|Bid||154.25 x 900|
|Ask||155.00 x 800|
|Day's Range||151.33 - 154.97|
|52 Week Range||42.97 - 176.50|
|PE Ratio (TTM)||N/A|
|Earnings Date||Oct 23, 2018 - Oct 29, 2018|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||188.55|
Sarepta Therapeutics CEO Douglas Ingram discusses the status of his company's drug trials and what's been driving the stock higher this year.
The FDA has lifted clinical hold on Sarepta's (SRPT) clinical study evaluating the Duchenne muscular dystrophy micro-dystrophin gene therapy program. The clinical hold was placed in July by the FDA.
The CHMP re-confirmed the negative opinion for Sarepta's (SRPT) Exondys, which is developed to treat individuals who have a specific type of Duchenne muscular dystrophy.
Sarepta Therapeutics Inc. shares rose 1.6% in Monday premarket trade after the U.S. Food and Drug Administration lifted a clinical hold from the company's gene therapy for the rare disease Duchenne muscular dystrophy. The FDA had previously placed the hold on July 25 "due to the presence of a trace amount of DNA fragment in research-grade third-party supplied plasmid," Sarepta previously said. Sarepta made and submitted an "action plan" to the FDA, which includes an audit of the plasmid supplier and Sarepta committing to using plasmid made according to the FDA's "good manufacturing practices" in the future. The company hopes to get a registration trial for the gene therapy program started by the end of the year, Chief Executive Doug Ingram said. Sarepta shares have surged 5.2% over the last three months, compared with a 6.3% rise in the S&P 500 and a 8.8% rise in the Dow Jones Industrial Average .
Sarepta Therapeutics, Inc. (SRPT), a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases, announced today that the Food and Drug Administration (FDA) has lifted the clinical hold for the Company’s Duchenne muscular dystrophy (DMD) micro-dystrophin gene therapy program. Sarepta previously announced on July 25, 2018, that the FDA placed the program on clinical hold due to the presence of trace amounts of DNA fragment in research-grade third-party supplied plasmid in a manufacturing lot.
Sage Therapeutics (SAGE), a clinical-stage biopharmaceutical company, is developing medicines for the treatment of life-altering central nervous system disorders like major depressive disorder, Parkinson’s disease, postpartum depression, and others.
European approval of the drug "is a matter of 'when' not 'if,'" according to one analyst note.
Sarepta Therapeutics Inc. said Friday that the Committee for Medicinal Products for Human Use (CHMP) European Medicines Agency (EMA) upheld the negative opinion for the company's conditional marketing application for eteplirsen, for the treatment of Duchenne muscular dystrophy. The stock was still inactive in premarket trade. "While largely anticipated, we are disappointed with the outcome of the CHMP re-examination and firmly believe that eteplirsen should be made available to patients in Europe, as it is in the United States," said Chief Executive Doug Ingram. The company had received the negative opinion on May 31, after which it requested a re-examination of the opinion. The stock had nearly tripled year to date (up 175%) through Thursday, while the S&P 500 has gained 9.6%.
Sarepta Therapeutics, Inc. (SRPT), a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has confirmed its 31 May 2018 negative opinion for a Conditional Marketing Application for eteplirsen. Eteplirsen is designed to treat approximately 13% of the Duchenne muscular dystrophy community who have genetic mutations amenable to exon 51 skipping.
The last change in the short interest score occurred more than 1 month ago and implies that there has been little change in sentiment among investors who seek to profit from falling equity prices. Index (PMI) data, output in the Healthcare sector is rising.
Solid Biosciences (SLDB) incurred a net loss of $17.98 million in the second quarter of 2018, which compares to a net loss of $11.31 million in the second quarter of 2017, translating to a net loss per share of $0.52 in the second quarter of 2018. Its net loss per share was $0.66 in the second quarter of 2017. The decrease in net loss per share was due to an increase in the company’s outstanding shares, which increased from 17.04 million in the second quarter of 2017 to 34.45 million in the second quarter of 2018.
In the second quarter, PTC Therapeutics generated revenues of $68.7 million—compared to $48.0 million in the second quarter of 2017, which reflected ~43% growth YoY (year-over-year). In the first half of 2018, PTC Therapeutics reported net revenues of $124.8 million—compared to $74.5 million in the first half of 2017.
