Sell LightPath Technologies For a 90% Monster Win!

April 10, 2017: Sell Sell LightPath Technologies for a 90% win in 69 days. Congratulations if you were able to make money on the trade.

February 15, 2017: Lightpath Technologies reports Q2 EPS of $0.06 versus the $0.02 estimate. Revenue also beat coming in at $5.9 million versus the $5 million estimate.

December 22, 2016: Roth Capital initiates coverage of LightPath Technologies with a Buy rating, and a price target of $2.50. Roth Capital thinks LightPath is a business that has reached a positive organic inflection point, generating attractive profitability driven by double-digit end market growth and strong product cost performance.

LightPath Technologies, Inc. provides optics and photonics solutions for the industrial, defense, telecommunications, testing and measurement, and medical industries.

Jazz Pharmaceuticals Announces Positive Results From Phase 3 TONES 3 and TONES 4

March 20, 2017: Jazz Pharmaceuticals announced positive efficacy results from two global multicenter studies in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA). JZP-110 demonstrated highly statistically significant differences in the co-primary efficacy endpoints in the TONES 3 study at the 300 mg, 150 mg, 75 mg and 37.5 mg dose arms and in the TONES 4 study in the combined JZP-110 treatment arm (300 mg, 150 mg, and 75 mg doses) compared to placebo. Based on the preliminary safety analysis, the most commonly reported adverse events (AEs) in these studies were consistent with those previously described in the Phase 2 clinical studies evaluating JZP-110 in narcolepsy.

The Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program is comprised of four studies, two in OSA, one in narcolepsy and one open-label, long-term safety and maintenance of efficacy study. The two Phase 3 OSA studies enrolled 652 total patients.
Efficacy Results of TONES 3 Study The TONES 3 study, or 14-003, is a 5-arm, parallel-group study evaluating four doses of JZP-110 (300 mg, 150 mg, 75 mg and 37.5 mg) and placebo for a 12-week period. The study enrolled 476 patients and was powered to detect differences between placebo and the 300 mg and 150 mg dose arms.

In TONES 3, JZP-110 demonstrated highly statistically significant improvement in the co-primary endpoints of Maintenance of Wakefulness test (MWT) and Epworth Sleepiness scale (ESS) at all doses. In addition, the key secondary endpoint of Patient Global Impression of Change (PGIc) scale demonstrated a highly statistically significant improvement in the 300 mg, 150 mg and 75 mg doses versus placebo. On the co-primary endpoints of MWT and ESS, the study demonstrated that treatment with JZP-110 significantly increased the patients’ ability to stay awake and significantly decreased patients’ subjective levels of sleepiness, respectively, compared to placebo. These effects were maintained throughout the course of the study.
Efficacy Results of TONES 4 Study The TONES 4 study, or 14-004, is a six-week study in which eligible subjects received four weeks of open-label treatment, and at the end of week 4, 126 patients who reported “much” or “very much” improvement on the PGIc scale and who had numerical improvements on the MWT and ESS at week 4 were then randomized 1:1 to receive either the same dose of JZP-110 received in the stable dose phase, or placebo, for two weeks in the randomized withdrawal phase.

In TONES 4, patients randomized to continue on JZP-110 maintained efficacy, while those randomized to placebo experienced a loss of efficacy, as measured by the co-primary and key secondary endpoints.

Preliminary Safety Results of TONES 3 and TONES 4 Studies Based on a preliminary safety analysis, the most commonly reported adverse events were headache, nausea, decreased appetite, dry mouth, anxiety, dizziness, insomnia, nasopharyngitis, and palpitations. There were six patients with serious adverse events (SAEs), two patients on placebo and four on JZP-110. None of these was deemed a treatment-related adverse event as assessed by the investigators. Additional safety information will be available based on the final analyses of the JZP-110 program, including results of the open-label, long-term safety and maintenance of efficacy study.

