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 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….)
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….)
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….)
March 4, 2017: Sell Editas Medicine for a 38% win in 55 days. Congratulations if you made money on the trade.
February 15, 2017: Editas Medicine confirms patent office decision favorable to Broad Institute in CRISPR Interference. Editas Medicine’s stock is up more than +27% on the news.
The U.S. Patent and Trademark Office (USPTO) (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 23, 2017: Wells Fargo initiated coverage of JUNO on February 22, 2017 with an Outperform rating. Then, one day later on February 23, 2017, Wells Fargo downgraded JUNO to market perform! Was this a rotational dump at $24 and we just provided Wells Fargo the liquidity they needed? I don’t know but my trust (Read More….)
Excellent presentation by Dr. Kevin Folta on biotechnology and GMO foods. Dr Folta makes the connection that humans have been genetically modifying things for hundreds of years and he uses the common dog and cat as an example. Basically Dr. Folta’s presentation breaks down to the idea that a lot of people need to take (Read More….)
The European Medicines Agency gave an update on the various T-cell therapies progressing through clinical trials across Europe. The video below is very important for those of us who trade biotechnology stocks as it shows the pipeline of promising new CAR-T cell therapies coming.
Overview of T-cell therapies – current status
Welcome and introductions (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 14, 2017: Sarepta Therapeutic’s stock has formed a candle over candle reversal after Feuerstein said, “Sarepta Therapeutics is being dragged down unfairly into the price-gouging muck by Marathon Pharmaceuticals.” Source: https://www.thestreet.com/story/14001431/1/defending
January 10, 2017: Baird reiterates a Buy rating on biotechnology firm Sarepta Therapeutics and set a price target of $102. Baird named Sarepta (Read More….)
February 14, 2017: JP Morgan making positive comments about Gilead Sciences, reiterates their Overweight rating. JP Morgan says that ahead of a presentation today at CROI (2/13-17, Seattle), GILD released the anticipated results from the Phase 2 trial evaluating its novel unboosted integrase inhibitor bictegravir (BIC) vs. ViiV’s dolutegravir (DTG) in treatment naive HIV patients (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: Sell Protalix Biotherapeutics for a monster 180% win! This is our biggest winner to date. Long upper shadow and Inverted Hammer candlestick are usually good take profit signals. Congratulations if you made money on the trade.
December 27, 2016: Protalix Biotherapeutics announced today the confirmation of the recent letter of intent to (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 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….)
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: 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 12, 2017: CVS announced that a low-cost epinephrine auto-injector option, the authorized generic for Adrenaclick manufactured by Impax Laboratories (IPXL), is available at all CVS Pharmacy locations at a cash price of $109.99 for a two-pack. This compares to a cash price of $649.99 for EpiPenand $339.99 for the authorized generic for EpiPen.
The (Read More….)
January 9, 2017: Huron Consulting Group formed a doji today, in oversold territory, on news it acquired Pope Woodhead & Associates. Huron Consulting Group says that it has expanded its life sciences strategy expertise with the acquisition of Pope Woodhead & Associates. The UK-based consulting firm provides market access capabilities to assist clients in developing (Read More….)