|Bid||93.65 x 1100|
|Ask||93.55 x 800|
|Day's Range||93.02 - 96.47|
|52 Week Range||90.24 - 165.87|
|Beta (3Y Monthly)||1.62|
|PE Ratio (TTM)||N/A|
|Earnings Date||Oct 22, 2019 - Oct 28, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||194.33|
Sarepta Therapeutics stock continued a three-day tumble Thursday after the Food and Drug Administration rejected its newest Duchenne muscular dystrophy treatment, dubbed golodirsen.
NEW YORK, Aug. 22, 2019 -- Levi & Korsinsky notifies investors that it has commenced an investigation of Sarepta Therapeutics, Inc. (“Sarepta or “the Company”) (NASDAQ:.
Investors need to pay close attention to Sarepta Therapeutics (SRPT) stock based on the movements in the options market lately.
NEW YORK, NY / ACCESSWIRE / August 22, 2019 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Sarepta Therapeutics, Inc.(“Sarepta” or the “Company”) (NASDAQ:SRPT). ...
Pomerantz LLP is investigating claims on behalf of investors of Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (SRPT). Such investors are advised to contact Robert S. Willoughby at firstname.lastname@example.org or 888-476-6529, ext. The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation.
The FDA just blocked Sarepta's new Duchenne muscular dystrophy drug. Sarepta calls it 'surprising.' But is it really? Continue reading...
On Monday, when the FDA came out against Sarepta's (SRPT) Duchenne muscular dystrophy drug Vyondys 53, investors knew the shockwaves would immediately hit shares. And they did. The stock plummeted as much as 18% in Tuesday trading as the FDA expressed concern over the possibility of infection and kidney toxicity from the Vyondys drug. Sarepta’s CEO quickly came out saying he was “surprised” by the decision, given that the FDA has not expressed this concern during the formal review. While the FDA isn’t giving the company much to work with, it is expected that the two sides will meet as Sarepta continues to work to bringing Vyondys to market. 5-star Cowen analyst Ritu Baral isn’t very moved by the bad news, as she maintains an Outperform rating on SRPT stock, along with $213 price target, which implies about 110% upside from current levels. Baral’s immediate reaction was the same as that of the Sarepta CEO — surprise. The analyst says she was “surprised by the FDA's reasons/concerns and did not anticipate a [Complete Response Letter] for safety reasons,” comparing Vyondys 53 to another Sarepta product, Exondys 51, which “has similar backbone chemistry and has never shown any serious safety signal (renal or port-related infection risk).” The analyst thinks the FDA’s decision is “not cleanly [logical],” and doesn’t think Sarepta needs to do too much work in order to satisfy requirements. Baral says the company “could address the current renal toxicity concerns with current clinical and preclinical dataset,” with the worst-case situation of “an expanded open-label safety database with the 30 mg/kg…” Overall, Baral views the port-related infection risk as easily addressable in the near term, like with analysis of the Exondys post-marketing experience (neither Exondys nor golo had any clinical infection signal and infusion times are generally identical). As a result, Baral says the FDA will eventually approve the drug, around 2021 by her estimates. Until then, the top analyst expects the company to address concerns and provide clarity on Vyondys’ path forward by the end of the year. All in all, Sarepta has had an up-and-down year. Shares shot up nearly 40% by March, before slipping 20% in the subsequent three months. By July, its stock was up yet-again, with respectable 45% gains for the year, just before crashing again this month. In one word: roller-coaster. But TipRanks analysis of 17 analyst ratings shows that Wall Street is not so confused on where SRPT is headed. All 17 analysts rate the stock a buy, with an average price target of $191.87, which represents an 88% return from current levels. (See SRPT's price targets and analyst ratings on TipRanks)
Shares of Sarepta Therapeutics Inc. fell 13% Tuesday morning on the news that the Food and Drug Administration had rejected the company’s marketing application for an experimental Duchenne muscular dystrophy drug.
