|Bid||92.96 x 900|
|Ask||93.49 x 900|
|Day's Range||92.00 - 97.47|
|52 Week Range||72.05 - 158.80|
|Beta (5Y Monthly)||2.04|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
Sarepta Therapeutics (SRPT) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
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.
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.
Applied Genetic's (AGTC) gene therapy candidate shows promise in an early-stage study to treat X-linked retinitis pigmentosa, a rare eye disorder.
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 ...
Sarepta Therapeutics announced it will partner with Roche to sell a key gene therapy outside the U.S. The deal is worth $1.15 billion initially to Sarepta. SRPT stock rocketed on the news.
Roche Holdings AG Basel ADR (OTC: RHHBY) said Monday that it has signed a licensing agreement with Sarepta Therapeutics Inc (NASDAQ: SRPT) to acquire the commercial rights to the latter's investigational gene therapy asset SRP-9001 outside of the U.S. The asset is being evaluated in Duchenne muscular dystrophy. DMD is a rare degenerative neuromuscular disorder that causes severe progressive muscle loss and premature death. Additionally, Sarepta could pocket $1.7 billion in potential regulatory and sales milestones, as well as royalties on net sales.
Sarepta (SRPT) grants ex-U.S. marketing rights of its gene therapy DMD candidate, SRP-9001, to Roche for an upfront payment of $1.15 billion. Sarepta is also eligible to receive $1.7 billion in milestone payments.
Benzinga Pro's Stocks To Watch For Monday Sarepta Therapeutics (SRPT) - Shares were up about 9% Monday morning following news of a partnership with Roche (RRHBY) for its investigational micro-dystrophin ...
The Swiss drugmaker closed a $4.3 billion deal to acquire Sparks Therapeutics this month, underscoring the growing appetite among large drugmakers for gene therapies. Roche will make an upfront payment of $750 million in cash and take a $400 million stake in Sarepta, priced at $158.59 per share, a premium of about 26% to the U.S. drugmaker's closing price on Friday.