Sell Anavex Life Sciences For a Huge 40% Win

April 30, 2017: Sell Anavex Life Sciences for a huge 40% win and congratulations if you made money on this trade.

January 8, 2017: Institutional traders are accumulating biotechnology firm Anavex Life Sciences according to recent 13F filings. The institutional traders who bought the most shares of Anavex Life Sciences are:

BlackRock Fund Advisors = bought 843,994 shares according to 11-11-2016 filing
BlackRock Institutional Trust = bought 284,540 shares according to 11-11-2016 filing
State Street Corp = bought 218,377 shares according to 11-14-2016 filing
Bank of New York Mellon = bought 129,276 shares according to 11-12-2016 filing
Black Rock Investment Management = bought 127,022 shares according to 11-11-2016 filing
D. E. Shaw & Co = bought 105,080 shares according to 11-14-2016 filing
SUSQUEHANNA International Group = bought 102,685 shares according to 11-14-2016 filing
GEODE CAPITAL Management = bought 46,739 shares according to 11-11-2016 filing
VANGUARD GROUP INC = bought 30,148 shares according to 11-14-2016 filing
California State Teachers Retirement System = bought 68,464 shares according to 11-11-2016 filing
NORTHERN TRUST CORP = bought 58,307 shares according to 11-12-2016 filing
TIAA CREF INVESTMENT MANAGEMENT = bought 25,129 shares according to 12-12-2016 filing

November 22, 2016: Anavex Life Sciences announces data on 41-Week treatment of ANAVEX 2-73 for patients with Alzheimer’s Disease; Investigational treatment suggests to curb cognitive and functional decline. At 41 weeks, Alzheimers patients taking a daily oral dose of ANAVEX 2-73 in the exploratory, not yet dose optimized Phase 2a clinical trial, showed a stabilization of cognitive and functional measures. This data of stabilization is promising since Alzheimers disease is a progressive disease where current therapeutics are only able to temporarily slow the worsening of dementia symptoms and not stop the disease from progressing.

At 41 weeks, oral daily dosing between 10mg and 50mg, ANAVEX 2-73 was well tolerated, and no patients discontinued treatment due to adverse events. There were no clinically significant treatment-related adverse events, and no serious adverse events.

Pre-specified exploratory analyses included the cognitive (MMSE) and the functional (ADCS-ADL) changes from baseline. A continued stabilization of both cognitive (MMSE) and functional (ADCS-ADL) measures in patients treated with ANAVEX 2-73 was observed. This correlation was positive with all measured scores (MMSE, ADCS-ADL, Cogstate, HAM-D and EEG/ERP).

About the ANAVEX 2-73 Phase 2a Study

The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts and a total of 32 mild-to-moderate Alzheimers patients. PART A is a simple randomized, open-label, two-period, cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration, adaptive trial lasting up to 5 weeks for each patient. PART B is an open-label extension for an additional 52 weeks. Initially planned for 26 weeks, PART B was extended to 52 weeks as a result of requests from patients and caregivers.

The primary endpoint of the Phase 2a trial is to establish safety, tolerability and maximum tolerated dose (MTD) of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints include dose response, bioavailability, and exploratory cognitive as well as functional measures using Mini Mental State Examination (MMSE) and evaluation of Alzheimers Disease Co-operative Study Activities of Daily Living Inventory (ADCS-ADL), as well as Cogstate test battery and EEG/ERP.

Anavex Life Sciences Corp. is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer.

Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial.

Sell Cancer Genetics For an Awesome 133% Win!

April 16, 2017: Sell Cancer Genetics for an incredible 133% win in 85 days and congratulations if you made money on the trade.

December 9, 2016: H.C. Wainwright/ Rodman & Renshaw reiterates a Buy rating on Cancer Genetics, and sets a price target of $6.

December 7, 2016: Cancer Genetics announced a collaboration with BeiGene, a global, clinical-stage, research-based biopharmaceutical company developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer. The two companies will work together on BeiGenes immune marker and genomics initiatives to accelerate studies of tumor microenvironment in cancer patients, which will aid in drug target identification and biomarker discovery.

