|Symbol||Name||Price (Intraday)||Change||% Change||Volume||Avg Vol (3 month)||Market Cap||PE Ratio (TTM)||52 Week Range|
|ICHBF||Industrias CH, S. A. B. de C. V.||5.48||+2.28||+71.23%||20,000||322||3.997B||N/A|
|TSNP||Tesoro Enterprises, Inc.||1.3800||+0.4500||+48.39%||270.515M||210.161M||5.377B||N/A|
|BILL||Bill.com Holdings, Inc.||184.69||+44.82||+32.04%||6.402M||1.462M||14.99B||N/A|
|FLGT||Fulgent Genetics, Inc.||141.52||+22.32||+18.72%||2.382M||2.148M||3.435B||66.13|
|YALA||Yalla Group Limited||35.28||+5.49||+18.43%||2.68M||2.477M||5.053B||N/A|
|ANGI||ANGI Homeservices Inc.||16.25||+2.23||+15.91%||3.77M||3.044M||8.122B||N/A|
|TBIO||Translate Bio, Inc.||30.92||+4.22||+15.81%||2.47M||1.262M||2.298B||N/A|
|HIMX||Himax Technologies, Inc.||12.56||+1.70||+15.65%||9.562M||3.005M||2.163B||155.06|
|DNMR||Danimer Scientific, Inc.||56.59||+7.83||+16.06%||2.608M||1.842M||4.817B||N/A|
|DM||Desktop Metal, Inc.||31.25||+4.18||+15.44%||6.069M||3.734M||7.085B||N/A|
|COLM||Columbia Sportswear Company||107.89||+14.14||+15.08%||1.427M||330,441||7.144B||66.60|
|MZDAY||Mazda Motor Corporation||4.5350||+0.5900||+14.96%||80,994||60,798||5.585B||8.59|
|YSG||Yatsen Holding Limited||24.55||+3.19||+14.93%||5.214M||3.813M||16.338B||N/A|
|KYMR||Kymera Therapeutics, Inc.||77.61||+9.85||+14.54%||126,966||177,488||3.45B||N/A|
|CCIV||Churchill Capital Corp IV||34.65||+4.43||+14.66%||64.877M||24.553M||8.966B||N/A|
|APPS||Digital Turbine, Inc.||88.08||+10.89||+14.11%||6.382M||3.744M||7.876B||213.79|
|HTHT||Huazhu Group Limited||57.55||+6.95||+13.74%||4.483M||1.709M||32.338B||82.10|
|EGO||Eldorado Gold Corporation||12.96||+1.46||+12.70%||7.312M||2.509M||2.272B||12.92|
|OZON||Ozon Holdings PLC||62.99||+7.11||+12.72%||1.83M||1.402M||12.833B||N/A|
|LGND||Ligand Pharmaceuticals Incorporated||203.03||+22.91||+12.72%||976,813||586,746||3.265B||N/A|
|TGTX||TG Therapeutics, Inc.||54.30||+5.77||+11.89%||3.925M||2.04M||7.483B||N/A|
|SANA||Sana Biotechnology, Inc.||39.12||+4.02||+11.45%||2.834M||5.864M||7.132B||N/A|
|BEAM||Beam Therapeutics Inc.||116.16||+11.84||+11.35%||1.471M||950,966||6.786B||N/A|
|KRTX||Karuna Therapeutics, Inc.||119.28||+12.07||+11.26%||312,732||155,424||3.197B||N/A|
|GRCL||Gracell Biotechnologies Inc.||30.57||+2.94||+10.64%||152,037||545,310||2.004B||N/A|
|WYNMF||Wynn Macau, Limited||1.7400||+0.1600||+10.13%||41,342||13,130||9.349B||1.46|
|ATVI||Activision Blizzard, Inc.||101.61||+8.93||+9.64%||17.048M||6.752M||78.53B||36.03|
|MFGP||Micro Focus International plc||6.77||+0.59||+9.55%||1.639M||1.499M||2.284B||N/A|
|GDRX||GoodRx Holdings, Inc.||56.63||+4.87||+9.41%||2.676M||3.068M||22.163B||N/A|
|BERY||Berry Global Group, Inc.||57.26||+4.90||+9.36%||2.188M||1.011M||7.667B||12.07|
|PENN||Penn National Gaming, Inc.||128.91||+10.57||+8.93%||6.043M||4.403M||20.023B||N/A|
|SWTX||SpringWorks Therapeutics, Inc.||88.91||+6.91||+8.43%||269,259||342,601||4.336B||N/A|
|DFH||Dream Finders Homes, Inc.||29.91||+2.31||+8.37%||502,771||1.244M||2.767B||N/A|
|HIMS||Hims & Hers Health, Inc.||23.99||+1.83||+8.26%||1.782M||3.165M||4.555B||N/A|
|SID||Companhia Siderúrgica Nacional||6.15||+0.46||+8.08%||3.782M||2.891M||8.711B||8.59|
|RVMD||Revolution Medicines, Inc.||53.23||+4.00||+8.13%||2.616M||557,883||3.533B||N/A|
