The Bizarre Assessment of Biotech Firms in the Stock Market The Clinical-Stage Biotechnology Firms  We are witnessing inexplicable evaluations of clinical-stage biotechnology companies. Bizarre is the best description of this group’s assessment which is based on incomes that do not exist in biotech firms that are yet to have approved and marketed products anywhere in the world. Unfortunately, the most impacted firms by the bizarre …

Cassava Sciences, Vertex Pharmaceuticals and Gilead Sciences All Have Good News Cassava Sciences & Alzheimer's Disease Cassava Sciences (SAVA) announced the initiation of a second Phase 3 trial of simufilam, its investigational drug for Alzheimer’s disease. This second Phase 3 study is designed to evaluate the safety and efficacy of simufilam over 78 weeks in approximately 1,000 Alzheimer’s . . . This content is for …

Gilead Sciences Collaboration with Arcus Biosciences Sends Stock Through the Roof There is no doubt that Gilead Sciences (GILD) is appreciating Arcus Biosciences (

Regenxbio and AbbVie Inc Agreement Regenxbio (RGNX) announced the successful closure of the collaboration and license agreement with AbbVie Inc (

Gilead Sciences and Merck Collaboration to Develop Long-Acting HIV Treatment  Gilead Sciences (GILD) and Merck (MRK) announced the start of a Phase 2 clinical study evaluating an investigational, once-weekly oral combination treatment regimen of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy. From Gilead Sciences and Merck Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences, …

Gilead Sciences New Data from Trodelvy® Study Gilead Sciences (GILD) has recently announced new data from the Phase 3 ASCENT study evaluating Trodelvy® in patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy has shown to improve progression-free survival (PFS . . . This content is for paid …

Vir Biotechnology Announced Positive Safety Findings from its Ongoing Trials for Chronic HBV Vir Biotechnology (VIR) announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection. The results comprised positive safety findings in addition to a reduction in hepatitis . . . This content is for paid …

Gilead Sciences Yescarta for Relapsed or Refractory Indolent Follicula Lymphoma If Kite Pharma - a Gilead Sciences (GILD) company, had been acquired by any firm other than Gilead the stock would have gained at least 20% because of the news announced a few days ago. Kite Pharma announced outstanding Yescarta® (axicabtagene ciloleucel) results from the pivotal ZUMA-5 trial. At a minimum follow . . . This …

Jounce Therapeutics Inc: US FDA Cleared IND Application for JTX-1811 Targeting CCR8 Jounce Therapeutics Inc (JNCE) - a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for its product JTX-1811, an anti-CCR8 antibody.

Gilead Sciences First-Quarter 2021 Financial Results Conference Call Info Gilead Sciences (GILD) management will host a conference call to discuss the company’s first-quarter 2021 financial results and will provide a business update today, Thursday, April 29, at 4:30 p.m. EST.  Investors can dial 1-877-359-9508 (U.S.) or 1-224-357-2393 (international) to reach . . . This content is for paid subscribers. Please click here to subscribe or here to …

Gilead Sciences and Eisai Pharmaceutical Co Submitted an Application to Japan's PMDA for Filgotinib Galapagos NV (GLPG) announced that Gilead Sciences (

Humanigen Product Lenzilumab Combination with CAR-T At the recommended Phase 2 dose, lenzilumab in combination with CAR-T demonstrated a 100% objective response rate and no severe cytokine release syndrome or severe neurotoxicity Lenzilumab reduced IL-6, CRP, ferritin, MCP-1, IL-8, and IP-10 (CXCL-10) among others Humanigen now plans to conduct a randomized, potentially registrational, Phase 2 study with lenzilumab combined with all commercially available CD19 CAR-T …

Vir Biotechnology and GlaxoSmithKline in April 2020  In April 2020, Vir Biotechnology and GlaxoSmithKline entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19). The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic …

FDA Grants Accelerated Approval for Gilead Sciences Trodelvy® The United States Food and Drug Administration (FDA) has granted accelerated approval of Gilead Sciences (GILD) product Trodelvy® (sacituzumab govitecan-hziy). The approval is for use of the product in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 …

