We have a lot of data that could be coming out next week from biotechnology stocks. A whopping 11 biotech stocks could be getting boosts next week on data releases. Keep in mind though that dates often change and results can be delayed. Also keep in mind that we are coming to the end of the strong time of year for biotech stocks which ends on October 1, 2018.
ALNY Stock Chart
ALNY stock does present a nice setup opportunity. Prices have been consolidating lately and the volatility has been reduced. There is a support zone below the current price at 94.32, a stop order could be placed below this zone. We notice that large players showed an interest for ALNY in the last couple of days, which is a good sign.
ALNY’s overall performance in the market is below average. Also recent price action is not that positive. Both the medium and short term picture give negative signs.
Givosiran is for acute hepatic porphyrias. Phase 3 completion of enrollment was announced August 21, 2018 with interim analysis due late-September 2018. Full data due early 2019.
The Company reiterated its previous guidance that it expects to report topline results of the interim analysis by the end of September 2018 in support of a potential accelerated approval, and topline results on the primary endpoint of annualized attack rate after six months of treatment in early 2019. The interim analysis is based on lowering of urinary aminolevulinic acid (ALA) levels from approximately 30 patients at three months of treatment as a surrogate biomarker that is reasonably likely to predict clinical benefit. Pending Company and FDA review of the program at the time of interim analysis and assuming positive results and acceptable safety, the Company continues to expect to submit an NDA at or around year-end 2018, seeking an accelerated approval.
The ENVISION Phase 3 trial is a randomized, double-blind, placebo-controlled, global, multicenter study to evaluate the efficacy and safety of givosiran in patients with a documented diagnosis of AHPs. Patients were randomized on a 1:1 basis to receive 2.5 mg/kg of givosiran or placebo subcutaneously administered monthly, over a 6-month treatment period. The primary endpoint is the annualized rate of porphyria attacks requiring hospitalization, urgent healthcare visit or hemin administration at home over the 6-month treatment period. The planned interim analysis will evaluate reduction of a urinary biomarker – ALA – in approximately 30 patients after three months of dosing, as a surrogate endpoint reasonably likely to predict clinical benefit. Key secondary and exploratory endpoints will evaluate reductions in the hallmark symptoms of AHPs, such as pain, nausea, and fatigue, as well as impact on quality of life.
Acute hepatic porphyrias (AHPs) are a family of rare, genetic diseases characterized by potentially life-threatening attacks and for many patients chronic debilitating symptoms that negatively impact daily functioning and quality of life. AHPs are comprised of four subtypes, each resulting from a genetic defect leading to deficiency in one of the enzymes of the heme biosynthesis pathway in the liver: acute intermittent porphyria (AIP), hereditary coproporphyria (HCP), variegate porphyria (VP), and ALAD-deficiency porphyria (ADP). These defects cause the accumulation of neurotoxic heme intermediates aminolevulinic acid (ALA) and porphobilinogen (PBG), with ALA believed to be the primary neurotoxic intermediate responsible for causing both attacks and ongoing symptoms between attacks. Common symptoms of AHPs include severe, diffuse abdominal pain, weakness, nausea, and fatigue. The symptoms of AHPs can often resemble that of other more common conditions such as irritable bowel syndrome, appendicitis, fibromyalgia, and endometriosis and consequently, patients afflicted with AHPs are often misdiagnosed or remain undiagnosed for up to 15 years. Currently, there are no treatments approved to prevent debilitating attacks and treat the chronic symptoms of the disease.
AMRN Stock Chart
AMRN stock shows a decent setup pattern. Prices have been consolidating lately. There is a resistance zone just above the current price starting at 3.04. Right above this resistance zone may be a good entry point. There is a support zone below the current price at 2.79, a stop order could be placed below this zone.
AMRN’s overall performance in the market is below average. Also recent price action is not that positive. Both the medium and short term picture give negative signs.
Vascepa REDUCE-IT outcomes trial for high Triglycerides With Mixed Dyslipidemia. Data is due before the end of September 2018.
The Vascepa cardiovascular outcomes study, REDUCE-IT™, is designed to provide data to support a significantly expanded market opportunity for Vascepa® (icosapent ethyl). The company announced that, as expected, it is making progress towards completion of this important study. The company reiterated that it anticipates reporting top-line results from REDUCE-IT before the end of September 2018.
