With the Bearish Dark Cloud Cover candlestick pattern that occurred on the biotech ETF IBB, personally I would stay away from biotech stocks right now.
IBB has also cut below its 200 day moving average on a Parabolic SAR sell signal. The MACD is negative as well.
If the market continues to pullback next week, IBB will likely be leading markets lower.
Remember, these high risk biotech stocks do NOT meet our stringent criteria for stock picks in the Premium service. This article is a free service provided to website visitors.
Top 7 Biotech Stocks To Watch
Roclatan for glaucoma. PDUFA date March 14, 2019.
The FDA has completed its initial 60-day review of the NDA (new drug application) for Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% and the FDA has determined that the application is sufficiently complete to permit a substantive review. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the Roclatan™ NDA is set for March 14, 2019. This date reflects a standard 10-month review period and is consistent with management’s expectations for the 505(b)(2) filing. The “Day 74” notification indicated that the FDA has not identified any potential review issues, and did not mention the need for an advisory committee.
“We are delighted with this positive news on our Roclatan™ NDA, and, if approved, we expect to be fully prepared to launch Roclatan™ using our existing sales force, which is already making excellent progress in the early months of our Rhopressa® launch,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
Roclatan™(netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, is a once-daily eye drop designed to reduce intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. It is a fixed dose combination of Aerie’s Rhopressa® (netarsudil ophthalmic solution) 0.02%, which is currently available in the United States, and widely-prescribed PGA (prostaglandin analog) latanoprost. Roclatan™ successfully achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1 and Mercury 2, and also achieved successful 12-month safety and efficacy results in Mercury 1. Aerie submitted the Roclatan™ New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in May 2018 and, in July 2018, the FDA set the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the Roclatan™ NDA for March 14, 2019. A third Phase 3 trial for Roclatan™, named Mercury 3, is currently underway in Europe but is not required for approval in the United States.
AERI stock is a blah setup right now. Prices have been consolidating lately and the volatility has been reduced. A pullback is taking place. There is a resistance zone just above the current price starting at $47.59. Right above this resistance zone may be lead to a breakout but don’t hold your breath.
The FDA and European Medicines Agency (EMA) have accepted the company’s New Drug Application (NDA) and Marketing Authorization Application (MAA) respectively, for investigational oral, once-daily siponimod (BAF312) for the treatment of secondary progressive multiple sclerosis (SPMS) in adults. This phase of multiple sclerosis (MS) can substantially impact lives, due to physical and cognitive impairments. To bring this treatment to the MS community as quickly as possible, Novartis used a review voucher to expedite the review of siponimod in the US. Regulatory action for siponimod is anticipated in the US in March of 2019 and in Europe in late 2019.
NVS stock looks like a nice setup. We see reduced volatility while prices have been consolidating in the most recent period. A pullback is taking place. There is a resistance zone just above the current price starting at $90.10 which could lead to a gap fill play. There is a clearly definable support zone at $89.67 but watch out for stop runners.
NVS is my favorite chart setup out of all biotech stocks to watch this week.
Vascepa REDUCE-IT outcomes trial with high triglycerides with mixed dyslipidemia. sNDA filing due late 1Q 2019. New data due March 18, 2019 4pm CT at ACC.
An Amarin investor/analyst conference call to discuss the presented data, including data from the late-breaker presentation, will be held on Monday, March 18 at 4:00 p.m. Central Time (CT) / 5:00 p.m. Eastern Time (ET) with several prominent physicians.
“Amarin remains committed to generating important new information about the epidemiology and treatment of patients with residual cardiovascular risk beyond LDL-C management to advance the medical community’s understanding of relevant factors to improve patient care,” said Craig B. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin. “The accepted ACC presentations sponsored by Amarin are a further demonstration of Amarin’s leadership in this area.”