Gilead Sciences is Granted FDA Approval for Trodelvy® Gilead Sciences (GILD), a company that has been granted more approvals than many are aware of except for the short analysts and their followers, today announced that the U.S. FDA has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or . . . This content is for paid subscribers. Please click here …

Prohost Letter #445 A Flashback and Future Projections 1. A Follow-Up on Recently Posted News from ProhostBiotech 2. Answering Questions 3. Development-Stage Firms to Outperform 4. Oversold Revenue-Generating Firms 5. Tables with FAIR 2021 Targets for the Prohost Selected Firms In This Issue We Discuss the Following Firms: Anixa Biosciences (

Gilead Sciences and Merck Announced Agreement for Long-Term HIV Combination Treatment Gilead Sciences (GILD) and Merck (MRK . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Prohost Letter #444 The End of the Year Issue was delayed because our 2020 Prohost Portfolio stocks’ targets for the year failed to materialize; nobody not even the authorities were capable of predicting the pandemic, which continues to plague the world. As 2021 approached, we were unable to the End of the Year issue on time as we lacked the information required for the fair …

Gilead Sciences Company, Kite Pharma, News Kite Pharma, a Gilead Company (GILD), announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Conditional …

Acquisitions  AstraZeneca Acquires Alexion Pharmaceuticals AstraZeneca (AZN) and Alexion Pharmaceuticals (ALXN) entered into a definitive agreement for . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

COVID-19 Vaccine Updates Pfizer’s (PFE)/BioNTech’s (BNTX) and Moderna’s (MRNA) COVID-19 vaccines have demonstrated safety at around 95% efficacy.   AstraZeneca (AZN) and Oxford University announced today that their COVID-19 vaccine was 90% effective in preventing infections. The efficacy average, however, was 70%, leading the stock to travel south rather than north.     Regardless of the efficacy differences AstraZeneca stated that it would immediately prepare …

Gilead Sciences News Results from Phase 2/3 CAPELLA trial evaluating Gilead Sciences (GILD) lenacapavir achieved the primary endpoint in heavily treatment-experienced people with multidrug-resistant HIV-1 infection. The study showed that 88% of participants receiving lenacapavir experienced at least a 0.5 log10 reduction in HIV-1 viral load by the end of 14 days of functional monotherapy as . . . This content is for paid subscribers. Please click here …

Gilead Sciences Veklury® (Remdesivir) was Approved by the US FDA The U.S. FDA approved Gilead Sciences (GILD) antiviral drug Veklury® (remdesivir) for COVID-19 infected patients who require hospitalization. Veklury halts the SARS-CoV-2 replication that causes COVID-19. Veklury is the first and only approved COVID-19 treatment (not vaccine) in the U.S.. The news announced that the drug is widely available in hospitals across the country. The …

Gilead and Galapagos Granted Marketing Authorization for Filgotinib by the EC Gilead Sciences (GILD) and Galapagos NV (

President Trump, the First Lady and COVID-19 Indeed, the complicated, nasty SARS-CoV-2 virus managed to infect President Trump and the First Lady when we were expecting a vaccine to soon be ready to protect the country and the world from COVID-19. The president’s physicians did not treat the him with any of the investigational vaccines in late-phase trials; vaccines being developed by: Moderna (MRNA), Novavax (NVAX) and …

Gilead Sciences News Is Not Just Gossip Real news, not just gossip, is spreading today about Gilead Sciences (GILD) nearing a deal to acquire the biotech firm Immunomedics (IMMU) for $20 billion. Immunomedics current market value is around $10 billion which means that Gilead is buying it at double its value. The deal could be announced on Monday, if not sooner, if the talks go …

Yesterday, under Today’s Highlights, we posted that the U.S. FDA issued a Complete Response Letter (CRL) to Gilead Sciences (GILD) with regard to the New Drug Application (NDA) for filgotinib – the investigational treatment for moderately to severely active rheumatoid arthritis (RA), in collaboration with Galapagos (GLPG). The FDA requested data from the ongoing MANTA and MANTA-RAy studies before completing its review of the NDA. …

