Biotech stocks and IBB are consolidating just below the 200 day moving average. While IBB has been consolidating the last couple of weeks, the CMF has been rising which is bullish.
We have a Parabolic SAR sell signal which favors the Bears so caution is warranted. It would be great to see IBB break above the 200 day MA next week and trigger a Parabolic SAR buy signal. If that happens, biotech stocks are On Like Donkey Kong.
With the larger events going on with IBB, here are a few biotech stocks with upcoming data releases that could see these stocks soar in the days ahead. Keep in mind that biotechnology stocks are extremely risky and the stocks below could also crash lower on data releases too. Also, watch out for pump and dump biotech stocks newsletters. With all the information available on the web, do you really think someone has some type of inside information on these biotech stocks that isn’t already known? Of course not. If you see a biotech stock listed below that is being pumped by a newsletter, it’s usually a good idea to stay away from that stock.
Biotech Stocks To Watch
We have the WORLD Symposium coming in early February 2019 which will bring with it a few data releases from biotechnology companies as listed below.
APL-130277 for Parkinson’s Disease with motor fluctuations. The PDUFA date is January 29, 2019 through partner Sunovion which is a private company.
“Through our ongoing work with people living with Parkinson’s disease, we know the community is eager for more treatment options that may help alleviate OFF episodes, which are often disruptive to their daily lives,” said Todd Sherer, Ph.D., CEO of The Michael J. Fox Foundation for Parkinson’s Research. “We’re heartened to see apomorphine sublingual film is successfully continuing through the regulatory process, and we are hopeful for its approval and future availability.” Two early-stage APL-130277 trials were funded in part by The Michael J. Fox Foundation.
“We are encouraged that the FDA has accepted our NDA for apomorphine sublingual film,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “There are currently few treatment options available to Parkinson’s disease patients for the as needed treatment of OFF episodes. We look forward to working with the FDA during the review period so that we can bring a much needed new treatment option to people living with Parkinson’s disease and OFF episodes.”
Apomorphine sublingual film (APL-130277), a novel formulation of apomorphine, a dopamine agonist, is being developed as a fast-acting sublingual film for the on-demand management of OFF episodes associated with Parkinson’s disease (PD). Apomorphine is the only agent approved for the acute, intermittent treatment of hypomobility, “OFF” episodes (“end-of-dose wearing OFF” and unpredictable “ON/OFF” episodes) associated with advanced PD and in the U.S. is currently approved as a subcutaneous injection. Apomorphine sublingual film is intended to rapidly convert people living with PD from the OFF to the ON state and has been studied for treatment of motor OFF episodes up to five times per day. Apomorphine sublingual film has not been approved by the U.S. Food and Drug Administration (FDA). In October 2016, Sunovion acquired Cynapsus Therapeutics Inc. (Canadian Specialty Central Nervous System Biotechnology Company), along with its product candidate APL-130277. The Michael J. Fox Foundation funded in part two Phase I trials of APL-130277 – a comparative biostudy in healthy volunteers and a dosing study in people with Parkinson’s disease.
More than one million people in the U.S. and an estimated four to six million people worldwide live with Parkinson’s disease (PD). PD is a chronic, progressive neurodegenerative disease characterized by motor symptoms, including tremor at rest, rigidity and impaired movement, as well as significant non-motor symptoms, including cognitive impairment and mood disorders. It is the second most common neurodegenerative disease behind Alzheimer’s disease, and the prevalence of PD is increasing with the aging of the population. OFF episodes are the re-emergence of symptoms (motor and non-motor) otherwise controlled by medications. OFF episodes can happen at any point during the day, often occurring in the morning after awakening and periodically throughout the day. OFF episodes are characterized, in part, by tremor, stiffness or slow movement. These episodes may disrupt a person’s ability to perform everyday activities and may be burdensome for patients, family and caregivers. OFF episodes are experienced by 40 to 60 percent of people with PD and may worsen in frequency and severity over the course of the illness.
AQST stock shows a decent setup pattern. We see reduced volatility while prices have been consolidating after a big pullback. We notice that large players volume is starting to rise over the last few days, which is bullish.
ALKS 5461 for major depressive disorder. The PDUFA date is January 31, 2019. The Advisory Committee Meeting on November 1, 2018 voted 2-21 against recommending approval. I don’t like gambling in stocks that have such a one-sided negative Advisory Committee vote.
“We were disappointed and surprised by the FDA’s characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the Advisory Committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants,” said Richard Pops, Chief Executive Officer of Alkermes. “We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission.”