The Vascepa cardiovascular outcomes study, REDUCE-IT, is progressing closer to completion with top-line results from the study anticipated to be reported before the end of September 2018. Amarin commented that final vital status data now has been secured for more than 99.5% of the 8,175 patients enrolled in the study. Consistent with late stage activities for large outcomes studies, efforts remain ongoing to adjudicate reported events, including major adverse cardiovascular events (MACE) within the primary endpoint that could not be adjudicated until after the last patient visits occurred. Efforts are also underway to complete the review of data for consistency and completeness across the more than 35,000 patient years in the trial, with emphasis on resolving remaining data queries to contribute to a robust and accurate database.
Amarin continues to prepare its commercial infrastructure for the announcement of the results of the REDUCE-IT study, including recent promotion of three high performing district sales managers to newly defined roles as regional directors in preparation for potential rapid sales force expansion and increasing levels of available Vascepa inventory. As previously stated, during 2018 we anticipate incremental inventory increases prior to REDUCE-IT results of up to approximately $10 million. As of June 30, 2018, we had increased inventory levels during 2018 by approximately half of the target increase amount with the balance of the increase scheduled for coming months.
ANAB Stock Chart
ANAB has an excellent technical rating and also presents a decent setup pattern. Prices have been consolidating lately and the volatility has been reduced. There is a support zone below the current price at 88.12, a stop order could be placed below this zone. We notice that large players showed an interest for ANAB in the last couple of days, which is a good sign. Another positive sign is the recent Pocket Pivot signal.
ANAB has been a medium performer in the overall market. Some doubts are observed in the medium time frame, but recent action was very positive.
ANB020 is for severe adult eosinophilic asthma. Phase 2a data is due Q3 2018.
“We made significant advances during the second quarter of 2018 in the clinical development of our first-in-class wholly-owned antibody therapeutics for patients with severe inflammatory conditions,” said Hamza Suria, president and chief executive officer of AnaptysBio. “We are excited to advance the clinical development of etokimab in large atopic disease markets, including our ongoing Phase 2b ATLAS trial in moderate-to-severe atopic dermatitis, our ongoing Phase 2a trial in severe eosinophilic asthma and our upcoming Phase 2 ECLIPSE trial in adult chronic rhinosinusitis with nasal polyps. Development of ANB019 in orphan diseases has been initiated with our Phase 2 GALLOP trial in generalized pustular psoriasis and upcoming Phase 2 POPLAR trial in palmoplantar pustulosis. We look forward to the five clinical efficacy readouts anticipated from our etokimab and ANB019 programs by the end of 2019, starting with our upcoming etokimab Phase 2a top-line data in eosinophilic asthma during the third quarter of 2018, as key milestones in our mission to bring novel treatments to patients with severe inflammatory diseases.”
AnaptysBio expects to report top-line efficacy and safety data, including improvement in Forced Expiratory Volume in One Second (FEV1), from its ongoing double-blinded, placebo-controlled severe eosinophilic asthma trial Phase 2a trial, where approximately 24 adult severe eosinophilic asthma patients are treated with a 300mg intravenous single dose of etokimab versus placebo, each in combination with inhaled corticosteroids and long-acting beta agonists as background therapy, in the third quarter of 2018.
ATRS Stock Chart
ATRS does present a nice setup opportunity. We see reduced volatility while prices have been consolidating in the most recent period. There is a support zone below the current price at 3.22, a stop order could be placed below this zone.
In the last year, ATRS was a medium performer in the overall market. The medium term is still looking fine, but we see some doubts in the shorter, more recent time frame.
XYOSTED (testosterone enanthate) is for testosterone deficiency. The PDUFA date is September 29, 2018.
Antares Pharma announced that the FDA acknowledged receipt of the Company’s March 29, 2018 resubmission to the Complete Response Letter (CRL) received in connection with the XYOSTED™ (testosterone enanthate subcutaneous injection) New Drug Application. The FDA considered this resubmission a complete, class 2 response and has assigned a user fee goal date of September 29, 2018.
GERN Stock Chart
GERN presents a decent setup pattern. We see reduced volatility while prices have been consolidating in the most recent period. There is a very little resistance above the current price.
GERN has decent performance in both the short and medium term time frames. Compared to the overall market, GERN is only an average performer.
Imetelstat IMbarkStudy for myelofibrosis. Phase 2 primary analysis data is due Q3 2018.
IMbark is the ongoing Phase 2 clinical trial to evaluate two doses of imetelstat in intermediate-2 or high-risk myelofibrosis (MF) patients who are refractory to or have relapsed after treatment with a JAK inhibitor.