Gilead Sciences Was Issued a CLR from the FDA for Filgotinib Gilead Sciences (GILD) is in receipt of a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Gilead Sciences CAR T Cell Product Tecartus Gets FDA Approval The U.S. FDA approved Kite - Gilead Sciences (GILD) chimeric antigen receptor (CAR) T cell therapyTecartus™ (brexucabtagene autoleucel). Tecartus has become the first and the only approved CAR T cell therapy for adults with relapsed or refractory mantle cell lymphoma (MCL). The FDA approval of . . . This content is for paid subscribers. Please …

AstraZeneca Plc and Gilead Sciences Potential Merger News spread through the media announcing that AstraZeneca Plc (AZN) has approached Gilead Sciences (GILD) regarding a possible, potential merger. People familiar with the subject (we don’t know who they are) believe that such a merger, if it materializes, would be the highest healthcare business deal on record. As told, the story recounts that AstraZeneca got in touch …

Gilead Sciences and Galapagos NV Announce Good News from Filgotinib Trial Gilead Sciences (GILD) and Galapagos NV (

Prohost Letter #440 Coronavirus The Therapeutics Gilead’s Remdesivir Treating COVID-19 patients requires therapeutic products that can deal with moderate and severe persistent symptoms that are unwilling to ease or completely disappear after weeks of isolation, when following the distancing and wearing masks. The first product proven effective and safe to be granted FDA Emergency Use Approval (EUA) happens to be remdesivir from Gilead Sciences (

The Week in Review #50 The World FOCUS is COVID-19 The world FOCUS right now is on life-saving accomplishments for COVID-19. In addition to safety measures that are being adopted by most citizens the following realizations that accomplishments might lead to a clear victory over the life-threatening novel coronavirus. They are: Successful Treatments that will alleviate the severity of symptoms from COVID-19 that is causing …

Gilead Sciences Gilead (GILD) stock soared after market hours adding $11 to the $1.90 the stock had gained during trading hours. Investors’ enthusiasm was raised when very promising results came out of a clinical trial for Gilead’s drug remdesivir given to COVID-19 infected people.   According to the news the University of Chicago’s Phase 3 trial results demonstrated that most COVID-19 infected patients treated with …

A Comprehensive Essay  Part 4 Our fair evaluation approaches of biotechnology and biopharma companies differ depending on the sizes and statuses of the firms. We reiterate our conviction that causing a selloff of development stage biotech stocks at every announcement of quarterly financial results because of lack of income is irrelevant and unfair to the firms and their stockholders. It does not make sense that …

COVID-19 at Its Peak? The number of deaths from the COVID-19 outbreak in NYC are expected to peak soon. This expectation is coming from a prestigious trustworthy Washington University. The news also stated that Italy is turning the corner if it has not already turned it. They are reporting the lowest death toll for two weeks. France also reported a slowing of daily deaths while …

COVID-19 and the Nation's Hospitals Disagreeable news with regard to the nation's hospitals is their unpreparedness to face a sudden crisis, let alone an unexpected and unprecedented pandemic. The system the hospitals are running on has been causing problems for a some time now, not just since the Coronavirus pandemic. Since the COVID-19 cases have been rushed to hospitals many unwarranted, unacceptable, intolerable and dangerous …

The Week in Review #49 The Stars from the Weeks Preceding the Novel Coronavirus Outbreak  Forty Seven Forty Seven (FTSV) was added to the

Stock Market Fluctuations and Volatility  Only history can remind us that what’s going on recently with the stock market is not new. Similar situations have taken place during the terms of every president since Ronald Reagan. Indeed, the same stock market's unexpected tumbling occurred during Reagan, Bush the father, Clinton, Bush the son, Obama and now Trump. As a matter of fact, history reminds us …

Treating and Preventing COVID-19 Treating COVID-19, Gilead Sciences With regard to treating patients with COVID-19 we believe the most expected product to be used during this virus' outbreak will be Gilead Sciences’ (GILD) product remdesivir. This product has reduced the severity of the coronavirus infection symptoms in animal testing and in a few . . . This content is for paid subscribers. Please click here to …

