Author: therawinformant

  • Mesoblast Tanks 35% Ahead Of FDA Meeting; Analyst Sees 85% Stock Upside

    Mesoblast Tanks 35% Ahead Of FDA Meeting; Analyst Sees 85% Stock UpsideAustralian biotech Mesoblast sank 35% on Tuesday ahead of this week’s US Federal Drug Administration (FDA) committee meeting, which will assess the efficacy of its flagship stem cell therapy candidate.The stock dived to $11.33 at the close on Tuesday and is currently down 1.9% in pre-market trading. Mesoblast (MESO) disclosed that the FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet on Thursday to review data supporting its Biologics License Application (BLA) for the approval of its stem cell candidate remestemcel-L for the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children, a severe immune response which can occur after a bone marrow transplant.There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer. The stem cell therapy candidate is also currently being studied in the US as a treatment for COVID-19 patients suffering from acute respiratory distress.The ODAC will vote in the afternoon session on Aug. 13 whether the available data support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD. The session will discuss the Phase 3 trial results and supporting clinical data included in the BLA. It will also discuss issues related to the characterization and critical quality attributes of remestemcel-L.The ODAC is an independent panel of experts that provides advice and recommendations based on potential issues highlighted by the FDA during their review of the efficacy and safety of marketed and investigational products for use in the treatment of cancer. One of the issues raised by the FDA is whether more evidence is needed to demonstrate the treatment delivers benefits to human patients.Although the FDA will consider the recommendation of the advisory committee, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding. The FDA is scheduled to make a decision on the application on Sept. 30.H.C. Wainwright analyst Swayampakula Ramakanth believes that the treatment is likely to be approved before the Sept. 30 deadline “due to a strong combination of safety and efficacy” adding that “the main issues raised by the FDA are addressable”.“Taking into consideration the FDA’s analyses, we believe the benefit of Ryoncil for pediatric patients with SR-aGVHD continue to significantly outweigh its risks,” Ramakanth wrote in a note to investors. “At the same time, we note that the agency could request the company to complete a post-marketing study in order to provide additional data.”Nonetheless, Ramakanth reiterated a Buy on Mesoblast along with a $21 price target, which implies potential upside of 85% from current levels. (See Mesoblast stock analysis on TipRanks)Overall MESO scores 5 unanimous Buy ratings from analysts which add up to a Strong Buy consensus. Despite the stock’s 54% rally this year, the $18.05 average price target still indicates 59% upside potential.Related News: Pfizer Inks Deal To Manufacture Gilead’s Covid-19 Remdesivir Treatment Inovio To Start P2/3 Study Of Covid-19 Candidate In Sept.; Shares Drop 8% Novavax Rises 5% On Earnings; $2B Covid-19 Vaccine Funding More recent articles from Smarter Analyst: * Eli Lilly, Innovent’s TYVYT Expanded Use Application Accepted In China * ASOS: ‘100% Profit Beat’ Cheers RBC Capital On Trading Update * Truist Securities Ramps Up Wayfair’s PT On Improving Profitability * Equinix Enters India With $161M GPX Global Deal; RBC Bullish

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  • Jumia reports Q2 earnings, operating loss down 44% from last year

    Jumia reports Q2 earnings, operating loss down 44% from last yearYahoo Finance’s Ines Ferre joins The First Trade to break down one of Yahoo Finance’s top trending tickers on Wednesday, Jumia. The e-commerce company posted its second quarter earnings report Wednesday morning.

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  • NVIDIA (NASDAQ:NVDA) Seems To Use Debt Rather Sparingly

    NVIDIA (NASDAQ:NVDA) Seems To Use Debt Rather SparinglySome say volatility, rather than debt, is the best way to think about risk as an investor, but Warren Buffett famously…

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  • Here’s Why We’re A Bit Worried About Moleculin Biotech’s (NASDAQ:MBRX) Cash Burn Situation

    Here's Why We're A Bit Worried About Moleculin Biotech's (NASDAQ:MBRX) Cash Burn SituationWe can readily understand why investors are attracted to unprofitable companies. For example, although Amazon.com made…

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  • Boeing’s Aircraft Deliveries Drop In July As More 737 MAX Cancellations Hit

