BHVN Stock

Zydis ODT formulation of rimegepant for migraine. Phase 3 data to be presented at AAN on May 7, 2019.

Surging large players volume and Twiggs Money Flow

BHVN stock is just an ok setup right now. While there’s no resistance above the current price, the stock has already done a massive run up. Chasing a biotech stock going into a clinical trial data release is often a really bad idea.

CYTK Stock

Reldesemtiv (CK-2127107) – FORTITUDE-ALS for amyotrophic lateral sclerosis (ALS). Phase 2 data to be presented at AAN May 5, 2019.

High volatility and high risk setup.

CYTK presents a good setup pattern. Prices have been consolidating lately and there is little resistance above the current price. Large players have showed an interest in CYTK over the last couple of days, and recently a Pocket Pivot (blue dot) signal occurred.

GWPH Stock

Epidiolex GWPCARE2 for dravet syndrome. Phase 3 data to be presented at AAN in late-breaker May 7, 2019.

Possible Bullish Flag pattern.

GWPH looks like a great setup opportunity. Prices have been consolidating lately. There is a resistance zone just above the current price starting at $169.43. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $164.99, a stop order could be placed below this zone. Large players showed an interest in GWPH stock in the last couple of days.

HRTX Stock

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.

Large players are moving on this stock as we head into the PDUFA next week.

HRTX looks like a great setup opportunity. We see reduced volatility while prices have been consolidating in the most recent period. There is a resistance zone just above the current price starting at $24.55. A break above this resistance zone and this stock could run. We notice that large players showed an interest for HRTX in the last couple of days.

NBRV Stock

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 had 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.

Plunging large players volume is a big concern.

The price action on NBRV looks great but what’s up with the plunging large players volume! We see reduced volatility while prices have been consolidating in the most recent period and there is little resistance above the current price. There is a support zone below the current price at $2.77, a stop order could be placed below this zone. NBRV is just an ok setup due to the plunging large players volume. Does somebody know something?

SNY Stock

Dengvaxia for Dengue. The PDUFA date under priority review is set for May 1, 2019.

Back on October 30, 2018, Sanofi announced that the FDA had accepted a Biologics License Application for Sanofi Pasteur’s dengue vaccine.

The dengue vaccine candidate has been granted priority review by the FDA as it would represent the first and only medical prevention tool against dengue, including severe dengue, which is considered an unmet medical need. The FDA set a Prescription Drug User Fee Act action date of May 1, 2019.

Dengue is endemic in the US territories of Puerto Rico and the US Virgin Islands. In 2010, Puerto Rico experienced the largest outbreak when more than 12,000 cases were confirmed. Incidence remained high in subsequent years, particularly in 2012 and 20131,2. Dengue represents a health and economic burden in Puerto Rico with total annual associated costs reaching an estimated $160.2 million.3

“Sanofi is committed to reducing the global burden of dengue,” said Dr. David Greenberg, Regional Medical Head North America, Sanofi Pasteur. “The vaccine has been evaluated in studies involving more than 40,000 people from 15 countries around the world with up to six years of follow-up data from large-scale investigations that included Puerto Rico as a study site.”

People can get dengue up to four times and dengue is unique in that the second infection tends to be worse than the first. This means that prevention of re-infection with another dengue serotype can help to reduce the individual risk of severe dengue, as well as the overall healthcare costs associated with hospitalization due to dengue.

The vaccine, known as Dengvaxia® in countries where it is approved, remains the only vaccine available for the prevention of dengue. The European Commission is expected to grant marketing authorization for Dengvaxia in December 2018.

Thursday of last week, SNY was a great buy but the huge gap up doji on Friday has negated much of Thursday’s buy signal. Who wants to chase a gap up doji higher?

SNY is not a good setup right now. The gap up doji has extended prices to far to the upside and to high above a support area. For a good entry it is better to wait for a consolidation.