The Market Soared Being optimistic about the greatness of American scientific capability does not mean underestimating the coronavirus' ability to infect, devastate and threaten human lives. Today the market is rebounding from the fear that caused the stock market to plummet in this past week. The rebounding was strong enough to demonstrate that Americans trust their country’s scientific capabilities as well as their scientists’ and …

Gilead Sciences to Acquire Forty Seven Gilead Sciences (GILD) and Forty Seven (FTSV) announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Forty Seven for $95.50 per share in cash. The transaction, which values Forty-Seven at approximately $4.9 billion, was unanimously approved by both the Gilead and Forty Seven Boards of Directors and is anticipated to close during the second quarter …

Moderna Therapeutics Among all the firms announcing their interest in working towards designing and producing a preventive vaccine for COVID-19 only Moderna (MRNA) has accomplished that job and delivered it to the health authorities to decide upon the next step. Moderna’s stock soared. The stock did not go up in expectation of the millions . . . This content is for paid subscribers. Please click here …

COVID-19 and the Stock Market The coronavirus that causes COVID-19 is the topic that swallowed all other topics this week. The virus is spreading to many countries around the world. Some media interpreted the CDC's warnings as being in direct conflict with the President while others showed understanding that the impact on the U.S. has so far been mild but the virus helped reveal the power …

Gilead and Moderna Stocks Will Outperform Today As stated in Prohost Letter #439 Gilead (GILD) investigational product remdesivir has offered hope towards treating infected people with COVID-19. Regarding the possibility of rapidly designing, creating and developing a preventive vaccine against COVID-19 Moderna Therapeutics (MRNA) seems to have accomplished this task. That’s why we were confident that Gilead’s and Moderna’s stocks will outperform today in a …

Prohost Letter #439 The Coronavirus Outbreak - COVID-19 The news announced that the coronavirus (now known as COVID-19) outbreak would affect not only people’s health and survival but the world’s economy, Wall Street’s performance, and especially the international giant industrial firms that are committed to China. British AstraZeneca (AZN

Synopsis The way many bloggers are interpreting the quarterly and yearly biotech companies’ financial results seems unfair and has proven to be. Amgen Amgen (AMGN): The stock gained over $10 yesterday and is trading now at $231. Many bloggers continue to attack the firm, mourning the loss of their protective patents on its over 30 years’ old products and ignore the record . . . …

As the Market Seems to Soar Our Eyes Are on the Following Biotech Stocks: Amgen (AMGN): A rebounding is expected following an unwarranted decline.   Gilead Sciences (GILD): A lot of good news from the firm, including the firm’s investigational product remdesivir that demonstrated positive results in beating the coronavirus infection. Read yesterday's article posted

Gilead Stock Is UP Gilead Sciences' (GILD) provided its antiviral experimental drug remdesivir to physicians for a small number of patients infected with the 2019 novel coronavirus (2019-nCoV) as a possible emergency savior . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

The EMA validated the MAA for the Gilead Investigational CAR T Product for MCL Kite, a Gilead (GILD) company, announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) of the investigational CAR T product KTE-X19 for adult patients with relapsed or refractory mantle cell lymphoma (MCL

A Comprehensive Essay Part 1 Yes, we have stories to tell about some of our picked stocks which proved to be highly successful after being condemned by erroneous evaluations from unfair analysts. Some of these firms faced problems that are not unusual for drug designing and developing firms. While trying to overcome their obstacles, the firms in question were faced with unfortunate debilitating attacks by …

Gilead’s CAR-T Product Yescarta Results Kite, a Gilead (GILD) subsidiary, announced new data from the ZUMA-1 trial of the CAR T Yescarta (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma. The data from the pivotal phase 2 study demonstrate that patients with refractory large B cell lymphoma were alive three years following a single infusion of Gilead’s CAR T immuno-oncology product Yescarta.  Analysis from …

