February 17, 2017: Medtronic announced Japan regulatory approval for the world’s smallest pacemaker, the Micra(TM) Transcatheter Pacing System (TPS). Japan’s Pharmaceuticals and Medical Device Agency (PMDA) granted approval for Micra based on positive data from the Medtronic Micra TPS Global Clinical Trial, which enrolled 744 patients and evaluated the safety and efficacy of the device (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 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 (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 8, 2017: Traders are bottom feeding in DexCom stock after Cowen says DexCom should be close to a bottom. Cowen reiterates an Outperform rating on DexCom, and sets a price target of $90. Cowen thinks DexCom should be close to a bottom and sees little risk to their 2017 30% Y/Y growth forecast (regardless (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, 2016: Ionis Pharmaceuticals and Akcea Therapeutics, a wholly-owned subsidiary of Ionis Pharmaceuticals, Inc., announced an exclusive, worldwide option and collaboration agreement with Novartis to develop and commercialize AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx. Ionis and Akcea are eligible to receive $225 million in near-term payments, including an immediate $75 million upfront option payment and a $100 (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 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 (Read More….)
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 30, 2016: Opko Health stock did a huge gap down today after a trading halt was put on the stock. Here’s what happened. Opko Health Phase 3 clinical study of hGH-CTP in growth hormone deficient adults showed there was no statistical difference between hGH-CTP and the placebo. However, after unblinding the study, OPKO identified (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….)