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 …

Yes, it is Sangamo’s (SGMO) zinc finger nuclease (ZFN) gene-editing technology, which for the first time in history enabled a patient to receive a treatment to edit the DNA of his cells directly inside the body. That was the news coming today from Sangamo. The Story Sangamo’s gene editing product known as SB-913 -- an investigational in vivo genome editing therapy was introduced for the first time …

Halozyme Therapeutics (HALO) announced that it will present nonclinical data at the 32nd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) which demonstrate the potential for PEGPH20, Halozyme's pegylated recombinant human hyaluronidase, to increase the infiltration of immune cells into the tumor microenvironment and enhance the efficacy of immuno-oncology drugs in an HA-accumulating murine colon tumor model. The study shows that degradation of hyaluronan (HA) …

A couple of days ago, Cellectis (CLLS), which uses its own proprietary gene editing technology known as “transcription activator-like effector nuclease (TALEN®)” in developing immunotherapies, received the following good news: The FDA has lifted the clinical hold, which the Agency has put on Phase 1 trials of Cellectis’ UCART123 product candidate.       The Story In February 2017, Cellectis received an Investigational New Drug (IND) approval …

Nektar Therapeutics (NKTR) stock rallied, reaching all-time high with positive results in every aspect of the firm’s fundamentals from reported finances, to reported products’ results, etc.,  Cash and investments in marketable securities at September 30, 2017, were $412.2 million as compared to $389.1 million at December 31, 2016. The cash includes the $150.0 million upfront payment by Eli Lilly & Company for the development and commercialization of NKTR-358. As Howard W. Robin, President and CEO of …

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 …

EXELIXIS For Exelixis’ excellent news, please read our latest article, "Exelixis’ (EXEL) Exceptional Financial Results and Corporate Achievements", under Today’s Highlights NEUROCRINE BIOSCIENCE Prohost Picked this firm on April 24, 2017, at $51 (see the Prohost Portfolio in the Prohost Letter). Today, Thursday, November 2, NBIX closed on  at $72.78 Up $11.85     In its Q3 report, Neurocrine Biosciences (NBIX) announced financial results that beat …

Cabozantinib Net Revenue for Q3 is $96.4 million. Total Revenue of $152.5 million  Net Income of $81.4 million, Diluted EPS $0.26 per Share Have these headlines said it all? Of course not, but what they said was sufficient to appreciate this firm when compared to other firms that were granted approvals more than three to four years ago, yet they are still spending much than what they earn. Exelixis’ (EXEL) drug …

Amgen (AMGN) and Kirin Holdings (Kirin) announced an agreement upon, which Kirin-Amgen, a joint venture between the two companies, will redeem Kirin’s shares in the joint venture and as a result, Kirin-Amgen will become a wholly-owned subsidiary of Amgen. The Kirin-Amgen joint venture was established in 1984 as a 50-50 joint venture between Amgen and Kirin to fund the global development of Epogen® (epoetin alfa). The scope of …

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.

Prohost Letter #414 GIANTS & DWARFS - We believe it’s a useful idea bringing The Week in Review into the Prohost Letter this time. We thought it would be easier for the readers to get last week’s updates and comments together with the Letter’s subjects and its Prohost Portfolio’s observations. In the Week that said au revoir, things happened that are worth citing. New development-stage …

Agenus (AGEN) announced that The Food and Drug Administration (FDA) granted marketing authorization to GlaxoSmithKline's (GSK) product Shingrix, a herpes zoster vaccine containing Agenus' proprietary immune adjuvant QS-21 Stimulon®. Shingrix vaccine is designed to prevent herpes zoster (shingles) in adults aged 50 years and older. The adjuvant in the vaccine is Agenus’ product QS-21 Stimulon. This adjuvant is to help improve the vaccine's effectiveness by …

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 …

Spectrum Pharmaceuticals (SPPI) announced an oral presentation of interim data from a Phase 2 clinical study evaluating the pan-HER inhibitor poziotinib in EGFR Exon 20 Mutant Non-Small-Cell Lung Cancer (NSCLC) by scientists from the MD Anderson Cancer Center. The data were presented at the 18th IASLC World Conference on Lung Cancer in Yokohama, Japan on October 15-18, 2017. The trial results from Poziotinib demonstrated evidence of significant anticancer activity in NSCLC …

Two game changing news has come together on October 16, 2017, both indicating that  Exelixis (EXEL) is on its way to reach its goal becoming the leader in the current oncology discovery and development field.  THE FIRST GOOD NEWS announced that the U.S. Food and Drug Administration (FDA) determined that Exelixis’ supplemental New Drug Application (sNDA) for the approval of Cabometyx® in patients with previously …

The Week in Review #8 Potential biotech winners inspired through COLLABORATION - When successful top-­tier drug developing firms such as Amgen (AMGN) or Merck (MRK) sign strategic collaborating agreements with small development-­stage biotech firms,...   &nbsp . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Yes, indeed, the FDA Advisory Committee Unanimously Recommends Approval of Investigational LUXTURNA™ (voretigene neparvovec) for Patients with Biallelic RPE65-mediated Inherited Retinal Disease LUXTURNA has the potential to be the first pharmacologic treatment for an inherited retinal disease (IRD) and the first gene therapy for a genetic disease in the United State First adeno-associated viral (AAV . . . This content is for paid subscribers. Please click here to subscribe …

Good news emanating from late phase trials by development-stage firms is always refreshing for Prohost, especially when the news brings hope for the suffering patients whose diseases are not adequately responding to existing treatments. Today GOOD news is coming from late Phase trials announcing that a product called Tenapanor has met all its Aprimary and secondary endpoints for irritable colon syndrome with constipation (IBS-C), which …

–The Agreement Covers the Development of Investigational Plasma Kallikrein Inhibitors for Diabetic Macular Edema (DME) – Upfront Fee ($37 Million).  Potential Milestone Payments. Royalties On Sales. The deal could be worth $750 million – Merck Acquires 9.9% Stake in KalVista in Private Placement.    -Phase 2 Clinical Trial for the Investigational Intravitreal DME Candidate KVD001 Still Planned to Initiate in 2017. Surprise? Indeed, it is. KalVista Pharmaceuticals …