|DDD||3D Systems Corporation||47.95||+3.55||+8.00%||5.97M||12.345M||5.953B||N/A|
|CELH||Celsius Holdings, Inc.||63.96||+4.66||+7.86%||784,475||1.486M||4.583B||799.50|
|EL||The Estée Lauder Companies Inc.||272.81||+19.76||+7.81%||3.113M||1.337M||98.65B||163.85|
|ARWR||Arrowhead Pharmaceuticals, Inc.||90.47||+6.55||+7.81%||1.49M||982,658||9.39B||N/A|
|WYNN||Wynn Resorts, Limited||116.99||+8.30||+7.64%||5.401M||3.214M||12.62B||N/A|
|ZM||Zoom Video Communications, Inc.||419.59||+29.61||+7.59%||9.759M||7.726M||122.474B||291.58|
|ASX||ASE Technology Holding Co., Ltd.||7.80||+0.54||+7.44%||3.955M||1.657M||16.112B||25.16|
|EXPI||eXp World Holdings, Inc.||134.97||+9.25||+7.36%||859,853||934,153||9.441B||390.09|
|WYNMY||Wynn Macau, Limited||17.31||+1.18||+7.32%||38,903||25,512||9.11B||1.45|
|EAF||GrafTech International Ltd.||11.00||+0.72||+7.00%||2.391M||2.165M||2.939B||6.18|
|WLTW||Willis Towers Watson Public Limited Company||223.91||+14.61||+6.98%||1.19M||1.025M||28.853B||27.41|
|PPERF||PT Bank Mandiri (Persero) Tbk||0.4800||+0.0312||+6.95%||102,993||90,375||23.422B||13.71|
|GT||The Goodyear Tire & Rubber Company||12.56||+0.80||+6.80%||5.631M||3.164M||2.928B||N/A|
|NNOX||Nano-X Imaging Ltd.||69.77||+4.40||+6.73%||1.116M||1.58M||3.23B||N/A|
|OUT||Outfront Media Inc. (REIT)||20.11||+1.25||+6.63%||1.635M||1.707M||2.904B||N/A|
|MRWSF||Wm Morrison Supermarkets PLC||2.4800||+0.1524||+6.55%||18,378||11,016||5.816B||18.51|
|LPLA||LPL Financial Holdings Inc.||125.68||+7.70||+6.53%||1.321M||647,148||9.965B||21.45|
|TCOM||Trip.com Group Limited||34.92||+2.13||+6.50%||6.035M||4.108M||20.71B||N/A|
|BRP||BRP Group, Inc.||27.37||+1.66||+6.46%||425,066||411,806||3.098B||N/A|
|KRNT||Kornit Digital Ltd.||97.04||+5.88||+6.45%||313,097||214,362||4.394B||N/A|
|DRNA||Dicerna Pharmaceuticals, Inc.||27.41||+1.66||+6.45%||978,859||705,058||2.057B||N/A|
|NSANY||Nissan Motor Co., Ltd.||11.85||+0.71||+6.42%||145,983||110,622||22.968B||3.56|
|SI||Silvergate Capital Corporation||125.50||+7.57||+6.42%||855,720||976,441||2.864B||92.28|
|AAGH||America Great Health||0.2100||+0.0125||+6.33%||386,467||264,647||4.25B||N/A|
|ATKR||Atkore International Group Inc.||58.54||+3.44||+6.24%||616,629||493,696||2.729B||14.17|
|TMHC||Taylor Morrison Home Corporation||28.91||+1.73||+6.36%||1.225M||1.171M||3.757B||17.48|
|SIMO||Silicon Motion Technology Corporation||59.59||+3.50||+6.24%||1.102M||395,559||2.094B||20.28|
|PLTR||Palantir Technologies Inc.||34.05||+2.00||+6.24%||62.033M||72.918M||63.944B||N/A|
|NSANF||Nissan Motor Co., Ltd.||5.84||+0.34||+6.18%||18,429||10,880||22.917B||3.51|
|MTCH||Match Group, Inc.||159.82||+9.19||+6.10%||3.533M||2.449M||42.509B||327.50|
|ALRM||Alarm.com Holdings, Inc.||102.12||+5.84||+6.07%||671,867||469,132||5.015B||69.42|
|NFE||New Fortress Energy Inc.||49.61||+2.81||+6.00%||404,935||517,382||8.663B||N/A|
|ZNH||China Southern Airlines Company Limited||30.03||+1.64||+5.78%||55,282||28,775||12.852B||13.35|
|PRG||PROG Holdings, Inc.||53.33||+3.03||+6.02%||612,381||809,756||3.603B||N/A|
ARK Invest Founder, CEO and CIO Cathie Wood joined Yahoo Finance's Jennifer Rogers on Yahoo Finance Presents to discuss Bitcoin, Reddit traders, electric vehicles and how to know when to sell.
