The top biotechnology stocks to watch for the week ahead.
A presentation of data from the pivotal Phase 3 SIERRA trial of Iomab-B has been selected as one of four late breaking oral presentations at the 2019 TCT or Transplantation & Cellular Therapy Meetings™ of ASBMT and CIBMTR, which is being held February 20 – 24 in Houston, Texas. In addition, three abstracts related to Actinium’s targeted conditioning pipeline have been accepted for poster presentations.
Sandesh Seth, Chairman and CEO of Actinium, said, “TCT is the ideal venue for us to present data and highlight our targeted conditioning programs as it is the pre-eminent medical meeting focused on bone marrow transplant and cellular therapy. We are excited to have multiple opportunities to highlight clinical data for Iomab-as well as update on Iomab-ACT, our newest program focused on lymphodepletion prior to CAR-T. In addition, we are involved with several events, educational and otherwise, that will enable us to educate a broad audience of investigators, researchers and potential partners about the SIERRA trial and our highly differentiated multi-disease, multi-target targeted conditioning pipeline. We expect this meeting to be a highly productive and consequential one for our company.”
ATNM has an ok setup pattern. Prices have been consolidating lately. There is a very little resistance above the current price. Very recently a bullish Pocket Pivot signal was observed. Still, large players volume and suggests not a lot of interest in this stock.
Loteprednol Gel 0.38% for Ocular Inflammation. PDUFA date coming on February 25, 2019.
The FDA has accepted the New Drug Application (NDA) for its sub-micron loteprednol etabonate ophthalmic gel, 0.38% with a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2019. If approved, the product would be the lowest concentrated loteprednol ophthalmic corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
“The sub-micron loteprednol etabonate ophthalmic gel, 0.38% will offer eye care professionals and their patients a lower concentration formulation with less frequent dosing compared to currently available formulations of loteprednol,” said Tracy Valorie, senior vice president, U.S. Pharmaceuticals and Surgical, Bausch + Lomb. “We are committed to developing innovative ophthalmic treatment options to help serve the needs of patients and look forward to bringing this new product to market.”
This investigative product utilizes a novel submicron particle to help increase ocular penetration and residence time in anterior segment tissues.
BHC stock does present a nice setup opportunity. Prices have been consolidating lately and the volatility has been reduced. 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 $25.33. Right above this resistance zone may be a good entry point. There is a support zone below the current price at 23.74, a stop order could be placed below this zone. Remember to follow the trade management techniques that millionaire and billionaires use.
Selinexor for Quadruple Refractory Multiple Myeloma. PDUFA date under priority review is not until April 6, 2019 but the Advisory Committee Meeting is next week on February 26, 2019. There’s a good chance the Advisory Committee could vote this one down IMO.
Yeah, everybody is dumping this stock. IMO stay away from this one.
MYO-101 for Duchenne muscular dystrophy – LGMD2E. Phase 1/2 data due on February 27, 2019.
Commencing at 8:00 a.m. Eastern Time (ET) on Wednesday February 27, 2019, it will host a webcast and conference call to announce results from the first 3-patient cohort of the phase I/IIa gene transfer clinical trial using MYO-101 to treat patients with Limb-Girdle Muscular Dystrophy Type 2E (beta-sarcoglycanopathy).
The 8:00 a.m. ET conference call presenting the MYO-101 LGMD results may be accessed by dialing (844) 534-7313 for domestic callers and (574) 990-1451 for international callers. The passcode for the call is 1693875. Please specify to the operator that you would like to join the “Sarepta hosted LGMD results Call.”
The 4:30 p.m. ET conference call to discuss fourth quarter and full-year 2018 results and corporate updates may be accessed by dialing (844) 534-7313 for domestic callers and (574) 990-1451 for international callers. The passcode for the call is 3768408. Please specify to the operator that you would like to join the “Sarepta Fourth Quarter and Full-Year 2018 Earnings Call.”
