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Recent

AstraZeneca Product Fasenra Approved in the US for Eosinophilic Granulomatosis with Polyangiitis 

September 19, 2024

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The U.S. FDA Approves Novartis' Kisqali® to Reduce the Risk of Recurrence in People with HR+/HER2- Early Breast Cancer

September 18, 2024

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AstraZeneca’s Imfinzi + Imjudo Demonstrated Unprecedented Overall Survival in Advanced Liver Cancer

September 17, 2024

0

Halozyme Therapeutics Announced FDA Approval of Roche’s Tecentriq Hybreza with ENHANZE

September 13, 2024

0

Johnson & Johnson Product TREMFYA® Receives U.S. FDA Approval

September 12, 2024

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AstraZeneca Product Fasenra Approved in the US for Eosinophilic Granulomatosis with Polyangiitis 

AstaZeneca Fasenra Approval AstraZeneca ( AZN ) product Fasenra (bevacizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) - a rare, immune-mediated vasculitis that can result in damage to multiple organs,...

September 19, 2024

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The U.S. FDA Approves Novartis' Kisqali® to Reduce the Risk of...

AstraZeneca’s Imfinzi + Imjudo Demonstrated Unprecedented Overall Survival in Advanced Liver...

Halozyme Therapeutics Announced FDA Approval of Roche’s Tecentriq Hybreza with ENHANZE

Johnson & Johnson Product TREMFYA® Receives U.S. FDA Approval

Travere Therapeutics Announces Full FDA Approval of FILSPARI®

Gilead Therapeutics and Genesis Therapeutics Announced Strategic Collaboration to Discover and...

Regenxbio Announces Positive Results of its Product RGX-121 for Hunter Syndrome...

Jeune Aesthetics: Reversing the Biology of Aging Skin to Meet the...

Merck Discontinues Two Late-Stage Keytruda Trials and Other Important Information

Trick or Trade

Merck Discontinues Two Late-Stage Keytruda Trials and Other Important Information

Merck Updates Merck ( MRK ) provided updates on two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630, stating that it discontinued Phase 3 KEYNOTE-867 trial evaluating KEYTRUDA in combination with stereotactic body radiotherapy ( SBRT ) for the treatment of patients...

August 29, 2024

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Serious is the Impact of Bad Circumstances

The Impact of Bad Circumstances Since early year 2024, in every Prohost Letter we have posted, we added a memo stating that we have decided to be careful not to underestimate the bad circumstances under which the world is currently...

August 6, 2024

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BioStem Technologies' Press Release and Conference Call Offered Encouraging News

BioStem Technologies Inc From Jason Matuszewski, CEO of BioStem Technologies ( BSEM ) , who stated, “BioStem had an outstanding fourth quarter. Revenue reached $11.5 million, nearly 14 times higher than revenue of roughly $0.8 million for last year’s comparable...

April 2, 2024

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Illumina Stock Price Will Rebound With or Without This News

Illumina in the NEWS On March 21, 2024, we learned that the EU antitrust regulators suffered a blow as an adviser to Europe's top court said that they exceeded their powers when they blocked U.S. Illumina's ( ILMN ) $7.1 billion...

March 22, 2024

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Selecting New Small Biotech Firms for Investment

During a discussion with colleagues about the best way to select small and new biotechnology firms for investment purposes, we started our answer by stating that selecting small and new biotechnology firms for investments is extremely challenging. As a matter...

March 20, 2024

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BioCardia Inc Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial

BioCardia Inc in the NEWS BioCardia, Inc. ( BCDA ) , a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, today announced positive interim results from the Phase III randomized controlled trial of its CardiAMP® autologous cell...

March 4, 2024

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Travere Therapeutics Fourth Quarter and Full Year 2023 Financial Results

Travere Therapeutics in the NEWS Yesterday, Feb. 15, 2024,   Travere Therapeutics, Inc. ( TVTX ) reported its fourth quarter and full year 2023 financial results and provided a corporate update. Eric Dube, Ph.D., president and chief executive officer of...