The bullish start to the week fizzled out on Tuesday, despite mostly-optimistic chatter. Credit Suisse's "recession dashboard" says there's not one in sight. "Key signals such as labor and credit trends remain quite healthy," explains Credit Suisse chief U.S. equity strategist Jonathan Golub.And, while he laments it, fund manager Kyle Bass made the case that central banks are going to continue doing anything and everything they can to keep the global economy propped up. JPMorgan's global head of quantitative and derivatives strategy Marko Kolanovic even went as far as saying last week's temporary inversion of the yield curve wasn't the cause for worry it might normally be.InvestorPlace - Stock Market News, Stock Advice & Trading TipsDisruption in Europe may have been the crux of the weakness. The United Kingdom may postpone the selection of the Bank of England's next governor until after Brexit, though Brexit itself remains up in the air. In Italy, Prime Minister Giuseppe Conte announced his resignation, simultaneously criticizing Deputy Prime Minister Matteo Salvini for calling for the no-confidence vote that led to his exit.Both cast a cloud of uncertainty over Europe, which was already struggling to maintain economic growth. * 10 Undervalued Stocks With Breakout Potential All told, the S&P 500 snapped a three-day win streak with its 0.53% setback on Tuesday. The Dow Jones Industrial Average wasn't quite as damaged, falling 0.37%, while the NASDAQ Composite ended the day 0.45% lower. Top News in the Stock Market TodayIt had little impact on shares, but it's a developing story that could matter more in the future. That is, on Tuesday, a string of personnel exits from the healthcare arm being developed by Apple (NASDAQ:AAPL) was thrust into the spotlight. The report named six key people who'd left the company in recent months, reportedly frustrated about the direction Apple's health business was moving. Some employees interviewed anonymously suggested tensions had been mounting for some time. The disruption calls into question how much traction Apple's health initiatives will garner in the foreseeable future.Walt Disney Company (NYSE:DIS) joined General Electric (NYSE:GE) as a recent accusee of misleading accounting, though in this case, the red flag is being waved by a former insider. Sandra Kuba, formerly a senior financial analyst with Disney that was terminated in 2017, suggested the entertainment giant had habitually reported more revenue than it had actually generated. Kuba went as far as to formally inform the Securities and Exchange Commission.Walt Disney denied the accusation, and given the small gain DIS stock mustered on an otherwise bearish day, investors aren't concerned.Investors are concerned about Sarepta Therapeutics (NASDAQ:SRPT), however, after the Food and Drug Administration responded to its most recent drug approval request with less than open arms. The FDA sent a so-called Complete Response Letter to Sarepta regarding concerns and questions it had about its Duchenne muscular dystrophy drug that's been in development for years.The letter is not a rejection, but it does suggest the FDA is so far unconvinced that the drug is worth greenlighting. SRPT stock fell more than 15% on the news. Big MoversDespite its clear capacity to put and keep itself in the spotlight, "meatless" meat company Beyond Meat (NASDAQ:BYND) hasn't impressed the analyst community. Until Tuesday, no analyst was willing to call the stock a "Buy" … that is, until today. JPMorgan analyst Ken Goldman upgraded BYND stock to that rating, explaining "We are encouraged that velocity -- sales per distribution point -- has been the primary driver of recent acceleration, as it suggests the products are catching on with consumers."The call pushed Beyond Meat shares up by more than 6%.It's not much of a household name, but for households that own a piece of electronics manufacturer Cemtrex (NASDAQ:CETX), that stake is worth 36% more today. Shares jumped nearly 30% in regular-hours action on Tuesday following an impressive second quarter report that saw an additional 6% advance in after-hours action. The promise of real profits within the next few quarters fanned the bullish flames.Not every big mover was necessarily a winner though. Madison Square Garden (NYSE:MSG) tumbled nearly 9% after the company's second-quarter bottom line fell short of estimates. Its new project in Las Vegas is proving costly but not fruitful.As of the time of this writing, James Brumley did not hold a position in any of the aforementioned securities. To learn more about James, visit his site at jamesbrumley.com, or follow him on twitter at @jbrumley. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 10 Cheap Dividend Stocks to Load Up On * The 10 Biggest Losers from Q2 Earnings * 5 Dependable Dividend Stocks to Buy The post Stock Market Today: Beyond Meat Makes a Friend on Wall Street appeared first on InvestorPlace.
Sarepta Therapeutics stock crashed Tuesday after the Food and Drug Administration left the biotech company twisting "in the wind" over its newest Duchenne muscular dystrophy treatment.
Sarepta Therapeutics stock tumbled on Tuesday after the Food and Drug Administration sent the company a letter raising concerns about its experimental muscular-dystrophy drug golodirsen.
Bank of America Merrill Lynch analyst Tazeen Ahmad reiterated a Buy rating and lowered the price target from $200 to $189. The renal toxicity highlighted by the FDA is not a concern, as antisense oligonucleotides are well known for their renal toxicity, particularly at high doses and frequency, Nomura analyst Marai said in a Monday note.
