Tag: Vertex Pharmaceuticals (VRTX)

An Early FDA Approval of Vertex’s Cystic Fibrosis Combo Symdeko

An Early FDA Approval of Vertex’s Cystic Fibrosis Combo Symdeko

Expected or not, we believe that the news announcing that the U.S. Food and Drug Administration (FDA) approval Vertex’s (VRTX) cystic fibrosis combo product Symdeko™ (tezacaftor/ivacaftor and ivacaftor) is good news. It is indeed excellent news for the many cystic fibrosis people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis trans-membrane conductance regulator (CFTR) gene or who have at least one mutation that …
Vertex: Next-Generation Correctors VX-659 and VX-445 for Triple Combinations Promise Significant Clinical Benefits for Around 90% of People with Cystic Fibrosis.

Vertex: Next-Generation Correctors VX-659 and VX-445 for Triple Combinations Promise Significant Clinical Benefits for Around 90% of People with Cystic Fibrosis.

Vertex (VRTX) announced the selection of two next-generation correctors, VX-659 and VX-445, to advance into Phase 3 development as part of two different triple combination regimens for people with cystic fibrosis (CF). The decision was based on data from initial Phase 2 trials, including new data from ongoing Phase 2 studies demonstrating mean absolute improvements in percent predicted forced expiratory volume in one second from baseline through four weeks of treatment …
Another Week of Outperformance

Another Week of Outperformance

The Week in Review #16 More Exciting Rallies in Prohost Picks - The past week and for several week fascinating outperformances have been seen for many of the Prohost Portfolio stocks. We continue to articulate that the good news is not only in the stocks’ rallies, but also in the outstanding stories behind them . . . This content is for paid subscribers. Please click here …
Vertex: Good News from Europe. Ablynx: Rejecting Novo Nordisk’s Aquisition Offers.

Vertex: Good News from Europe. Ablynx: Rejecting Novo Nordisk’s Aquisition Offers.

VERTEX From Europe, Vertex (VRTX) was informed that the European Commission has granted an extension of the Marketing Authorization for ORKAMBI® (lumacaftor/ivacaftor). Orkambi is for cystic fibrosis (CF) in people with two copies of the F508del mutation, including children ages 6 through 11 Reimbursement: In countries such as Ireland, reimbursement agreements will lead to rapid access to ORKAMBI. In other countries across the European Union, Vertex will begin a country-by-country reimbursement process. Clinical trial Results …
The Week in Review #9

The Week in Review #9

The Week in Review #9 KNOCKING DOWN THE BIOTECH STOCKS - Knocking down the biotech companies’ stocks during the announcement of the quarterly reports is no news. Most investors in the stock market, especially those who invest in the biotech sector have become familiar with this pattern . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
CRISPR Therapeutics’ Worthwhile Deal

CRISPR Therapeutics’ Worthwhile Deal

CRISPR Therapeutics (CRSP) and Massachusetts General Hospital Cancer Center (MGHCC) have entered into a two-year research collaboration and license option agreement to develop Novel T cell therapies for cancer. As part of the collaboration, CRISPR/Cas9 gene editing technology will be utilized to improve upon current T cell therapies in development addressing unmet needs in both hematologic and solid tumors.  This improvement is expected to occur by combining the …
Reasons for Vertex’s & Illumina’s Outperformance

Reasons for Vertex’s & Illumina’s Outperformance

Synopsis Most of the Prohost picked stocks gained momentum and closed higher at the end of the week. Some rallied because that’s what they were supposed to do after the quarterly financial when most biotech stocks are subjected to selloffs, including those that have clearly outperformed in real life. The most outperforming of our picked stocks in July and continue to outperform are Illumina (ILMN) …
Vertex: A Cystic Fibrosis Institution with a Bright Future

Vertex: A Cystic Fibrosis Institution with a Bright Future

Yesterday, Wednesday July 19, Vertex’s (VRTX) stock added over 20% to its value, recording a new all time high. Why? On Tuesday the firm announced a better than technical analysts’ and its own expectations’ results in three trials testing its cystic fibrosis (CF) drugs VX-152, VX-440 and VX-659 combined with two the its cystic fibrosis drugs. The positive data came from Phase 1 and Phase …
Prohost Letter #408

Prohost Letter #408

Prohost Letter #408 AT A GLANCE - Continued from the Previous Prohost Letter #408 In the Past issue #407, we picked the following firms: NEUROCRINE BIOSCIENCES (NBIX) Treating Tardive Dyskinesia CYTOMX Improving On Cancer Immunotherapy CELYAD SA (CYAD) Bringing Solutions To Immunotherapy Problems Please Read the articles written about these firms in the Issue #407 In This Issue We Add  NEW LINK GENETICS...
Prohost Letter #406