BeiGenes clinical-stage drug candidates inhibit four major oncology targets, including Brutons tyrosine kinase (BGB-3111), the immune checkpoint receptor PD-1 (BGB-A317), the PARP family of proteins (BGB-290), and the RAF dimer protein complex (BGB-283). Each of BeiGenes drug candidates has demonstrated promising early anti-tumor activity and a favorable safety profile and has the potential to be a best-in-class or first-in-class product. These drug candidates are being evaluated as monotherapies and in combination regimens for the treatment of a variety of cancers, including solid tumors and hematological malignancies. CGI will provide biomarker and central laboratory for multiple clinical trials for BeiGenes BGB-3111, BGB-A317, and BGB-290 programs to promote accelerated market entrance and identify subsets of patient populations.

December 5, 2016: Cancer Genetics announces it is on Merck’s list of national reference laboratories offering the PD-L1 22C3 pharmDx immunohistochemistry (IHC) assay, the first U.S. Food and Drug Administration (FDA)-approved companion diagnostic test for pembrolizumab, KEYTRUDA, for PD-L1 testing in non-small cell lung cancer (NSCLC). The company first started offering the DAKO PD-L1 IHC 22C3 pharmDx test in early 2016 and was recently listed as a national reference laboratory.

Cancer Genetics now offers all the available FDA approved companion diagnostics for PD-L1 testing across several cancer indications and is providing these tests for both patient management in the clinical setting as well as for immuno-oncology trials sponsored by leading pharmaceutical companies. Cancer Genetics is now supporting over 100 clinical studies and trials, and over 30 with a component for immuno-oncology testing and monitoring.

Cancer Genetics, Inc. offerers diagnostic products and services that enable precision medicine in the field of oncology. Products and services being developed at CGI are poised to transform cancer patient management, increase treatment efficacy, and reduce healthcare costs. CGI’s cutting-edge proprietary tests and state-of-the-art reference laboratory provide critical genomic information where patients and their physicians need it most – to diagnose, monitor and inform cancer treatment.

Sell Portola Pharmaceuticals For a 45% Win!

April 10, 2017: Sell Portola Pharmaceuticals for a 45% win and congratulations if you made money on the trade.

December 27, 2016: Portola Pharmaceuticals price target raised to $29 from $20 at Credit Suisse, reiterates Neutral rating.

December 26, 2016: Biotechnology firm Portola Pharmaceuticals had revenue of $12.1 million in 2015. For 2016, revenue is on track to more than double to $26.2 million.

December 23, 2016: Portola Pharmaceuticals reports that the FDA accepts NDA for priority review for betrixaban, a prophylaxis of venous thromboembolism (VTE) Granting priority review for betrixaban, an oral, once-daily Factor Xa inhibitor anticoagulant, for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. A priority review shortens the FDA review timeline to six months from the standard review period of 10 months. The application for betrixaban, an FDA-designated Fast Track investigational drug, was deemed sufficiently complete to permit a substantive review and has been given a Prescription Drug User Fee Act (PDUFA) action date of June 24, 2017. Additionally, Portola announced that the European Medicines Agency (EMA) had validated its Marketing Authorization Application (MAA) for betrixaban for extended-duration prophylaxis of VTE in adults with acute medical illness and risk factors for VTE. The EMAs Committee for Medicinal Products for Human Use (CHMP) is reviewing the application under a standard 210-day review period.

December 19, 2016: Portola Pharmaceuticals announced it had signed a $50 million loan agreement with Bristol-Myers Squibb Company and Pfizer Inc. that provides additional funding toward development and clinical studies of AndexXa (andexanet alfa), an investigational compound that is a potential antidote for Factor Xa inhibitors. Under the terms of the agreement, Bristol-Myers Squibb and Pfizer will each loan Portola $25 million. The principal and interest will be repaid primarily through royalties on AndexXa commercial sales. No shares, warrants, options or other equity components were or will be issued in connection with the loan. The non-secured loan does not involve any transfer of patent ownership or licenses.