Firstly, Forty-Seven and IVERIC bio  We remind that the two condemned stocks Forty-Seven (FTSV) and  IVERIC bio (

Prohost Letter #437 An All Time High Market More Prohost Picks Have Reached the 2019 Targets The stock market performance has reached an all-time high with more of our picks reaching or nearing the Prohost 2019 price targets. There are stories to tell about some devastated stocks which many believed were dead and buried but were surprisingly resurrected, and their stocks are going up. Another …

The Week in Review #46 The Quarterly Financial Results The quarterly financial results that analysts and investors relied on for years to evaluate biotech firms, including development stage firms, seem to change. Investors have finally realized that development-stage firms have no marketed drugs and no revenues, hence, no incomes and should be evaluated based on the clinical trial results of their pipeline products. They saw …

The Week in Review #44 Quarterly Financial Results What Was Seen and What Was Ignored History and self-experiences enabled investors to expect and swallow biased reactions following the announcements of the biotech sector’s firms’ quarterly results. Investors have long been expecting negative reactions towards small development-stage biotech firms following the announcement of their quarterly financial results. What they did not expect is for the same …

Spring Bank Pharmaceuticals, Gilead Sciences and HBV If Spring Bank Pharmaceuticals’ (SBPH) product inarigivir in combination with Gilead Sciences’ (GILD) Vemlidy® could validate the current encouraging results of the ongoing trials on chronic hepatitis B virus (HBV) infection, then the small underestimated firm would hand the giant biotech firm a valuable gift that could increase its sales revenues of its liver disease franchise.    The …

Prohost Letter #436 What Are We Experiencing Now? The bizarre market underperformance progressing rather than regressing and the good economy and the employment gains are the least utilized factors after being the most influential on the stock market performance. We are witnessing the most bullish analysts being confused, hesitating to give their followers a crystal clear explanation about the market’s skepticism, anger and volatility. The …

The Medicines Company ORION-10 Study for ASCVD The Medicines Company (MDCO) announced positive topline results from the ORION-10 Phase 3 clinical trial in patients with atherosclerotic cardiovascular disease (ASCVD). The ORION-10 trial conducted with . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

The Week in Review #41 We Are Still Witnessing … The bizarre market performance that started in early 2019: In the past couple of months the great enthusiasm and response of the market to the undeniably strong economic indicators and the lowest unemployment figures turned, for mysterious reasons, to a perturbed-looking volatile market beast. The biotech stocks have given back most of their deserved gains …

 The News Prohost Was Waiting for to Post Its Special Letter Prohost has one eye on the development-stage biotech and biopharmaceutical companies' scientific fundamentals and accomplishments as well as the financial results on the revenue-generating firms. Prohost has the second eye on the market performance, its volatility and the possible reasons it sinks every other day, or every other week, in calmer days during a …

Gilead Sciences Activities There is no doubt that Gilead Sciences (GILD) is doing whatever it takes to expand, improve and upgrade its pipeline products. For the last couple of months, each and every week, we heard news about collaborations with some companies and investment in others as well as licensing products from large, medium-sized and small firms. In less than ten . . . This content is for …

Gilead and Galapagos Global Research Collaboration Gilead Sciences (GILD) and Galapagos NV (GLPG) entered into a 10-year global research and development collaboration. Gilead will gain access to innovative compounds, including six molecules currently in clinical trials, more than 20 preclinical programs and a proven drug discovery platform. Galapagos will receive a $3.95 billion upfront payment and a $1.1 billion equity investment from Gilead. Galapagos will use the …

Gilead to File NDA for Filgotinib for Rheumatoid Arthritis Meeting with the U.S. Food and Drug Administration (FDA) Gilead (GILD) announced it discussed with the agency the Phase 3 FINCH studies; as well as the ongoing Phase 2 MANTA safety study assessing semen parameters with its filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn’s disease. As a result of this discussion a path forward has …