February 16, 2024

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Could Precision Biosciences Gene Editing Firm Become the Only Company to Cure the Life-Threatening HBV Resistant Infection 

Precision BioSciences Receives Pre-IND Feedback from US FDA for PBGENE-HBV as it Advances Towards Clinical Readiness Precision BioSciences ( DTIL ) is an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated...

February 15, 2024

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OKYO Pharma Limited: Another Ophthalmology Firm with Promising Eye Treatment

Improving eyesight is speeding towards treating devastating eye diseases from the Retina in the back of the eye to the cornea on the front surface of the eye. As we wrote in Prohost Letter #457 , the current biotechnology revolution...

January 11, 2024

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Vertex Pharmaceuticals Provides Pipeline and Business Updates in Advance of Upcoming Investor Meetings

Vertex Pharmaceuticals Updates Vertex Pharmaceuticals ( VRTX ) announced multiple program updates ahead of the upcoming investor meetings in January, including the 42 Annual J.P. Morgan Healthcare Conference, which took place on January 8, 2024. From Vertex Pharmaceuticals Reshma Kewalramani,...

January 9, 2024

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Today’s Highlights

Gilead Therapeutics and Genesis Therapeutics Announced Strategic Collaboration to Discover and Develop Novel Therapies

Gilead Sciences and Genesis Therapeutics Gilead Sciences ( GILD ) and Genesis Therapeutics, Inc. announced today that the companies have entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets. Genesis Therapeutics is pioneering...

September 10, 2024

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Gilead Sciences Livdelzi Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA

Gilead Sciences Approval Gilead Sciences ( GILD ) today announced that the U.S. FDA has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis ( PBC ) in combination with ursodeoxycholic acid ( UDCA ) in adults...

August 15, 2024

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Akero Therapeutics Reports Q2 2024 Financial Results and Business Update

Akero Therapeutics Q2 and Business Update Akero Therapeutics ( AKRO ) reported second-quarter financial results for the period ending June 30, 2024,  and provided business updates. From Akero Therapeutics Andrew Cheng, president and CEO said, “The second quarter of 2024...

August 9, 2024

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Lexeo Therapeutics Announces Positive Data of lx2006 for the Treatment of Friedreich Ataxia Cardiomyopathy

Lexeo Therapeutics in the NEWS On July 15, 2024, Lexeo Therapeutics ( LXEO ) announced positive interim data of LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy. Across both the Lexeo SUNRISE-FA Phase 1/2 clinical trial ( NCT05445323 )...

July 16, 2024

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Illumina Acquired Fluent BioSciences to Accelerate Single-Cell Analysis and Discovery to a Broader Customer Base

Illumina Inc The latest take over by Illumina, Inc. ( ILMN ) has been a company with advanced technology known as Fluent BioSciences , a developer of emerging and highly differentiated single-cell technology.   From Illumina Inc Informing the biotech...

July 10, 2024

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Advanced Micro Devices to Buy the Largest Private AI Lab in Europe

Advanced Micro Devices in the NEWS  Advanced Micro Devices ( AMD ) today announced the signing of a definitive agreement to acquire Silo AI, the largest private AI lab in Europe, in an all-cash transaction valued at approximately $665 million. The...

July 10, 2024

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Alnylam Pharmaceuticals: Positive Topline Results from HELIOS-B Phase 3 Study of Vutrisiran

Alnylam Pharamceuticals Announcement June 24, 2024, Alnylam Pharmaceuticals ( ALNY ) announced positive topline results from its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy ( ATTR-CM )....

June 24, 2024

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Sarepta Therapeutics Announces Expanded US FDA Approval of ELEVIDYS to Duchenne Muscular Dystrophy Patients

Sarepta Therapeutics in the NEWS On June 20, 2024, Sarepta Therapeutics ( SRPT ) announced that the U. S. FDA has approved an expansion to the labeled indication for ELEVIDYS (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy (DMD)...