Data to be presented includes:
Late-Breaking Clinical Trial
Reduction in Total Ischemic Events with Icosapent Ethyl in REDUCE-IT™. Deepak L. Bhatt, Philippe Steg, Michael Miller, Eliot Brinton, Terry Jacobson, Steven Ketchum, Ralph Doyle, Rebecca Juliano, Lixia Jiao, Craig Granowitz, Jean Claude Tardif, John Gregson, Stuart Pocock, and Christie Ballantyne, for the REDUCE-IT Investigators
Original Presentation 409-16. March 18, 9:00 to 9:10 am Central Time (CT) in the Main Tent (Great Hall)
Follow-up, Deep Dive II Presentation 412-16. March 18, 1:30 to 1:35pm Central Time (CT) in Room La Nouvelle C
- Eicosapentaenoic Acid Inhibits Membrane Lipid Oxidation in a Concentration-Dependent Manner at Pharmacologic Doses In Vitro. R. Preston Mason, and Samuel C. R. Sherratt
Presentation 1180-452 / 452. March 16, 3:45 PM – 4:30 PM CT in Poster Hall F
- Burden of Atherosclerotic Cardiovascular Disease Risk in Persons with Elevated Triglyceride Levels According to Statin Use. Nathan D. Wong, Wenjun Fan, Sephy Philip, Craig Granowitz, and Peter Toth
Presentation 1178-417 / 417. March 16, 3:45 PM – 4:30 PM CT in Poster Hall F
- Long-term Statin Persistence Is Poor Among High-Risk Patients with Baseline Peripheral Artery Disease: A Real-World Administrative Claims Analysis of the Optum Research Database. Peter P. Toth, Craig Granowitz, Michael Hull, and Sephy Philip
Presentation 1134-435 / 435. March 16, 10:00 AM – 10:45 AM CT in Poster Hall F
- Triglycerides as a Risk Factor for Coronary Heart Disease: What Measure and What Cutoff? Ann Marie Navar, Neha Pagidipati, Hillary Mulder, Tsion Aberra, Sephy Philip, Craig Granowitz, and Eric Peterson
Presentation 1331-414 / 414. March 18, 9:45 AM – 10:30 AM CT in Poster Hall F
- Increased Residual Cardiovascular Risk in US Veterans and Moderately-Elevated Baseline Triglycerides and Well-Controlled LDL-C Levels on Statins. Sarah Leatherman, Ryan Ferguson, Isabelle Weir, Cynthia Hau, Craig Granowitz, Kelly Harrington, Sephy Philip, Peter Toth, Deepak L. Bhatt, and William Boden
Presentation 1060-09. March 18, 1:15 PM – 1:25 PM CT in Prevention Moderated Poster Theater Poster Hall F
AMRN looks like a good setup. We see reduced volatility while prices have been consolidating. A pullback is taking place, which may present a nice opportunity for an entry. There is a very little resistance above the current price. AMRN could be tracing out a Cup and Handle pattern. There is a support zone below the current price at $21.39, a stop order could be placed below this zone but watch out for stop hunters.
DKN-01 and Paclitaxel for endometrial cancer. Phase 2 presentation at Society of Gynecologic Oncology Meeting March 18, 2019, 6PM GMT.
The Company will be presenting at the Society of Gynecologic Oncology 2019 Annual Meeting on Women’s Cancer, being held March 16-19, 2019 in Honolulu, HI.
The P204 study is a Phase 2 basket study of DKN-01 as both a monotherapy and in combination with paclitaxel in patients with advanced endometrioid unterine (EEC) and endometrioid ovarian (EOC) cancers. These malignancies have a percentage of patients with mutations in the Wnt pathway. The study consists of four dosing groups and will enroll up to 94 patients using a Simon 2-Stage design in each group. The primary objective in each independent study group is to determine the overall response. Secondary objectives include measures of efficacy such as overall survival and progression free survival, and to evaluate the safety of the treatment regimen.
Leap Presentation Details:
Abstract Number: 65
Title: Safety and efficacy of a DKK1 inhibitor (DKN-01) as monotherapy or in combination with paclitaxel in patients with Wnt activated recurrent gynecologic malignancies
Session Title: Oral Featured Poster Session II: Trials, Basic Science and Translational Science
Date: Monday, March 18
Time: 6:00 – 7:00 PM GMT
Location: Hawaii Convention Center 313AB
LPTX does not look like a good setup. I do not see a quality setup at the moment. Worse, prices have been extended to the upside lately so any entry would be chasing. For a good entry it is better to wait for a consolidation pattern to form.
