through the third quarter of 2020."
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DPLO | Hot Stocks07:38 EDT Diplomat Pharmacy CEO says 'we continue to believe in our business model' - Brian Griffin, Chairman and CEO of Diplomat, commented "We continue to believe in our business model and long-term prospects and we remain encouraged by our pipeline for 2020, despite our reduced guidance for 2019. We are pleased that infusion therapies continue to demonstrate strength and we are taking actions to improve our core specialty pharmacy business, rebuild our PBM and enhance our financial flexibility. At the same time, our Board has concluded that a broad review of strategic alternatives is in the best interests of the Company and our shareholders. While this is taking place, we intend to maintain our focus on executing our strategic plan, improving our businesses and supporting our shareholders, patients and their providers, payers, as well as our manufacturer partners and our employees."
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MLNT | Hot Stocks07:33 EDT Melinta Therapeutics CEO John Johnson resigns - Melinta Therapeutics announced changes to its board of directors and executive management team. David Gill, a current Melinta board member, has been named chairman of the board of directors, effective immediately, succeeding Kevin Ferro, who voluntarily resigned from the position and the board of directors. John Johnson voluntarily resigned from his position as chief executive officer due to changes in the Company's circumstances and in order to pursue other opportunities. Johnson will serve as acting CEO for at least 30 days to work through the transition, including the search process and appointment of a permanent successor. Johnson also resigned from his position as director, effective immediately. Additionally, and at the request of the board of directors, Johnson will remain a strategic advisor to Melinta for at least six months.
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DPLO | Hot Stocks07:31 EDT Diplomat Pharmacy announces review of strategic alternatives - Diplomat Pharmacy announced that its Board of Directors is reviewing strategic alternatives. At the direction of its Board of Directors, the company is reviewing strategic alternatives focused on maximizing shareholder value. The strategic alternatives expected to be considered include, but are not limited to, a sale or merger of the company, continuing to pursue value-enhancing initiatives as a standalone company, capital structure changes, or the sale or other disposition of certain of the company's businesses or assets. Diplomat has retained Foros Securities LLC as financial advisor and Sidley Austin LLP as legal advisor to assist with its strategic alternatives review. "We are focused on growing our Specialty business with health plans and hospital systems, positioning the PBM business for growth and improving operating efficiency, while maintaining high standards of patient and customer care," said Brian Griffin, Chairman and CEO of Diplomat. "At the same time, the Board believes that a broad review of strategic alternatives is in the best interests of the Company and our shareholders."
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AVDL | Hot Stocks07:30 EDT Avadel expects cash to be sufficient to fund operations into 2021 - The company said, "Cash, cash equivalents and marketable securities were $79.3M as of June 30, 2019, compared to $79.9M as of March 31, 2019 and $99.9M as of December 31, 2018. Based on our current FT218 clinical development plan, anticipated cost structure and hospital products revenue projections, cash is expected to be sufficient to fund operations into 2021. This includes completion of the REST-ON study and disclosure of top-line results. The Company has convertible debt of $144M due in 2023."
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AXGT | Hot Stocks07:23 EDT Axovant expects data from patients dosed with AXO-AAV-GM1 in Q4 - The company said, "Dosed first patient in the AXO-AAV-GM1 clinical program, with initial data expected in the fourth quarter of calendar 2019. Enrollment of patients will continue throughout calendar 2019 and 2020."
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AXGT | Hot Stocks07:22 EDT Axovant expects data from patients dosed with AXO-AAV-GM2 in Q4 - The company said, "Investigators recently dosed a second patient with AXO-AAV-GM2. The patient was a 7-month old with early symptomatic infantile Tay-Sachs disease, and AXO-AAV-GM2 was delivered into the thalamus bilaterally as well as into the cisterna magna and lumbar intrathecal space, the planned route of administration for patients in the program. We expect to enroll patients in a multi-subject clinical trial in the second half of calendar 2019 and into 2020 and expect to provide additional data in fourth quarter of calendar 2019."