On September 13, PTC Therapeutics’ stock price closed at $47.33, which is ~0.66% growth from the close of $47.02 the previous day.
Sarepta Therapeutics (SRPT) has returned 169.97% YTD (year-to-date). In the second quarter, it reported EPS of -$0.43, surpassing the consensus estimate by $0.46. EXONDYS 51 sales were $73.5 million in the quarter, which is a YoY (year-over-year) rise of 110%. Wall Street analysts have projected a 12-month consensus target price of $188.58, which is a 25.54% rise over its closing price on September 13. By the end of 2018, Sarepta Therapeutics plans to submit a rolling NDA (New Drug Application) to the FDA for golodirsen, an investigational phosphorodiamidate Morpholino oligomer (or PMO) therapy, in Duchenne muscular dystrophy (or DMD) due to deletions in the DMD gene related to exon 53 skipping.
Sarepta Therapeutics (SRPT) is a commercial-stage biopharmaceutical company focused on developing unique RNA-targeted therapeutics, gene therapy, and other genetic products targeted for rare neuromuscular diseases. Sarepta’s first product on the market, Exondys 51 (eteplirsen), is indicated for treating Duchenne muscular dystrophy (or DMD). In June, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a negative opinion for eteplirsen.
Sarepta Therapeutics (SRPT) incurred a net loss of $109.27 million in the second quarter of 2018 compared to a net loss of $63.05 million in Q2 2017. Its net loss per share was $1.15 in the second quarter of 2017. Despite the surge in revenues, Sarepta’s net loss widened due to higher operating expenses, which increased from $98.35 million in the second quarter of 2017 to $176.96 million in the second quarter of 2018.
Gene therapy involves repairing or replacing disease-causing genes. Investor interest in gene therapy stocks has remained buoyant throughout 2018. According to Allied Market Research, the gene therapy market is expected to grow at a 33.3% CAGR (compound annual growth rate) to $4.4 billion by 2023.
The indices are being jerked around on some news headlines today. These headlines trigger very obvious "buy" algorithms that took the indices into positive territory. Within about 30 minutes the move was totally reversed but some buyers have remained and have the indices off the lows.
The indices have been slowly drifting lower after a gap up open. Early breadth was around 3 to 1 positive but its now down to around 4-3 positive. The bulls are not producing much positive momentum but the bears are doing an even worse job of producing negative momentum.
Sarepta Therapeutics CEO Doug Ingram wants the company to start giving its Duchenne muscular dystrophy gene therapy to children in the approval trial by the end of this year. "We have a big ambition to potentially be to the community within two years thereafter," he says. Sarepta Therapeutics CEO Doug Ingram told CNBC on Friday he has a "big ambition" to get the company's Duchenne muscular dystrophy gene therapy to patients as quickly as possible.
In the second quarter, Spectrum Pharmaceuticals (SPPI) generated net revenues of $24.2 million compared to $34.3 million in Q2 2017. In the first half of the year, Spectrum Pharmaceuticals reported net revenues of $54.7 million compared to $63.4 million in H1 2017.
Sarepta Therapeutics (SRPT) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Sarepta Therapeutics, Inc. (SRPT), a global biopharmaceutical company focused on the discovery and development of precision genetic medicines for the treatment of rare neuromuscular and other rare diseases, will ring Nasdaq’s Opening Bell today in recognition of World Duchenne Awareness Day (WDAD), an observance recognized annually around the world on September 7. “We are fully committed to our mission of bringing a longer, richer life to patients with Duchenne muscular dystrophy. Along with other healthcare companies dedicated to fighting this disease, we believe we may stand at the threshold of a new frontier, unlocking the potential of precision genetic medicine to make a profound difference in the lives of individuals living with rare genetic disease,” said Doug Ingram, Sarepta’s president and chief executive officer.
The Street has a lot of faith in Sarepta Therapeutics, Inc. (NASDAQ: SRPT ). The biotech firm notched its 20th bullish rating Thursday to further neutralize a lone Hold. The Rating Credit Suisse analysts ...