SAGE Stock and LGND Stock
Brexanolone – SAGE-547 (202C) for moderate postpartum depression. PDUFA date extended three months to March 19, 2019. Advisory Committee meeting November 2, 2018 voted 17-1 recommending approval.
The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of the New Drug Application (NDA) for ZULRESSO™ (brexanolone) injection for the treatment of postpartum depression (PPD). The previously disclosed December 19, 2018 PDUFA goal date has been extended by a period of three months to March 19, 2019.
After the recent positive FDA Advisory Committee meeting, Sage submitted a proposed Risk Evaluation and Mitigation Strategies (REMS) program with Elements to Ensure Safe Use (ETASU) in response to the FDA’s request. Under PDUFA VI, FDA can elect to extend the PDUFA goal date by three months for submission of a REMS with ETASU not submitted in the original NDA, and FDA has elected to do so. The FDA has not requested any additional clinical data or any additional information from the Company as part of the extension.
“Our primary goal remains bringing treatment to women suffering from PPD as quickly as possible. In light of this unexpected delay, we will work diligently with the FDA to ensure that the unmet medical need of women suffering with PPD can be addressed expeditiously,” said Jeff Jonas, M.D., chief executive officer of Sage.
If approved, ZULRESSO is expected to be scheduled by the U.S. Drug Enforcement Administration (DEA), consistent with other approved GABAergic therapies. The DEA is required to issue an interim final rule controlling the drug within 90 days of approval. Preparations continue for a potential U.S. commercial launch of ZULRESSO for the treatment of PPD, which is now planned for June 2019, if the NDA is approved and post-DEA scheduling.
ZULRESSO has been granted Breakthrough Therapy Designation and is the first medicine under FDA review specifically for the treatment of PPD, the most common medical complication of childbirth. It is estimated that PPD affects approximately one in nine women who have given birth in the U.S. and 400,000 women annually. Symptoms of PPD may include sadness, anxiety, irritability, withdrawing from friends or family, having trouble bonding with her baby and thinking about harming herself or, more rarely, her baby.
On November 2, 2018, the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted (17 yes, 1 no) that data support the favorable benefit-risk profile of ZULRESSO for the treatment of PPD when administered by qualified staff in a facility that has been certified under a REMS program. The committees based their joint recommendation on the safety and efficacy data from three placebo-controlled clinical studies.
Postpartum depression (PPD) is a distinct and readily identified major depressive disorder that is the most common medical complication of childbirth, affecting a subset of women typically commencing in the third trimester of pregnancy or within four weeks after giving birth. PPD may have devastating consequences for a woman and for her family, which may include significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. Suicide is the leading cause of maternal death following childbirth. Postpartum depression is estimated to affect approximately one in nine women who have given birth in the U.S. and 400,000 women annually. More than half of these cases may go undiagnosed without proper screening. There are no FDA approved therapies specifically indicated for PPD and there is a high unmet medical need for improved pharmacological therapy in PPD.
SAGE is just a blah setup right now. Prices have been consolidating lately and the volatility has been reduced. There is a resistance zone just above the current price starting at $159.49 but with a falling Twiggs Money Flow it could take time for this resistance level to be tested.
LGND does not look like a decent setup. Prices have been extended to the downside lately and you don’t want to try and catch a falling knife. For a good entry it is better to wait for a consolidation.
JZP-110 for excessive sleepiness associated with narcolepsy. PDUFA date extended by three months to March 20, 2019.
“We appreciate the opportunity to work with the FDA to complete the review process as soon as possible,” said Jed Black, M.D., senior vice president, Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine. “We are committed to addressing unmet needs in sleep medicine and look forward to offering solriamfetol as a meaningful treatment option for patients living with excessive daytime sleepiness associated with narcolepsy or OSA.”
JAZZ looks like a bad technical entry right now. Yes, the stock is pulling back but the large players have been selling the stock many months now and we can’t yet determine if that selling is over. There is a resistance zone starting at $142. If JAZZ can break through that resistance level, we may have a good entry point but with the weak large players volume and Twiggs Money Flow, don’t hold your breath waiting.
Disclosure: I do not hold any position in any stocks mentioned in this article.