'[History] shows you that actually equities are the best asset class for store of value,' says the Investment Strategy Group's head, Sharmin Mossavar-Rahmani.
After an epic short squeeze fueled a surge in GameStop's share price to a high of $483 on Jan. 28 -- up from $18.84 on Dec. 31 -- the stock began to sell off. Trading restrictions imposed by Robinhood and other brokerages that limited how many GameStop shares investors could buy no doubt contributed to the decline. GameStop's stock recovered some of its recent losses on Friday.
The Super Bowl ad that Robinhood is airing this weekend doesn’t talk much about stocks, and maybe that’s for the better. A surge in stock trading by retail investors has put the investing app in the spotlight, and it’s likely to stay there for several months. In the weeks ahead, the company’s CEO, Vlad Tenev, is set to testify before Congress, and after that—perhaps as soon as the second quarter—Robinhood is expected to go public.
Hedge funds have once again found themselves in their customary role as Wall Street’s biggest villains. In a frenzied few weeks of trading, investors co-ordinating their actions on social media platform Reddit succeeded spectacularly in their aim of damaging the hedge fund of one of Wall Street’s most respected traders, Melvin’s Gabe Plotkin, a protégé of billionaire Steve Cohen. The fund lost billions of dollars on its GameStop short position and was forced to seek a bailout.
(Bloomberg) -- Online trading apps with game-like features are getting increased scrutiny from the U.S.’s top brokerage watchdog, adding to regulatory headaches for Robinhood Markets and other firms that played key roles in last month’s frenzied buying of GameStop Corp.The Financial Industry Regulatory Authority laid out its beefed-up focus on apps in its annual exam priorities, saying it would be closely monitoring how brokerages disclose potential risks and supervise their customers’ use of online trading tools, which have been embraced by an army of retail investors during the coronavirus pandemic.“This focus includes risks associated with app-based platforms with interactive or ‘game-like’ features that are intended to influence customers, their related forms of marketing, and the appropriateness of the activity that they are approving clients to undertake,” Finra, which is funded by the brokerage industry, said in the Feb. 1 report.The heightened attention comes as Robinhood’s wildly-popular trading platform draws intense criticism from consumer advocates and some lawmakers over GameStop’s remarkable surge and crash. Detractors argue that the nudges incorporated into apps inappropriately encourage customers to keep trading and may straddle the line of providing stock recommendations, which would subject firms to tighter rules.Robinhood vehemently denies that it provides recommendations. If Robinhood was found to be offering advice, it would trigger a series of obligations, including that the firm act in the best interest of its customers.Robinood didn’t immediately respond to a request for comment. The Securities and Exchange Commission is also examining how brokerages handled increased trading volumes during the January tumult and firms’ decisions to restrict buying of GameStop and other stocks. The regulator is looking into whether brokerages complied with rules and were consistent in how they made disclosures to their clients.Robinhood has repeatedly said that it limited some customer orders last week and sought billions in dollars from its investors because the Depository Trust & Clearing Corp. dramatically raised capital requirements. The DTCC is charged with overseeing the plumbing of stock trading.While Finra didn’t name any specific firms in its report, it laid out a number of considerations that brokerages with interactive and “game-like” features should evaluate, including:If communications with clients amount to a “recommendation” and, if so, whether firms are acting in a customer’s “best interest.”Whether disclosure of risks, fees and costs are sufficient.Whether firms need to improve or create systems to supervise “game-like” communications with customers.Whether firms are doing enough to prevent false, misleading or exaggerated statements.Whether firms are appropriately supervising customers’ options trading and the opening of new accounts.For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.?2021 Bloomberg L.P.