    Boeing’s Aircraft Deliveries Drop In July As More 737 MAX Cancellations HitBoeing Co.’s aircraft deliveries declined in July, while order cancellations for its 737 MAX aircraft continued as travel restrictions tied to the coronavirus pandemic have throttled commercial jet demand.The ailing plane maker said that last month 43 of its 737 MAX aircraft were cancelled. AerCap canceled orders for 15 of its 737 aircraft, which have been grounded since March 2019 following a second crash.Boeing (BA) delivered only 4 planes in July – two 787 Dreamliners and two freighters – down from 10 in June taking the total to a monthly 52 net cancellations. The aerospace giant did not receive any new orders in July, as air travel demand has been disrupted in an effort to contain the coronavirus pandemic.Total year-to-date deliveries amounted to 74 aircraft with gross orders of 59 planes. As of the end of July, Boeing lost a total of 836 plane orders this year. The report comes as the company said last month that it would cut production of its 787 and 777/777X aircraft after posting a larger 2Q loss than estimated.The coronavirus travel restrictions have resulted in a deep cut in the number of commercial jets and services Boeing customers need over the next few years. As such, global airlines suffering billions of dollars in losses have been seeking to cancel or delay some of the orders they have with Boeing.Shares in BA have plunged 45% year-to-date, but analysts have a cautiously optimistic Moderate Buy consensus on the stock. That’s with a $187.63 average analyst price target (4.2% upside potential).For now Cowen & Co’s Cai Rumohr is sitting on the sidelines with a $150 price target, saying that deliveries remain depressed even though some COVID-19-related travel restrictions have eased. (See BA stock analysis on TipRanks)“BA delivered only four aircraft in July vs. ten in June and our July est. of 17. The primary shortfall was in the 787, where BA delivered two 787's vs. our est. of 11. It also missed on the 767 (1 vs. 3E) and 777 (1 vs. 2E),” Rumohr wrote in a note to investors. “Customer deferrals remain the key issue as customers push out accepting 787 deliveries given international travel remains depressed.”Related News: American Airlines Shares Lifted By Air Travel Demand Data Boeing Is Said To Delay New 777X As Demand For Large Jets Throttles MGM Spikes 14% As IAC Makes $1B Investment Amid Online Gambling Bet More recent articles from Smarter Analyst: * Qualcomm Wins US Antitrust Ruling; Top Analyst Says Decision Lifts Stock Overhang * Stifel Lifts Lumentum’s PT After 4Q Earnings Beat Estimates * Zoom Video Drops 8% After Salesforce Sells Off Stake * J2 Global Surges 15% On Earnings Beat; RBC Upgrades To ‘Buy’

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  • Did Hedge Funds Make The Right Call On Callon Petroleum Company (CPE) ?

    Did Hedge Funds Make The Right Call On Callon Petroleum Company (CPE) ?How do you pick the next stock to invest in? One way would be to spend days of research browsing through thousands of publicly traded companies. However, an easier way is to look at the stocks that smart money investors are collectively bullish on. Hedge funds and other institutional investors usually invest large amounts of […]

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  • Is Cameco (TSE:CCO) Set To Make A Turnaround?

    Is Cameco (TSE:CCO) Set To Make A Turnaround?If you're looking at a mature business that's past the growth phase, what are some of the underlying trends that pop…

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  • Did Hedge Funds Make The Right Call On Verastem Inc (VSTM) ?

    Did Hedge Funds Make The Right Call On Verastem Inc (VSTM) ?We know that hedge funds generate strong, risk-adjusted returns over the long run, which is why imitating the picks that they are collectively bullish on can be a profitable strategy for retail investors. With billions of dollars in assets, professional investors have to conduct complex analyses, spend many resources and use tools that are not […]

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  • Tesla Splits Stock to Make Lofty Shares Attainable Again

    Tesla Splits Stock to Make Lofty Shares Attainable Again(Bloomberg) — Tesla Inc. is splitting its richly valued shares in a 5-for-1 exchange, a move designed to make the stock less expensive for individual investors after the company become the world’s most valuable automaker.Each stockholder of record on Aug. 21 will receive a dividend of four additional shares of common stock for each one they own, the electric-car maker said Tuesday in a statement. The shares, which have more than quadrupled since March to close above $1,600 last month, pared a gain of as much as 7% early Wednesday to trade up 4.8% to $1,440.63 as of 9:46 a.m. in New York.The split aims to capitalize on and support Tesla’s recent surge, which has pushed its market capitalization to more than $256 billion, exceeding the value of Toyota Motor Corp. and Ford Motor Co. combined. The massive rally for the shares has priced them out of reach for some smaller retail investors just as the EV industry is capturing their imagination.“At a time where the appetite for the stock and overall EV story continues to gain momentum, I think it’s a smart move,” said Dan Ives, an analyst at Wedbush who rates the shares the equivalent of a hold. Tesla is taking after Apple Inc., which Ives said other tech giants are likely to emulate.Apple announced a 4-for-1 stock split after the close on July 30 and retail traders have piled in to bet on further gains. Tesla will start trading on a split-adjusted basis Aug. 31.More AccessibleTesla has been a favorite stock for day traders and other retail investors lately. At one point last month, nearly 40,000 Robinhood account holders added shares of the carmaker during a four-hour span. The surge has been a boon to other electric-car companies, some of which have yet to actually produce a vehicle.“The stock split is a recognition of the fact that the market is increasingly influenced by individual investors, including those looking to gain exposure to next-generation transportation,” Ben Kallo, a Robert W. Baird analyst who rates Tesla the equivalent of a hold, wrote to clients.Tesla’s gains have been partly fueled by speculation the company is likely to join the S&P 500 after it reported the latest in a string of profitable quarters. That would make the stock a must-buy for mutual and exchange-traded funds that seek to mimic the benchmark index.Read more: When Tesla Hits S&P 500, It’ll Spark Wildest Passive Trade EverThe timing of the split may have come as a surprise to close followers of Tesla Chief Executive Officer Elon Musk’s Twitter feed. He was asked on June 30 whether he had any thoughts about a Tesla stock split and said it was worth discussing at the company’s annual meeting, which isn’t until Sept. 22.(Updates with shares after market opening on Wednesday in second paragraph.)For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.

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  • What Kind Of Shareholders Hold The Majority In Enphase Energy, Inc.’s (NASDAQ:ENPH) Shares?

    What Kind Of Shareholders Hold The Majority In Enphase Energy, Inc.'s (NASDAQ:ENPH) Shares?Every investor in Enphase Energy, Inc. (NASDAQ:ENPH) should be aware of the most powerful shareholder groups…

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