AstraZeneca and Merck PARP Inhibitor Lynparza The AstraZeneca (AZN) and Merck (MRK) PARP inhibitor Lynparza (olaparib) has been granted approval in Europe for first-line maintenance monotherapy . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Prohost Letter #432 The ASCO 2019 Special Edition SPRAYING FEAR The Victims Are The most disturbed victim of the instigated and irrelevant fear against investing in the stock market is the market itself. Indeed, baseless fear campaigns frighten positive investors while encouraging short-selling investors to maximize their selling which intensifies the markets volatility. We have been experiencing this phenomenon since the beginning of 2019. Market …

AT ASCO Gilead Sciences and Yescarta® By Acquiring Kite Pharma Gilead Sciences(GILD) gained Kite’s CAR T technology and its FDA approved therapy Yescarta.  At the ASCO 2019 two new analyses were presented from the ZUMA-1 clinical trial of Yescarta®  in adult patients with relapsed or . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

The Misleading Market? The biotech stocks continue to begin their daily trading relying on opinionated articles implanted by bloggers on the Internet rather than on the firms’ voiced news.  It is unfortunate that we continue to observe many investors incapable of pinpointing the differences between the fake and the real in interpreting the news. We do not blame them; however, as those who are misleading …

Gilead and insitro Collaborate to Discover and Develop Novel Therapies for NASH using ISH Gilead Sciences (GILD) and insitro entered into a strategic collaboration to discover and develop treatments for nonalcoholic steatohepatitis (NASH). NASH A chronic form of liver disease characterized by excess fat in the liver, inflammation, and liver cell damage. Inflammation and liver cell damage can cause scarring of the liver or fibrosis. Ultimately leading …

  Conquering NASH Gilead and Novo Nordisk Conquering NASH What was Gilead Sciences' (GILD) announcement at EASL? What is Gilead doing to find effective treatments for NASH? Why would Novo Nordisk's (

Prohost Letter #430 Rheumatoid Arthritis and Gilead The FINCH 1 trial: Has it reached its primary endpoints? How did the drugs respond as compared to placebo; what is the disability index, clinical remission, disease activity rate and safety results? What’s happening with Gilead’s HIV product? Read about Gilead’s collaboration with Galapagos. See how Prohost answers these questions in this issue #430 of the Prohost Letter. …

The Week in Review #39 During the Departed Week Three Prohost Portfolio Picks Hit Their 52-Week Highs The three picks referred to in the above title are, Novartis (NVS), Array (AARY) and Ionis (IONS). Previous Prohost Letters discussed Novartis and Array and continued to remind that they are Prohost favorites. The time has come to take a deeper look at Ionis; starting with the reasons …

CRISPR Therapeutics' (CRSP) stock added around $8 today while reporting financial results for the fourth quarter and full year ended December 31, 2018. Here is what Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics, has stated,“This past year was truly transformational for CRISPR Therapeutics as we achieved milestones across our key programs in β-thalassemia, sickle cell disease and immuno-oncology. We’re pleased with the progress we’ve made in …

From the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) Prostate Cancer A presentation by Bayer demonstrated improvement in the treatment of non-metastatic castration-resistant prostate cancer. Separate presentations by Bristol-Myers and Janssen also demonstrated improvement in metastatic castration-resistant prostate cancer. Non-Metastatic Castration Resistant Prostate Cancer Bayer Results from pivotal Phase 3 ARAMIS trial with Bayer’s (BAYRY) and Orion Corporation’s jointly-developed product darolutamide plus …

Gilead Sciences (GILD) has news that begins with an announcement today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Epclusa® (sofosbuvir 400mg/velpatasvir 100mg). Epclusa is once-daily treatment for adults with chronic hepatitis C virus (HCV) infection with decompensated cirrhosis, and for patients with chronic HCV infection without cirrhosis or with compensated cirrhosis who have had prior treatment with a direct-acting antiviral therapy (DAA). In Japan, no treatment option …

Gilead Sciences (GILD) and Scholar Rock Holding Corporation (SRRK) announced entering into a strategic collaboration to discover and develop highly specific inhibitors of transforming growth factor beta (TGFβ) activation for the treatment of fibrotic diseases. Under the terms of the agreement Gilead has exclusive options to license worldwide rights to product candidates that emerge from the following three Scholar Rock TGFβ programs:  – Inhibitors that target activation of latent …

