With the start of Q2 upon us next week, it’s a bad time to try and determine when significant data releases are coming. Most penny stock companies will issue statements saying sometime in Q2 2019 or even by the end of April 2019. It’s definitely more challenging at the beginning of a quarter to try and predict when significant trial read outs for the quarter are coming.
Vyleesi (Bremelanotide) for female sexual dysfunction (FSD). The PDUFA date was extended to June 23, 2019.
“In 2018, we achieved several key milestones including receiving two approvals from the U.S. Food and Drug Administration (FDA), launching both the Makena subcutaneous auto-injector and Feraheme broad label, and receiving FDA acceptance of our new drug application for VyleesiTM (bremelanotide). In addition, we bolstered our pipeline by adding two promising late-stage development assets, AMAG-423 and ciraparantag, targeting orphan patient populations,” said William Heiden, AMAG’s president and chief executive officer.
“As we enter 2019, AMAG is in a unique position with a number of growing commercial products that together generate significant cash flows, allowing us to invest in the development and launch of our new pharmaceutical products. We have built an innovative and diversified portfolio that I believe positions us well for long-term growth and will deliver significant shareholder value,” added Mr. Heiden.
AMAG presents an ok setup opportunity. Prices have been consolidating lately and the volatility has been reduced but it keeps taking legs lower after consolidations. However, large players are showing an interest in AMAG stock over the last couple of weeks but the negative Twiggs Money Flow suggests the stock could chop out sideways longer. I’m not a real big fan of the chart folks.
HTX-011 for post operative pain. The PDUFA date under priority review is set for April 30, 2019.
Back on December 31, 2018, Heron Therapeutics announced that the FDA had accepted the new drug application (NDA) for Heron’s investigational agent, HTX-011, and has granted it a Priority Review designation. HTX-011 is a long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. HTX-011 is the first and only dual-action fixed-combination product specifically designed to address both postoperative pain and inflammation in a single administration at the surgical site. The NDA for HTX-011, which was submitted on October 30, 2018, comprises data from five Phase 2 clinical trials and two Phase 3 clinical trials that included over 1,000 patients undergoing five different surgical procedures. The FDA also indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. The FDA set a Prescription Drug User Fee Act goal date of April 30, 2019.
“We are pleased to receive Priority Review designation for the HTX-011 NDA,” said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “We believe that HTX-011 could have a considerable impact on the lives of patients by significantly reducing the proportion of patients who experience severe pain and receive opioids after surgery, especially at discharge. We look forward to continuing to work closely with the FDA during the review process with the goal of bringing this important product to patients in 2019.”
The FDA had previously granted Breakthrough Therapy designation for HTX-011 based on the results of Phase 2 studies and two completed Phase 3 studies, which showed that HTX-011 produced significant reductions in both pain intensity and the need for opioids through 72 hours post-surgery compared to placebo and bupivacaine solution, the standard-of-care. The FDA has now granted Priority Review designation to the NDA for HTX-011. Priority Review designation is for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment or prevention of serious conditions. HTX-011 is the first and only non-opioid, long acting local anesthetic to demonstrate in Phase 3 studies a statistically significant reduction in severe pain and an increase in the number of patients who require no opioids for 72 hours postoperatively versus bupivacaine solution, the standard-of-care. The overall safety profile of HTX-011, administered locally into the surgical site without a needle, was similar to that of the well-established safety profile of bupivacaine solution, without evidence of meloxicam-related toxicities.
“Despite ongoing efforts to prevent opioid abuse, patients continue to receive large quantities of opioids for postsurgical pain,” said Jay Redan, M.D., FACS, Medical Director of Minimally-Invasive General Surgery at Florida Hospital Celebration Health. “There is a significant need for safe, effective and non-addictive options that can decrease opioid exposure and improve the patient recovery experience, as well as make an impact on the opioid epidemic by significantly reducing the amount of opioids necessary to take home for pain management.”