(Bloomberg) -- Even with Friday’s bounce, GameStop Corp. wrapped up its worst week on record as a stunning reversal of fortune wiped out $18 billion from the video-game retailer’s stock-market value.The stock fell 80% in the last five days, its worst weekly performance on record, to $63.77 in New York. The 19% gain on Friday after Robinhood Markets removed buying limits still left it far below last week’s high of $483 as retail trader demand and excitement across platforms like Reddit simmered.GameStop’s market value slipped to $4.4 billion, a far cry from the $33.7 billion value it hit on on Jan. 28 when it briefly became the largest company in the Russell 2000 Index. AMC Entertainment Holdings Inc., which also had limits removed on trading, edged lower in Friday’s session and capped off its worst week on record with a 48% drop.“The saga isn’t over for GameStop and the other stocks making headlines in recent weeks, but it is likely winding down,” said Craig Birk, chief investment officer at Personal Capital.“Bigger picture, the army of retail day traders will simply move on to the next thing.”Robinhood announced that it would remove buying limits in an update on the trading platform’s support page a day after it loosened restrictions on purchases of the two stocks. Both had skyrocketed since late January as day traders who populate Reddit’s WallStreetBets forum sought to fend off short-sellers.GameStop’s volatile session came as trading volume roared back for the busiest session since Jan. 27. With almost 80 million shares swapping hands, the rate of buying and selling was higher than what’s been seen over the past week. The stock continued to edge higher in postmarket trading, rising 1.8% at 5:20 p.m. New York time.“Since certain brokerage firms announced yesterday that they lifted all trading restrictions, you may again see some buyers entering the market,” said Amy Kong, chief investment officer of Barrett Asset Management. “It is hard to assess if this saga is over, and the energy could very well resurge through another stock.”While GameStop has shed $29.2 billion in value since its peak, the stock is still up more than 200% this year. AMC suffered a similar fate after falling 66% from last week’s high as retail traders flocked to other corners of the stock market, such as small drug developers.Robinhood’s temporary restrictions on the Reddit group’s favorite stocks last week triggered an outcry among retail traders who said the brokerage had sided with hedge funds and institutional money. In order to shore up its capital amid the trading frenzy, the trading app operator has had to borrow or raise billions of dollars.Trading in other Reddit-favored names was mixed with apparel company Naked Brand Group Ltd., and cannabis company Sundial Growers Inc. trading lower. Retailer Express Inc. was among other “meme stocks” that erased gains to fall. Zomedica Corp. powered higher by 27%.Short interest for GameStop fell just below 50% from a high of 140%, according to data from S3 Partners. The receding level of bets against the company and similar peers had been a key factor in the stocks’ roller-coaster moves over recent weeks, but could signal a breather before the next bout of mayhem.“The short interest in GameStop and others created a rare situation of extreme volatility,” said Birk. “We may not see anything that dramatic again for a while, but price moves in whatever is trending will likely remain elevated.”Limits on trading and the quick declines for the likes of GameStop and Express led retail investors to snap up biotechnology companies like Cassava Sciences Inc. The small drug developer has boomed 557% this year to become one of the top stocks in the Nasdaq Composite Index. Cassava fell 29% on Friday.(Adds postmarket trading in sixth paragraph)For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.?2021 Bloomberg L.P.
(Bloomberg) -- Millions of new users have flocked to Reddit Inc. forums amid feverish trading activity spurred by discussion on the subreddit WallStreetBets, the company said on Friday.“The fact that so many users decided to do this in such a short period of time is the amazing part,” the company wrote in a blog post.“Notably between January 24th-30th, there was a 10x increase of new users viewing r/WallStreetBets,” Reddit said, adding that “the community has significantly increased by 5.6 million users over the past two weeks.” Reddit disputed the idea that automated accounts were responsible for the surge in traffic. “This looks like a bunch of new users trying to engage in the community versus a new and awful surplus of ‘bots,’” according to the post. The Reddit analysis contradicts a statement made to CBS News by an anonymous moderator of the group, which suggested bots played a major role in the conversation.The news comes as U.S. Securities Exchange Commission is investigating whether fraud played a role in the massive swings of GameStop Corp., AMC Entertainment Holdings Inc. and other stocks.According to Reddit, GameStop, AMC and silver were all key topics of conversation on the site. “After a brief speculative discussion into the intrinsic value of precious metals, the community spoke up and then doubled-down on fundamentals, meaning the vast majority of those silver posts are anti-silver,” the post said.For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.?2021 Bloomberg L.P.
Synaptics stock spiked Friday after the chip maker offered upbeat guidance for the March quarter, as the company saw robust demand for components.
Rating Action: Moody's confirms El Salvador's B3 ratings, changes outlook to negative, concluding review for downgradeGlobal Credit Research - 05 Feb 2021New York, February 05, 2021 -- Moody's Investors Service, ("Moody's") has today confirmed the Government of El Salvador's long-term issuer and senior unsecured ratings at B3. Moody's also changed the outlook to negative. This concludes the review for downgrade that was initiated on 16 November 2020.While financing conditions will remain very tight in both the domestic and external markets this year and next, Moody's expects the government to begin consolidating its finances in the second half of this year, which would catalyze access to multilateral debt financing to cover most of its funding needs this year, lowering the likelihood of a credit event in the next two years.The negative outlook captures the credit risks associated with implementation risks of their forthcoming fiscal adjustment efforts, high liquidity risks driven by large gross financing needs in 2021-23 and persistent debt sustainability concerns despite an expected fiscal adjustment.