ALKS does present a good setup opportunity. We see reduced volatility while prices have been consolidating. There is a resistance zone just above the current price starting at $34.12. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $34.06, a stop order could be placed below this zone. We recently had a Pocket Pivot signal (blue dot) which is bullish. The rising Twiggs Money Flow is another bullish sign.
SNA-001 for the reduction of light-pigmented hair. Phase 3 data is due sometime in late January or early February 2019.
SNA-001 is a topical photoparticle therapy designed to enhance the effects of laser treatment for hair reduction of unwanted light-pigmented hair. Light-pigmented hair reduction is a $3+ billion market in the U.S.
Laser hair removal is the highest volume aesthetic procedure performed globally. Traditional laser hair removal methods are largely ineffective for patients with light-pigmented hair (i.e. white, gray, blond, light brown and light red). As a result, patients are often turned away by healthcare practitioners if their hair color is too lightly pigmented.
SNA-001 is the first effective hair removal solution for light-pigmented hair.
SNA-001 uses precisely engineered silver particles to facilitate local tissue injury (hair follicle) through a process called selective photothermolysis. The particles are designed to work with current installed base of lasers in practices. Multiple additional indications possible.
SNNA stock presents an ok setup. Prices have been consolidating and the volatility has been reduced. There is a very little resistance above the current price. We notice that large players showed an interest for SNNA in the last couple of days, which is a good sign. What I don’t like is that the Twiggs Money Flow is still negative which suggests the stock could flat-line for awhile longer.
DWP-450 for glabellar lines. CRL was announced on May 16, 2018. A new PDUFA date was set for February 2, 2018.
The glabella is the skin between the eyebrows and above the nose. It also refers to the underlying bone which is slightly depressed, and joins the two brow ridges.
David Moatazedi, President and Chief Executive Officer of Evolus, stated, “We have worked diligently to advance our regulatory submission for DWP-450. With this notice from the FDA we remain on track to launch commercially in the U.S. in Spring 2019. We look forward to providing an update on the status of our application per our PDUFA date of February 2, 2019 and to continuing the development of our sales and marketing strategy for DWP-450.”
Evolus is a company dedicated to aesthetic medicine focused on providing physicians and their patients with expanded choices in aesthetic treatments and procedures. Evolus’ lead candidate DWP-450, also known by the chemical name prabotulinumtoxinA, is a 900 kDa purified botulinum toxin type A complex that was approved by Health Canada for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients under 65 years of age and is being evaluated for marketing approval in the United States and other areas.
EOLS stock is an ok setup. Prices have been consolidating lately. A pullback is taking place, which may present an opportunity for an entry. There is a resistance zone just above the current price starting at $15.80. Right above this resistance zone may be a good entry point. Last week we had a Pocket Pivot signal (blue dot) which is usually bullish but instead of EOLS stock going up, it sold off as traders used the liquidity from new buyins to sell out of their own positions. That’s some fairly cutt-throat trading in EOLS stock.
AVR-RD-01 for Fabry disease. A Phase 1 study update and two-year data for first patient is coming at the WORLD Symposium on February 6, 2019.
The clinical trial updates related to the Company’s gene therapy program for AVR-RD-01 in Fabry disease will be presented at WORLDSymposium, an annual conference dedicated to lysosomal diseases, being held February 4-8, 2019 in Orlando, Florida. AVROBIO will host an event for analysts and investors in conjunction with the conference, with a presentation and webcast beginning at 5:30 p.m. ET on Wednesday, February 6, 2019 in addition to the data presentations made as part of the WORLDSymposium program.
AVR‑RD‑01 is a gene therapy being investigated in patients with Fabry disease. Designed to be a one-time therapy, its mechanism of action is by inserting the GLA gene that encodes functional αgalactosidase A (AGA, the enzyme that is deficient in Fabry disease), with the goal of enabling continuous AGA production and distribution to tissues and organs.
AVROBIO, Inc., is a Phase 2 clinical-stage gene therapy company developing gene therapies to potentially cure rare diseases with a single dose. AVROBIO’s lentiviral-based gene therapies employ hematopoietic stem cells that are collected from the patient and then modified with a lentiviral vector to insert a functional copy of the gene that is defective in the target disease. AVROBIO is focused on the development of its gene therapy, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.
AVRO shows a decent setup pattern. Prices have been consolidating lately and the volatility has been reduced. Large players volume is really taking off which is bullish but the Twiggs Money Flow is still negative which suggests the stock could chop-out sideways for awhile longer BUT the positive divergence between large players volume and price looks awesome!
