|Bid||0.0000 x 1000|
|Ask||0.0000 x 800|
|Day's Range||0.1810 - 0.1918|
|52 Week Range||0.1210 - 2.0000|
|Beta (5Y Monthly)||1.59|
|PE Ratio (TTM)||N/A|
|Earnings Date||May 12, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||1.50|
KemPharm, Inc. (KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today confirmed that the Company has received a filing communication from the U.S. Food and Drug Administration (FDA), commonly known as the “Day-74 Letter.” The Day-74 Letter stated that the New Drug Application (NDA) for KP415 is sufficiently complete to permit a substantive review by the FDA, and that the target goal date under the Prescription Drug User Fee Act (PDUFA) is March 2, 2021. In addition, the Day-74 Letter indicated that the FDA is not currently planning to hold an advisory committee to discuss the KP415 NDA.
Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 5:00 p.m. ET Corporate and Regulatory Highlights: KP415 NDA filing accepted by FDA on.
Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Tuesday, May 12, 2020, 5:00 p.m. ET CELEBRATION, Fla., May 06, 2020 -- KemPharm, Inc. (Nasdaq:.
KemPharm, Inc. (KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today confirmed that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational product candidate, KP415. Per the definitive collaboration and license agreement (the “License Agreement”) between KemPharm and an affiliate of Gurnet Point Capital (GPC), KemPharm is eligible to receive a regulatory milestone payment of $5 million within thirty (30) days following FDA acceptance of the KP415 NDA.
KemPharm, Inc. (KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that it has submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for its investigational product candidate, KP415, to the U.S. Food and Drug Administration (FDA). KP415 is KemPharm’s product candidate for the treatment of attention deficit hyperactivity disorder (ADHD) which contains serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH).
KP415 NDA Remains on Track for Q1 2020 Submission CELEBRATION, Fla., Feb. 28, 2020 -- KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company focused on the.
Which names are capable of hitting the ball out of the park? The pros will say healthcare stocks. Rookies and seasoned Street veterans alike argue the space contains exciting investment opportunities, with several boasting upside potential that’s often unmatched by stocks in other sectors.For companies that call this area of the market home, a few key milestones such as data readouts, regulatory filings or drug approvals can speak volumes about its future prospects. As a result, all it takes is a single positive outcome to send share prices through the roof. However, there’s a reason these stocks have earned a Wall Street reputation as being risky plays. When a healthcare name’s shares plummet, more often than not, the driver can be traced back to one negative catalyst.It makes sense, then, that the strength of these volatile investment opportunities can be difficult to gauge. So, what’s an investor to do? We suggest heading to TipRanks.Using TipRanks' Stock Screener tool, we were able to narrow our search results and find 3 compelling healthcare stocks. Each of these Buy-rated tickers has been flagged by the analysts as having the potential to double over the next year thanks to new drug applications (NDAs). When a company files an NDA, it is the formal last step that involves applying to the FDA to get the approval required to market a new drug in the U.S. Let's take a closer look.Aquestive Therapeutics (AQST)Initially focused on developing treatments for central nervous system (CNS) conditions, Aquestive Therapeutics wants to drastically improve patients’ quality of life. While shares have taken a 30% hit year-to-date, some members of the Street believe its innovative drug delivery technology makes it a stand-out.On top of this, its recent NDA submission for one of its lead candidates could be a major catalyst for shares. Back in December, the company announced that the final piece of the rolling NDA for Libervant (AQST-203), its buccal (inside of the cheek) soluble film formulation of diazepam for acute refractory/repetitive seizures (ARRS), had been completed.JMP Securities analyst Jason Butler tells investors that this filing is a significant component of his bullish thesis. “We view this as a positive sign of management’s execution and look forward to a likely 2020 launch of Libervant,” he commented.Based on favorable data from the single crossover trial of Libervant as well as the fact that no patients failed on the therapy, Butler sees greatness in store. With this in mind, the five-star analyst attached a $23 price target to his Outperform rating. (To watch Butler’s track record, click here)Like Butler, Wedbush’s Liana Moussatos also takes a bullish approach when it comes to AQST. She predicts the FDA will accept the NDA for review sometime between Q4 2019 and Q1 2020. With the already reported clinical data making approval very likely in her view, the analyst estimates that annual sales could reach $204 million in 2024 after its potential October 2020 U.S. launch.This prompted Moussatos to reiterate an Outperform rating. If that wasn’t enough, her $37 price target suggests massive upside potential. We’re talking 811% here. (To watch Moussatos’ track