EXELIXIS Good News about CABO The FDA has determined that Exelixis’ (EXEL) cabozantinib New Drug Application (NDA) for advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA granted Priority Review to the filing and assigned a Prescription Drug User …

Halozyme Therapeutics (HALO) seems to have closed the previously announced $150 million royalty-backed debt transaction with investment funds managed by Pharmakon Advisors and Athyrium Capital Management.  The debt is said to be secured by future royalties of ENHANZE™ products, received from Halozyme's collaborations Roche and Baxalta only. Halo declared delight with the conclusion of this deal as it is a non-dilutive financing and because it finds …

Theravance Biopharma (TBPH) announced the commercial launch of VIBATIV® (telavancin) in Canada. VIBATIV is a once-daily antibiotic with a dual mechanism of action against Gram-positive bacteria, including difficult-to-treat methicillin-resistant Staphylococcus aureus (MRSA). The drug is approved in Canada for adult patients with hospital-acquired bacterial pneumonia (HAP) and ventilator-associated bacterial pneumonia (VAP) known or suspected to be caused by susceptible isolates of Staphylococcus aureus including methicillin-susceptible S. aureus (MSSA) and MRSA. VIBATIV is …

The Market is Surely Ignoring the Historical Summit Biotech achievements are standing on Right Now     The latest biotech sector’s breakthroughs we presented was the novel powerful gene editing techniques CRISPR/cas9 and TALEN. Our article in the Prohost Letter #390 meant to enable the reader to understand that the evolution in biological sciences, especially in sequencing and analyzing the genome of the sick and healthy cells, has reached a stage …

Escaping the slaughter, or taking advantage of it, or  accumulating the stocks we love, or turning from positive to negative investors are all choices on the table. The problem is that the prophets stop prophesizing at times when prophesies are badly needed. The prophets themselves are asking questions, rather than providing answers. The experts and officials who know better and were just claiming that the …

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 …

Of the Biotech Sector’s Selloff Testing the lows in biotech firms’ stock prices is nothing but testing the biotech investors’ degree of vulnerability to fear. Fear leads many biotech investors to hysterically sell their stocks just by hearing negative stories about the sector. The stock selloff continues even when the frightening fabricated stories happen not to make sense that convince mature people to believe them. …

The Evolution of Liquid Biopsy TWO PIANISTS, GUARDANT HEALTH and C4 THERAPEUTICS Biotech firms are bringing future technologies and treatments into the present days, while Stock Market’s evaluators are assessing their values with out-of-date inappropriate methods. The unfair evaluations add to the firms’ burdens and devastate investors who pick the best biotech firms and lose their money nonetheless. The two players we are presenting today …

Improving the management of inflammatory and autoimmune diseases has been a dream that seems to be happening slowly but surely in the past years. The improvement has gained energy and speed in 2015. The advancement in treatments has been demonstrated on several inflammatory and autoimmune diseases, including psoriatic arthritis, rheumatoid arthritis (RA), Crohn’s disease, systemic lupus erythematosus (SLE) and many other autoimmune diseases. Psoriasis   …

Exelixis Announces Positive Results from Subgroup Analyses of the METEOR Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma - The results will be Presented at ASCO 2016 Genitourinary Cancers Symposium this month. - Data further highlight clinical benefit of cabozantinib across subgroups of patients with advanced renal cell carcinoma   - METEOR data are the foundation for the U.S. NDA filing submitted …

On Oct. 28, 2015, Gilead Sciences (GILD) announced that it has submitted a New Drug Application (NDA) to the FDA for an investigational, once-daily fixed-dose combination of the approved nucleotide analog polymerase inhibitor sofosbuvir (Sovaldi®) abbreviated as (SOF) and the investigational pan-genotypic NS5A inhibitor velpatasvir, abbreviated as (VEL) for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The NDA was supported by …

The market looks like angry, probably very angry, as stocks are in a severe selloff mood. There will be many explanations like usual, but it is difficult for us to speculate this time over the correctness of the offered explanations, including the Iran Saudi Arabia crisis, which led to an increase in the oil price whose decrease has caused the previous market’s bad mood. Like …

Prohost Letter #389 Happy New Year 2016 Wishing You Good Health Peace of Mind Love And happiness  We expect 2016 to be the year that fulfills many of our great expectations about successfully managing intractable and life-threatening malignant and non-malignant disease. We expect the biotech firms to bring us more cures based on the maturation of genetic engineering processes following a lot of trial and …

When you do your due diligence, you do not lose your faith in what you believed in giving up to the hype that’s sprayed around you. We were happy today to hear Array BioPharma (ARRY) report that results from the Phase 3 NEMO clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma. The trial met its primary endpoints. We are happy, but not surprised, …

Halozyme Therapeutics (HALO) and Eisai Inc. presented a scientific poster entitled, “Pegylated Recombinant Human Hyaluronidase PH20 (PEGPH20) Enhances Efficacy of Eribulin Mesylate (HALAVEN®) in Triple Negative Breast Cancer Xenografts” at the 38th Annual San Antonio Breast Cancer Symposium (SABCS). The Combination used in the preclinical testing HALAVEN® (eribulin mesylate) injection, which belongs to Eisai inc., is indicated for patients with metastatic breast cancer who have received at least two prior …

XOMA Announces License Agreement with Novo Nordisk for XMetA Program in Diabetes – Novo Nordisk acquires exclusive global rights to XMetA program, but for diabetes only, while XOMA  retains commercialization rights for rare disease indications – $5.0 million upfront payment. But the agreement includes up to $290.0 million in additional potential milestone payments – XOMA is entitled to tiered royalties XOMA (XOMA) announced it has …

Prohost Letter #388 TOPICS - 1. AN INDISPENSABLE SHORT INTRODUCTION 2. GENE EDITING 3. GENE THERAPY 4. CANCER IMMUNOTHERAPY 1. GENE EDITING Exon Skipping: Biomarin (BMRN); Sarepta (SRPT); These firms are waiting FDA approvals for Duchenne Muscular Dystrophy (DMD) Gene Editing Technology Competitors: Cellectis S.A. (CLLS); CRISPR; PTC Therapeutics (PTCT) Firms Using Different Approaches For DMD Treatment (see Below) Zink Finger Tech: Sangamo (SGMO); RNAi …

In our yesterday’s article asking about how the FDA advisory committee has to vote regarding Biomarin product Kyndrisa (drisapersen) for Duchenne muscular dystrophy. We got the answer yesterday during the meeting that took a much longer time than committees’ meetings usually take. At the end of the long session that included several patients’ and patients’ relatives’ testimonies, the FDA Advisory Committee was incapable of voting for …

Today, the FDA advisory panel will discuss BioMarin (BMRN) product drisapersen for Duchenne muscular dystrophy based on documents released to the committee by the FDA. The FDA said, “The benefit of drisapersen in exon 51 skip amenable patients is inconclusive at this time. Therefore, the benefit-risk assessments were not made.” Analysts interpreted the FDA statement as a condemnation of the drug, which does not really tell what the FDA meant …

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 …