The stock market rally raced back to record highs, amid stimulus hopes and bullish earnings from Google and others. Jeff Bezos is stepping down as Amazon CEO.
The Dow Jones Industrial Average rose in today's stock market for the fifth straight day despite the labor market missing expectations.
GameStop stock was up Friday after Robinhood lifted trading restrictions on the Reddit short-squeezed stocks, but regulators said they will review the practices.
The advertising platform also reported preliminary Q4 2020 results with a nearly 20% advance in revenue.
As the trading frenzy in GameStop Corp shares and other social media favorites recedes, investors are eyeing signs of potential market stress that could weigh on broader stock performance in coming weeks. For now, U.S. equities appear to be looking past last week's surge in volatility that led the S&P 500 to its biggest weekly decline since October. The S&P 500 and Nasdaq posted records for a second straight session on Friday.
(Bloomberg) -- Rarely do predictions come true so fast.Seven days ago, with GameStop Corp. still north of $300, Bloomberg News sounded out institutional investors for their prognosis on the stock. No one foresaw a bright future. On Wall Street, unanimity is unusual. So was the outcome. A week later, $18 billion has been erased.Of the many divisions the GameStop saga laid bare, none was wider than that between retail day traders and the securities industry’s professional class. While none of the pros said they were happy to be right when reached Friday, each said the prediction was an easy one to make.Here’s what Kim Forrest, who is chief investment officer of Bokeh Capital Partners in Pittsburgh, said last week: “Some day people are going to put down the phone and get back to work. Then there’s going to be too many sellers and not enough buyers of that stock.”Here’s what she says now: “I’m not saying it can’t go up again for a little while, but there’s still always going to be a limit to how high it can go because interest is just going to wane at a certain point,” said Forrest. She described showing her husband a GameStop chart, likening it to a stake driven into the ground.That plunges in GameStop and other retail favorites coincided with buying restrictions imposed by the Robinhood investment app will do little to heal the rift between day traders and Wall Street. Shares of the video-game retailer have declined about 85% since hitting an intraday all-time high of $483 on Jan. 28. Despite a 15% rally Friday, it’s on pace for its worst week on record, though still up 230% for the year.Last week, Barry James, portfolio manager at James Investment Research, said he’d never seen a rally like GameStop’s end well. While early bulls “made quite a killing,” others won’t be as fortunate. “That’s just the way these things work out. They end up returning to a fair valuation.”Bearish bets in GameStop are fewer now, a sign that many investors have covered positions. Short interest has fallen below 50% of its free-floating shares, down from a high of roughly 140% reached earlier this year, data compiled by S3 Partners show. The number of shares borrowed to short the stock has dropped by 32.4 million over the last week to reach 25.4 million.“All of those things play into it starting to return to normal,” James said.As shares of GameStop fell this week, so did activity in its options. The average volume of contracts betting on gains in GameStop fell to half of that last week, while the volume in bearish ones subsided by a third. Just like last week, puts continue to be more active than calls -- the ratio of the two hovered around 2.3 times on Thursday, though still far from a 3.4 level seen last Wednesday, Bloomberg data show.Steve Chiavarone, portfolio manager and equity strategist at Federated Hermes, says he watched for correlations between GameStop’s up and down moves and the overall market. Last week, while GameStop rallied, many hedge funds were forced to sell other positions to cover losses, leading to speculation it could morph into a wider market selloff. The opposite happened this week, with the S&P 500 gaining near 5% since last Friday, while GameStop tumbled.“The risk to overall de-leveraging and downward pressure on the market has subsided and, therefore, this looked like more of a contained issue than something that could have bled into a greater level of market disruption,” he said by phone. It gave his firm confidence to add to equities within their asset-allocation recommendations. “From our perch, it looks like things have settled meaningfully,” he said.Norm Conley, chief executive officer of JAG Capital Management, last week said the whole GameStop ride had been the wildest thing he’d seen in markets in nearly three decades.Now he says: “You never know how long these sorts of things will last but you can be pretty sure it’s not sustainable for the long term,” Also: “Trading propositions or trading action in securities or commodities could be often crazy to some degree in the short term, but investing propositions usually do not look that crazy.”For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.?2021 Bloomberg L.P.
The Dow Jones rallied as Kamala Harris cast her first tiebreaking vote in the Senate to advance a coronavirus stimulus package. GameStop stock rallied.
In this article we examine Maplelane Capital‘s top 10 stock holdings. You can skip our discussion of the hedge fund’s performance and its investment philosophy in this article, and go directly to Maplelane’s Top 5 Stock Holdings. The $3.5 billion New York-based hedge fund Maplelane Capital fell 33% last month due to its short bets […]
A class action lawsuit filed in California Southern District Court on January 28, 2021 has been amended to include six hedge fund companies worth billions of dollars, a total of ten online brokers who manipulated the stock market, and the thirteen stocks involved.