December 15, 2016: Heavy call activity detected in Portola Pharmaceuticals of 1500 Jan 20 calls traded at $1.15.

Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases.

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.

Teligent FDA Approves Clobetasol Propionate Gel

March 8, 2017: Teligent announced it has received approval of the Company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Clobetasol Propionate Gel, 0.05%. This is Teligent’s second approval for 2017, and its thirteenth approval from its internally-developed pipeline of topical generic pharmaceutical medicines.

Based on recent QuintilesIMS Health data from January 2017, the total addressable market for this product is approximately $10.9 million.

March 06, 2017: Teligent announced it has received approval of the Company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Triamcinolone Acetonide Ointment USP, 0.5%. This is Teligent’s first approval for 2017, and its twelfth approval from its internally-developed pipeline of topical generic pharmaceutical medicines.

Based on recent QuintilesIMS Health data from January 2017, the total addressable market for this product is approximately $4.4 million.

January 03, 2017: Biotechnology firm Teligent announced it has received approval of three of the Company’s abbreviated new drug applications (ANDAs) from the U.S. Food and Drug Administration (FDA) of Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram and 1 mg/gram, Clindamycin Phosphate Topical Solution USP, 1% and Flurandrenolide Ointment USP, 0.05%. These approvals were received on December 30, 2016, and brings Teligent’s total approvals from its internally developed pipeline of topical generic pharmaceutical products in 2016 to nine.

November 30, 2016: Teligent announced it has received approval of the Company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Clobetasol Propionate Lotion 0.05%. This is Teligent’s sixth approval from its internally developed pipeline of topical generic pharmaceutical products.

Based on recent IMS Health data from October 2016, the total addressable market for this product is approximately $19.5 million. Teligent originally submitted this ANDA to the FDA in September 2015.

Jason Grenfell-Gardner, President, and CEO said, “Teligent received FDA approval for Clobetasol Propionate Lotion 0.05% in just less than fifteen months from our original submission date in September 2015. This is our second product approved from our pipeline of applications filed in Generic Drug User Fee Amendments (“GDUFA”) Year 3, which began on October 1, 2014. Teligent now has two products which have been approved by the FDA in a first round review, which exceeds current industry average review time periods published by the FDA in October of 2016. This is our thirteenth product in our domestic portfolio, and our commercialization team expects to launch this product in the first quarter of 2017.”

Teligent, Inc., a specialty generic pharmaceutical company, develops, manufactures, and markets topical formulations in the United States.

Orexigen Therapeutics Sell For 157% Win!

February 16, 2017: Sell Orexigen Therapeutics for a 157% win in 36 days! Congratulations if you were able to make money on this trade.

January 25, 2017: Orexigen Therapeutics announced that Laboratorios Farmaceuticos Rovi has launched Mysimba in Spain. Mysimba is approved by the European Medicines Agency for the management of weight in adult patients (=18 years) with an initial Body Mass Index (BMI) of = 30 kg/m2 (obese), or = 27 kg/m2 to January 4, 2017: Orexigen Therapeutics, Inc. unveiled “Brains Behind Weight Loss,” a new, national direct-to-consumer advertising campaign demonstrating to patients how the brain plays an important role in weight loss. The campaign will underscore how CONTRAVE (naltrexone HCl/bupropion HCl), an FDA-approved prescription weight-loss medicine, is believed to work on two important areas of the brain the hypothalamus (hunger center) to reduce hunger and the mesolimbic reward system to help control cravings. (The exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood). CONTRAVE is the number one prescribed weight loss brand in the United States.

The CONTRAVE campaign is Orexigen’s first collaboration with Young & Rubicam New York since being tapped as agency of record. Kicking off at the start of the season amidst New Year’s resolutions, the campaign emphasizes the strong connection between the brain and weight loss. The visually intriguing images feature real women who arrange themselves to simulate depictions of the human brain.

