|Bid||50.00 x 900|
|Ask||62.50 x 800|
|Day's Range||49.57 - 52.14|
|52 Week Range||33.43 - 56.50|
|Beta (3Y Monthly)||2.06|
|PE Ratio (TTM)||N/A|
|Earnings Date||Nov 6, 2017 - Nov 10, 2017|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||64.36|
EVP, CFO, Treasurer & Sec. of Zogenix Inc (30-Year Financial, Insider Trades) Michael P Smith (insider trades) sold 15,000 shares of ZGNX on 08/09/2019 at an average price of $50 a share. Continue reading...
EMERYVILLE, Calif., July 30, 2019 -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it will report its.
The company's stock dropped 20 percent in April. Now it has largely recovered and is lining up to ask the FDA to approve its drug for Dravet syndrome.
Zogenix, Inc. (ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it has completed enrollment for, and randomized the last patient into the treatment period of, Study 1601, the Company’s Phase 3 clinical trial of its lead investigational therapy, FINTEPLA® (ZX008, fenfluramine), for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), a severe and often treatment-resistant childhood-onset epilepsy. Study 1601 is a multi-national, randomized, double-blind, placebo-controlled trial of two fixed doses of FINTEPLA as adjunctive therapy for seizures in children and adults with LGS. After establishing a baseline seizure frequency for four weeks, patients are randomized into one of three treatment groups (0.2 or 0.8 mg/kg/day FINTEPLA, maximum of 30 mg/day, or placebo) for a two-week period of dose titration before being held at a fixed dose for 12 weeks of maintenance treatment. The study randomized a total of 263 patients, with approximately 87 subjects per group. The primary endpoint of the clinical trial is the change in the number of seizures that result in drops between baseline and the combined titration and maintenance periods at the 0.8 mg/kg/day dose compared to placebo. The key secondary endpoints include change in the number of drop seizures between baseline and the combined titration and maintenance periods at the 0.2 mg/kg/day dose compared to placebo, and the proportion of patients achieving a 50% reduction in drop seizures. Patients who complete the maintenance treatment period may be eligible to enter a 12-month open-label extension to evaluate the long-term safety, tolerability and effectiveness of FINTEPLA in LGS.
Biotech is a tough market to follow. Promising research avenues hit roadblocks, clinical trials can fail, and regulators can withhold approval. And all of that can happen to companies that frequently operate at a loss, with high initial overhead costs and a long road toward profitability.The rewards, however, are great. A new drug hitting the market, or news of a successful long-term trial, can bring in new investors and give a tremendous boost to a company’s shares. We’ve sorted through the data to find three biotechs that are making waves. These are mid- to large-cap firms, with new drugs in the pipeline or recently released, and high expectations for near-term returns. Amarin Corporation, Plc. (AMRN)Cardiac disease is a leading killer, and the American consumer is willing to pay a premium for cholesterol-reducing drugs of proven efficacy. Amarin has entered that niche with its sole product, Vascepa, a new drug based on Omega-3 fatty acids.You’ve heard of Omega-3, of course – it has been promoted for years as a dietary supplement for cardiovascular health. With Vascepa, Amarin has concentrated the active factors to create, not a supplement, but a hypertriglyceridemia drug for the specific treatment of high cholesterol. Vascepa was approved by the FDA in 2012, was promptly entered into the multi-year REDUCE-IT study, and in September 2018 Amarin announced the study results. In the controlled study of 8000 patients over six years, Vascepa showed significant results in preventing heart attacks. AMRN shares jumped from under $3 per share to over $15, and have held those gains.Now the company is looking to use its profits for expansion. Per Roth Capital’s Yasmeen Rahimi, “Amarin provided record revenue for the first half of 2019 for Vascepa, guided $380M-420M for 2019 and unveiled its plans to increase its U.S. sales team to about 800 in October 2019.” Rahimi sees this move as the beginning for Vascepa, heralding the drug’s conversion to a true money-maker for the Amarin. She gives the stock a $31 price target, suggesting an upside of 33%.Jefferies analyst Michael Yee agrees with the rosy outlook for Vascepa’s profit potential. He notes the “positive pre-announcement with upside Q2 sales beat and full-year guidance raise supporting the