Flexion Therapeutics Stock Higher on FDA Approval of Zilretta

Flexion Therapeutics stock has rocketed higher on FDA approval of Zilretta. Zilretta is the first and only extended-release, intra-articular injection for osteoarthritis knee pain.

Michael Clayman, M.D., President and Chief Executive Officer of Flexion said, “The approval of Zilretta marks a major advancement in the treatment landscape for managing OA knee pain. It comes at a time when our society is in urgent need of non-addictive therapies to help the millions of Americans who suffer from this condition. We believe that Zilretta has the potential to be a transformative medicine for the more than five million patients who receive an intra-articular injection for OA knee pain each year.”

Zilretta’s peak potential sales could hit $750 million but that could be a conservative estimate. With additional revenues from label expansion and potential new indications such as osteoarthritis of the hip and shoulder (for which clinical trials are anticipated to initiate by the end of this year), Zilretta’s sales could easily top $1 billion and that doesn’t include international sales.
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Cryoport Stock Gets Janney Montgomery Scott Price Target of $12

Cryoport stock received a price target hike from Janney Montgomery Scott to $12 which is 42% upside from the previous close of $8.45.

Cryoport provides cryogenic logistics solutions to the life sciences industry through its packaging, information technology, and cold chain logistics expertise. The Company provides logistics solutions for biologic materials, such as immunotherapies, stem cells, chimeric antigen receptors (CAR)-T cells, and reproductive cells for clients.

If someone wants to ship something cryogenically using UPS, FedEx, or DHL, they are directed to Cryoport by these shipping companies.

A whopping 70% of Cryoport’s business comes from biopharma companies. About 15% comes from human reproduction needs and another 15% comes from animal health needs.
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Celsion Corporation Retraces 61.8 Percent After Exploding Higher

Celsion Corporation has done a 61.8 percent Fibonacci retracement after exploding 180 percent higher last week after releasing data from its Ovation Study.

The Ovation Study is a Phase Ib dose escalating clinical trial combining GEN-1, the company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced Stage III/IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.
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Sell Immunogen For an Incredible 101% Win

May 7, 2017: Sell Immunogen for a 101% win in 85 days and congratulations if you made money on the trade.

April 19, 2017: Immunogen’s stock popped 13% today on an upgrade from Leerink Partners. Leerink Partners raised Immunogen to an Outperform rating, from Market Perform, and set a price target of $8. Leerink Partners is upgrading Immunogen based on their higher level of conviction on lead asset mirvetuximab soravtansine providing an attractive risk/reward in context of the stock’s current valuation.

January 2, 2017: Biotechnology firm Immunogen announced that results from the Phase 1 expansion cohort evaluating mirvetuximab soravtansine (IMGN853) in patients with folate receptor alpha (FRa)-positive platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology. The data demonstrate the potential clinical benefit of mirvetuximab soravtansine for the treatment of platinum-resistant ovarian cancer.

Immunogen said, “Standard single-agent therapy for patients with platinum-resistant ovarian cancer typically has a response rate below 20% and median progression-free survival below four months. Mirvetuximab soravtansine generated encouraging efficacy and tolerability data in the Phase 1 trial that suggest the potential to improve clinical outcomes for this patient population.”

The Phase 1 expansion cohort enrolled 46 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors were positive for FRa. Patients were dosed with mirvetuximab soravtansine once every three weeks. Mirvetuximab soravtansine demonstrated single-agent activity in the 46-patient cohort with a 26% confirmed response rate and median progression free survival (PFS) of 4.8 months. In a subset of 23 patients with low, medium or high FRa, who had received three or fewer prior lines of therapy, there was a 39% objective response rate (ORR) and median PFS of 6.7 months. On the basis of the study findings and additional data demonstrating the importance of FRa expression levels with mirvetuximab soravtansine, the Company has designed the Phase 3 FORWARD I study to enroll patients with platinum-resistant ovarian cancer with one to three prior therapies and with medium or high FRa. This group of patients in the Phase 1 expansion cohort exhibited a 44% ORR and a median PFS of 6.7 months.

Mirvetuximab soravtansine exhibited a manageable safety profile. Adverse events (AEs) were generally mild with the majority being grade 1 or grade 2 (least severe grades). The most commonly observed AEs were diarrhea, blurred vision, nausea, and fatigue.

Immunogen said, “These results demonstrate that mirvetuximab soravtansine is active in platinum-resistant ovarian cancer, with encouraging response rates and progression-free survival combined with a manageable safety profile. On the basis of these findings, we have moved confidently into a Phase 3 registration study evaluating this promising agent against the standard of care in the platinum-resistant setting. In addition, we are evaluating combination regimens to assess mirvetuximab soravtansine in expanded patient populations and will begin reporting data from these combinations in mid-2017.”