January 18, 2017: Leerink reiterates their Outperform rating on Jazz Pharmaceuticals and sets a price target of $182 after yesterday evenings FDA updates regarding a generic Xyrem (naracolepsy) application appear to be a net-positive for JAZZ as the FDA concurrently ruled (in a citizens petition [CP]) that it won’t allow generic substitutes to carve-out safety/dosing language that is patent protected. At a minimum, firm expects the approved generic will need to successfully litigate the Xyrem formulation (ends mid-2020E) and DDI patents (expires 2033E) before launching as they believe an at-risk launch against two battletested patent families would be financial catastrophic. Ultimately, todays update provides much needed visibility into how the FDA views the safety risk of omitting divalproex DDI (drug-drug interaction) and dosing language from the Xyrem package insert. Some investors believed generic companies’ ability to “carve out” the DDI information from their labels would allow them to argue they didn’t infringe the DDI patents. Based on last night’s ruling, it would appear this generic noninfringement strategy on the DDI patents is foreclosed. Further, with JAZZs DDI patents withstanding the invalidity challenge in multiple inter partes reviews (IPR) relating to the obviousness of those patents, those patents now appear much stronger and likely to withstand two central arguments they’d anticipate when the patent dispute moves to the district court in May 2017 (lead case). Based on the above considerations, firm believes the generic companies will be more likely to accept JAZZ’s likely settlement offer to launch in late 2025E since the risk of getting blocked until 2033E looks increasingly probable.

January 17, 2017: The U.S. Food and Drug Administration (FDA) has approved Jazz’s Xyrem, the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, which is a potentially debilitating disease. Cataplexy is a primary symptom of narcolepsy where patients suddenly lose muscle tone, including voluntary muscle control, while awake. Muscle weakness or paralysis associated with cataplexy may cause a person to collapse. Approximately 70 percent of people with narcolepsy have cataplexy. Sodium oxybate is the only medication approved to treat cataplexy in patients with narcolepsy.

The use of Xyrem has been associated with serious side effects including seizures, trouble breathing, changes in alertness, coma, and death. Additionally, the active ingredient in Xyrem (and in the newly approved generic) is sodium oxybate. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB). GHB has not been approved for any medical use and has the potential for abuse, such as in cases of sexual assault.

Because of the potential risks associated with Xyrem, it is subject to strict safety controls on prescribing and dispensing under a program called a Risk Evaluation and Mitigation Strategy (REMS). FDAs approval of generic sodium oxybate is subject to a REMS with strict safety controls that are comparable to those currently required for Xyrem.

Specifically, under both the Xyrem REMS and the generic sodium oxybate REMS, sodium oxybate can be prescribed only by a certified prescriber, and dispensed only to an enrolled patient by a certified pharmacy. Only a certified pharmacy that ships directly to patients can dispense sodium oxybate. Sodium oxybate will not be available in retail pharmacies.

In approving this generic version of Xyrem, the FDA is maintaining strict safety requirements for sodium oxybate, while providing patients with access to a generic medication option for narcolepsy. Source: http://www.fda.gov/Drugs/DrugSafety/ucm537281.htm

January 9, 2017: At the JP Morgan conference, Jazz said it plans to expand via M&A and partnerships this year; Affirms FY16 $9.90-10.30 versus $10.02 estimate; Revenue $1.5 billion versus $1.49 billion estimates.

December 15, 2016: Cantor Fitzgerald initiates JAZZ with an Overweight rating and a price target of $187.

Jazz Pharmaceuticals plc is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing important products that address unmet medical needs. The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology.

As part of our unwavering commitment to improving patients’ lives, we are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise. We do this through a growth strategy of growing sales of the existing medicines in our portfolio; acquiring commercial products or product candidates that are in late-stage development, and pursuing focused development of our pipeline of differentiated therapies.

Sell Exact Sciences For a 55% Win!

March 4, 2017: Sell Exact Sciences for a 55% win in 37 days. Congratulations if you were able to make money on the trade and always remember to sell your positions before you get the sell alert from me. I review more than 200 open stock positions over the weekend when I have time and so my sell signals are always going to come later.

March 2, 2017: A study from Exact Sciences Corp. and Mayo Clinic released today by the American Association of Cancer Research (AACR) shows promise for the development of a blood-based lung cancer test. Researchers conducted a multi-round study of nearly 400 patients, which demonstrated high accuracy for detecting lung cancer at all stages.