thesis of strong Vascepa launch and greater outlook and opportunity than consensus expectations.” Yee adds that he sees the stock moving higher to the upside on increases future sales. His price target, $30, implies a 29% potential for share price gains.Amarin has been doing well, on Vascepa’s strong reviews and success in the market. The stock has a unanimous analyst consensus of ‘Strong Buy,’ based on 6 buy ratings in the past three months. The average price target, $32, gives a 41% upside to the share price of $23.View AMRN Price Target & Analyst Ratings Detail Gilead Sciences, Inc. (GILD)Gilead is well-established in the pharma sector – it’s a major player on the American medical research scene, and holds a dominant position the HCV and HIV drug research segments. Casual consumers are more likely to encounter Gilead through its popular anti-viral drug Tamiflu, marketed as an OTC preventative and treatment for the flu.In recent development, Gilead has been moving filgotinib, a potential treatment for rheumatoid arthritis, forward in testing. Filgotinib is now if Phase III trials, and the company has announced that it will file a New Drug Application with the FDA – the next step in getting approval before marketing.Writing from RBC Capital, four-star analyst Brian Abrahams notes several factors that are boosting GILD stock. Filgotinib’s regulatory progress is prominent on the list. Abrahams also says that stock’s “valuation looks cheap and at a floor,” and points out the “strong balance sheet and solid dividend yield.”That last is an important point; most biotech firms do not pay any dividend, but Gilead initiated payments in 2015. The yield is now up to 3.68%, and payouts are $2.52 annualized, making it a strong incentive for investors. Abrahams’ price target on GILD, $91, indicates a 32% upside to the stock.Alethia Young, of Cantor Fitzgerald, has been following Gilead for several years, and had previously estimated that filgotinib would launch in the US in 2022 with initial sales up to $93 million. Citing the “positive" U.S. filing update,” she now believes that the timeline has moved up by at least one year and sees a potential approval in late 2020. She raised her price target on the stock to $88 to reflect her optimism.Gilead’s overall rating is a ‘Moderate Buy,’ based 13 buys, 5 holds, and 1 sell assigned during the past three months. The stock’s current share price is $68, and the average price target is $79; this gives GILD shares a 15% upside potential.View GILD Price Target & Analyst Ratings Detail Zogenix, Inc. (ZGNX)Like many smaller biotech research firms, Zogenix does not yet have a drug on the market. Unlike most such firms, however, Zogenix’ main research program is a reuse of a previously approved drug, fenfluramine. This was used in the past as a treatment for obesity; Zogenix has been researching its potential has a seizure treatment for children with the rare disease Dravet Syndrome. The studies have reached Phase III, and have shown some promise.The company’s stock took a hit, however, when the FDA last quarter ‘refused to file’ Zogenix’ application for fenfluramine as a new drug, branded Fintepla, for seizure treatment. ZGNX shares lost more than $10, and the company had to shift focus to bureaucratic streams.ZGNX got a boost last month, when the FDA reversed course. Regulators have said that they will permit the new drug application for Fintepla, and without additional preclinical toxicity data. According to Danielle Brill, pharma sector analyst from Piper Jaffray, this was the “best case scenario for Zogenix.” She says, “Although breakthrough therapy status was rescinded due to the recent approvals of two other drugs for Dravet Syndrome, expect an expedited review [with] approval and launch by Q2 of 2020. [Do] not expect the delay to have any meaningful impact on Fintepla's overall commercial potential.” She gives ZGNX shares a $64 price target, suggesting a 34% upside.Difei Yang, of Mizuho, also sees the FDA’s regulatory reversal as a win for Zogenix. She says, “A priority review is highly likely and the FDA's decision is a positive.” Yang bumped her price target up to $65, indicating confidence in a 36% upside.Zogenix’ upbeat regulatory outlook has given it support in the markets. Shares stand at $47, up $8 since the FDA decision. The average price target is $61, giving the stock a 28% upside potential. And like Amarin, the analysts are unanimous on ZGNX – 9 buy ratings give it a ‘Strong Buy’ consensus rating.View ZGNX Price Target and Analyst Ratings DetailVisit TipRanks’ Trending Stocks tool to see what else is hot in today’s markets.
