NDA (New Drug Application) for PEDMARKTM to be completed in early 2020Strong financial position with $15.2 million in cash and no debt RESEARCH TRIANGLE PARK, N.C., Nov. 12,.
Fennec Pharmaceuticals Inc. (Nasdaq:FENC; TSX: FRX), a specialty pharmaceutical company, today announced it has completed its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARK™ (a unique formulation of sodium thiosulfate) for intravenous use and submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sodium thiosulfate (tradename to be determined). The PEDMARK™ indication requested is for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.
RESEARCH TRIANGLE PARK, N.C., March 05, 2020 -- Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of.
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)
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NDA (New Drug Application) and Marketing Authorization Application (MAA) completed in February 2020Commercial readiness activities in U.S. underway for potential launch of.
As of late, it has definitely been a great time to be an investor in Fennec Pharmaceuticals Inc. (FENC).
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Fennec Pharmaceuticals Inc. (FENC) (FRX.TO), a specialty pharmaceutical company focused on the development of PEDMARK™ (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity from cisplatin in pediatric cancer patients, today announced that it intends to offer its common shares in an underwritten public offering. In addition, Fennec intends to grant the underwriters a 30-day option to purchase up to an additional 15% of its common shares offered in the public offering. Cantor Fitzgerald & Co. is acting as the sole book-running manager for the proposed offering.
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~ FDA Set a PDUFA Target Action Date for PEDMARKTM of August 10, 2020 ~~ Marketing Authorization Application (MAA) Validated by the EMA in February 2020 ~~ Strengthened its.
Fennec Pharmaceuticals Inc. (FENC) (FRX.TO), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate ) for the prevention of platinum-induced ototoxicity from cisplatin in pediatric cancer patients, today announced the closing of its previously announced underwritten public offering of 4,800,000 common shares at a public offering price of $6.25 per share. In addition, Fennec has granted the underwriters a 30-day option to purchase up to an additional 720,000 common shares. A final prospectus supplement and the accompanying prospectus relating to and describing the offering was filed with the SEC.
Hedge funds are known to underperform the bull markets but that's not because they are bad at investing. Truth be told, most hedge fund managers and other smaller players within this industry are very smart and skilled investors. Of course, they may also make wrong bets in some instances, but no one knows what the […]
Fennec Pharmaceuticals Inc. (FENC) (FRX.TO), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate ) for the prevention of platinum-induced ototoxicity from cisplatin in pediatric cancer patients, today announced that in connection with its previously completed underwritten offering on May 4, 2020 of $30,000,000 at a price of $6.25 per share, the option granted to the underwriters was exercised for 660,204 shares at a price of $6.25 per share for additional gross proceeds of $4,126,275. Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK™ for the prevention of platinum-induced ototoxicity in pediatric patients.
RESEARCH TRIANGLE PARK, N.C., Oct. 02, 2019 -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM.
Fennec Pharmaceuticals Inc. (FENC) (FRX.TO), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity from cisplatin in pediatric cancer patients, today announced the pricing of its underwritten public offering of 4,800,000 common shares at a public offering price of $6.25 per share. In addition, Fennec has granted the underwriters a 30-day option to purchase up to an additional 720,000 common shares. Fennec anticipates the total gross proceeds from the offering (before deducting the underwriting discounts and offering expenses) will be $30 million, excluding any exercise of the underwriters’ option to purchase additional shares.
TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, today announced that it has appointed Jodi A. Cook, PhD to its board of directors. Dr. Cook currently serves as Head of Gene Therapy Strategy at PTC Therapeutics, Inc., a global biopharmaceutical company focused on the development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders.
Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for the company’s New Drug Application (NDA) for PEDMARK™ (a unique formulation of sodium thiosulfate). PEDMARK is an investigational drug for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to <18 years of age with localized, non-metastatic, solid tumors.
Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company, today announced that the company’s Marketing Authorization Application (MAA) for its investigational drug, sodium thiosulfate (unique formulation) for infusion (tradename to be determined in EU), has passed validation and is now under evaluation by the European Medicines Agency (EMA). The MAA for Pediatric Use Marketing Authorization (PUMA) was filed in early February 2020 for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.