record, click here)All in all, the rest of the Street is on the same page. With 5 Buy ratings assigned in the last three months versus no Holds or Sells, the message is clear: AQST is a Strong Buy. At $18, the average price target puts the upside potential at 350%. (See Aquestive stock analysis on TipRanks)KemPharm, Inc. (KMPH)KemPharm’s claim to fame is its LAT technology, which it uses to develop proprietary prodrugs. Ahead of its KP415 NDA filing, originally slated for January 2020, investor attention has shifted towards KMPH.Along with its commercial partner, Gurnet Point Capital, the company engineered the candidate as a treatment for ADHD, an attention deficit disorder. H.C. Wainwright analyst Oren Livnat stated, “We continue to think the Street underappreciates that KemPharm may have the ideal ADHD partner in GPC, which is led almost entirely by the former Shire U.S. commercial leadership, is deep-pocketed, and, with KP415 as its first commercial product, is highly incentivized to fully resource the launch to establish a successful CNS platform.”While the drug’s pivotal efficacy study produced somewhat disappointing top-line results, Livnat is “cautiously optimistic”. He argues that the FDA will support the expected 0.5-13 hour profile implied by the data. “FDA understands methylphenidate (MPH) PK/PD well, and if KP415 data are analyzed similar to other approved ADHD drugs, its best-in-class 0.5-13 hour profile is confirmed, in our view,” he explained.Livnat does, however, remind investors that he doesn’t expect to see any abuse-deterrent claims on the drug’s label. That being said, he points out that Vyvanse, the ADHD market leader, also doesn’t have any of these claims. This gives approval in January 2021 and launch in the first half of 2021 a strong likelihood, according to the analyst.As Livnat projects KP415 peak end-sales of $340 million and more than $60 million in peak royalty revenue, it is no surprise, then, that the four-star analyst maintained a Buy rating. Despite cutting the price target by 50 cents, the $2.50 forecast still leaves room for a potential twelve-month gain of 558%. (To watch Livnat’s track record, click here)Looking at the consensus breakdown, 2 Buys and 1 Hold published over the previous three months add up to a Moderate Buy analyst consensus. Not to mention the $3.80 average price target suggests 901% upside potential. (See KemPharm price targets and analyst ratings on TipRanks)Fennec Pharmaceuticals (FENC)This biotech develops a unique formulation of sodium thiosulfate (STS), PEDMARK, as a way to potentially prevent cisplatin-induced hearing loss in pediatric patients. With Fennec finalizing its rolling NDA for PEDMARK, one analyst thinks 2020 could be a big year.The company’s management stated during its third quarter earnings release that the application should be completed in Q1 2020. David Nierengarten of Wedbush wrote in a recent note that the biotech brought on Shubh Goel as chief commercial officer in order to get ready for a possible PEDMARK launch in the second half of 2020. “Ms. Goel has extensive experience in marketing and commercial operations/strategy of oncology drugs with positions held at companies including Takeda Oncology, ARIAD Pharmaceuticals, Bayer, AVEO Oncology, Celgene and Odonate Therapeutics,” he noted.Nierengarten added, “If approved we believe STS could be widely adopted in pediatric patients with localized cancers that are recommended cisplatin treatment, particularly in the under-five age group where hearing loss risk is highest. We view the economics in this setting as attractive, especially considering the high cost and limited benefit associated with cochlear implants and hearing aids, the only available treatment options for these patients.”While Nierengarten acknowledged that third quarter 2019 research and development expenses decreased to $0.8 million, from $1.8 million in the prior-year quarter, the five-star analyst cites the completion of a number of activities needed for PEDMARK regulatory approval as being the reason for this.In line with his bullish take on the healthcare name, Nierengarten left his Outperform rating and $16 price target unchanged. Should the target be met, shares could be in for a 156% twelve-month gain. (To watch Nierengarten’s track record, click here)As for the rest of the Street, it has been relatively quiet in terms of other analyst activity. One other analyst has issued a bullish call, making the consensus rating a Moderate Buy. In addition, the $16.50 average price target implies shares could soar 164% over the next twelve months. (See Fennec stock analysis on TipRanks)
KemPharm, Inc. (KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that it received notice from the Nasdaq Listing Qualifications Panel (the “Hearings Panel”) of The Nasdaq Stock Market LLC (“Nasdaq”) that it has granted the Company’s request to transfer its listing from The Nasdaq Global Market to The Nasdaq Capital Market effective today, January 15, 2020. Further, the Hearings Panel has also granted the Company an extension until May 13, 2020, to regain compliance with the Market Value of Listed Securities (“MVLS”) continued listing requirement of The Nasdaq Capital Market, conditioned upon achievement of certain milestones included in a plan of compliance which the Company previously submitted to the Hearings Panel.