Both conference calls will be webcast live under the investor relations section of Sarepta’s website at www.sarepta.com and will be archived there following the call for 90 days. Please connect to Sarepta’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
SRPT presents a decent setup pattern. Prices have been consolidating lately. The rising large players volume and Twiggs Money Flow look good. There is a resistance zone just above the current price starting at $139.99. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $138.98, a stop order could be placed below this zone. Remember to follow the trade management techniques that millionaire and billionaires use.
HS-110 and nivolumab (Opdivo) for Non-small cell lung cancer (NSCLC). Phase 2 interim data to be presented at 2019 ASCO-SITC February 28, 2019.
Back on January 14, 2019, Heat Biologics announced that it had dosed its first patient in its Phase 2 clinical trial investigating HS-110 in combination with Merck’s anti-PD1 checkpoint inhibitor, KEYTRUDA® (pembrolizumab), in patients with advanced non-small cell lung cancer (NSCLC). This expansion of the Company’s Phase 2 trial into first-line maintenance treatment with Keytruda follows positive interim results reported last year on previously treated patients receiving HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo® (nivolumab). Heat will continue to dose patients with HS-110 in combination with Opdivo® as well.
The Company amended its Phase 2 master protocol to include additional patient cohorts in the front-line maintenance setting for advanced NSCLC. Patients in these cohorts will have received a minimum of 9 weeks of pembrolizumab, with or without chemotherapy, and will begin maintenance treatment receiving HS-110 with pembrolizumab ± pemetrexed. Patients will be evaluated for objective response rate as well as progression-free and overall survival.
Daniel Morgensztern, MD, Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine and lead investigator for this trial, commented, ”Results from the ongoing Phase 2, multicenter clinical trial combining HS-110 with Bristol-Myers Squibb’s checkpoint inhibitor nivolumab (Opdivo®), suggest that HS-110 may enhance the efficacy of checkpoint inhibitors in patients with advanced lung cancer. Expanding this trial to include Merck’s anti-PD-1 checkpoint inhibitor pembrolizumab (KEYTRUDA®) is an important next step in evaluating the broad potential of this platform technology.”
Jeff Wolf, Heat’s CEO, further noted, ”The expansion of this trial to include a combination of HS-110 with KEYTRUDA® is in line with our strategy to combine our T-cell activation platform with multiple checkpoint inhibitors. We are very excited to begin dosing patients in this cohort.”
New interim data on those patients in this ongoing Phase 2 trial that have been treated with the HS-110 plus nivolumab combination have been selected for oral presentation at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium on February 28.
HTBX stock is a good setup. Prices have been consolidating lately. 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 $1.45. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $1.32, a stop order could be placed below this zone. We notice that large players showed an interest for HTBX in the last couple of days, which is a good sign. Very recently a Pocket Pivot signal (blue dot) was observed. Remember to follow the trade management techniques that millionaire and billionaires use.
PRN1008 for Pemphigus. Phase 2 trial met primary endpoint. Final data to be presented at AAD meeting March 2, 2019.
An abstract has been accepted for oral presentation at the Late-Breaking Research during the 2019 American Academy of Dermatology annual meeting in Washington, D.C.
The abstract, “Final results of the Believe-PV proof of concept study of PRN1008 in pemphigus,” will be presented as part of the Late-Breaking Research: Clinical Trials on Saturday, March 2, 2019 at 2:10pm ET in Ballroom A of the Walter E. Washington Convention Center.
Principia is a late-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology. Principia’s proprietary Tailored Covalency® platform enables Principia to design and develop reversible and irreversible covalent, small molecule inhibitors with potencies and selectivities that have the potential to rival those of injectable biologics yet maintain the convenience of a pill. PRN1008, a reversible covalent BTK inhibitor, is being evaluated in a Phase 3 clinical trial in patients with pemphigus, an orphan autoimmune disease, and in a Phase 2 clinical trial in patients with immune thrombocytopenic purpura, a rare hematological disease. PRN2246, a covalent BTK inhibitor which crosses the blood-brain barrier, has completed a Phase 1 clinical trial in healthy volunteers, and has been partnered with Sanofi for development in multiple sclerosis and, potentially, for other diseases of the central nervous system. PRN1371, a covalent inhibitor of Fibroblast Growth Factor Receptor (FGFR) is being evaluated in a Phase 1 trial in patients with bladder cancer.