June 21, 2024

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Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention

Gilead Sciences' Lenacapavir Demonstrated 100% Efficacy in Preventing HIV Gilead Sciences, Inc. ( GILD ) today announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor,...

June 20, 2024

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Altimmune Important Upcoming Presentations

Altimmune Today, June 18, 2024, Altimmune ( ALT ) announced oral presentations on pemvidutide, an investigational GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH, at the American Diabetes Association’s ( ADA ) 84thScientific Sessions, to...

June 18, 2024

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Prohost Letters

Prohost Letter #461 ~ Preventing HIV Infection and Treating Primary Biliary Cholangitis

Prohost Letter #461 Preventing HIV Infection and Treating Primary Biliary Cholangitis Gilead Sciences Gilead Sciences’ ( GILD ) stock price has been paralyzed for more than three consecutive years.  The long paralysis of Gilead reminds us of Amgen Therapeutics whose...

August 21, 2024

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Prohost Letter #460 ~ Treating IgA Nephropathy

Prohost Letter #460 Treating IgA Nephropathy Immunoglobulin A ( IgA ), the antibody of the immune system known to fight infections, can itself cause two important diseases. It can attack the body causing autoimmune diseases and  can build up glomeruli...

June 1, 2024

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Prohost Letter #459 ~ NAFLD & NASH

Prohost Letter #459 ~ NAFLD & NASH NAFLD is Non-Alcoholic Fatty Liver Disease, and NASH is Non-Alcoholic Steatohepatitis. We will start with NAFLD.   NAFLD The Non-Alcoholic Fatty Liver Disease is caused by excessive fat building up inside the liver...

March 3, 2024

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Prohost Letter #458 ~ Obesity

Prohost Letter #458 ~ Obesity Finally, obesity is being recognized as a severe sickness. Indeed, obesity is several devastating diseases, which  include  cardiovascular diseases, high blood pressure, Type 2 diabetes, cancers, sleep apnea, breathing problems, and more.  Many studies demonstrated...

December 18, 2023

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Discovering The Root Causes of Diseases

Prohost Letter #457 Discovering The Root Causes of Diseases   Biotech firms with solid scientific fundamentals are racing towards unveiling the root-causes of various diseases that have yet to be completely unveiled. Knowing the root causes of diseases enabled some...

September 15, 2023

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Treatments for Untreatable Diseases

Prohost Letter #456 Treatments for Untreatable Diseases The revolution in biotechnology is not meant to offer just improvements on approved and marketed drugs. We are witnessing novel investigational products demonstrating safety, efficacy, statistically significant and clinically meaningful results in treating...

July 16, 2023

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Prohost Letter #455

Prohost Letter #455 Introduction Our Prohost Letter disappeared for six months. Several reasons dictated our decision to temporarily halt its publication. The major reason was the devastating visit of COVID-19. COVID -19 paralyzed many countries. It devastated the world’s economy,...

June 28, 2023

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Gilead Sciences - Still Way Undervalued

Prohost Letter #453 Gilead Sciences Still Way UNDERVALUED Finally, many analysts who happened to downgrade Gilead Science’s ( GILD ) stock for years are upgrading it. Demonstrating time and time again its scientific genius in saving millions of people from...

December 29, 2022

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Treating Untreatable Disease - NASH

Prohost Letter #452 Treating Untreatable Disease - NASH Non Alcoholic Steatohepatitis  The efforts spent on treating Non Alcoholic Steatohepatitis (NASH) have reached a promising stage where clinical trial data from the clinical-stage and revenue-generating biotech firms have demonstrated capability of...

October 13, 2022

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Prohost Letter #461 ~ Preventing HIV Infection and Treating Primary Biliary Cholangitis

Prohost Letter #461 Preventing HIV Infection and Treating Primary Biliary Cholangitis Gilead Sciences Gilead Sciences’ ( GILD ) stock price has been paralyzed for more than three consecutive years.  The long paralysis of Gilead reminds us of Amgen Therapeutics whose...

