|Bid||8.91 x 4000|
|Ask||9.00 x 800|
|Day's Range||6.74 - 8.99|
|52 Week Range||4.32 - 54.54|
|Beta (3Y Monthly)||N/A|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 14, 2019 - Aug 14, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||8.93|
(Bloomberg) -- Sarepta Inc.’s bizarre plunge last week over an “erroneous” safety report only galvanized the one analyst on Wall Street who isn’t bullish on the stock.Oppenheimer’s Hartaj Singh remains skeptical of the company’s valuation, aspirations and the lack of disclosures, which came to a head after one of its drugs was cited in a government database tracking adverse events. That posting triggered a sell-off in the stock even though Sarepta said the safety signal wasn’t submitted by an employee or the principal investigator leading the drug’s clinical trial.A broader lack of transparency surrounding Sarepta’s gene therapy trials in Duchenne muscular dystrophy has stoked questions from investors, according to Singh. The company has run its trials at one center, while peers have expanded to multiple sites.“People are puzzled with why the data hasn’t been presented” by a person that isn’t associated with the company, said Singh, the only analyst tracked by Bloomberg who doesn’t have a buy rating on the stock. Lack of clarity about the data combined with an escalating market valuation that now tops $9 billion -- 16th-largest in the Nasdaq Biotechnology Index -- suggests Sarepta investors are “pricing in perfection at these levels,” he said.“The study is ongoing and blinded and will remain blinded -- and that is why the data haven’t been presented,” a Sarepta spokeswoman commented by telephone.Last week’s safety posting followed at the heels of Sarepta announcing that it was increasing the number of patients in a closely watched study and delaying the start of a trial that would use commercial scale of its gene therapy.A key for bullish investors had been the drug’s superior safety profile and more proof of clinical benefit versus competitors like heavyweight Pfizer Inc. and small-cap Solid Biosciences Inc. At the same time, Sarepta has only treated “four boys over the last few years,” Singh said. Potential regulatory clearance isn’t likely until late 2021 if the company gets accelerated approval, or could take until 2023 while the company gathers more data, he said. Some other analysts expect sales could start in 2021.“We have initiated and completed dosing 24 patients in the Phase 2 study and are dosing up to 40 total patients while doing the manufacturing work to start the Phase 3 trial with commercial drug in early 2020,” the company’s spokeswoman said. “We’re moving with incredible urgency.”Singh said in a phone interview that gene therapy is “much more complicated and going to take a lot more time than people are expecting, and we’ve said that since April. The gap between Sarepta and Pfizer is probably in months as opposed to the current thinking that it’s in years.”To be sure, manufacturing concerns have long been a bear argument that buy-rated analysts have dismissed as irrelevant. Sarepta said setbacks for Pfizer and Solid Biosciences helped persuade the company to spend more time optimizing its commercial production capabilities. And Wall Street bulls say that will help reduce risks for the program, which is the first of its kind.While focus has been on Sarepta and its gene therapy portfolio, the drugmaker already sells Exondys 51 for patients with DMD, and may add another drug to its arsenal next week with the upcoming FDA decision for Vyondys 53 (formerly golodirsen). That drug would have the potential to treat about 8% of boys with exon 53-skipping DMD. Analysts expect it could bring in $217 million in sales by 2022 if approved, compared to $1.5 billion for the gene therapy and $496 million for Exondys 51, data compiled by Bloomberg show.(Updates with company comments in the fifth and eighth paragraphs.)To contact the reporter on this story: Bailey Lipschultz in New York at email@example.comTo contact the editors responsible for this story: Catherine Larkin at firstname.lastname@example.org, Steven FrommFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
– Additional patient dosed at 2E14 vg/kg in second cohort of IGNITE DMD trial – – Study protocol amended to expedite clinical execution of SGT-001 – – Recent $60M.
Sarepta (SRPT) reports wider year-over-year loss. However, revenues increase year over year. The company plans expansion of gene therapy program into other indications including multiple sclerosis.
SVB Leerink acted as the exclusive placement agent to the Company in connection with the private placement. In this private placement, the Company is selling 10,607,525 shares of common stock at a price of $4.65 per share, representing a premium to the share price as of market close on July 25, 2019.
Sarepta's (SRPT) shares surge after safety issues are observed in Pfizer's early-stage clinical study related to its gene therapy for DMD.
Pfizer (PFE) presents early data from a study on its investigational gene therapy for DMD. However, the study highlighted some serious side effects in two out of the six participants.
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 […]
Sarepta Therapeutics stock rocketed in high volume Friday after Pfizer said its gene therapy test is on pause following serious side effects in two boys with Duchenne muscular dystrophy.
Bain Capital has unveiled an approximately $1.1 billion life sciences fund, its second targeting the fast-growing industry, a spokesperson for the private equity giant said Wednesday. As a private equity firm, it generally makes later-stage investments than many of the venture capital firms that target the biotech sector.
Biotech giant Vertex Pharmaceuticals announced plans Thursday to acquire a Cambridge-based preclinical gene editing startup, giving a run for the money to fellow Cambridge drugmaker Sarepta Therapeutics and others developers of drugs for Duchenne muscular dystrophy.
NEW YORK, May 16, 2019 -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Solid Biosciences Inc..
An analyst suggested investors look at Sarepta Therapeutics' array of gene therapies on Tuesday after rival Solid Biosciences reported its key gene therapy caused side effects in a patient.
(Bloomberg Opinion) -- It’s easy to get excited about gene therapies, a group of new medicines that have the potential to cure diseases in one treatment. The saga of Solid Biosciences Inc. is a reminder that tweaking genes isn’t a trivial task. These therapies are full of promise, but they’re not entirely there yet.
The gene therapy developer appears to be struggling to find a safe and effective dose of its experimental Duchenne muscular dystrophy treatment.
Solid Biosciences said in the earnings release that, among the two patients randomized in the second cohort of the Phase 1/2 study dubbed IGNITE, one was dosed with 2E14 vg/kg of its DMD gene therapy candidate and another was added to the control group. The patient in the treatment arm experienced a transient decline in platelet count, considered a serious adverse event, or SAE, related to the study. The patient also experienced a transient elevation of transaminases as well as a transient increase in bilirubin, higher than two times the upper limit of normal, which was reported as an SAE related to the study, the company said.
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on May 13) BioSig Technologies Inc (NASDAQ: BSGM ) Milestone Pharmaceuticals ...
– Dosing of SGT-001 initiated in second cohort of patients in the IGNITE DMD clinical trial at 2E14 vg/kg – – Clinical activities underway at additional study sites –.
How do you pick the next stock to invest in? One way would be to spend hours 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 […]
Wave Life Sciences (WVE) announces final safety data from a phase I DMD study evaluating suvodirsen and provides design update for phase II/III stage development of the candidate.
Bain Capital is in the process of raising money for a second life sciences fund, less than two years after it amassed $720 million for its inaugural fund targeting the fast-growing sector. Bain revealed the new fund in a securities filing last week. The filing does not say how much the Boston-based private equity firm is hoping to raise.
CAMBRIDGE, Mass., April 15, 2019 -- Solid Biosciences Inc. (NASDAQ:SLDB) today announced that preclinical data from its gene therapy program for Duchenne muscular dystrophy.
Gene therapy continues to be in focus given the recent spate of deals and acquisitions. We highlight four stocks, which have promising gene therapy candidates in their pipeline.
With one drug already being considered by the FDA, Sarepta Therapeutics Inc. is now planning to submit another drug for Duchenne muscular dystrophy to the FDA this year.