Agenus (AGEN) announced recently that it entered into an immuno-oncology (I-O) partnership with Gilead Sciences (GILD). The partnership is focused on developing and commercializing up to five novel I-O therapies. The terms of the agreement Agenus is entitled to receive a $120 million upfront cash payment and a $30 million equity investment.   The agreement also includes approximately $1.7 billion in potential future fees and milestones. …

The Chinese National Medical Products Administration (NMPA) has approved Gilead’s (GILD) HIV combination product Descovy®.  In China, Descovy is to be indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) in adults and adolescents (aged 12 years and older with a body weight of at least 35 kg). TAF, which is part of the combination treatment, is a novel, targeted prodrug of …

The Week in Review #35 Politics and the Market The market tumbled today as Theresa May, the Prime Minister of England, delayed the Brexit vote!  The question becomes, what will be put forth next as a legitimate reason for bringing the market down and eroding investors’ gains? The weather? A war among gangs in a fourth-world country? Maybe the resignation of the chairman of a …

Today, the market took another beating as a result of either an intentional or an unintentional lack of clearance by professionals in describing correctly the standing of employment and other current economic realities. They pinpointed irrelevant reasons in an effort to justify the Stock Market's tumbling.  One big headline was that 150,000 added jobs did not meet expectations. They never explained whether those jobs were all …

The Week in Review #33 WE CALL IT THE BAD MARKET The Federal Reserve’s raising of the interest rate does not and should not mean a demise of the companies trading on the NASDAQ and other stock exchanges. The biotech group of firms with strong scientific fundamentals will not stop innovating and bringing breakthroughs to millions of people who are desperate for them if an …

IMMUNOTHERAPY  The Checkpoint Inhibitors The most revered news was the discovery of the checkpoint proteins on the surface of the immune system cells. The checkpoint proteins’ natural job is to put a break on the immune system cells to prevent them from attacking people’s own body cells. An immune attack on host cells can lead to disabling and life-threatening autoimmune diseases. Long before the scientists …

The Week in Review #30 FROM THE DEPARTED WEEK In the past week, we came across a lot of news announcing research, clinical trial results, collaborations, product approvals and acquisitions. Much of the departed week’s news though, does not represent complete stories, especially the ones related to research. They represented early works in progress offering no concrete results that we can evaluate. Important news for …

Gilead Sciences (GILD) has news that we felt good about it for a company that saved millions of lives from the minute, but monster viruses HIV and HCV. Curing millions of patients with HCV, has led Gilead to decide that the time has come for bringing cures to many horrible diseases. Yesterday, September 12, the news announced that Gilead and Precision BioSciences have entered into …

The Week in Review #29 PROHOST AGGRESSIVE PORTFOLIO  - The aggressive portfolio hosts biotech firms with solid scientific fundamentals and prominent scientists whose stocks have plummeted following some setbacks. A setback could be a failure of an investigational product to meet the endpoints of its clinical trial or that the small biotech firm has taken long to achieve its goals . . . This content …

Gilead Sciences’ (GILD) and Galapagos’ (GLPG) product filgotinib – a highly selective JAK1 inhibitor has met the primary efficacy endpoint in Phase 2 TORTUGA trial in adults with moderately to severely active ankylosing spondylitis (AS). Patients treated with filgotinib achieved significantly greater improvements compared to those who took a placebo. The results came from the Phase 2 of the TORTUGA – a multi-center, randomized, double-blind, …

The Week in Review #28 The approval of revolutionary products created by biotech firms with solid scientific fundamentals, superior scientists and advanced technologies is what motivates us to pick for investment biotech and biopharmaceutical firms. So, let’s see what has been approved in the parting week  from firms that we picked for investment.       IMPORTANT APPROVALS       Prohost Picked Firm     …

The Week in Review #23  ASCO  2018 - Small  publicly-­traded  oncology  biotech  firms,  large  oncology  biotech  firms,  and  giant  biopharmaceutical  firms,  in  addition  to  some  private  biotech  companies,  all  presented  results  and  observations  about  their  cancer  drugs  at  the  2018  American  Society  of  Clinical  Oncology  (ASCO)   meeting.  Most  presentations  were  useful,...