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TRCO | Hot Stocks07:21 EDT Tribune Media CEO says Q2 results 'strong' - "Tribune Media's second quarter financial results were strong thanks to continued year-over-year growth in core advertising, digital advertising and retransmission revenues; all of which largely offset the anticipated decline in political advertising revenue during the quarter," said Peter Kern, Tribune Media Company's CEO. "In addition to the revenue growth in these areas, we were able to keep a tight grip on our cost structure. As a result, total expenses, excluding the expected increase in network affiliate fees from the Fox renewal last year, were down on a year-over-year basis. Our second quarter results reflect the great work that continues to be done by our employees in advance of our pending transaction with Nexstar Media Group-we're very proud of their tremendous dedication. We look forward to obtaining regulatory approval of the transaction soon and remain on track to close before the end of the third quarter."
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AXGT | Hot Stocks07:21 EDT Axovant expects data from SUNRISE-PD Phase 2 trial of AXO-LENTI-PD in Q4 - The company said, "Initiated second dose cohort of the SUNRISE-PD study of AXO-LENTI-PD in April, and we expect initial data from up to six patients in this cohort in the fourth quarter of calendar 2019. In June, we provided a six-month update on the first cohort of AXO-LENTI-PD in Parkinson's disease patients. AXO-LENTI-PD was observed to be generally well tolerated at six months and continued to demonstrate benefits in both patients across multiple measures after a single administration. At month six, the patients experienced an average improvement from baseline in UPDRS III OFF score of 17 points, representing an average improvement of 29%, and the Parkinson's Disease Questionnaire-39 Summary Index score showed a 32-point reduction from baseline, an approximate 65% improvement."
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CTST | Hot Stocks07:19 EDT CannTrust announces withdrawal of auditor's report - CannTrust Holdings announced that the company's independent auditor, KPMG LLP, Chartered Professional Accountants, has informed the company that effective August 8, it is withdrawing its report dated March 27, on the company's consolidated financial statements as at and for the year ended December 31, 2018 and its interim report to the Audit Committee dated May 13, 2019 on the unaudited condensed interim consolidated financial statements as at and for the three month period ended March 31, and therefore, the KPMG reports should no longer be relied upon. KPMG remains CannTrust's independent auditor. The company's cooperation with KPMG is being directed by the company's Audit Committee and a special committee of its board of directors which is conducting an ongoing investigation into various matters. As previously disclosed, Management is of the view that there is significant uncertainty with respect to the potential impact of pending Health Canada decisions on the valuation of the Company's inventory and biological assets and revenue recognition. Accordingly, CannTrust cautions against any reliance on its consolidated financial statements as at December 31, 2018 and interim consolidated financial statements as at and for the three month period ended March 31, 2019. CannTrust is continuing to cooperate with Health Canada and the impact of the matters being investigated by the Special Committee on CannTrust's financial results is unknown at this time. Further updates, to the extent material, will be provided as they become available. KPMG's decision was prompted by the company's caution against reliance on its financial statements for the year ended December 31, 2018 and for the three months ended March 31, 2019, as well as the recent sharing with KPMG of newly uncovered information from the Special Committee's investigation, including information that led to senior leadership changes announced on July 25, 2019. KPMG was not aware of the information recently shared by the company when it issued the KPMG Reports and had relied upon representations made by individuals who are no longer at the company. "We will continue cooperating with our auditor and regulators, and take whatever steps are necessary to restore full trust in the company's regulatory compliance. Our medical patients, customers, shareholders and employees deserve nothing less", said Robert Marcovitch, the company's CEO.
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VYGR | Hot Stocks07:12 EDT Voyager expects cash, cash equivalents to fund operations to mid-2022 - The company said, "Cash, cash equivalents, and marketable debt securities as of June 30, 2019 were $327.5 million, as compared to $358.5 million on March 31, 2019. Based on the Company's current operating plan, the Company continues to anticipate full-year 2019 operating expenses to range between $130 million and $140 million, before accounting for amounts reimbursable under the Neurocrine Biosciences collaboration, and anticipates cash, cash equivalents and marketable debt securities at year end of approximately $280 million to $290 million. Voyager continues to anticipate that its cash, cash equivalents and marketable debt securities will be sufficient to fund projected operating expenses and capital expenditure requirements to mid-2022."
