|Bid||124.45 x 900|
|Ask||126.25 x 800|
|Day's Range||123.28 - 125.83|
|52 Week Range||72.05 - 158.80|
|Beta (5Y Monthly)||2.19|
|PE Ratio (TTM)||N/A|
|Earnings Date||Feb 24, 2020 - Mar 01, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||196.27|
Shareholder rights law firm Robbins LLP reminds investors that a purchaser of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) filed a class action complaint for alleged violations of the Securities Exchange Act of 1934 between September 6, 2017 and August 19, 2019. Sarepta Therapeutics focuses on the discovery and development of RNA-based therapeutics, gene therapy, and other genetic medicine for the treatment of rare diseases. Sarepta's products pipeline includes its drug golodirsen for the treatment of duchenne muscular dystrophy ("DMD").
For those who like patterns, biotech names’ growth stories tend to look remarkably similar. These stocks are less reliant on earnings reports and more on a few select markers which can decide what direction they will take in the near-term. A favorable outcome from a regulatory committee or promising data from a clinical trial can send the stock soaring. Conversely, rejection or disappointing readouts can send the company’s share price tumbling down. While they present possible mercurial upside, these tickers aren’t for the faint of heart because although the patterns usually play out, the direction they might take is very hard to predict.So, how should investors choose which biotechs to invest in? There are different strategies, of course, but one trusted way is to listen to the experts. Investment bank BTIG is a well-known name on the Street, housing several top analysts. The company has identified three companies in the sector that will present new data over the coming months, and BTIG analysts think positive results can propel each of them forward.Using the Stock Comparison tool from TipRanks, a company that tracks and measures the performance of analysts, we were able to zero in on their choices and find out why the firm finds them so compelling. Let’s get familiar with the data at hand. Sarepta Therapeutics (SRPT)Let’s start off with a good example of the impact regulatory forces can have on a stock. Sarepta Therapeutics made headlines towards the end of 2019, when the FDA approved Vyondys 53, the company’s treatment for Duchenne muscular dystrophy (DMD) patients with exon 53 mutations. The approval came as a surprise as only a few months earlier, Sarepta received the dreaded CRL (complete response letter) from the FDA following its original submission. As is de rigueur in the sector, Sarepta stock responded to the announcement by soaring over 30% in a day.In addition to the recently approved drug, the genetic disorder-focused biotech has a robust pipeline, with gene therapy programs in DMD and LGMD (Limb Girdle Muscular Dystrophy). BTIG’s Tim Chiang believes the company is steadily progressing with these key programs.The analyst said, “We believe SRPT is making progress on the gene therapy manufacturing front, and has achieved yields sufficient to begin study 301 (which we think could enroll up to a hundred or more patients). We believe SRPT plans to provide an interim look at data from this study in ~15 patients dosed (evaluating expression levels at ~3 months post dosing). In LGMD2E, SRPT has dosed two patients in the higher dose cohort, with a third patient to be dosed shortly. We expect a data read out from this high dose arm in early 2Q.”Chiang expects that US gene therapy sales in the DMD market will reach a peak in 2024, with the figure landing at roughly $2 billion. There are three companies currently in the race to develop gene therapies for the treatment of DMD; Sarepta, according to the analyst, is leading the way and could be the first to enter the US market with its gene therapy for DMD in the second half of 2021.Chiang added, “We think one of the key differences among the 3 micro-dystrophin gene therapy programs in the clinic are that both Solid Biosciences (SLDB, Neutral) and Pfizer have studies where ascending dose cohorts are being utilized. In contrast, Sarepta’s study incorporates just one dose (2E14 vg/kg).”So, what does this mean? It means Chiang kept his Buy rating on Sarepta, along with a price target of $190. Should the target be met, investors stand to see a handsome 64% gain over the next year. (To watch Chiang’s track record, click here)The Street, too, is bullish on the DMD fighter. A Strong Buy consensus rating breaks down into 18 Buys and a single Hold. The average price target comes in at $204.33 and indicates potential upside of 76%. (See