Following completion of the IMbark protocol-specified primary analysis, Janssen must notify Geron whether it elects to maintain the license rights and continue the development of imetelstat in any indication (Continuation Decision). Geron expects the protocol-specified primary analysis for IMbark to begin by the end of the second quarter of 2018. As such, the company expects the Continuation Decision to occur by the end of the third quarter of 2018.
INSM Stock Chart
INSM does present a nice setup opportunity. Prices have been consolidating lately. There is a very little resistance above the current price. We notice that large players showed an interest for INSM in the last couple of days, which is a good sign.
INSM scores bad on all fronts: it is a bad performer in the overall market and both the medium and short term pictures are negative.
ALIS is for nontuberculous mycobacterial (NTM) lung disease. The PDUFA date under priority review is September 28, 2018. An Advisory Committee Meeting on August 7, 2018 voted 12-2 supporting approval.
. If approved, ALIS will be the first and only therapy in the U.S. specifically indicated for the treatment of patients with NTM lung disease caused by MAC.
“We are very pleased by the outcome of today’s advisory committee meeting, which recognized the role ALIS may be able to play in addressing the significant unmet medical need among patients suffering from NTM lung disease caused by MAC, a chronic, debilitating and potentially fatal infection,” said Will Lewis, President and Chief Executive Officer of Insmed.
The advisory committee’s recommendation was based on briefing materials developed from Insmed’s new drug application (NDA) for ALIS, which was submitted under accelerated approval provisions and includes data from the Phase 3 CONVERT study. The study met its primary endpoint of culture conversion by Month 6 with statistical significance for once-daily ALIS when added to guideline-based therapy (GBT) compared with GBT alone in patients with refractory NTM lung disease due to MAC.
“The patients included in our Phase 3 clinical trial represent the most difficult-to-treat segment of the NTM lung disease population, having already failed treatment with current guideline-based therapy. The committee’s favorable recommendation brings us one step closer to providing the first and only FDA-approved treatment for these patients. We look forward to working closely with the FDA as it completes its review of our application,” said Paul Streck, M.D., Chief Medical Officer of Insmed.
In a separate vote, the committee voted against the safety and effectiveness of ALIS in the broadest population of adult patients with NTM lung disease caused by MAC.
The FDA is not bound by the committee’s recommendation but takes its input into consideration when evaluating whether to approve Insmed’s NDA for ALIS, which is currently under Priority Review by the FDA with an action date of September 28, 2018 under the Prescription Drug User Fee Act (PDUFA). The FDA has previously designated ALIS an orphan drug, a breakthrough therapy, and a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act.
NTM lung disease is a rare and serious disorder associated with increased rates of morbidity and mortality. There is an increasing prevalence of lung disease caused by NTM and Insmed believes it is an emerging public health concern worldwide. Patients with NTM lung disease may experience a multitude of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum, and fatigue. Patients with NTM lung disease frequently require lengthy hospital stays to manage their condition. Insmed is not aware of any approved inhaled therapies specifically indicated for refractory NTM lung disease caused by MAC in North America, Japan or Europe. Current guideline-based approaches involve use of multi-drug regimens not approved for the treatment of NTM lung disease, and treatment can be as long as two years or more.
The prevalence of human disease attributable to NTM has increased over the past two decades. In a decade long study (1997 to 2007), researchers found that the prevalence of NTM lung disease in the U.S. was increasing at approximately 8% per year and that NTM patients on Medicare over the age of 65 were 40% more likely to die over the period of the study than those who did not have the disease. In the U.S., Insmed estimates there will be between 75,000 and 105,000 patients with diagnosed NTM lung disease in 2018, of which the Company expects 40,000 to 50,000 will be treated for NTM lung disease caused by MAC. Insmed expects that between 10,000 and 15,000 of these patients will be refractory to treatment. In Japan, Insmed estimates there will be between 125,000 and 145,000 patients with diagnosed NTM lung disease in 2018, with approximately 60,000 to 70,000 of those patients being treated for NTM lung disease caused by MAC and 15,000 to 18,000 of these treated patients being refractory to treatment. Insmed also estimates there will be approximately 14,000 patients with diagnosed NTM lung disease in the EU5 (comprised of France, Germany, Italy, Spain and the United Kingdom) in 2018, of which the Company estimates approximately 4,400 will be treated for NTM lung disease caused by MAC and approximately 1,400 of these treated patients will be refractory to treatment.
