March 20, 2017: Nektar Therapeutics announced positive results from the SUMMIT-07 Phase 3 efficacy study of NKTR-181, a first-in-class opioid analgesic. NKTR-181 is a new chemical entity (NCE) that is the first full mu-opioid agonist molecule designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction (Read More….)
March 9, 2017: Amicus Therapeutics has commenced the commercial launch of the precision medicine Galafold in Italy following the final publication of reimbursement guidelines by the Ministry of Health (Ministero della Salute). Galafold is now reimbursed in Italy as a therapy for long-term treatment of adults and adolescents aged 16 years and older with a (Read More….)
GBT exploded into position #1 gaining 31% last week. Nomura initiated coverage of GBT with a Buy rating and a price target of $50. Let’s go ahead and book profits on Monday if you haven’t already. Remember folks, sell into strength and don’t wait for me to issue a sell signal before cashing out and (Read More….)
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 (Read More….)
The CAR T cell 19 trial done by the National Cancer Institute yielded amazing results. Out of 46 patients with refractory relapse leukemia given a single dose of CDR 19 CAR T cells, 65% had a complete response rate. The NCI study even showed the eradication of leukemia that had gone to the spinal fluid (Read More….)
CAR-T cell therapy to cure cancer is a big deal folks. Unfortunately it’s still in clinical trials and then the cost of producing individual CAR-T cells for a specific patient is extremely high. Nevertheless advances are being made in mass producing CAR-T cells that everyone can use like what Cellectis is doing.
Check out this (Read More….)
February 12, 2017: Biotechnology firm Ocular Therapeutix’s stock is surging higher on rising money flow after the company announced on January 23, 2017, that it had resubmitted an NDA for Dextenza. Ocular Therapeutix announced on January 23, 2017, that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) (Read More….)
February 11, 2017: Selling ACADIA Pharmaceuticals Monday for about a 15.8% win. Congratulations if you were able to make money on the trade.
February 5, 2017: ACADIA Pharmaceuticals Inc reportedly receives takeover approach from AstraZeneca according to an article on StreetInsider. Source: http://www.streetinsider.com/Hot+M+and+A/ACADIA+%28ACAD%29+Said+to+Receive+Takeover+Offer+from+AstraZeneca+%28AZN%29+-+Source/12496195.html
Pfizer may also have interest in acquiring lead drug candidate Nuplazid but (Read More….)
February 07, 2017: Zimmer Biomet announced today the international release of the Subchondroplasty (SCP) Procedure. The Company received CE Mark approval for the commercialization of its SCP Procedure to facilitate distribution in the European Union (EU) and other countries that recognize the CE Mark. Zimmer Biomet also received approval for distribution in Canada, Singapore, Malaysia (Read More….)
February 1, 2017: Regeneron Pharmaceuticals, Inc. and Sanofi today announced that Health Canada approved Kevzara™ (sarilumab), an interleukin-6 (IL-6) receptor antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
Kevzara (Read More….)
January 31, 2017: Sell Ocera Therapeutics for a -77% loss. OCRX’s long-awaited Phase 2 program disappointed as IV OCR-002 missed the primary endpoint. This stock did not pass my quality control (rising earnings and revenue) when I began tracking it but there was lots of buzz around IV OCR-002 results coming at the end of (Read More….)
January 25, 2017: Asterias Biotherapeutics’ stock is moving higher after the company announced on January 24, 2017, positive efficacy results from the company’s ongoing SCiStar Phase 1/2a clinical trial that showed additional motor function improvement at 6-months and 9-months following administration of 10 million AST-OPC1 cells in AIS-A patients with complete cervical spinal cord injuries (Read More….)
January 25, 2017: Jefferies reiterates TherapeuticsMD with a Buy rating and a price target of $18. Jefferies says that the investor tour of local compounding pharmacy provided unique insights into ‘001 market opportunity and reinforced our view that the bioidentical E+P VMS market is at a minimum 5.1M scrips or $714-$893M in sales (assumes 100% (Read More….)
January 23, 2017: TheStreet.com’s Feuerstein says Celgene should considering buying Biogen. Source: http://realmoney.thestreet.com/articles/01/23/2017/5-reasons-celgene-should-buy-biogen
January 13, 2017: Biogen presented new data from the Phase 3 ENDEAR study of SPINRAZA (nusinersen), which demonstrated a statistically significant reduction in the risk of death or permanent ventilation in SPINRAZA-treated infants with spinal muscular atrophy (SMA) compared to untreated infants. (Read More….)
January 10, 2017: Novo Nordisk A/S B announces marketing authorization granted by European Commission for Fiasp for treatment of diabetes in adults. Novo Nordisk expects to launch Fiasp in the first European countries in the first half of 2017. The authorisation covers all 28 European Union member states.
Fiasp is the brand name for fast-acting (Read More….)
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 (Read More….)
January 7, 2017: Biotechnology firm CTI BioPharma announced on January 4, 2017 that the full clinical hold (February 2016) implemented by the U.S. Food and Drug Administration (FDA) on all clinical trials conducted under the Investigational New Drug (IND) application for pacritinib has now been removed. The Company’s complete response submission included, among other items, (Read More….)
January 6, 2017: Halozyme Therapeutics reported topline results from the combined analysis of Stages 1 and 2 and Stage 2 alone of its HALO 202 study, a Phase 2 randomized, multi-center clinical trial of lead investigational drug PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer patients.
Among the findings, the (Read More….)
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 (Read More….)
Overnight Analyst Actions:
MBLY Buy Monness Crespi
Overnight Headlines By Ticker:
ITEK Inotek Pharmaceuticals Corporation
1/3 07:34 Announces Top-line Results for MATrX-1, First Phase 3 Trial of Trabodenoson for Glaucoma fails to meet primary endpoint. GuerillaStockTrading coverage of this company dropped.
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 (Read More….)