UKONIQ is approved for adult patients with relapsed or refractory marginal zone lymphoma after at least one prior anti-CD20 based regimen UKONIQ is approved for adult patients with relapsed or refractory follicular lymphoma after at least three prior lines of systemic therapy UKONIQ is the first and only inhibitor of PI3K-delta and CK1-epsilon for relapsed/refractory MZL and FL U.S. Commercial launch now underway Company to host conference call on Monday, February 8, 2021 at 8:30 AM ET NEW YORK, Feb. 05, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the U.S. Food and Drug Administration (FDA) has approved UKONIQ? (umbralisib), for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. UKONIQ is the first and only, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. Accelerated approval was granted for these indications based on overall response rate (ORR) data from the Phase 2 UNITY-NHL Trial (NCT02793583). Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial. This application was granted priority review for the MZL indication. In addition, UKONIQ was granted Breakthrough Therapy Designation (BTD) for the treatment of MZL and orphan drug designation (ODD) for the treatment of MZL and FL. Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, “Today’s approval of UKONIQ marks a historic day for our Company with this being our first approval and we are extremely pleased to be able to bring our novel inhibitor of PI3K-delta and CK1-epsilon to patients with relapsed/refractory MZL and FL. We have built a commercial team with significant experience who will immediately start to engage our customers to educate them on UKONIQ and how to access the product for patients in need and expect to make UKONIQ available to US distributors in the next few days.” Mr. Weiss continued, “We want to thank the patients, physicians, nurses and clinical coordinators for their support and participation in our clinical trials, and the FDA for their collaboration throughout this process. We remain dedicated to patients with B-cell diseases and our mission of developing treatment options for those in need.” “Despite treatment advances, MZL and FL remain incurable diseases with limited treatment options for patients who relapse after prior therapy and no defined standard of care. With the approval of umbralisib we now have a targeted, oral, once-daily option, offering a needed treatment alternative for patients,” stated Dr. Nathan Fowler, Professor of Medicine at The University of Texas MD Anderson Cancer Center and the Study Chair of the UNITY-NHL MZL &FL cohorts. “The approval of umbralisib for the treatment of relapsed/refractory marginal zone lymphoma and follicular lymphoma offers patients a new treatment option, and new hope in the fight against these diseases,” stated Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. EFFICACY & SAFETY DATA IN RELAPSED/REFRACTORY MZL AND FLThe efficacy of UKONIQ monotherapy was evaluated in two single-arm cohorts, within the Phase 2 UNITY-NHL clinical trial, in 69 patients with MZL who received at least 1 prior therapy, including an anti-CD20 regimen, and in 117 patients with FL who received at least 2 prior systemic therapies, including an anti-CD20 monoclonal antibody and an alkylating agent. The UNITY-NHL Phase 2 trial is an open-label, multi-center, multi-cohort study with patients receiving UKONIQ 800 mg once daily. The primary endpoint was independent review committee (IRC) assessed overall response rate (ORR) according to the Revised International Working Group Criteria. Endpoint per IRCUKONIQMZL (n=69)UKONIQFL (n=117)ORR, n (%)34 (49)50 (43)95% CI37.0, 61.633.6, 52.2Complete Response, n (%)11 (16)4 (3.4)Partial Response, n (%)23 (33)46 (39)Duration of Response Median, months (95% CI)NR (9.3, NE)11.1 (8.3, 16.4) Range, months0.0+, 21.8+0.0+, 20.9+ CI, confidence interval; NR, not reached; NE, not evaluable +Denotes censored observation The safety of UKONIQ monotherapy was based on a pooled population from the 221 adults with MZL and FL in three single arm, open label trials and one open label extension trial. Patients received UKONIQ 800 mg orally once daily. Serious adverse reactions occurred in 18% of patients who received UKONIQ. Serious adverse reactions that occurred in ≥2% of patients were diarrhea-colitis (4%), pneumonia (3%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (>15%), including laboratory abnormalities, were increased creatinine (79%), diarrhea-colitis (58%, 2%), fatigue (41%), nausea (38%), neutropenia (33%), ALT increase (33%), AST increase (32%), musculoskeletal pain (27%), anemia (27%), thrombocytopenia (26%), upper respiratory tract infection (21%), vomiting (21%), abdominal pain (19%), decreased appetite (19%), and rash (18%).ABOUT UKONIQ? (umbralisib) 200 MG TABLETSUKONIQ is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. PI3K-delta is known to play an important role in supporting cell proliferation and survival, cell differentiation, intercellular trafficking and immunity and is expressed in both normal and malignant B-cells. CK1-epsilon is a regulator of oncoprotein translation and has been implicated in the pathogenesis of cancer cells, including lymphoid malignancies. UKONIQ is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. These