The Week in Review #22 What Went Right or Wrong in the Biotech Sector During the Departing Week? - A lot happened in the biotech sector during the week, which departed at midnight. Topping the list of the week’s events was the approval of Portola’s (PTLA) product  Andexxa . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Kite, a Gilead Company, and Sangamo Therapeutics Announce Collaboration to Develop Next-Generation Engineered Cell Therapies for Cancer Kite, a Gilead (GILD) company, and Sangamo Therapeutics (SGMO) announced a worldwide collaboration agreement for using Sangamo’s zinc finger nuclease (ZFN) technology platform for the development of next-generation ex vivo cell therapies in oncology. Kite will use Sangamo’s ZFN technology to modify genes to develop next-generation cell therapies for autologous and allogeneic use in treating …

Celgene (CELG) and Juno (JUNO) announced the signing of a definitive merger agreement upon which Celgene has agreed to acquire Juno. Celgene will pay $87 per share in cash, or a total of approximately $9 billion, net of cash and marketable securities acquired and Juno shares already owned by Celgene (approximately 9.7% of outstanding shares). The transaction was approved by the boards of directors of both companies. Juno …

Prohost Letter #416 Part 1 The Year In Review - 2017 Unheard of Programs - AN AWESOME YEAR for the biotech sector regarding its accomplishments. Many of the accomplished programs were unheard of regarding the degree of their positive impact on medical practice. Unfortunately, many of these accomplishments, which included the making of new discoveries, the creation of novel advanced technologies and the design of …

Gilead Sciences (GILD) has unsurprisingly agreed to acquire Cell Design Labs in a structured buy out valued for up to $567 million, including the shares of Cell Design Labs held by Kite, the CAR T firm that Gilead has recently acquired. Brian Atwood, President and CEO of Cell Design Labs, Inc., said, “Bringing our robust technology platforms under the Gilead umbrella, with its outstanding research …

The Treatment is Not A New Way as Being Stated, It is Only the Target, Which Has Been Changed   Outstanding news announced that leukemia patients who relapsed after being treated with the chimeric receptor antigen T cell (CAR T) targeting CD-19 were saved from imminent death by a CAR T targeting CD-22. The new treatment, which is being presented in some articles as a …

The Week in Review #11 A New Era - Faster than the speed of light, the management of diseases is shifting from fast improvement to a total gigantic unprecedented change. Some of the conquering approaches towards providing long-­lasting cures look as if the outcome of magic rather than mere science . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Important news has come from the FDA, which issued new guidelines to speed the introduction of treatments with human cells and tissues, including gene therapy. Cracking down on rogue clinics offering dangerous or unproven versions of gene therapy or stem cell therapy is also included in the report. Scott Gottlieb, the commissioner of the FDA stated that regenerative medicine and other important gene therapy treatments …

The Week in Review #10 NO CONSPIRACY THEORIES - But this is what’s happening - In the past issue of The Week in Review, we wrote about the irrational pattern of selling the biotech stocks during the announcement of the quarterly results and how some investors are taking advantage of this pattern to sell their stocks before the quarterly results . . . This content …

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.

As expected by those who welcome good news from publicly-traded firms, the Food and Drug Administration (FDA) has given the green light to a second CART immuno-oncology product with the trade name Yescarta.  This drug, which has been developed by Kite Pharma is now belonging to Gilead Sciences (GILD) together with the rest of Kite’s CAR T wealthy pipeline after Gilead acquired Kite less than …

The Week in Review #7 A lot more happened in the past week regarding improving the treatment of cancer and of other devastating diseases. This issue contains discoveries that aim at improving breakthrough immuno-­oncology treatment outcomes. Here are some of the breakthrough technologies and treatments that might improve, by-­far, the management of cancer . . . This content is for paid subscribers. Please click here to …