Sarepta stock analysis on TipRanks) IMV Inc. (IMV)IMV’s market performance in 2019 was a disappointing affair; The stock lost 39% of its value along the way. By contrast, 2020’s performance so far has been the exact opposite - and some. The stock is up by 58% year-to-date. According to BTIG’s Thomas Shrader, there is more to come, too.The cancer fighter’s lead candidate is DPX-Survivac, which targets the surviving TAA (tumor associated antigen) that is overexpressed in more than 20 different types of cancers. Clinical data so far has been promising, with long disease-free intervals in the ovarian cancer (OC) adjuvant setting and compelling treatment response rates in both OC and DLBCL (diffuse large B-cell lymphoma). Important DPX-Survivac data is expected this quarter which Shrader notes “could greatly de-risk the current programs and potentially demonstrate the utility of the low-COGS DPX platform to deliver many other TAAs and neoantigens.”The 5-star analyst added, “The drug has shown robust and prolonged CD8 TCell responses in the adjuvant setting and a Phase 1b/2 trial has shown a 100% DCR and 60% ORR in the subgroup of patients with non-bulky disease (tumor burden < 5 cm) most of which are platinum-resistant (few treatment options). The company expects to provide topline Phase 2 monotherapy data in mid-February 2020 that we expect to be an important catalyst for the story.”Ahead of this upcoming data readout, Shrader is siding with the bulls. The analyst initiated coverage of IMV with a Buy rating along with an $8 price target. The implication? Further gains in the shape of 75% over the next 12 months. (To watch Shrader’s track record, click here)The Street agrees. A total of 6 Buys add up to a unanimous Strong Buy consensus rating. With an average price target of $9.31, the analysts see potential upside of 104% for IMV over the coming 12 months. (See IMV stock analysis on TipRanks) Cue Biopharma Inc. (CUE)A fellow company taking the fight to cancer is Cue Biopharma. In 2019, Cue’s exceptional performance beat the market considerably. The stock added an astounding 238% to its share price throughout the year. Following such a surge, though, is this the right time to get in on this high-flying biotech?Yes, it is, according to BTIG’s Thomas Shrader. In fact, the 5-star analyst just recently initiated coverage of Cue with an emphatic Buy rating. The thumbs up comes with a price target of $26, indicating Shrader believes an additional 71% will be added to Cue’s share price over the next 12 months.So, what’s all the fuss about, then? A cure for cancer is one of modern medicine’s most coveted prizes. Cue is working on an immunotherapy platform which will assist immune systems by recognizing solid tumor cells and repeatedly attacking them until they stop working.The company’s lead candidate is CUE-101, which was developed for patients with head and neck cancer driven by human papillomavirus (HPV). Topline results from a Phase 1 trial are expected later this year, and so far, results have been promising.Shrader said, “Data to date is preclinical but the lead programs termed CUE-101 has exploited well defined subunits and demonstrated tumor antigen-specific T-cells responses without the accompanying systemic immune toxicities that characterize many competing approaches… Preclinical data confirm both robust T-Cell responses and an attractive safety profile setting the stage for clinical studies. These studies have stated (first dosing September 2019) and, based on the preclinical safety profile, will begin with doses that could be efficacious. Clinical data validating the overall approach are expected around 3Q20 and, if promising, a significant pipeline in additional applications should be de-risked.”Currently, the rest of the Street remains rather quiet on Cue, with only one other analyst chipping in with a take on the biotech’s prospects. The additional Buy recommendation means Cue receives a Moderate Buy consensus rating. The average price target comes in at $24 and implies upside potential of 58%. (See Cue Biopharma stock analysis on TipRanks)
Sarepta Therapeutics, Inc. (SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on January 31, 2020 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to nineteen individuals hired by Sarepta in January 2020. The employees received, in the aggregate, options to purchase 24,310 shares of Sarepta's common stock, and in the aggregate, 12,175 restricted stock units (“RSUs”). The options have an exercise price of $115.96 per share, which is equal to the closing price of Sarepta's common stock on January 31, 2020 (the “Grant Date”).