PRNB stock is an ok setup. Prices have been consolidating lately. There is a support zone below the current price at $29.44, a stop order could be placed below this zone.
VP-102 for Molluscum contagiosum. Phase 3 trials met primary endpoints on January 9, 2019. Data to be presented at AAD meeting March 2, 2019.
Results from two pivotal Phase 3 clinical trials of its lead product candidate, VP-102, will be presented in a late-breaking oral presentation during the annual meeting of the American Academy of Dermatology (AAD) being held March 1-5, 2019 in Washington, DC.
VP-102 is a proprietary topical drug-device combination therapy in development for the treatment of molluscum contagiosum, a highly contagious, primarily pediatric, viral skin infection that affects an estimated six million people in the United States, and for which there is currently no FDA-approved treatment.
The presentation, “CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Studies Investigating VP-102, a Drug-Device Combination Containing a Novel Topical Formulation of Cantharidin, for the Treatment of Molluscum Contagiosum,” will take place during the Late-Breaking Research: Clinical Studies/Pediatric Session on Saturday, March 2 from 3:30-5:30 p.m. in Room 154A. The results will be presented by lead investigator, Dr. Lawrence F. Eichenfield, Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital-San Diego.
The CAMP-1 and CAMP-2 studies enrolled 528 patients in total and were conducted at 31 centers in the United States. The trials evaluated the safety and efficacy of VP-102 compared to placebo in patients two years of age and older with molluscum contagiosum. Complete clearance of molluscum lesions was evaluated by assessment of the number of lesions at study visits over 12 weeks.
Verrica will also present an abstract from its Phase 2 Innovate study in an online e-poster titled “Innovate: A Phase 2 Study Investigating VP-102, a Drug-Device Combination Containing a Novel Topical Formulation of Cantharidin, for the Treatment of Molluscum Contagiosum.”
Verrica is currently advancing its lead product VP-102, a proprietary topical drug-device combination therapy containing a topical solution of 0.7% cantharidin in a novel, single-use applicator, for the treatment of molluscum contagiosum, verruca vulgaris (common warts), and external genital warts.
Molluscum contagiosum, or molluscum, is a highly contagious, primarily pediatric, viral skin infection affecting an estimated six million people in the United States. It is caused by a pox virus that produces multiple raised flesh-colored papules, or skin lesions. Molluscum typically presents with 10 to 30 lesions, and in some cases over 100 lesions. If left untreated, molluscum lesions persist for an average of 13 months with some cases remaining unresolved for more than two years. There are currently no FDA-approved drugs for molluscum.
VRCA does present a very good setup. We see reduced volatility while prices have been consolidating in the most recent period but a pullback is taking place and the large players volume and Twiggs Money Flow are both falling. Don’t try and catch a falling knife.
REGN, SNY Stocks
Dupixent (dupilumab) Atopic dermatitis 12-17 year-olds. PDUFA date under priority review March 11, 2019.
Back on November 6, 2018, Regeneron Pharmaceuticals and Sanofi announced that the FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable. Currently, there are no FDA-approved systemic biologic medicines to treat adolescents with moderate-to-severe atopic dermatitis. The target action date for the FDA decision is March 11, 2019.
The sBLA is supported by data from a pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent monotherapy in adolescent patients with moderate-to-severe atopic dermatitis, which were presented at the European Academy of Dermatology and Venereology in September 2018.
Dupixent works by inhibiting interleukin-4 and interleukin-13 (IL-4 and IL-13) signaling, which is one of the important contributors to Type 2 inflammation, a systemic response known to play a role in moderate-to-severe atopic dermatitis.
