Verastem Price Target Set 364 Percent Higher By Cantor Fitzgerald

Verastem stock had a price target set 364% higher than its current price by Cantor Fitzgerald. Cantor Fitzgerald has a buy rating on the stock.

Verastem is on track for duvelisib NDA in Q1 2018, to include accelerated approval request for follicular lymphoma. Duvelisib is a dual inhibitor of two enzymes called phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. Both are associated with the growth and survival of malignant B cells and T cells.
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Incyte Corporation Rising Large Players Volume in Ascending Triangle

Incyte Corporation stock has rising large players volume in an Ascending Triangle pattern. The large players volume rising while Incyte has been consolidating is a bullish pattern.
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BioDelivery Sciences Symmetrical Triangle On Rising Large Players Volume

Biodelivery Sciences is in a Symmetrical Triangle pattern on rising large players volume.

There 5 Buy ratings on Biodelivery Sciences and 1 Hold rating. The consensus price target is $4.50 which represents 52.54% upside from the current price.
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Verastem Inc Price Target Raised By Cantor Fitzgerald

Verastem Inc price target was raised to $17 by Cantor Fitzgerald last week. The new $17 price target represents 330% upside from the previous close of $3.95. Cantor has a Buy rating on the stock.

Cantor Fitzgerald is respected on Wall Street but they do not have the most accurate analysts IMO. Oppenheimer Holdings Inc is a more followed analyst than Cantor Fitzgerald. It’s no surprise then that I think it’s more significant that on October 12, 2017, Oppenheimer reiterated their Buy rating on Verastem Inc stock and set a price target of $6 which represents an upside of 52% from the previous close. The $6 price target seems more down-to-earth and achievable than Cantor’s stratospheric $17 price target.
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ContraVir Pharmaceuticals Short Covering On Maxim Price Hike

ContraVir Pharmaceuticals stock had short covering ahead of a price target hike by Maxim Group. A new $4 price target was set by analysts at Maxim Group on Thursday, October 19, 2017, which represents a 451% upside from the previous close of $0.73. Maxim has a Buy rating on ContraVir Pharmaceuticals stock.
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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.