ALIS is a novel, inhaled, once-daily formulation of amikacin that is in late-stage clinical development and under regulatory review by the FDA for adult patients with NTM lung disease caused by MAC. Amikacin solution for parenteral administration is an established drug that has activity against a variety of NTM; however, its use is limited by the need to administer it intravenously and by toxicity to hearing, balance, and kidney function. Insmed’s advanced pulmonary liposome technology uses charge neutral liposomes to deliver amikacin directly to the lung where it is taken up by the lung macrophages where the NTM infection resides. This prolongs the release of amikacin in the lungs while minimizing systemic exposure, thereby offering the potential for decreased systemic toxicities. ALIS’s ability to deliver high levels of amikacin directly to the lung distinguishes it from intravenous amikacin. ALIS is administered once daily using an optimized, investigational eFlow® Nebulizer System manufactured by PARI Pharma GmbH (PARI), a portable aerosol delivery system.
LOXO Stock Chart
LOXO has only a medium technical rating, but it does show a decent setup pattern. 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 161.11. Right above this resistance zone may be a good entry point. There is a support zone below the current price at 158.33, a stop order could be placed below this zone.
In the last year, LOXO was one of the better performers, although we are getting mixed signals now in both the short and medium term time frames.
LOXO-292 is for RET-fusion non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors. Phase 1 updated data due at IASLC September 25, 2018, 3:15-4:45 p.m. ET. NDA filing due late-2019.
Abstracts from its LOXO-292 and larotrectinib programs have been accepted for presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer to be held September 23-26, 2018, in Toronto, Canada.
The LOXO-292 oral presentation will provide an updated analysis of patients with RET fusion non-small cell lung cancer (NSCLC) enrolled in the dose escalation cohorts of the ongoing LIBRETTO-001 Phase 1/2 clinical trial. The larotrectinib poster will provide an analysis of patients with TRK fusion NSCLC enrolled to the larotrectinib clinical program.
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach.
Genomic alterations in the RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC). Both RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as “oncogene addiction,” renders such tumors highly susceptible to small molecule inhibitors targeting RET.
Larotrectinib is an oral and highly selective investigational tropomyosin receptor kinase (TRK) inhibitor in clinical development for the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In clinical trials, larotrectinib demonstrated anti-tumor activity in patients with tumors harboring NTRK gene fusions, regardless of patient age or tumor type. In an analysis of 55 RECIST-evaluable adult and pediatric patients with NTRK gene fusions, larotrectinib demonstrated a 75 percent centrally-assessed confirmed overall response rate (ORR) and an 80 percent investigator-assessed confirmed ORR, across many different types of solid tumors. The majority of all adverse events were grade 1 or 2.
Larotrectinib has been granted Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA.
OMER Stock Chart
OMER presents a decent setup pattern. We see reduced volatility while prices have been consolidating in the most recent period. There is a very little resistance above the current price. Another positive sign is the recent Pocket Pivot signal.
OMER has decent performance in both the short and medium term time frames. Compared to the overall market, OMER is only an average performer.
OMS721 is for IgA nephropathy. Phase 3 trial enrollment initiated February 2018. Phase 2 data is due September 2018.
SNDX Stock Chart
SNDX does present a nice setup opportunity. Prices have been consolidating lately.
SNDX scores bad on all fronts: it is a bad performer in the overall market and both the medium and short term pictures are negative.
E2112 is for HR+, HER2- breast cancer. Phase 3 PFS data is due Q3 2018.
“We made great progress across multiple programs during the first half of this year, including presentation of data from all three cohorts of ENCORE 601 and completion of target enrollment in ENCORE 602 and 603. We also initiated the first combination trial for the SNDX-6352 program, which will evaluate its safety in combination with durvalumab (IMFINZI®),” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “We continue to expect the progression free survival results from E2112, our ongoing Phase 3 trial of entinostat plus exemestane in HR+, HER2- breast cancer, later this quarter, and the third prespecified interim analysis of overall survival in November. We also anticipate sharing next steps for the entinostat-KEYTRUDA® (pembrolizumab) combination program in both non-small cell lung cancer and melanoma by the end of the year.”