Dupixent is currently approved in the U.S. as a treatment for adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable; and as add-on maintenance treatment for patients 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of moderate-to-severe (adolescents 12 to 17 years of age) and severe (children 6 months to 11 years of age) atopic dermatitis not well controlled on topical prescription medications.
Dupixent is also approved for use in certain adult patients with moderate-to-severe atopic dermatitis in countries of the European Union, and other countries including Canada and Japan. In the U.S., more than 60,000 adult patients with atopic dermatitis have been prescribed Dupixent to date.
The safety and efficacy of Dupixent in adolescents with atopic dermatitis have not been fully evaluated by any regulatory authority.
Regeneron and Sanofi are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other Type 2 inflammation, including pediatric (6 months to 11 years of age) atopic dermatitis (Phase 3), pediatric asthma (Phase 3), chronic rhinosinusitis with nasal polyps (Phase 3), eosinophilic esophagitis (Phase 2/3), grass allergy (Phase 2) and peanut allergy (Phase 2). A future trial is planned for chronic obstructive pulmonary disease. Dupixent is also being studied in combination with REGN-3500, which targets IL-33. These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority. Dupilumab was discovered using Regeneron’s proprietary VelocImmune® technology that yields optimized fully human antibodies, and is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
REGN presents a decent setup pattern. Prices have been consolidating lately and the volatility has been reduced. There is a resistance zone just above the current price starting at $427.04. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $421.50, a stop order could be placed below this zone. Remember to follow the trade management techniques that millionaire and billionaires use.
SNY stock is not a good setup right now. Prices have been extended to the downside lately. Don’t try and catch a falling knife. For a good entry it is better to wait for a consolidation.
CELG, RHHBY Stock
TECENTRIQ (atezolizumab) plus Abraxane for Triple-negative breast cancer. The PDUFA date is set for March 12, 2019.
Data from the phase III apact® trial with ABRAXANE® as adjuvant therapy in patients with surgically resected pancreatic cancer (event-driven). PDUFA action date of March 12, 2019 for the supplemental Biologics License Application (sBLA) submission filed by Roche of Tecentriq® (atezolizumab) in combination with ABRAXANE® for the initial treatment of patients with PD-L1-positive, metastatic triple-negative breast cancer.
CELG presents an ok setup pattern. Prices have been consolidating lately. A pullback is taking place but I don’t like the falling large players volume.
RHHBY does not look like a decent setup. Prices have been extended too far to the upside. It is better to wait for a pullback or consolidation before taking a long entry.
RHHBY also has Tecentriq+cb+etoposide – IMpower133 for Squamous non-small cell lung cancer (NSCLC). The PDUFA date, under priority review, is coming March 18, 2019.
“It’s been more than 20 years since there has been a new initial treatment option for extensive-stage small cell lung cancer that delivers a clinically meaningful survival benefit,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “We are working closely with the FDA to bring this Tecentriq-based regimen to people with this difficult-to-treat type of lung cancer as soon as possible.”
This sBLA is based on results from the Phase III IMpower133 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with ES-SCLC. The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified.
Tecentriq is currently approved by the FDA to treat people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has ALK or EGFR gene abnormalities.
Roclatan for Glaucoma. The PDUFA date is coming on March 14, 2019.
Back on July 23, 2018, Aerie Pharmaceuticals reported that it had received the “Day 74” notification from the FDA earlier than scheduled. The FDA 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 does present a good setup IMO. We see reduced volatility while prices have been consolidating in the most recent period but it’s hard to determine which way the stock could break. I really like the positive divergence between large players volume and price but the negative Twiggs Money Flow suggests the stock could chop out sideways for a bit longer.
BAF312 for secondary progressive multiple sclerosis. The PDUFA date, under priority review, is set for sometime in March 2019 but the exact date was not given.
Novartis announces FDA and EMA filing acceptance of siponimod, the first and only drug shown to meaningfully delay disability progression in typical SPMS patients. Both the US Food and Drug Administration (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.