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AZN | Hot Stocks07:07 EDT AstraZeneca announces overall survival data from FLAURA trial - AstraZeneca announced overall survival, or OS, results from the Phase III FLAURA trial, a randomized, double-blinded, multicenter trial of Tagrisso in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer, or NSCLC, whose tumors have epidermal growth factor receptor, or EGFR, mutations. Tagrisso showed a statistically-significant improvement in OS, a secondary endpoint in the FLAURA Phase III trial, compared with erlotinib or gefitinib both of which were previous standard-of-care treatments in this setting. The FLAURA trial met its primary endpoint in July 2017, showing a statistically-significant and clinically-meaningful improvement in progression-free survival, increasing the time patients lived without disease progression or death from any cause. The safety and tolerability of Tagrisso was consistent with its established profile.
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SMLP | Hot Stocks07:01 EDT Summit Midstream appoints Heath Deneke as CEO - Summit Midstream announced that its board has appointed Heath Deneke to serve as president and CEO of Summit Midstream, effective September 16. Deneke will also join the board of Summit Midstream GP, LLC. Leonard Mallett, who has been serving as president and CEO of Summit Midstream Partners on an interim basis since February, will continue to serve as the company's COO and will report to Deneke. Deneke joins Summit Midstream Partners from Crestwood Equity Partners, where he most recently served as executive VP, COO and a member of the office of the chairman since August 2017, where he was responsible for commercial development and operations of its midstream businesses, including assets in the Bakken, Barnett, Fayetteville, Marcellus, Powder River and Permian basins.
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BRO | Hot Stocks06:48 EDT Brown & Brown acquires assets of WBR Insurance - Brown & Brown has acquired substantially all of the assets of WBR Insurance Agency, Wilson Insurance Agency, Bell Insurance Agency and Robertson Insurance Agency, collectively, WBR Insurance. With roots dating back to 1982, WBR Insurance recently became an independent insurance broker after operating for most of its history as part of Nationwide Mutual Insurance Company's distribution model. Headquartered in Virginia Beach, Virginia, the firm offers property and casualty insurance products to businesses and individuals in Virginia and other states along the East Coast. Following the acquisition, the WBR Insurance team will operate from their existing office as a branch location of Brown & Brown's Norfolk, Virginia operations.
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FHB | Hot Stocks06:34 EDT First Hawaiian board approves $50M increase to stock repurchase program - First Hawaiian announced that the company's Board of Directors has approved a $50M increase in its stock repurchase program to up to $150M of its outstanding common stock during 2019. The company had completed approximately $40M of stock repurchases through June 30, leaving a remaining authorization of $110M for 2019. The company recently sold approximately $400M in shared national credits at a weighted average price of 99.7%, and an estimated loss of $1.2M. The company will use the proceeds from these sales to reduce its balance of public time deposits and to fund the additional $50M of stock repurchases. The company estimates these actions will be neutral to earnings per share while maintaining capital ratios near current levels.
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DXYN | Hot Stocks06:07 EDT Dixie Group to sell and lease Santa Ana facility - Dixie Group has entered into a letter of intent to sell to CenterPoint Properties Trust the company's Santa Ana, California facility. The transaction is subject to entering into a definitive purchase and lease agreement. The property consists of 10 acres with one building totaling approximately 200,000 square feet. The transaction is anticipated to close in early October. The purchase price is in excess of $40M dollars and is anticipated to generate an after tax gain on sale in excess of $20M. Simultaneously, under the agreement, the company shall sign a lease for 10 years with two 5-year renewal options. Daniel Frierson, CEO, said, "This transaction, along with our becoming profitable in the second quarter excluding restructuring related charges, helps ensure our long term financial stability."