AACR released an abstract of the study today, ahead of the presentation of the results on April 2, 2017, during the AACR 2017 annual meeting. The findings from the study of 398 patients (311 controls and 87 cancers) demonstrate that biomarkers in plasma achieved high accuracy for all types and stages of lung cancer. Using two independent regression modeling approaches, a panel of four novel methylated DNA markers demonstrated a sensitivity of 91-96 percent at a specificity of 90-94 percent.

More studies are needed to corroborate accuracy, however, this plasma DNA test approach appears to be a promising new method and may serve as a rational follow-up to the common findings of lung nodules on CT scanning and may have application in screening for lung cancer.

February 21, 2017: Roth Capital raised Exact Sciences to Buy from Neutral and set a price target of $26. The price target was raised to $26 from $15. Roth Capital says Exact Sciences announced Q4 revenues in-line with its pre-announcement beat driven by strong volumes and higher ASPs, and unveiled 2017 guidance above expectations.

February 5, 2017: On February 2, 2017, Exact Sciences announced that Cologuard® is included in the Medicare Advantage Advance Notice and Draft Call letter. Cologuard’s inclusion in the final Star Ratings will allow Medicare Advantage plans to increase their Star Rating when patients complete Exact Sciences’ non-invasive colon cancer screening test.

Kevin Conroy, chairman and CEO of Exact Sciences said, “The proposed inclusion of Cologuard in the Star Ratings program is an important step toward it becoming a standard of care for colon cancer screening. Health insurers would be eligible to receive Medicare Advantage Star Rating quality credit when their members are screened using Cologuard.”

The Centers for Medicare and Medicaid Services (CMS) Medicare Advantage Star Ratings are directly impacted by the Healthcare Effectiveness Data and Information Set (HEDIS). The HEDIS quality measures were updated by the National Committee for Quality Assurance (NCQA) on October 3, 2016, to include Cologuard on an every three-year screening schedule. CMS’s proposal to broaden the colorectal cancer screening quality measure is subject to a 60-day public comment period. The proposal aligns the Star Ratings with the HEDIS quality ratings and the colorectal cancer screening guidelines of the U.S. Preventive Services Task Force, the American Cancer Society and others. Just as HEDIS 2017 quality measures are used to audit and report the 2016 performance of providers and health systems, the Stars Ratings use the HEDIS data to calculate the quality performance of Medicare Advantage plans.

January 8, 2017: Exact Sciences guides Q4 revenue from $34.9 million to $35.4 million versus the $29.5 million estimate. Q4 saw the completion of approximately 82,000 Cologuard tests during the fourth quarter of 2016, which represents growth of 114 percent from the same period of 2015.

More than 9,500 health care providers ordered Cologuard for the first time during the fourth quarter ended Dec. 31, 2016. The number of providers who have ordered Cologuard since it was launched increased to nearly 60,000 during 2016, an increase of 122 percent from the prior year.

Insurance coverage of Cologuard expanded by 67 percent during 2016. Coverage has increased by 62 million lives since June 2016, when Cologuard was included in the U.S. Preventive Services Task Force’s final colorectal cancer screening recommendations. More than 163 million people are in health plans that cover Cologuard as of January 6, 2017.

January 5, 2017: Exact Sciences announced that the Blue Cross Blue Shield Association’s (BCBSA) Center for Clinical Effectiveness “Evidence Street” recently released a positive review of Cologuard to its members. BCBSA is a national federation of 36 Blue Cross and Blue Shield companies that insure one in three Americans. This continues the positive momentum for Cologuard, as coverage increased by 67 percent in 2016 and nearly 163 million Americans are now in health plans that cover the non-invasive colorectal cancer screening option. The BCBSA’s Center for Clinical Effectiveness is an organization that assesses the effectiveness of medical devices, procedures, and biological products through comprehensive reviews and clinical evidence. The Evidence Street assessment follows other positive reviews of Cologuard, which is now included in the recommendations of the U.S. Preventive Services Task Force, and the colorectal cancer screening guidelines of the American Cancer Society and the National Comprehensive Cancer Network. This assessment is influential for association members and non-members who look to the Center for Clinical Effectiveness for guidance. BCBSA does not endorse specific companies or products nor make coverage decisions.

