March 24, 2017: DexCom is pleased to announce that the U.S. Centers for Medicare & Medicaid Services (CMS) has published an article clarifying criteria for coverage and coding of the Dexcom G5 Mobile system, the only therapeutic CGM under this CMS classification. People covered by Medicare who have either Type 1 or Type 2 diabetes (Read More….)
March 22, 2017: OPKO Pharmaceuticals LLC, a subsidiary of OPKO Health, Inc. announces that the Company has received orphan drug designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for OPKO’s oligonucleotide-based AntagoNAT (CUR-1916) for the treatment of Dravet Syndrome. Currently, there is no approved treatment for Dravet Syndrome in (Read More….)
March 22, 2017: Medtronic Inc announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve(TM) Evolut(TM) PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval comes on the heels of new 30-day clinical data that (Read More….)
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 (Read More….)
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 (Read More….)
February 28, 2017: Ionis Pharmaceuticals reports Q4 EPS of +$0.21 (GAAP) versus the -$0.20 estimate. Revenue also beat coming in at $160.3 million versus the $82 million estimate.
CEO Stanley T Crooke said, “In 2017, we expect to be breakeven or profitable at the operating line on a pro forma basis, driven in part (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 6, 2017: Cellectis announced that it has received an Investigational New Drug approval from the FDA to conduct Phase 1 clinical trials with UCART123, the Company’s most advanced, wholly owned TALEN gene-edited product candidate, in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). This marks the first allogeneic, “off-the-shelf” (Read More….)
February 01, 2017: Lannett Company reports Q2 EPS of $0.92 versus the $0.83 estimate. Revenue also beat coming in at $170.9 million versus the $169 million estimate.
The CEO said, “Higher sales across a number of products and the addition of KU’s operations were key drivers to the 35% increase in our fiscal 2017 (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 29, 2017: Astellas Pharma and Ironwood Pharmaceuticals announced today top-line results indicating that the Phase III clinical trial of linaclotide conducted in Japan in adults with chronic constipation (CC) met its primary endpoint.
Linaclotide is approved in Japan as the first prescription treatment for adults with irritable bowel syndrome with constipation (IBS-C). Linaclotide is (Read More….)
OREX continues to be our dominant stock pick up a whopping +80% since profiled on GuerillaStockTrading.com
The biggest new gainer this last week was PLX which rocketed higher after it received FDA Orphan Drug Designation for CTP-656 for the treatment of Cystic Fibrosis.
Another big climber was CGIX after it launched its entry into comprehensive (Read More….)
January 27, 2017: Aratana Therapeutics hot stock tip sent in through GuerillaStockTrading website. The catalyst is that with four FDA approvals for dogs, the company is transitioning from an R&D company to a revenue producing company this year. Thank you for sending in this hot stock tip with the catalyst.
January 24, 2017: Elanco Animal (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 10, 2017: In a JPM slide presentation, Horizon Pharma says it’s on track to deliver $2 billion in total net sales by 2020.
December 22, 2016: Horizon Pharma announces that it has received a Notice of Allowance from the United States Patent and Trademark Office for U.S. patent application number 13/610,580, entitled “Methods of (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 9, 2017: Biotechnology firm PTC Therapeutics’ stock broke above the 200 day MA today as it received notification from the European Commission (EC) of its adoption of a positive decision granting annual renewal of the conditional marketing authorization for Translarna (ataluren). The positive decision is based on the recent renewal recommendation by the Committee (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….)
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.
February 28, 2016: Novartis announced that the FDA has approved Afinitor for the treatment of some tumors. The FDA has approved everolimus (Afinitor) for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. The approval was based on demonstration of improvement in progression-free survival (PFS) in a multicenter, randomized (2:1), placebo-controlled trial of everolimus 10 mg orally once daily plus best supportive care (BSC) to placebo plus BSC. (Read More….)
December 29, 2016: Sell Eli Lilly for an 8.8% gain in 12 trading days. Congratulations if you were able to make money on the trade.
December 16, 2016: Adocia and Lilly announce successful completion of an insulin pump study with BioChaperone Lispro in people with Type 1 diabetes. This is a successful completion of an (Read More….)