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CGC | Hot Stocks06:07 EDT Canopy Growth to acquire Beckley Canopy - Canopy Growth announced that it has entered into an agreement to acquire the global cannabinoid-based medical researcher Beckley Canopy. The acquisition brings together Canopy's wholly owned research program with the Beckley Canopy research platform which is partly owned by Canopy Growth in order to combine teams, programs and clinical work all under a single strategic plan. The research arm in turn directly supports the commercial efforts of Spectrum Therapeutics around the world. As part of the acquisition, Canopy Growth also acquires the outstanding shares in Spectrum Biomedical UK, the commercial arm of the company in the United Kingdom, as that markets begins to develop into a commercially viable opportunity. Spectrum Therapeutics will leverage Beckley Canopy's intellectual property, accelerate its research programs, build evidence around the company's products and formulations and improve patient access to cannabinoid-based medicines globally. Beckley Canopy was formed as a joint venture in January 2018 between Beckley Research & Innovations, or BRI, and Canopy Growth to research and develop clinically validated cannabis-based medicines, with a focus on intellectual property protection. The research platform combined European and North American-based leaders in cannabis research from BRI and Canopy Growth to create UK-based European partnership. Since its inception, Beckley Canopy has made progress in three initial areas of research, namely cancer pain, opioid sparing and smoking cessation, with further research in progress. Once the acquisition is complete, Beckley Canopy will be fully integrated into the current Spectrum Therapeutics platform and management team in Europe, a region of focus for the company as policy surrounding medical cannabis and patient access continues to evolve. The acquisition remains subject to certain regulatory approvals and closing conditions, and if satisfied, is expected to close within the next 60 days.
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NKTR BMY | Hot Stocks06:06 EDT Nektar says analysis showed differences in two early batches of cancer drug - Nektar Therapeutics (NKTR) President and CEO Howard Robin said on the company's earnings conference call that an analysis of the Pivot-02 trial found differences in two early batches of the cancer drug, bempegaldesleukin. "We're disappointed to have discovered this historical problem with these early manufacturing lots," Robin said, adding that partner Bristol-Myers (BMY) remains "very committed" to the development program, "particularly in light of the recent breakthrough designation in melanoma." Shares of Nektar are down 31% in pre-market trading.
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WTRH | Hot Stocks06:05 EDT Waitr Holdings engages advisors to explore strategic alternatives - Waitr Holdings said in last night's earnings release, "After consideration of recent interest expressed in the Company as a result of its dominant position in core small to medium sized markets, along with a consolidating landscape in the industry as recently announced transactions from other companies in the restaurant delivery space would indicate, Waitr recently commenced a review to explore and evaluate potential strategic alternatives to enhance shareholder value. These alternatives could include, among others, continuing to execute the Company's business plan, including an increased focus on certain standalone strategic initiatives, the disposition of certain assets, a strategic business combination, a transaction that results in private ownership or a sale of the Company, or some combination of these. The Company has engaged Evercore and Jefferies as financial advisors to assist the Board with its strategic alternatives review."
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GTLS | Hot Stocks06:04 EDT Chart Industries names John Bishop as COO - Chart Industries announced that John Bishop is joining Chart and will assume the role of COO effective August 21. Bishop most recently worked for Morgan Stanley's investment bank as Head of Global Oilfield Services and a member of the North American Upstream team. Prior to that, Bishop spent 10 years with Citigroup's Global Energy Group, and worked for Deloitte Consulting and Motorola.
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NKTR BMY | Hot Stocks05:32 EDT Nektar says finalizing bempegaldesleukin program despite 'some delays' - Nektar Therapeutics said last night in its earnings release, "Nektar is making good progress advancing our multiple programs in immuno-oncology, immunology and pain. With our partner Bristol-Myers Squibb, although we've experienced some delays, we are working to finalize the development program for bempegaldesleukin in combination with nivolumab in a number of tumor types and which are designed to support registration for this unique I-O doublet. We have a number of registrational trials already started and we recently received a breakthrough designation from FDA for bempeg and nivo in the setting of first-line untreated metastatic melanoma. Our partner Eli Lilly will be initiating several new studies later this year for NKTR-358, our T regulatory stimulator candidate. These studies will expand the program with additional indications beyond lupus. We recently filed an IND with the FDA for NKTR-255, our IL-15 agonist, and will initiate our first-in-human clinical study this quarter in patients with relapsed, refractory NHL and in patients with multiple myeloma."
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