Prohost Letter #406

Prohost Letter #406 A Special Prohost Issue SYNOPSIS REASONS FOR THE FOLLOWING PROHOST PICKS RALLIES VERTEX Vertex (VRTX): Great news about 2016 revenues & earnings Growth and pipeline. FROM YESTERDAY: Tremendous Revenues Growth. Cystic fibrosis (CF) revenues grew up around 75%. FOR TOMORROW:  Boosting  the  pipeline  value  by Advancing CF novel correctors into Phase 2 trials while Producing and advancing new CF correctors. PROJECTIONS: Continued …
Prohost Letter #405

Prohost Letter #405

Prohost Letter #405 Synthetic Biology (3) We have already decided upon becoming shareholders the day synthetic biology firm called Synthetic Genomics turns public. We reiterate that firms specialized in synthetic biology are numerous private and publicly traded. Some are promising, others are walking in place and a few have plummeted. With the general underperformance of synthetic biology stocks, many shareholders abandoned ship. Investors felt that …
Vertex and Merck KGaA Agreement Suits Both Firms

Vertex and Merck KGaA Agreement Suits Both Firms

Vertex (VRTX) entered into a licensing agreement with Merck KGaA, Darmstadt, Germany for the worldwide development and commercialization of four research and development programs that the firm believes represent novel approaches to cancer treatment Merck KGaA will license two clinical-stage programs targeting DNA damage and repair, along with two additional novel pre-clinical programs. Upon the agreement Vertex will receive an upfront payment of $230 million, …
Prohost Letter #403 Part 2

Prohost Letter #403 Part 2

Prohost Letter #403 Part 2 Continued From Wednesday Instead of continuing yesterday article about Agenus, we decided to post it all so that the reader can find it in one place. Important changes and additions have been made especially under the headline “Near-­Term Priorities, Possibilities and Catalysts”, which are important to read. Learning More About AGENUS Since its inception, Agenus (AGEN), previously known as Antigenics, …
Learning from Pfizer Acquisition. Regeneron to Fight Zika and More

Learning from Pfizer Acquisition. Regeneron to Fight Zika and More

Pfizer accepted to pay $14 billion in cash to acquire Medivation. It is important for investors to know what Pfizer is after with regard to this acquisition so that investors could sense the current deep-pocketed biopharmaceutical firms’ preferences in selecting their takeover targets. Recognizing the facts behind Pfizer’s decision could also protect investors from being mislead by negative bloggers who, while serving their own agendas, …
Gilead and Genmab Agreement. A Quick Look at Moderna

Gilead and Genmab Agreement. A Quick Look at Moderna

GILEAD & GENMAB To Access Genmab’s (GEN) bispecific antibody technology, Gilead (GILD) signed a new agreement with Genmab. The King of HIV treatment objective is to use its exclusive license from Genmab to produce an HIV bispecific monoclonal antibody therapeutic. Gilead is paying around $5 million in upfront payment and up to $277 million in milestones. Genmab will also be entitled to one-digit royalty of …
Prohost Letter #392

Prohost Letter #392

Prohost Letter #392 February 28, 2016 - How could it be possible for any genius to make intelligent guesses about the market's next moves when highly regarded experts, including Nobel Prize winners in economics, remained quizzical about the recent horrifying performances of publicly traded stocks? Since the beginning of 2016, the stock market has been made to look as if a runaway train with many passengers …
About the News from Incyte and Vertex

About the News from Incyte and Vertex

Incyte: A Good Company Facing Irrelevant Investors’ Reaction  Incyte decided to stop an early ongoing trial of a combination treatment ruxolitinib (Incyte) plus regorafenib (Bayer) for colon cancer after observing the combination wasn’t working. Both drugs are approved for different indications and both are doing well in the market. At this moment in the market chaos, this news looked as if a terrible thing that must cause an unwarranted …
Prohost Letter #390

Prohost Letter #390

Prohost Letter #390 COMPANIES USING CRISPR GENE EDITING TOOLS - The Firms Launched with CRISPR Patents Either Pending or Disputed! What Does This Mean? What are these Firms’ Priorities? But First: A Reminder In the last issue, Prohost #389, we pinpointed the gene editing technologies and techniques and demonstrated the difference between gene editing, which is genetic engineering, i.e., making changes in the genes themselves, and antisense …
Vertex: Orkambi Approved In Europe. What Vertex Is Doing to Further improve CF Treatments

Vertex: Orkambi Approved In Europe. What Vertex Is Doing to Further improve CF Treatments

Europe Approves Orkambi® The European Commission has granted Marketing Authorization for Orkambi® (lumacaftor/ivacaftor), for cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation. There are approximately 12,000 people with CF ages 12 and older who have two copies of this mutation. Vertex will now begin the country-by-country reimbursement approval process across the European Union (EU). They said: The …
Prohost Letter #386

Prohost Letter #386

Prohost Letter #386 An Evaluation of Prohost Picks and Some Other Interesting Biotechnology Companies (Part 2) (Continued from Previous Prohost Letter #385) See Page Listening to Top-tier biotech firms’ presentations we could not resist appreciating their accomplishments, which made us dare to predict that the time has come for the self-serving preachers to find it extremely hard to convince shareholders to to sell stocks of …