President and CEO of Zogenix Inc (NASDAQ:ZGNX) Stephen J Farr sold 34,225 shares of ZGNX on 07/03/2019 at an average price of $48.01 a share.
Zogenix stock popped Thursday after the Food and Drug Administration said the biotech company can resubmit its application for a seizure treatment without running additional studies.
Zogenix, which focuses on developing rare disease therapies, said following the receipt of the minutes of a May 30 Type A meeting with the FDA, it plans to resubmit the NDA for Fintepla, its investigational asset for the treatment of seizures associated with Dravet syndrome, in the third quarter. The Type A meeting was scheduled after the FDA issued a Refusal to File letter April 5, citing two issues: non-submission of non-clinical studies and an incorrect version of a clinical dataset within the application. The FDA has agreed to the company's plan to resubmit the NDA without the inclusion of the new chronic toxicity studies requested by the agency.
Zogenix, Inc. (ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that following receipt of final minutes from the U.S. Food and Drug Administration (FDA) from the Type A meeting held on May 30, 2019, the Company intends to resubmit its New Drug Application (NDA) for FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome in the third quarter of this year.
Is Zogenix, Inc. (NASDAQ:ZGNX) a good bet right now? We like to analyze hedge fund sentiment before doing days of in-depth research. We do so because hedge funds and other elite investors have numerous Ivy League graduates, expert network advisers, and supply chain tipsters working or consulting for them. There is not a shortage of […]
NEW YORK, NY / ACCESSWIRE / June 11, 2019 / The Klein Law Firm announces that class action complaints have been filed on behalf of shareholders of the following companies. If you suffered a loss you have ...
Glancy Prongay & Murray LLP (“GPM”) reminds investors of the upcoming June 11, 2019 deadline to file a lead plaintiff motion in the class action filed on behalf of Zogenix, Inc. (“Zogenix” or the “Company”) (NASDAQ: ZGNX) investors who purchased securities between February 6, 2019 and April 8, 2019, inclusive (the “Class Period”). If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Lesley Portnoy, Esquire, at 310-201-9150, Toll-Free at 888-773-9224, or by email to email@example.com, or visit our website at www.glancylaw.com. On April 8, 2019, Zogenix announced that it received a refusal to file letter from the U.S. Food and Drug Administration (“FDA”) regarding Zogenix’s new drug application (“NDA”) for FINTEPLA, Zogenix’s proposed treatment for seizures associated with Dravet syndrome.
NEW YORK, NY / ACCESSWIRE / June 11, 2019 / The securities litigation law firm of The Gross Law Firm issues the following notice on behalf of shareholders in the following publicly traded companies. Shareholders ...
NEW YORK, NY / ACCESSWIRE / June 11, 2019 / Bronstein, Gewirtz & Grossman, LLC reminds investors that a class action lawsuit has been filed against the following publicly-traded companies. You can review a copy of the Complaints by visiting the links below or you may contact Peretz Bronstein, Esq. If you suffered a loss, you can request that the Court appoint you as lead plaintiff.
NEW YORK, NY / ACCESSWIRE / June 10, 2019 / Levi & Korsinsky, LLP announces that class action lawsuits have commenced on behalf of shareholders of the following publicly-traded companies. Shareholders ...
LOS ANGELES, CA / ACCESSWIRE / June 10, 2019 / The Schall Law Firm , a national shareholder rights litigation firm, announces the filing of a class action lawsuit against Zogenix, Inc. ("Zogenix" ...
NEW YORK, NY / ACCESSWIRE / June 10, 2019 / Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Zogenix, Inc. (NASDAQ: ZGNX) from February 6, 2019 through April 8, ...