Frustrated with the slow pace of drug discovery and desperate to help their loved ones, untrained family members take the work into their own hands by starting biopharma companies. But few such companies have been successful.
Investors seeking out high growth for their portfolios will often turn to biotech stocks. The biotechnology industry, which has become densely populated as our understanding of living systems and organisms continues to expand, has earned a reputation on Wall Street for its explosive potential ... and high volatility.In contrast to companies in other sectors, the gains and losses in even the best biotech stocks hinge less on earnings results, and more on a few key indicators such as trial-data readouts or verdicts from regulatory agencies. Product approvals unlock vital revenues, so a single positive update can function as a catalyst that propels shares to new highs.Of course, there's a reason risk-averse investors shy away from these stocks: The opposite also holds true.Wall Street pros rightly advise a cautious approach when evaluating the biotechnology industries. We find that monitoring the analyst community can be helpful on a couple fronts: For one, we can see where the pros are putting their faith. Also, analysts can provide much-needed insight into many stocks that get little media coverage, and whose progress can be difficult to gauge unless you're a medical expert.We used TipRanks' Stock Screener tool to comb through hundreds of biotechnology stocks to identify promising picks - ones that have received enough lopsided support from analysts that they earn TipRanks' top Strong Buy consensus rating. Here, we have found five top biotech stocks with overwhelmingly bullish sentiment from the analyst community, and price-growth projections of between 28% and 82%. SEE ALSO: 8 Stock Picks Getting Hit by Coronavirus Fears
Shares of SRPT stock toppled Thursday after U.S. regulators unveiled the concerns that led them to initially reject Sarepta Therapeutics' newest Duchenne muscular dystrophy drug, Vyondys 53.
NEW YORK, Jan. 23, 2020 -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder law firm, is investigating certain officers and directors of Cardinal Health,.
Patient deaths, testing concerns and “weak arguments.” Those are just a few of the issues the FDA had with Sarepta Therapeutics’s recent drug application, according to new documents released this week.
(Bloomberg Opinion) -- Today’s Food and Drug Administration moves much faster than it used to. That may not always be a good thing. A review of drug approvals by the agency from researchers at Harvard Medical School released Tuesday found that the FDA is approving drugs more rapidly with weaker evidence than it did in the past. That can be beneficial when it leads to needed medicines getting to market quickly, and I believe that’s the agency’s intent. As the study’s authors highlight, however, this emphasis on speed and flexibility could be eroding standards. It may be time for a gut check.The gold standard for demonstrating efficacy — and the surest way of winning drug approval — is to demonstrate success in large, well-controlled studies that result in a hard outcome. But there are faster ways to get to market. In 1992, Congress created the accelerated approval program, which can green light medicines based on “surrogate” endpoints that predict rather than confirm benefit for patients, or those that have shown a shorter-term benefit. It’s one of several initiatives that have changed how the agency works. According to the study, 80.6% of approvals between 1995 and 1997 were supported by at least two pivotal trials. That number dropped to 52.8% between 2005 and 2017. Companies that get accelerated approval have to prove their drug works with a confirmatory trial in order to gain full approval, but there’s no hard timetable no when that must be done. Thus, drugmakers often don't hurry to conduct those tests. This is problematic at best, dangerous at worst.Here’s just one case: In 2016, Sarepta Therapeutics Inc. sought approval of a medicine to treat a rare muscle-wasting disease in young boys based on weak evidence from a tiny trial. In the face of significant public pressure, the FDA approved Exondys 51 even though one of its scientists called the treatment “an elegant placebo” in a report. Sarepta is selling the drug for over $300,000 a year but has continually delayed a confirmatory trial. It’s now years away from completion, and there have been no real consequences for the delay.When companies do complete post-approval trials, it sometimes