indications are approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.IMPORTANT SAFETY INFORMATIONInfections: Serious, including fatal, infections occurred in patients treated with UKONIQ. Grade 3 or higher infections occurred in 10% of 335 patients, with fatal infections occurring in <1%. The most frequent Grade ≥3 infections included pneumonia, sepsis, and urinary tract infection. Provide prophylaxis for Pneumocystis jirovecii pneumonia (PJP) and consider prophylactic antivirals during treatment with UKONIQ to prevent CMV infection, including CMV reactivation. Monitor for any new or worsening signs and symptoms of infection, including suspected PJP or CMV, during treatment with UKONIQ. For Grade 3 or 4 infection, withhold UKONIQ until infection has resolved. Resume UKONIQ at the same or a reduced dose. Withhold UKONIQ in patients with suspected PJP of any grade and permanently discontinue in patients with confirmed PJP. For clinical CMV infection or viremia, withhold UKONIQ until infection or viremia resolves. If UKONIQ is resumed, administer the same or reduced dose and monitor patients for CMV reactivation by PCR or antigen test at least monthly.Neutropenia: Serious neutropenia occurred in patients treated with UKONIQ. Grade 3 neutropenia developed in 9% of 335 patients and Grade 4 neutropenia developed in 9%. Monitor neutrophil counts at least every 2 weeks for the first 2 months of UKONIQ and at least weekly in patients with neutrophil count <1 x 109/L (Grade 3-4) neutropenia during treatment with UKONIQ. Consider supportive care as appropriate. Withhold, reduce dose, or discontinue UKONIQ depending on the severity and persistence of neutropenia.Diarrhea or Non-Infectious Colitis: Serious diarrhea or non-infectious colitis occurred in patients treated with UKONIQ. Any grade diarrhea or colitis occurred in 53% of 335 patients and Grade 3 occurred in 9%. For patients with severe diarrhea (Grade 3, i.e., > 6 stools per day over baseline) or abdominal pain, stool with mucus or blood, change in bowel habits, or peritoneal signs, withhold UKONIQ until resolved and provide supportive care with antidiarrheals or enteric acting steroids as appropriate. Upon resolution, resume UKONIQ at a reduced dose. For recurrent Grade 3 diarrhea or recurrent colitis of any grade, discontinue UKONIQ. Discontinue UKONIQ for life-threatening diarrhea or colitis.Hepatotoxicity: Serious hepatotoxicity occurred in patients treated with UKONIQ. Grade 3 and 4 transaminase elevations (ALT and/or AST) occurred in 8% and <1%, respectively, in 335 patients. Monitor hepatic function at baseline and during treatment with UKONIQ. For ALT/AST greater than 5 to less than 20 times ULN, withhold UKONIQ until return to less than 3 times ULN, then resume at a reduced dose. For ALT/AST elevation greater than 20 times ULN, discontinue UKONIQ. Severe Cutaneous Reactions: Severe cutaneous reactions, including a fatal case of exfoliative dermatitis, occurred in patients treated with UKONIQ. Grade 3 cutaneous reactions occurred in 2% of 335 patients and included exfoliative dermatitis, erythema, and rash (primarily maculo-papular). Monitor patients for new or worsening cutaneous reactions. Review all concomitant medications and discontinue any potentially contributing medications. Withhold UKONIQ for severe (Grade 3) cutaneous reactions until resolution. Monitor at least weekly until resolved. Upon resolution, resume UKONIQ at a reduced dose. Discontinue UKONIQ if severe cutaneous reaction does not improve, worsens, or recurs. Discontinue UKONIQ for life-threatening cutaneous reactions or SJS, TEN, or DRESS of any grade. Provide supportive care as appropriate. Allergic Reactions Due to Inactive Ingredient FD&C Yellow No. 5: UKONIQ contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons, frequently in patients who also have aspirin hypersensitivity.Embryo-fetal Toxicity: Based on findings in animals and its mechanism of action, UKONIQ can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose.Serious adverse reactions occurred in 18% of 221 patients who received UKONIQ. Serious adverse reactions that occurred in ≥2% of patients were diarrhea-colitis (4%), pneumonia (3%), sepsis (2%), and urinary tract infection (2%). Permanent discontinuation of UKONIQ due to an adverse reaction occurred in 14% of patients. Dose reductions of UKONIQ due to an adverse reaction occurred in 11% of patients. Dosage interruptions of UKONIQ due to an adverse reaction occurred in 43% of patients. The most common adverse reactions (>15%), including laboratory abnormalities, in 221 patients who received UKONIQ were increased creatinine (79%), diarrhea-colitis (58%, 2%), fatigue (41%), nausea (38%), neutropenia (33%), ALT increase (33%), AST increase (32%), musculoskeletal pain (27%), anemia (27%), thrombocytopenia (26%), upper respiratory tract infection (21%), vomiting (21%), abdominal pain (19%), decreased appetite (19%), and rash (18%).Lactation: Because of the potential for serious adverse reactions from umbralisib in the breastfed child, advise women not to breastfeed during treatment with UKONIQ and for at least one month after the last dose.Please visit www.tgtherapeutics.com/prescribing-information/uspi-ukon for full Prescribing Information and