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 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: UBS initiates Vertex Pharmaceuticals Inc with a Buy rating and a price target of $106. UBS is launching coverage of US Biotechnology with a positive outlook buoyed by (1) a better line-up of drug launches for 2017 (Biogen’s Spinraza for SMA; Regeneron’s Dupixent for atopic dermatitis, and Incyte’s Olumiant for rheumatoid arthritis), (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….)
February 28, 2017: Actinium Pharmaceuticals announced that they received a notice of allowance from the United States Patent and Trademark Office (USPTO) for a patent claiming the methods for generating a radioimmunoconjugate comprised of actinium-225, an alpha emitting radioisotope, conjugated to monoclonal antibodies. Actinium-225 is the radioisotope used in Actinium’s Actimab-A, a drug candidate in (Read More….)
February 28, 2017: Endo International reports Q4 EPS of $1.77 versus the $1.63 estimate. Revenue also beat coming in at $1.24 billion versus the $1.15 billion estimate.
CEO Paul Campanelli said, “Endo’s core assets include a Generics business, which is the fourth largest in the U.S. based on sales, that possesses a growing sterile (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 22, 2017: Bellicum Pharmaceuticals announced updated clinical results of the BP-004 study. To date, 122 pediatric patients have undergone treatment with BPX-501. Investigators reported on 91 patients with 100 days of follow-up, 73 patients with six months, and 45 patients with more than one year of follow-up. Genetic blood diseases (n=54) include SCID (Severe (Read More….)
February 17, 2017: Celgene announced that its phase III SUNBEAM trial, evaluating the efficacy and safety of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis (RMS), met the primary endpoint in reducing annualized relapse rate (ARR), compared to weekly interferon (IFN) ß-1a (Avonex).
SUNBEAM evaluated two (Read More….)
February 16, 2017: Sell Orexigen Therapeutics for a 157% win in 36 days! Congratulations if you were able to make money on this trade.
January 25, 2017: Orexigen Therapeutics announced that Laboratorios Farmaceuticos Rovi has launched Mysimba in Spain. Mysimba is approved by the European Medicines Agency for the management of weight in adult (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 6, 2017: Mylan stock got my attention today because the stock climbed on the news that Mylan has to pay $96.5 million in settlement of the Provigil antitrust class action suit. The settlement covers allegations that Mylan delayed launching its generic version of Cephalon narcolepsy drug Provigil in exchange for payment from Cephalon. The (Read More….)
February 5, 2017: Sell Teva Pharmaceutical for a -1.54% loss. Sorry folks but better to get out for a small loss as not sure how big of penalties we’re looking at IF Teva is found guilty of actually doing what the State of California is saying they did but I’m thinking possibly hundreds of millions. (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 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 17, 2017: Avondale Partners raised McKesson to Market Outperform from Market Perform.
January 17, 2017: McKesson agrees to $150 million settlement with DOJ over failure to report suspicious orders of drugs. The nationwide settlement requires McKesson to suspend sales of controlled substances from distribution centers in Colorado, Ohio, Michigan and Florida for multiple years. (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 3, 2017: Canaccord Genuity, Roth Capital, and HC Wainwright/Rodman & Renshaw all scrambled for the exist in Inotek Pharmaceuticals after the company announced Top-line Results for MATrX-1, First Phase 3 Trial of Trabodenoson for Glaucoma fails to meet its primary endpoint. I am dropping coverage of the company, RIP.
December 20, 2016: Canaccord Genuity (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….)