More than 80% of people with relapsing-remitting MS (RRMS) – the most common form of the condition at diagnosis – go on to develop SPMS, with or without relapses,. SPMS is a form of MS that leads to progressive, irreversible disability, such as the need for enhanced walking aids and wheelchairs, bladder dysfunction and cognitive decline, largely independent of relapses. Following the initial RRMS course, there is a gradual increase in the number of patients transitioning to SPMS, with around 25% progressing by 10 years post-onset, 50% by 20 years and more than 75% by 30 years,.
“We are excited to see a potential new treatment on the horizon,” said Bruce Bebo, Executive Vice President Research, National MS Society, United States. “It is a significant milestone in our unrelenting search for treatments that can benefit adults living with secondary progressive MS who currently have few options.”
“Siponimod is the first investigational medicine to show a significant delay in disability progression in typical SPMS patients,” said Paul Hudson, Chief Executive Officer, Novartis Pharmaceuticals. “With siponimod, we underpin our strong commitment to the MS community by reimagining care for people whose lives have been considerably disrupted by this devastating illness. We are closely working with the FDA and EMA to ensure siponimod is available for patients as soon as possible.”
The regulatory application is based on data from the EXPAND study, a randomized, double-blind, placebo-controlled Phase III study, comparing the efficacy and safety of siponimod versus placebo in people living with typical SPMS. At study initiation, more than 50% of patients in the EXPAND study relied on a walking aid. Results from the pivotal study showed siponimod significantly reduced the risk of three-month confirmed disability progression versus placebo (primary endpoint; 21% versus placebo, p=0.013). Siponimod also meaningfully delayed the risk of six-month confirmed disability progression (26% vs placebo, p=0.0058) and demonstrated favorable outcomes in other relevant measures of MS disease activity and progression. Further, more advanced analyses of the EXPAND study showed that siponimod reduced the risk of disability progression largely disassociated from relapses (three-month disability progression, range 14-20%; six-month disability progression 29-33%).
In addition, Novartis conducted the BOLD study, a randomized, double-blind, placebo-controlled, adaptive dose-ranging, Phase II study in patients with RRMS. The study showed that siponimod significantly reduced the annualized rate of relapses (ARR) over six months compared to placebo (ARR siponimod 2 mg vs. placebo 0.20 vs. 0.58 (p=0,041)).
In Switzerland, Swissmedic granted fast track authorization procedure for siponimod in SPMS. Discussions with additional health authorities regarding siponimod are ongoing.
Siponimod is an investigational, selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor. Siponimod binds to the S1P1 sub-receptor on lymphocytes, which prevents them from entering the central nervous system (CNS) of patients with multiple sclerosis. This leads to the anti-inflammatory effects of siponimod. Siponimod also enters the CNS and binds to the S1P5 sub-receptor on specific cells in the CNS (oligodendrocytes and astrocytes). By binding to these specific receptors, siponimod has the potential to modulate damaging cell activity, and preclinical studies suggest that it may prevent synaptic neurodegeneration and promote remyelination in the CNS.
Multiple sclerosis (MS) is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss. In adults, there are three types of MS: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS). Approximately 85% of people with MS have RRMS, where the immune system attacks healthy tissue. In children and adolescents, RRMS accounts for nearly all cases (approximately 98%).
The evolution of MS results in an increasing loss of both physical and cognitive (e.g. memory) function. This has a substantial negative impact on the lives of the approximately 2.3 million people worldwide affected by MS, of which between three and five percent are estimated to be children or adolescents,.
 Kappos L, Cree B, Fox R, et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomized, phase 3 study. Lancet. Published online March 22, 2018. http://dx.doi.org/10.1016/S0140-6736(18)30475-6.
 Multiple Sclerosis International Federation. Atlas of MS 2013. http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf. Accessed October 2018.
 Tremlett H, et al. The natural history of secondary-progressive multiple sclerosis. Mult Scler. 2008:14:314-324.