Medication Guide. Physicians, pharmacists, or other healthcare professionals with questions about UKONIQ should visit www.UKONIQ.com. ABOUT TG PATIENT SUPPORTThe TG Patient Support is a comprehensive program designed by TG Therapeutics to support patients through their treatment journey and the reimbursement process. More information about the TG Patient Support program is accessible by phone at 1-877-TGTXPSP (1-877-848-9777); by fax at 1-877-778-1329 or at www.UKONIQ.com/patient/patientsupport. ABOUT MARGINAL ZONE LYMPHOMAMarginal zone lymphoma (MZL) comprises a group of indolent (slow growing) mature B-cell non-Hodgkin lymphomas (NHLs). MZL is generally considered a chronic and incurable disease. With an annual incidence of approximately 8,200 newly diagnosed patients in the United States1,2, MZL is the third most common B-cell NHL, accounting for approximately ten percent of all NHL cases. MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL)3.ABOUT FOLLICULAR LYMPHOMAFollicular lymphoma (FL) is typically an indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes. It is the second most common form of NHL. FL is generally not curable and is considered a chronic disease, as patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 13,200 newly diagnosed patients1,2, FL is the most common indolent lymphoma accounting for approximately 17 percent of all NHL cases4.CONFERENCE CALL INFORMATIONThe Company will host a conference call on Monday, February 8, 2021 at 8:30 AM ET to discuss the UKONIQ approval. In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live webcast will be available on the Events page, located within the Investors & Media section, of the Company's website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.ABOUT TG THERAPEUTICS, INC. TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from the U.S. FDA for UKONIQTM (umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has two programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development. For more information, visit www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and Linkedin.UKONIQTM is a registered trademark of TG Therapeutics, Inc. __________________________________________________ 1National Cancer Institute. SEER Cancer Statistics Review 2008-2017: Non-Hodgkin Lymphoma. Table 19.26. http://tbbeji.tw.seer.cancer.gov/csr/1975_2017/results_single/sect_19_table.26_2pgs.pdf. Accessed January 19, 2021.2National Cancer Institute. SEER Cancer Stat Facts: Non-Hodgkin Lymphoma. http://thai727.tw.seer.cancer.gov/statfacts/html/nhl.html. Accessed January 19, 2021.3 Lymphoma Research Foundation: Marginal Zone Lymphoma http://makenjr.top.lymphoma.org/aboutlymphoma/nhl/mzl/4 Lymphoma Research Foundation “Follicular Lymphoma” Cautionary StatementThis press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such forward looking statements include but are not limited to statements regarding expectations for the timing and commercial launch and availability of UKONIQ? (umbralisib) for relapsed or refractory (R/R) marginal zone lymphoma (MZL) and follicular lymphoma (FL); clinical trials, including the confirmatory trial for UKONIQ in R/R MZL and FL; and anticipated healthcare professional and patient acceptance and use of UKONIQ for the FDA-approved indications. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially include the following: the Company’s ability to establish and maintain a commercial infrastructure, and to successfully launch, market and sell UKONIQ or future products, if approved; failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the potential for variation from the Company’s projections and estimates about the potential market for UKONIQ or the Company’s product candidates due to a number of factors, including for example, limitations that regulators may impose on the required labeling for the proposed treatment population for UKONIQ or our other product candidates; the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); potential regulatory challenges to the Company’s plans to seek expanded or additional indications for UKONIQ in the U.S. or plans to seek marketing approval for the product in additional geographies, outside of the U.S.; the Company’s reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for its clinical and commercial products, including UKONIQ; the uncertainties inherent in research and development; and the risk that the ongoing COVID-19 pandemic and associated government control measures have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in our other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Jenna Bosco Senior Vice President, Corporate Communications TG Therapeutics, Inc. Telephone: 877.575.8489 Email: email@example.com PDF attachments accompanying this release are available at http://ml.globenewswire_com.federalismosolidale.com/Resource/Download/e3586449-8f68-4532-aa66-9d93452ec247 http://ml.globenewswire_com.federalismosolidale.com/Resource/Download/c6b34caf-fefa-4014-80ec-bb9404c86fff http://ml.globenewswire_com.federalismosolidale.com/Resource/Download/590c4cb8-995f-4a5b-99a0-f087cfc88833 http://ml.globenewswire_com.federalismosolidale.com/Resource/Download/6da473d8-7630-44cf-9bd5-c48d6246c467
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