reveals a mistake. Eli Lilly & Co.’s cancer drug Lartruvo got accelerated approval in 2016. Lilly then pulled the medicine from the market last year after a larger trial found no benefit. That’s a rare outcome, but there are many expensive drugs on the market that have never moved beyond surrogate endpoints. A study of 93 accelerated cancer drug approvals between 1992 and 2017 found that only 19 had proved to help patients live longer in a followup trial. There are some good reasons for faster approvals, as former FDA Commissioner Scott Gottlieb outlined in a Twitter response this week to a critical New York Times editorial penned on Jan. 11. Scientists are better at evaluating the safety of medicines and trial design has improved, for example. And advances have made it easier to create drugs that target small populations and have dramatic effects, Gottlieb wrote.He makes good points. But the agency arguably hasn’t found the right balance between embracing advances and maintaining a high bar. It certainly has a ways to go on post-approval follow up. America is entirely unable to control the price of new medicines; the approval of marginal drugs has financial consequences. The FDA will soon face one of its most important and controversial decisions yet. Biogen Inc. is seeking approval for the first purportedly disease-modifying Alzheimer’s drug — a medicine that could be used by millions of people and cost billions — without good evidence that it works. The agency often uses unmet need as a justification for shifting standards, and there’s no bigger unmet need than Alzheimer’s. That doesn’t justify an approval based on one failed trial and another that is a questionable success at best.The agency will have to decide whether to review or approve the medicine in the next year or so. This choice is an opportunity to resist public pressure and move back toward demanding firmer proof of efficacy before drugs hit the market. To contact the author of this story: Max Nisen at firstname.lastname@example.orgTo contact the editor responsible for this story: Beth Williams at email@example.comThis column does not necessarily reflect the opinion of 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/opinionSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.
Sarepta Therapeutics, Inc. (SRPT), the leader in precision genetic medicine for rare diseases, announced that it has appointed John C. Martin, Ph.D., to its Board of Directors, effective today. Dr. Martin brings decades of executive leadership to Sarepta’s board, having played an instrumental role in building one of the world’s foremost biotechnology companies. During his 20-year tenure as chief executive officer of Gilead Sciences, he oversaw the growth of the company and development of its scientific portfolio into 24 marketed products.
Applied Genetic's (AGTC) gene therapy candidate shows promise in an early-stage study to treat X-linked retinitis pigmentosa, a rare eye disorder.
Shareholder rights law firm Robbins LLP announces that a purchaser of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) filed a class action complaint for alleged violations of the Securities Exchange Act of 1934 between September 6, 2017 and August 19, 2019. Sarepta Therapeutics focuses on the discovery and development of RNA-based therapeutics, gene therapy, and other genetic medicine for the treatment of rare diseases. Sarepta's products pipeline includes its drug golodirsen for the treatment of duchenne muscular dystrophy ("DMD").
CAMBRIDGE, Mass., Jan. 06, 2020 -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management.
Hedge funds and other investment firms that we track manage billions of dollars of their wealthy clients' money, and needless to say, they are painstakingly thorough when analyzing where to invest this money, as their own wealth also depends on it. Regardless of the various methods used by elite investors like David Tepper and David […]
A gene therapy invented at Nationwide Children's Hospital just landed a licensing deal worth up to $2.8 billion for a Boston biotech, and now the company's Columbus office will play a big role in getting the treatment to the market.
Sarepta Therapeutics Inc (NASDAQ: SRPT ) has entered a partnership with Roche (OTC: RHHBY ) to commercialize SRP-9001, its gene therapy for Duchenne Muscular Dystrophy, outside of the U.S. The deal secures ...
Biopharma M&A activity scaled record highs in 2019, with a few mega mergers announced involving names such as Bristol-Myers Squibb Co (NYSE: BMY ), Roche Holdings AG Basel ADR (OTC: RHHBY ) and AbbVie ...