 Selmaj K, et al. Siponimod for patients with relapsing-remitting multiple sclerosis (BOLD): an adaptive, dose-ranging, randomised, phase 2 study. Lancet Neurol. 2013;12(8):756-67.
 Gergely P et al. The selective sphingosine 1-phosphate receptor modulator BAF312 redirects lymphocyte distribution and has species-specific effects on heart rate.Br J Pharmacol 2012;167(5):1035-47.
 Tavares A, et al. Brain distribution of MS565, an imaging analogue of siponimod (BAF312), in non-human primates. Neurology. 2014;82(10):suppl. P1.168.
 Gentile A, et al. Siponimod (BAF312) prevents synaptic neurodegeneration in experimental multiple sclerosis. Journal of Neuroinflammation 2016;13(1):207.
 PubMed Heath. Multiple Sclerosis (MS). http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001747/. Accessed October 2018.
 Tullman M. Overview of the epidemiology, diagnosis and disease progression associated with multiple sclerosis. Am J Managed Care. 2013;19(2 Suppl):S15-20.
 Multiple Sclerosis Society. Types of MS. https://www.mssociety.org.uk/what-is-ms/types-of-ms. Accessed October 2018.
Although NVS has an excellent technical rating, the quality of the presented setup is not ideal at the moment. Price movement has been extended to the upside and so new long positions would be chasing. It is probably a good idea to wait for a consolidation first.
Vascepa REDUCE-IT outcomes trial for High Triglycerides With Mixed Dyslipidemia. sNDA filing due late Q1 2019. New data due March 18, 2019 at ACC.
New data showing the reduction in total major adverse cardiovascular (i.e., ischemic) events shown in the landmark REDUCE-IT™ cardiovascular outcomes trial has been accepted for presentation as late breaking clinical trial data at the American College of Cardiology’s (ACC) 68th Annual Scientific Session on March 18, 2019 in New Orleans, LA.
The presentation is planned for 9:00 to 9:10 am Central Time in the Main Tent (Great Hall). The final presentation time will be available here: https://www.abstractsonline.com/pp8/#!/5758/presentation/57960. These late-breaking clinical trial results have been characterized by ACC as practice-changing cardiovascular research. These data reflect important clinical findings beyond the positive primary results of the study released in November 2018.
REDUCE-IT, an 8,179-patient cardiovascular outcomes study, was completed in 2018. REDUCE-IT was the first multinational cardiovascular outcomes study that evaluated the effect of prescription pure EPA therapy, or any triglyceride lowering therapy, as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, had elevated triglyceride levels (135-499 mg/dL). A large portion of the male and female patients enrolled in this outcomes study were diagnosed with type 2 diabetes.
AMRN is a decent entry opportunity but it’s starting to move fast. Prices have been extended to the upside lately. For a good entry it is better to wait for a consolidation but large players volume is rising and so is the Twiggs Money Flow.
Brexanolone – SAGE-547 (202C) for postpartum Depression. The PDUFA date was extended three months to March 19, 2018. Advisory Committee meeting November 2, 2018 voted 17-1 recommending approval.
Back on November 20, 2018, Sage Therapeutics announced that 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.
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.
Brexanolone is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor. ZULRESSOTM (brexanolone) injection has completed Phase 3 clinical development for postpartum depression and a New Drug Application is currently under review with the U.S. Food and Drug Administration. ZULRESSO for the treatment of PPD has been granted Breakthrough Therapy Designation by the FDA and PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA). The FDA has conditionally accepted the proprietary name ZULRESSO for Sage’s intravenous formulation of brexanolone.
SAGE has an excellent technical rating and also presents a decent setup pattern. Prices have been consolidating lately and the volatility has been reduced. 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 $160.79. Right above this resistance zone may be a good entry point. Remember to follow the trade management techniques that millionaire and billionaires use.
Disclosure: I do not hold any position in any stock mentioned in this article.