The Phase 3 registration trial of entinostat plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer, E2112, is 98% enrolled as of the end of July. ECOG-ACRIN Cancer Research Group, the trial sponsor, had notified the Company that the Data Safety Monitoring Committee (DSMC) completed the final progression free survival (PFS) analysis in November 2017. The trial is proceeding as planned, and Syndax continues to anticipate that enrollment will be complete in the third quarter of 2018, at which time the result of the PFS analysis will be released to the Company. In addition, interim overall survival (OS) analyses are scheduled to occur every May and November. Two interim OS analyses have already occurred, with the next analysis expected this November.
SPPI Stock Chart
Although the technical rating is only medium, SPPI does present a nice setup opportunity. Prices have been consolidating lately and the volatility has been reduced. There is a support zone below the current price at $19.80, a stop order could be placed below this zone. We notice that large players showed an interest for SPPI in the last couple of days, which is a good sign.
In the last year, SPPI was one of the better performers, although we are getting mixed signals now in both the short and medium term time frames.
Poziotinib for non-small cell lung cancer (NSCLC) with exon 20 insertion mutation in EGFR or HER2. Phase 2 abstract noted ORR 58%; PFS 5.6 months. Further data to be presented on September 24, 2018.
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced new interim poziotinib data from the MD Anderson Phase 2 non-small cell lung cancer (NSCLC) study which appeared in an online abstract as part of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. The interim results, which include data from the EGFR cohort and, for the first time, the HER2 cohort, are preliminary and based on data through May 3, 2018. More robust and updated data will be presented in an oral session on September 24 at the conference in Toronto, Canada.
“These results add to a growing body of evidence supporting the role of poziotinib in patients with EGFR and HER2 exon 20 mutations, and are a real advance for these patients for whom no targeted therapies have been effective so far,” said John Heymach, M.D., Ph.D., Chairman and Professor, Department of Thoracic/Head and Neck Medical Oncology, University of Texas, MD Anderson Cancer Center. “I am highly encouraged by these results and the evolution of poziotinib data. Our study is the single largest data set in this high unmet need patient population and I am excited to present updated data during an oral session at the IASLC World Conference on Lung Cancer.”
Data appearing in the abstract were current as of May 3, 2018. 40 patients of the 50 patient EGFR cohort had data available for the efficacy analysis. In the 40 patients, poziotinib continued to show robust efficacy with an objective response rate (ORR) of 58% in this heavily pre-treated population. Median progression free survival (PFS) was 5.6 months (95%-CI 5.06-NA). The disease control rate was 90%. In the HER2 cohort the ORR was 50% and the disease control rate was 83%. The most common adverse events were skin-rash (27.5%), diarrhea (12.5%), and paronychia (7.5%). 45.0% of patients required dose reduction to 12mg, while 17.5% of patients required dose reduction to 8mg. Updated data will be presented at the conference and will include data into September.
“We are thrilled with the data presented in the abstract and look forward to a more robust data set on September 24th,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “Additionally, we believe the treatment potential of poziotinib may go well beyond the previously treated lung cancer setting. We are actively expanding the poziotinib clinical program to explore poziotinib in new areas including first-line treatment of NSCLC, treatment of other solid tumors with EGFR or HER2 mutations, and combination therapies.”
Spectrum Pharmaceuticals will be hosting a live webcast on September 24 following the oral presentation.
TGTX Stock Chart
The technical rating of TGTX is bad and it also does not present a quality setup at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first.
TGTX’s overall performance in the market is below average. Also recent price action is not that positive. Both the medium and short term picture give negative signs.
TG-1101 and TGR-120, UNITY-CLL study for chronic Lymphocytic Leukemia (CLL) and non-Hodgkin’s Lymphoma (NHL). Phase 3 top-line data is due by the end of summer 2018.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, “We are extremely pleased with the data presented today during the ASCO annual meeting. We believe there is a need for novel treatment options for patients who are intolerant to the currently approved BTK and PI3K therapies and believe the data shown today demonstrates that umbralisib can be used effectively in these patients.” Mr. Weiss, continued, “We continue to be pleased with the safety and efficacy profile of umbralisib and believe umbralisib single agent, or umbralisib plus ublituximab referred to as ‘U2’, can become important treatment options across multiple b-cell malignancies. We also look forward to presenting updated umbralisib integrated safety data at the European Hematology Association (EHA) annual congress in a couple of weeks, as well as the topline response rate data from the UNITY-CLL Phase 3 trial by the end of summer 2018.”
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both ublituximab and umbralisib, or the combination of which is referred to as “U2”, are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future.