December 12, 2016: Exact Sciences announced today under a recently-signed contract, Humana Inc. agreed to cover Cologuard as an in-network service for its members, effective January 1, 2017. Under terms of the agreement, Cologuard will be available to most Humana beneficiaries with no co-pay. Humana covers nearly 10 million recipients and is the nation’s fifth-largest commercial insurer.

With Humana’s inclusion of Cologuard as an in-network service, the test is now covered by a cross-section of health plans nationwide with more than 153 million members. This is an increase of more than 50 million members since June 2016 when Cologuard was included as an A-rated service in the colorectal cancer screening guidelines of the U.S. Preventive Services Task Force. More than 68 percent of Cologuard’s addressable population are enrolled in plans that cover the test.

Exact Sciences Corp. is a molecular diagnostics company focused on colorectal cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. Stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer.

ARIAD Pharmaceuticals Sell For 86.7% Win!

January 9, 2017: Sell ARIAD Pharmaceuticals on the news that it will be acquired by Takeda for $24 per share. This was a monster 86.7% win for us. Congratulations if you were able to make money on the trade.

January 4, 2017: Seeing heavy weekly call activity in Ariad Pharmaceuticals: 1,684 Jan 13 $13 calls trade at $0.40

December 7, 2016: ARIAD Pharmaceuticals announced that the investigational medicine brigatinib demonstrated 15.6 month systemic median progression-free survival in ALTA Study. The clinical data on brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in ALK-positive (ALK+) non-small cell lung cancer (NSCLC) patients who had experienced disease progression on crizotinib therapy. As of May 31, 2016, the data show that of patients on the 180-mg regimen with a median follow-up of 11 months, 55% achieved confirmed objective response as assessed by the investigator. In this arm, the median progression-free survival (PFS) was 15.6 months in this post-crizotinib setting, by both investigator and independent review committee (IRC) assessment. Additionally, in this arm, 67 percent of patients with measurable brain metastases achieved a confirmed intracranial objective response, and intracranial PFS was 18.4 months among patients with any brain metastases at baseline. These data will be presented today at the International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer (WCLC) being held in Vienna.

The ALTA Trial

The ALTA (ALK in Lung Cancer Trial of AP26113) trial enrolled 222 patients with ALK+ NSCLC who had been treated with and experienced disease progression on their most recent crizotinib therapy. Patients were randomized one-to-one to receive either 90 mg of brigatinib once per day (QD) (Arm A), or 180 mg QD, preceded by a lead-in dose of 90 mg QD for seven days (Arm B). Also, patients were stratified by presence of brain metastases at baseline and best response to prior crizotinib therapy.

The primary endpoint of the ALTA trial is investigator-assessed confirmed objective response rate (ORR) as measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Key secondary endpoints include PFS, confirmed ORR assessed by an IRC, overall survival (OS), CNS response and PFS, duration of response, safety and tolerability.

Key Data from the ALTA Trial UpdateBrigatinib Efficacy and Safety in ALK+ NSCLC Patients:

A total of 222 patients with ALK+ NSCLC treated with prior crizotinib therapy were randomized in the study (110 patients in Arm B at the 180-mg dose level with a seven-day lead-in at 90 mg and 112 patients in Arm A at the 90-mg dose level). The last patient was enrolled in the study in September 2015.

The median follow-up was 11 months in Arm B and 10.2 months in Arm A. ALTA trial data presented at the 2016 American Society of Clinical Oncology (ASCO) meeting, as of February 29, 2016, had median follow-up of 8.3 months in Arm B and 7.8 months in Arm A.Investigator-assessed confirmed ORR in Arm B was 55 percent. IRC-assessed confirmed ORR in Arm B was 54 percent. Investigator-assessed confirmed ORR in Arm A was 45 percent. IRC-assessed confirmed ORR in Arm A was 49 percent.

In a subgroup analysis of confirmed ORR by baseline characteristics, there was no difference in confirmed ORR based on prior chemotherapy versus no prior chemotherapy.

The subgroup analysis by best response to prior crizotinib (partial or complete response versus other) suggests that patients who had achieved partial or complete responses to prior crizotinib treatment had a significantly higher confirmed ORR, compared with patients who did not reach these reactions.