August 21, 2024

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News & Comments

Jeune Aesthetics: Reversing the Biology of Aging Skin to Meet the Growing Demand

 Jeune Aesthetics Announces Phase 1 Positive Interim Safety and Efficacy Results for KB301 On August 28, 2024,  Jeune Aesthetics, Inc. , a wholly-owned subsidiary of Krystal Biotech ( KRYS ) announced positive interim safety and efficacy results from both Cohorts...

September 4, 2024

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Galderma Receives U.S. FDA Approval for Nemluvio® for Adult Patients with Prurigo Nodularis

Galderma: FDA Approval for Nemluvio® Today, August 13, 2024, Galderma ( GALD.SW ) announced that the U.S. FDA has approved its product Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection aimed at treating adults with prurigo nodularis.  Galderma exists in...

August 13, 2024

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SCG Cell Therapy: FDA Approved IND Application of Product SCG142 to Initiate Phase 1/2 Clinical Trial for A Next Generation HPV and its cancers.

SCG Cell Therapy FDA Approval SCG Cell Therapy Pte Ltd (SCG) is a biotech company developing novel immunotherapies for infectious diseases and their associated cancers, announced that United States FDA has approved its investigational New Drug ( IND ) application...

July 1, 2024

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Mitsubishi Tanabe Pharma America Announced the Presentations of its ND0612 in Parkinson’s Disease at 10th Congress of the European Academy of Neurology  

From Mitsubishi Tanabe Pharma America Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at Mitsubishi Tanabe Pharma America said, “We are excited to be at the Congress of the European Academy of Neurology ( EAN ) this year...

June 28, 2024

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 AstraZeneca: The U.S. FDA Approved IMFINZI in Combination with Carboplatin and Paclitaxel followed by IMFINZI Monotherapy for Adults with Primary Advanced or Recurrent Endometrial Cancer

US FDA Approval for AstraZeneca's IMFINZI AstraZeneca ( AZN ) : The trial results of the FDA newly approved combination products demonstrated a reduction in the risk of disease progression or death by 58% in patients with dMMR endometrial cancer...

June 17, 2024

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Regeneron: Improved Hearing to Normal Levels in a Child with Profound Genetic Deafness 

Regeneron in the NEWS Regeneron Pharmaceuticals ( REGN ) announced today that the investigational gene therapy DB-OTO improved hearing to normal levels in one child (dosed at 11 months of age) within 24 weeks, and initial hearing improvements were observed...

May 8, 2024

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INmune Bio Inc. Update on Two Alzheimer Disease Patients Who Continued to Receive XPro Product

INmune Bio Press Release   INmune Bio (NASDAQ: INMB ) is pleased to share an update on two patients from the Phase 1b trial completed in 2021 who have continued to receive XPro™ for treatment of Alzheimer’s Disease ( AD )...

April 30, 2024

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Cerevel Therapeutics Announces Positive Results for Tavapadon in Phase 3 Adjunctive Trial for Parkinson’s Disease

Cerevel Therapeutics in the NEWS Cerevel Therapeutics ( CERE ) announced positive topline results from its pivotal Phase 3 TEMPO-3 trial for tavapadon, the first and only D1/D5 receptor partial agonist being studied as once a day treatment for Parkinson’s...

April 20, 2024

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Italfarmaco Received FDA Approval for Duvyzat™ for the Treatment of Duchenne Muscular Dystrophy

Italfarmaco in the NEWS  From Milan, Italy: Today, Italfarmaco announced that the U.S. Food and Drug Administration ( FDA ) has approved Duvyzat™ (givinostat) - a novel histone deacetylase ( HDAC ) inhibitor, for the treatment of patients 6 years or...