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells.

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 Catalyst Pharmaceuticals For a 47% Gain

April 16, 2017: Sell Catalyst Pharmaceuticals for a 47% gain in 60 days and congratulations if you made money on the trade.

January 4, 2017: The popular SeekingAlpha blogger Hawkinvest, with over 5,000 followers, posted a positive article on Catalyst Pharmaceuticals today that got the stock moving higher. Hawkinvest writes

Biotech and healthcare stocks underperformed in 2016 and that means this is a sector that could offer value and rebound potential in 2017. With all of this in mind, I have been looking for “hidden gems” in the biotech sector. I have recently found a couple of very interesting investment opportunities that offer an excellent risk to reward ratio and one of the stocks I am bullish on now is Catalyst Pharmaceuticals, Inc

Catalyst Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development and commercialization of therapies for people with rare debilitating diseases. Its lead product candidate is Firdapse, a proprietary form of amifampridine phosphate, which completed Phase III clinical trial for the treatment of patients with Lambert-Eaton Myasthenic syndrome; and is in small blinded clinical trial to treat Congenital Myasthenic syndromes, as well as is in Phase II/III clinical trial for the treatment of MuSK-antibody positive myasthenia gravis.

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.

Sell Global Blood Therapeutics For a Huge 91% Win!

March 4, 2017: Sell Global Blood Therapeutics for a monster 91% win in 41 days! Congratulations if you were able to make money on the trade.

January 4, 2017: JPMorgan Chase initiates coverage of biotechnology firm Global Blood Therapeutics with an Overweight rating and a price target of $25. JPMorgan thinks GBT440 is a promising wholly owned asset targeting a broad and underserved market, as such current levels could provide an attractive entry point despite the relative lack of critical upcoming data.

GBT440-001 is a randomized, placebo-controlled, double-blind, single and multiple ascending dose study. This ongoing Phase 1/2 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of GBT440 in both healthy subjects and adults with SCD. The study is being conducted in three parts: Part A (single dose administration), Part B (multiple dose administration, daily for 15 days in healthy subjects and 28 days in SCD patients) and Part C (multiple dose administration, daily for 90 days in SCD patients). Some patients in Part C have taken GBT440 for up to 6 months.

Results presented at ASH showed:

– All 41 SCD patients receiving GBT440 for up to six months have demonstrated a profound and durable reduction in hemolysis (red blood cell destruction) as assessed by hemoglobin, reticulocytes, and/or bilirubin.

– All patients taking GBT440 showed profound and durable reductions in irreversibly sickled cells compared with those taking a placebo.

Results from Part C (dosing for at least 90 days) demonstrate that among the 13 GBT440-treated patients:

– Patients treated with GBT440 for at least 90 days showed a clinically significant increase in hemoglobin (greater than 1 g/dL increase) compared with 14 placebo patients (46 percent vs. 0 percent; p=0.006).

Patients treated with GBT440 had a sustained reduction in irreversibly sickled cells compared with placebo-treated patients (-76.6 percent vs. +9.7 percent; p<0.001).- GBT440 was well tolerated up to six months of dosing. The most common treatment-related adverse events were Grade 1/2 headache and gastrointestinal disorders and occurred at similar rates in the placebo and GBT440 arms. There were no drug-related serious or severe adverse events. No sickle cell crises events occurred in study participants while on GBT440. Exercise testing data showed normal tissue oxygen delivery (no change in oxygen consumption compared to placebo).

– Absorption, Metabolism and Excretion of GBT440 a Novel Hemoglobin S (HbS) Polymerization Inhibitor for the Treatment of Sickle Cell Disease (SCD), in Healthy Male Subjects (Abstract #2487)

– Results of a study evaluating the pharmacokinetics, metabolism, and excretion of GBT440 given orally to healthy subjects showed that the drug was completely excreted from the body, with a half-life of approximately three days. This is much shorter than the lifespan of a red blood cell (about 120 days) of a healthy subject, suggesting that the binding of GBT440 to hemoglobin is a reversible process. The data also suggests that the pharmacokinetics of GBT440 are unlikely to be affected in patients with renal disorders.

Global Blood Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need.

GBT440 is Global Blood Therapeutics leading drug candidate which targets the underlying mechanism of red blood cell sickling and offers the potential to treat sickle cell disease (SCD) rather than only its symptoms.