But analysts say the rejection could have a ripple effect far outside of the walls of Sarepta's Cambridge headquarters.
(Bloomberg Opinion) -- For a small biotechnology firm, Sarepta Therapeutics Inc. has made a lot of waves at the Food and Drug Administration. The 2016 approval of its first drug, Exondys 51 – which targets the deadly muscle-wasting disease Duchenne Muscular Dystrophy (DMD) – caused a schism at the agency. A highly organized and vocal group of parents and patients saw hope for boys otherwise resigned to a short and challenging life, helping it gain green-light status, while an agency detractor called the drug an “elegant placebo.” Sarepta’s second drug-approval attempt didn’t go so well. On Monday, the FDA rejected the company’s follow-up drug Vyondys 53, intended for another subset of DMD patients. According to the surprised company, the agency’s principal concerns were with infections related to ports used to infuse the drug, and kidney toxicity observed in pre-clinical models but not seen in the actual trial.If those are the only problems, Vyondys could be back on track in relatively short order. But we don’t know if that’s all there is to it or whether there’s a simple fix because Sarepta didn’t share the FDA’s full rejection letter. The truth is, Sarepta may have a longer, rougher path to further FDA approvals than it previously thought, and its struggles could have a bearing on other drug developers in similar situations.Vyondys likely won’t be approved until at least next year now. That’s not a deal-breaker; the drug was expected to contribute only a modest portion of Sarepta’s future sales. But analysts think the rejection could be about more than a few infections, which may be the reason the company’s shares plunged as much as 20% in early trading Tuesday. Royal Bank of Canada analyst Brian Abrahams suggested in a research note Tuesday that this decision may represent a backlash to Exondys’s approval. It also could be a signal that the agency is upping its safety bar in some cases. There may be something to that. Both Exondys and Vyondys appear able to produce tiny amounts of the protein that boys with DMD lack. It isn’t clear, based on Sarepta’s small trials, that this leads to a real-world benefit. Reliable confirmatory data may not arrive for years.Advocates argue that the FDA should be biased toward approval, when there are no good options even if the data is somewhat scant. Exondys tested the limits of that argument, and it can cost as much as $1 million per year. Potential safety issues for such expensive therapies can make the push for approval harder to support.In the case of Vyondys, the FDA appears to have dug pretty deep for a problem. But if Exondys was an exception and the agency continues to apply a higher standard through the inevitable criticism, another similar medicine of Sarepta’s in development called casamirsen could be in trouble as well. Investors also have to decide if they need to worry about the company’s crucial next generation of drugs, which are gene therapies. Unlike Exondys, which needs to be dosed for years, these medicines could have a long-term impact after just one treatment. Sarepta has produced promising early results for its lead DMD gene therapy, and analysts expect it to generate a billion dollars in sales in 2021. There’s no direct relationship between Vyondys and the gene therapies; the latter work in an entirely different way and don’t have the same kind of efficacy questions. But they are still risky bets that rely on small trials and may require some degree of FDA flexibility.The agency might be in an especially cautious mood in regards to gene therapies after a damaging data fracas recently related to a highly regarded drug made by Novartis AG. Any slowdown for Sarepta would give competitors including Pfizer Inc., Solid Biosciences Inc., and Audentes Therapeutics Inc. opportunities to catch up. At least a chunk of Sarepta’s multi-billion market value likely comes from the perception that it has the magic touch at a more flexible FDA. A previous strength may be turning into a weakness.To contact the author of this story: Max Nisen at email@example.comTo contact the editor responsible for this story: Beth Williams at firstname.lastname@example.orgThis column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.For more articles like this, please visit us at bloomberg.com/opinion©2019 Bloomberg L.P.
The CRL to golodirsen NDA comes as a surprise for Sarepta (SRPT) and investors as no issues were raised by the FDA during the review period that could have lead to non-approval of the candidate.
Sarepta announced Monday after the market close the FDA issued a complete response letter for its NDA seeking accelerated approval for golodirsen injection for treating Duchenne muscular dystrophy, or DMD, in patients with confirmed mutation amenable to exon 53 skipping. Sarepta clarified that renal toxicity was observed in pre-clinical models at doses that were ten-fold higher than the dose used in clinical studies.
Pharmaceutical company Sarepta Therapeutics plunging today after the FDA rejected its second drug for muscular dystrophy. Cantor Fitzgerald lowered its price target for the stock, saying the FDA's decision "could be political." Yahoo Finance's Anjalee Khemlani joins Akiko Fujita.