XOMA Establishes Proof-of-Concept for 358 in Congenital Hyperinsulinism and Hypoglycemia Post-Bariatric Surgery Congenital Hyperinsulinism Phase 2 study completed and multi-dose study protocol approved in the United Kingdom. Xoma initiates multi-dose study in hypoglycemic Post-Bariatric Surgery patients The NEWS A few days ago, Xoma announced news about trial results that the firm believes were promising and successful in establishing proof-of-concept for its . . . This …

It seems that the global Takeda (TKPYY) has guessed well what it should pick in order to bring the most effective targeted treatments to cancer patients allover the globe. Cancer management has unreservedly changed. What seems now to have become the best treatment choices are those that would accommodate the new wave of extremely promising immunotherapy approaches. To reach its ultimate success, immunotherapy drugs require …

Incyte and Calithera Biosciences Announce Global Collaboration to Develop and Commercialize CB-1158, a Small Molecule Arginase Inhibitor                         Incyte (INCY) and Calithera Biosciences (CALA) announced a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology. CB-1158 is currently being studied in …

Prohost Letter #404 Part 1 HAPPY SPIRITUAL HOLIDAYS HAPPY NEW YEA

Today, Jounce Therapeutics has begun trading on the NASDAQ under the ticker symbol (JNCE).  The Company, which focuses on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced the pricing of its initial public offering of 6,365,000 shares of common stock at a public offering price of $16.00 per share for aggregate gross proceeds of $101,840,000. In addition, Jounce granted the underwriters …

A few months ago, we heard news that a Belgium firm called Celyad (CYAD) has concluded a deal worth over $300 million with Ono Pharmaceutical. The deal gives Ono the rights to Celyad’s allogeneic NKR-2 T-cell immunotherapy in Japan, Korea and Taiwan. This news did not mean a lot to investors as Celyad had yet to recover from a heartbreaking  setback in a late phase trial …

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, …

Amgen (AMGN) The Journal of the American Medical Association (JAMA) published findings from three Phase 3 studies of Parsabiv (etelcalcetide), an investigational intravenous calcimimetic agent in the U.S. The studies evaluated Amgen’s drug Parsabiv in more than 1,700 adults with secondary hyperparathyroidism on hemodialysis and showed that the drug produced statistically significant and clinically meaningful reductions in serum parathyroid hormone (PTH) levels, a key marker …

ARIAD Pharmaceuticals’ (ARIA) stock jumped 75% today. The oncology firm entered into a definitive agreement to be acquired by Takeda Pharmaceutical Company Limited under which Takeda will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, or a total enterprise value of approximately $5.2 billion, representing a premium of approximately 75 percent over ARIAD’s closing price on January 6, 2017. Under …

Extremely important, not just exciting, were the results of Halozyme Therapeutics’s (HALO) Phase 2 randomized, multi-center clinical trial of its PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer. The results demonstrated a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving …

GILEAD (GILD) One analyst who aimed at bringing only the negatives about biotech has finally succeeded in convincing other critics and media bloggers that Gilead would not be good for investment until the firm acquires a company that can expand its meager oncology franchise. His story became the melody hummed by every blogger, ignoring the fact that the firm’s revenues and income have doubled overnight …

Hi and Happy New Year 2017 In a couple of days, you will receive the NEW Year 2017 issue #404 of the Prohost Letter where we will set out our prediction regarding breakthrough achievements that we believe will change the way diseases will be treated. Our long article tackles great technological capabilities that we expect will advance products to the market and improve state-of-the-art approaches …

MANUFACTURING ISSUES?!  Why PORTOLA Stock Rallied? On Aug. 17, 2016, we learned that the FDA sent a Complete Response Letter (CRL) to Portola Pharmaceuticals (PTLA) regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa), which is an antidote important for the safety use of several new Factor Xa inhibitors anticoagulants aimed at replacing Coumadin (warfarin). The Factor Xa inhibitors anticoagulants have many advantages over …

Observing the biotech sector’s stock prices post losses yesterday, Wednesday, Dec. 21 convinced us that investors and traders in the biotech sector might have wrongly interpreted a bipartisan Senate report regarding the high price of drugs. The report is the outcome of a study that forms the basis of a recommendation that would enable the Congress take the right action against unjustified increases in the …

Ionis Pharmaceuticals (IONS) has further good news with a new revelation from Akcea Therapeutics, a wholly-owned subsidiary of Ionis Pharmaceuticals that the Phase 3 COMPASS study met its primary endpoint. COMPASS is a randomized, double-blind, placebo-controlled, 26-week Phase 3 study evaluating the firm’s drug volanesorsen in 113 patients with severe hypertriglyceridemia.   The average incoming triglyceride level of patients in the study was 1,261 mg/dl. …

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, …

ProhostLetter #403 Part 1 On December 8, 2016 under News & Comments Prohost commented on President Elect Trump’s statement that he is going to bring down the exorbitant drug prices. The Skyrocketing Prices of Drugs Like everybody else we happen to talk to, we agree that the prices of drugs have skyrocketed to a level that made them unaffordable. It is a serious problem that …

Today we have good news and bad news. The good news is coming from Regeneron (REGN)through two sources: The first is the European Medicines Agency accepting Regeneron’s and Sanofi’s (SNY) Filing for the approval of Dupixent (dupilumab) for moderate to severe atopic dermatitis. A probable second source could be the bad news about the failure of Ophthotech’s (OPHT) drug Fovista® combo with Lucentis in demonstrating superiority …

President Elect Trump was quoted in a Time person of the year as saying “I am going to bring down drug prices.” The President Elect did not say he is going to bring down the drug producing and developing firms. Mr. Trump did not say he will bring down medical research, which is mostly conducted by the biotech and pharmaceutical firms. He did not say …

Bellicum Pharmaceuticals (BLCM) announced results from the BP-004 multicenter clinical trial for children with Primary Immune Deficiencies (PIDs) and hemoglobinopathies. The candidates received an add-back of Bellicum’s BPX-501 modified T cells following a haploidentical, T cell-depleted hematopoietic stem cell transplant (haplo-HSCT). The data were presented in oral and poster sessions today during the 58th Annual Meeting of the American Society of Hematology (ASH). Results: All …