HTX-011, which utilizes Heron’s proprietary Biochronomer® drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine alone in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted an NDA to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December 2018. The FDA set a Prescription Drug User Fee Act goal date of April 30, 2019.
The chart of HRTX is just an ok setup.
Prices have been consolidating lately and the volatility has been reduced. There is a resistance zone just above the current price starting at $25.91. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $24.05, a stop order could be placed below this zone.
What I really like about this stock is the CrAzY revenue growth! Revenue growth over the last year is an incredible 151.81%! Even better, revenue growth QoQ is a shocking 186.92%. The problem though is that the company is valued at $1.9 billion and yet they only did $77.5 million in sales last year. Great revenue growth but the stock is already so darn pricey!
Contepo for complicated urinary tract infections (cUTI). The PDUFA date under priority review is set for April 30, 2019.
Back on January 14, 2019, Nabriva Therapeutics announced that the FDA has updated the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the CONTEPO New Drug Application (NDA) from June 30, 2019 to April 30, 2019. The two-month acceleration is due to a clarification of the classification and subsequent expedited review period for the CONTEPO NDA submitted in October 2018. In addition to priority review, CONTEPO has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of several serious infections, including cUTI.
Urinary tract infections (UTIs) are a significant health problem in both the community- and hospital-based treatment settings. It is estimated that 150 million UTIs occur yearly worldwide, accounting for $6 billion in health care expenditures, according to the American Urological Association. Patients with complicated urinary tract infections (cUTIs), which includes acute pyelonephritis (kidney infection), have pyuria and bacteria in their urine, in association with features such as fever, chills, malaise or flank/back pain, in the setting of a functional or anatomical abnormality of the urinary tract or a history of catheterization. Patients who fail to respond to an initial course of antibiotics may develop a cUTI, which occurs when the bacteria are embedded in the bladder wall or ascend to the kidneys, where they can multiply more slowly and are much harder to address with antibiotics. In most cases, cUTIs occur following treatment for a normal UTI because antibiotics were given too late, for too short a period of time, at too low of a dose course or the wrong antibiotic was used and did not provide adequate spectrum of coverage. An estimated three million cases of cUTIs are treated in the hospital setting in the United States each year for Gram-negative infections. Enterobacteriaceae are the most common pathogens causing cUTIs and, currently, widespread antibiotic resistance limits the effective treatment options for cUTI. Ineffectively managed cUTI can lead to increased treatment failure rates, recurrence of infection, increased re-hospitalization, and increased morbidity and mortality.
CONTEPO™ (fosfomycin for injection, previously referred to as ZTI-01 and ZOLYD) is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as ESBL-producing Enterobacteriaceae. Intravenous (I.V.) fosfomycin has been approved for a number of indications and utilized for over 45 years in Europe to treat a variety of infections, including cUTIs and other serious bacterial infections. CONTEPO utilizes a new dosing approach, originally developed by Zavante (which Nabriva Therapeutics acquired), to optimize its pharmacokinetics and pharmacodynamics. Nabriva Therapeutics believes these attributes, along with the positive clinical experience worldwide, support CONTEPO as a first-line treatment for cUTIs, including acute pyelonephritis, suspected to be caused by MDR pathogens. At least 20 percent of cUTIs are caused by MDR bacteria and limited treatment options are available in the U.S. In addition, non-clinical data have shown that CONTEPO acts in combination with certain other antibiotics to improve bacterial killing.
NBRV stock shows a decent setup pattern. We see reduced volatility while prices have been consolidating in the most recent period. A pullback is taking place, which may present a nice opportunity for an entry. There is a very little resistance above the current price. There is a support zone below the current price at $2.38, a stop order could be placed below this zone. The large players volume looks InSaNe! Some big players like this stock and are accumulating ahead of the PDUFA announcement.
Over the last 6 months, insider transactions are up whopping 265.53%! Revenue is up over +81% over the last year. The company is valued at $166.6 million and it did $9.7 million in sales last year so still a bit pricey but not as outrageously priced as HRTX above.
Disclosure: I do not hold any position in any stocks mentioned in this article.