SB-318 for MPS Type 1. Phase 1/2 preliminary safety and biochemical measurements data is due at the WORLD Symposium on February 7, 2019.
The clinical data from the Company’s inherited metabolic diseases development programs will be presented at WORLD Symposium, an annual conference dedicated to lysosomal diseases being held February 4-8th, 2019 at the Hyatt Regency Orlando in Orlando, Florida.
The WORLDSymposium program includes two platform presentations from clinical trials of Sangamo’s zinc finger nuclease (ZFN)-mediated in vivo genome editing product candidates, SB-318 and SB-913, which are being evaluated for the treatment of mucopolysaccharidosis type I (MPS I) and type II (MPS II), respectively:
“CHAMPIONS: A Phase 1/2 clinical trial with dose escalation of SB-913 ZFN-mediated in vivo human genome editing for treatment of MPS II (Hunter syndrome)”
Presenter: Joseph Muenzer, M.D., Ph.D., University of North Carolina School of Medicine
February 7th, 2019 at 11:00 a.m. Eastern Time
“EMPOWERS: A Phase 1/2 clinical trial of SB-318 ZFN-mediated in vivo human genome editing for treatment of MPS I (Hurler Syndrome)”
Presenter: Paul Harmatz, MD, UCSF Benioff Children’s Hospital Oakland
February 7th, 2019 at 11:15 a.m. Eastern Time
The SB-913 (MPS II) presentation is expected to include interim data on safety and biochemical measurements at up to 24 weeks from six subjects enrolled in the three dose cohorts of the CHAMPIONS Study. The SB-318 (MPS I) presentation is expected to describe the scientific rationale for SB-318, the clinical trial design, and preliminary safety and biochemical measurements at up to four weeks from the first three patients enrolled in the EMPOWERS Study.
Sangamo expects to provide additional SB-913 and SB-318 updates in 2019 as data accumulate and mature in these clinical development programs.
SGMO stock presents a beautiful 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 $11.89. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $11.45, a stop order could be placed below this zone. Large players volume has been uptrending for months which suggests that SGMO stock could really go on a positive data release. Another bullish is the recent Pocket Pivot signal (blue dot). This is my favorite biotech stock setup for this week!
Iclaprim – REVIVE-2 for acute bacterial skin and skin structure infections (ABSSSI). The PDUFA date is February 13, 2019.
“The NDA acceptance by the FDA is an important milestone for Motif Bio and reflects the dedication and commitment of our team who have worked tirelessly to accomplish this,” said Graham Lumsden, Chief Executive Officer of Motif Bio. “We believe that, if approved, iclaprim could be an important new treatment option for patients with serious skin infections. We look forward to working closely with the FDA as we move through the review process with the goal of bringing iclaprim to patients as quickly as possible.”
More than 3.6 million patients with ABSSSI are hospitalised annually in the U.S. It is estimated that up to 26% of hospitalised ABSSSI patients have renal impairment. Hospitalised patients with obesity, diabetes and/or poor kidney function are particularly vulnerable to vancomycin-associated kidney injury. Many standard of care Gram-positive antibiotics are not suitable for treatment of hospitalised ABSSSI patients with these conditions due to efficacy and/or safety issues.
The NDA includes data from two Phase 3 trials (REVIVE-1 and REVIVE-2) evaluating iclaprim for the treatment of patients with ABSSSI. In both trials, iclaprim achieved the primary endpoint of non-inferiority (NI) (10% margin) compared to vancomycin, the current standard of care, at the early time point (ETP), 48 to 72 hours after the start of administration of the study drug, in the intent-to-treat (ITT) patient population. Iclaprim also achieved NI (10% margin) at the test of cure endpoint, 7 to 14 days after study drug discontinuation, in the ITT patient population.
Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA. If iclaprim is approved as a new chemical entity with QIDP designation, it will be eligible for 10 years of market exclusivity in the U.S. starting from the date of approval, under the Generating Antibiotic Incentives Now Act (the GAIN Act).
MTFB stock presents an ok 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 resistance zone just above the current price starting at $10.11. Right above this resistance zone may be a good entry point. Both large players volume and the Twiggs Money Flow have been rising the last few weeks while MTFB stock has chopped out and gone sideways; however, both are rolling over and turning down and so I would want to wait for an entry to see how this plays out.
Disclosure: I do not hold any position in any stock mentioned in this article.