December 26, 2016: Orexigen Therapeutics recently announced that its wholly owned subsidiary Orexigen Therapeutics Ireland Ltd. and Biologix FZCO, have executed a commercialization and distributorship agreement in the Middle East for Contrave (naltrexone HCl / bupropion HCl prolonged release) monotherapy for weight management in overweight or obese adult patients.

This agreement covers ten countries in the Middle East: Saudi Arabia, the United Arab Emirates, Kuwait, Oman, Qatar, Bahrain, Lebanon, Jordan, Iraq, and Iran. Under the terms of the agreement, Biologix will be responsible for obtaining regulatory approvals and local product registrations in each of the ten countries and for all commercialization activities. Orexigen will supply Contrave to Biologix at an agreed transfer price. Biologix expects Contrave to be available for patients in some countries starting in the third quarter of 2017.

December 8, 2016: Orexigen Therapeutics announced that its wholly owned subsidiary Orexigen Therapeutics Ireland Ltd. and Consilient Health Ltd. had executed a commercialization and distributorship agreement for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in the UK and Ireland. Mysimba is approved by the European Medicines Agency, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (=18 years) with an initial Body Mass Index (BMI) of = 30 kg/m2 (obese), or = 27 kg/m2 to November 16, 2016: Orexigen Therapeutics announces the presentation of data for OREX-1019, a preclinical candidate for treatment and management of drug addiction Announced the presentation of preclinical data for OREX-1019 (BU10119) at Neuroscience 2016, the 46th annual meeting of the Society of Neuroscience, being held this week in San Diego. OREX-1019 is being evaluated by Orexigen as a treatment for opioid and cocaine addiction and was exclusively licensed by the company in 2015. OREX-1019 is a member of an orvinol compound series developed by Dr. Stephen Husbands, Ph.D. at the University of Bath in the United Kingdom.The data presented this week, “A buprenorphine analog attenuates drug-primed and stress-induced cocaine reinstatement,” was assembled by a team of researchers led by Dr. John Traynor, Ph.D. of the University of Michigan. The biochemical profile of several members of the licensed orvinol compound series, including OREX-1019, demonstrates reduced Mu opioid receptor activity compared to buprenorphine. The presented data provide in vivo evidence for the compound’s therapeutic potential in drug addiction management and suggest a wider use in cocaine addiction.

November 8, 2016: Orexigen Therapeutics announces commercialization and distributorship agreement with Valeant for Contrave (naltrexone HCl / bupropion HCl extended release) in Australia and New Zealand Announced that Valeant Pharmaceuticals International, Inc. (Valeant), through a wholly-owned subsidiary, will commercialize Contrave (naltrexone HCl / bupropion HCl extended release) in Australia and New Zealand. Under the terms of the agreement between Valeant and Orexigen’s wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., Valeant will be responsible for obtaining regulatory approvals and for all commercialization activities. Orexigen will supply Contrave tablets to Valeant for an agreed transfer price and certain potential sales milestone payments. Orexigen expects Valeant to file for regulatory approvals in both countries in the first half of 2017.

Orexigen and Valeant Pharmaceuticals International, Inc. previously announced commercialization agreements for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in 20 countries in Central and Eastern Europe and Contrave in Canada and South Africa.

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen developed Contrave (naltrexone HCl and bupropion HCl extended-release), which is approved in the United States. Orexigen’s strategy for Contrave is to pursue marketing authorizations worldwide and pharmaceutical partnerships for global commercialization.

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.

Stock Market Prediction Show For the Week of December 12 2016

A weekly Saturday night show that attempts to predict market direction for the week ahead by looking at a variety of technical and fundamental indicators.

This week’s show features Trump’s comments about bringing down drug prices, the incredible trial results from Bellicum Pharmaceuticals that cured all 35 children in the trial, takeover rumors surrounding Depomed, Hooker Furniture crushing earnings and revenue estimates, the candle over candle reversal on Cytosorbents after they received a new reimbursement code from Germany, Volaris candle over candle reversal after they announced a new flight route called Volaris Costa Rica, Calavo Growers candle over candle reversal after receiving a Buy rating from Vertical Group, and more.