Responses in Arm B included a confirmed partial response in a patient with the ALK kinase domain G1202R mutation at baseline, which is associated with resistance to all approved tyrosine kinase inhibitors (TKIs).

Median PFS was 15.6 months by both investigator assessment and IRC assessment in Arm B. Median PFS was 8.8 months by investigator assessment and 9.2 months by IRC assessment in Arm A.

The probability of OS at one year was 82 percent and 71 percent in Arm B and Arm A, respectively. The median OS had not been reached in either arm.Of the 44 patients with measurable intracranial brain metastases at baseline, the IRC-assessed intracranial ORR was 67 percent (12/18) in Arm B and 46 percent (12/26) in Arm A.

The median IRC-assessed intracranial PFS was 18.4 months in Arm B and 15.6 months in Arm A.The most common treatment-emergent adverse events (TEAEs; = 30% of all patients, [Arm B/A]), regardless of relationship to treatment, were nausea (43%/36%), diarrhea (39%/21%), cough (36%/23%), headache (30%/28%) and increased blood creatine phosphokinase (CPK) (33%/11%).TEAEs, grade =3, occurring in =4 percent of all patients (excluding neoplasm progression; Arm B/A), were increased CPK (10%/3%), hypertension (6%/6%), pneumonia (5%/3%) and increased lipase (3%/5%).

A subset of pulmonary adverse events (AEs) with early onset (median: Day 2; range: Day 1-9) occurred in six percent of all patients (grade =3 in 3% of patients); no such events with early onset occurred after dose escalation to 180 mg QD in Arm B.

Discontinuations and dose reductions due to AEs (Arm B/A) were 10 percent/three percent and 23 percent/eight percent, respectively. Discontinuations due to documented progressive disease (Arm B/A) were 23 percent and 30 percent.

The company said, “We are encouraged by the maturing efficacy and safety profile of brigatinib in this later data cut, which adds three months of follow up compared to the data presented at ASCO. These data are intended to be submitted to the European Medicines Agency in early 2017 for marketing approval. Pending regulatory review, we expect that brigatinib may become an important therapeutic option for the crizotinib-resistant population.”

November 29, 2016: ARIAD Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Iclusig (ponatinib) full approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL. Iclusig was initially approved in December 2012 under the FDAs accelerated approval program, which provides patients earlier access to promising new drugs that treat serious conditions based on a surrogate endpoint while the company conducts additional studies to confirm the drugs clinical benefit. The therapy was granted the FDAs orphan drug designation because it is intended to treat a rare disease or condition.

This full approval and label update is based on 48-month follow-up data (as of August 2015) from the pivotal Phase 2 PACE clinical trial of Iclusig in heavily pretreated patients with resistant or intolerant CML or Ph+ ALL. These data were presented at the 2016 meetings of the American Society for Clinical Oncology and the European Hematology Association (EHA).

About Iclusig(ponatinib) Tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel, Canada and Japan.

In the U.S., Iclusig is a kinase inhibitor indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.

Limitations of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.

November 7, 2016: ARIAD Pharmaceuticals beat on EPS, reporting Q3 EPS of -$0.12 versus the -$0.19 estimate. Revenue also beat coming in at $46 million versus the $41.9 million estimate.

– Affirming FY16 guidance for global Iclusig net product and royalty revenue of $170 million to $180 million.

– Affirming FY16 guidance for research and development expense of $175 million to $180 million, and sales, general and administration expense of $120 million to $125 million.

– Affirming FY16 guidance for cash, cash equivalents, and marketable securities at December 31, 2016, of $280 million to $290 million.

ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines.

Editas Medicine Rising Twiggs Money Flow

Editas Medicine has an explosive Twiggs Money Flow on the chart.

Editas Medicine is a risky biotechnology stock with no P/E.

The catalyst is none other than the Biotech Discovery of the Century. Yeah, that sounds like major hype and maybe somebody is drinking the Kool-Aid. Nevertheless, the chart looks pretty sweet with the rising Twiggs Money Flow.

Disclosure: I do not any position in Editas Medicine.