Construction on Virgin Trains USA’s $4 billion expansion from West Palm Beach to Orlando is underway, thanks to one transaction that helped make that possible. The Miami-based intercity passenger train in April finalized a $1.75 billion private activity bond offering that completely funded construction of the existing system in South Florida to be expanded into Orlando International Airport. The train's Phase 2 expansion is expected to create more than 10,000 temporary construction jobs over the life of the project, and will generate $653 million in federal, state and local tax revenue.
Note: A previous version of this story incorrectly identified the type of transaction that KemPharm completed. A local pharmaceutical company has restructured more than $70 million in debt, giving the firm greater cash solvency as it works to gain approval for a drug. Celebration-based KemPharm Inc. (Nasdaq: KMPH) entered a debt restructuring agreement for $77.7 million of principal, the company announced Dec. 18.
Venture capital is critical for startups and early-stage companies. It funds companies as they scale up while also providing business expertise and industry connections.
KemPharm, Inc. (KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced its entry into a December 2019 Exchange Agreement and Amendment to Facility Agreement, Senior Secured Convertible Notes and Warrants (the December 2019 Exchange Agreement) with Deerfield (as defined below) and Delaware Street Capital (DSC, as further defined below). Under the December 2019 Exchange Agreement, the Company will effect a series of transactions, which, among other things, will push the principal and interest payments on outstanding debt in principal amount of $77.7 million to a new maturity date of March 31, 2021.
Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today, November 14, 2019, at 5:30 p.m. ET CELEBRATION, Fla., Nov. 14, 2019 -- KemPharm, Inc..
Conference Call and Live Audio Webcast with Slide Presentation Scheduled forThursday, November 14, 2019, 5:30 p.m. ET CELEBRATION, Fla., Nov. 12, 2019 -- KemPharm, Inc..
KemPharm, Inc. (KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today provided a commercial update related to its FDA-approved prodrug product, APADAZ® (benzhydrocodone and acetaminophen, or APAP, tablets), which has been licensed to KVK-Tech, Inc. (“KVK-Tech”) for commercialization. Specifically, KVK-Tech has informed KemPharm that APADAZ and its authorized generic (AG-APADAZ) will be available nationally beginning in November 2019. In addition, KemPharm provided updates on formulary access for AG-APADAZ, including its inclusion on the preferred drug lists for the respective Medicaid plans in Alabama and Utah.
KemPharm, Inc. (KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced that study results demonstrating the ability of KP415 to be administered without regard to food and via alternative dosing methods was presented at the 66th Annual American Academy of Child and Adolescent Psychiatry (AACAP) Meeting in Chicago. KP415 is KemPharm’s prodrug product candidate of d-methylphenidate (d-MPH) being developed for the treatment of attention deficit hyperactivity disorder (ADHD). On September 3, 2019, KemPharm entered into a license and collaboration agreement with an affiliate of Gurnet Point Capital (“GPC”) for the commercial rights to KP415 and related development products.
If you own shares in KemPharm, Inc. (NASDAQ:KMPH) then it's worth thinking about how it contributes to the volatility...
KemPharm, Inc. (KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced today that, on September 18, 2019, Danny L. Thompson provided notice of his resignation from the Company’s Board of Directors, citing personal health reasons. Following Mr. Thompson’s resignation, the Board has appointed Richard W. Pascoe, the Company’s Lead Independent Director and a standing member of the Audit Committee, to serve as Chairman of the Audit Committee, effective September 18, 2019.
CELEBRATION, Fla., Sept. 17, 2019 -- KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs,.
KemPharm also announced its entry into a debt exchange agreement and other amendments to its senior debt facility (the Exchange Agreement) with funds managed by Deerfield Management Company, L.P. (Deerfield), potentially reducing its debt outstanding by up to $22 million over a period of 240 days, and up to $30 million, in the aggregate. Under the terms of the License Agreement, KemPharm will receive an upfront payment of $10 million, and is eligible to receive pre-approval cost reimbursements, regulatory milestone payments both prior to and upon approval, and sales milestone payments totaling as much as $483 million, as well as tiered royalty payments on a product-by-product basis for net sales under the License Agreement. These royalty rates range, on a product-by-product basis, from a percentage in the high single digits up to the mid-twenties for U.S. net sales, and a percentage in the low to mid-single digits of net sales in each country outside of the U.S.
CELEBRATION, Fla., Aug. 13, 2019 -- KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today.
If you want to know who really controls KemPharm, Inc. (NASDAQ:KMPH), then you'll have to look at the makeup of its...