March 22, 2024

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Abbott Laboratories Launches a New PROTALITY™ Brand to Maintain the Muscle Mass of Adults Pursuing Weight Loss by Various Means

Abbott Laboratories New PROTALITY™ for Maintaining Muscle Mass During Weight Loss Abbott Laboratories ( ABT ) announced the launch of its new PROTALITY™ brand. The high-protein nutrition shake is the first product to support the adults interested in pursuing weight loss...

February 1, 2024

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Impacting News

AstraZeneca Product Fasenra Approved in the US for Eosinophilic Granulomatosis with Polyangiitis 

AstaZeneca Fasenra Approval AstraZeneca ( AZN ) product Fasenra (bevacizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) - a rare, immune-mediated vasculitis that can result in damage to multiple organs,...

September 19, 2024

0

The U.S. FDA Approves Novartis' Kisqali® to Reduce the Risk of Recurrence in People with HR+/HER2- Early Breast Cancer

Novartis FDA Approval Yesterday, September 17, 2024, Novartis ( NVS ) announced that the United States FDA has approved Kisqali®(ribociclib) in combination with an aromatase inhibitor ( AI ) for adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor...

September 18, 2024

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AstraZeneca’s Imfinzi + Imjudo Demonstrated Unprecedented Overall Survival in Advanced Liver Cancer

AstraZeneca Imfinzi + Imjudo Updated results from the HIMALAYA Phase III trial have demonstrated that AstraZeneca ( AZN ) Imfinzi (durvalumab) plus Imjudo (tremelimumab) showed a sustained clinically meaningful overall survival ( OS ) benefit at five years for patients...

September 17, 2024

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Halozyme Therapeutics Announced FDA Approval of Roche’s Tecentriq Hybreza with ENHANZE

Halozyme Therapeutics in the NEWS Halozyme Therapeutics, Inc. ( HALO ) announced that Roche received U.S. Food and Drug Administration ( FDA ) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology. Tecentriq Hybreza™ can be...

September 13, 2024

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Johnson & Johnson Product TREMFYA® Receives U.S. FDA Approval

Johnson & Johnson FDA Approval Yesterday, September 11, 2024,  Johnson & Johnson ( JNJ ) announced that the FDA has approved TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis ( UC ) - a chronic...

September 12, 2024

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Travere Therapeutics Announces Full FDA Approval of FILSPARI®

Travere Therapeutics Approval Travere Therapeutics, Inc., ( TVTX ) announced that the U.S. FDA has granted full approval to FILSPARI® (sparsentan) to slow kidney function decline in adults with primary IgAN who are at risk of disease progression. In February 2023, based...

September 11, 2024

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Regenxbio Announces Positive Results of its Product RGX-121 for Hunter Syndrome  

Regenxbio Positive Results Regenxbio ( RGNX ) announced positive results from the Phase I/II/III CAMPSIITE® trial of RGX-121 for patients with Mucopolysaccharidosis Type 2 ( MPS II ), also known as Hunter syndrome. The results were presented at the Society...

September 5, 2024

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Good News for Vertex Pharmaceuticals and for Crispr Therapeutics

Vertex Announces CASGEVY™ Reimbursement Agreement with NHS England Vertex Pharmaceuticals ( VRTX ) announced a reimbursement agreement with NHS England for eligible transfusion-dependent beta-thalassemia ( TDT ) patients to access the CRISPR/Cas9 gene-edited therapy, CASGEVY™ (exagamglogene autotemcel).  The United Kingdom...

August 27, 2024

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Cytokinetics Reports Management Update and Q2 2024 Financial Results

Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing, and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. The company is developing small-molecule drug candidates specifically...

August 12, 2024

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Exelixis Announces Q2 2024 Financial Results and Provides Corporate Update  

Exelixis Q2 Results and Corporate Update Yesterday, Aug. 6, 2024, Exelixis, ( EXEL ) reported financial results for the second quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial,...

August 7, 2024

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