Exelixis (EXEL) completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Cabometyx® (cabozantinib) tablets for previously treated patients with advanced hepatocellular carcinoma (HCC). The sNDA submission is based on results from the CELESTIAL randomized pivotal phase 3 trial of Cabometyx in patients with advanced HCC who received prior sorafenib. Some History: On October 16, 2017, Exelixis announced that the independent data …

Prohost Letter #419 RE-­EVALUATION ONLY - The Prohost Portfolio comprises biotechnology and biopharmaceutical companies, that we believe have solid scientific fundamentals and dedicated managements. All the firms in the portfolio, except a few, have proprietary technologies, which enable the firms’ scientists to design in house safer and more effective new molecular entity therapeutic molecules . . . This content is for paid subscribers. Please click here …

Alnylam (ALNY) announced that Sanofi Genzyme declined its opt-in for the development and commercialization of the RNAi product lumasiran, an investigational RNAi therapeutic for the treatment of Primary Hyperoxaluria Type 1 (PH1). Based on this decision, Alnylam intends to rapidly advance lumasiran into a Phase 3 pivotal study in late 2018, and to commercialize lumasiran globally, assuming product approval. Alnylam has also announced that the FDA has granted lumasiran …

The Week in Review #19 Targeting the Root-­Cause of Diseases - Investing in the Future is Currently the Best Way - Stopping aberrant genes from causing diseases has taken time to move from wishful thinking to reality. Through trial and error, various different approaches have been tested over the years, including attempts at genetic engineering... &nbsp . . . This content is for paid subscribers. …

Extremely important news has come from Montreal, Canada carrying the announcement by Theratechnologies (TSX:TH) and its partner TaiMed Biologics (TaiMed) that the FDA has granted approval of Trogarzo™ (ibalizumab- uiyk) Injection. The approval is for Trogarzo to be used with other ARTs for HIV-1 infection in heavily treated adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. Trogarzo™ is a humanized monoclonal antibody created for multidrug resistant …

Regeneron’s (REGN) pipeline products have still a lot of good news to announce. The latest is about its product Dupixant (dupilumab) which has already been FDA approved for atopic dermatitis. Now, there are reasons to believe that this drug could be also approved as an add-on maintenance for people with moderate to severe Asthma. The news has come from both Regeneron and its partner Sanofi (SNY), stating that …

On March 4, 2018, Aimmune Therapeutics (AIMT) – a biopharmaceutical company developing treatments for potentially life-threatening food allergies confirmed the superior news that brings hope to children and adults who are susceptible to peanut allergic reactions. The results from the firm’s pivotal Phase 3 PALISADE trial of its product AR101 for the treatment of peanut allergy were presented at the 2018 American Academy of Allergy, Asthma & Immunology–World Allergy Organization Joint Congress …

Prohost Letter #418 Observing Queer Stories  PORTOLA - Portola (PTLA) has been granted approval of an important factor Xa inhibitor Bevyxxa (betrixa-­ban for extended prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for a life-­threatening VTE . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

FERTILITY Fertility is what guarantees the presence of humans on the planet Earth. The reproductive system in men and women are the engines of fertility that creates living beings. These important engines get disturbed in some people, which represents a problem that needs repair. Life sciences arts have done a good job towards overcoming the causes that would prevent a couple from bearing children. Still …

The Food and Drug Administration (FDA) approved AstraZeneca (AZN) Checkpoint inhibitor drug Imfinzi® (durvalumab) for patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT). Explaining the importance of this approval, Scott J. Antonia, M.D., Ph.D., Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida and investigator …

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 …

Portola Pharmaceuticals and the CHMP’s Oral Explanations for Andexanet Alfa and Betrixaban Portola (PTLA) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated a positive trend vote on the Marketing Authorization Application (MAA) for Portola’s factor Xa inhibitor antidote andexanet alfa. The agency has also communicated a negative trend vote for betrixaban, the firm’s oral, Factor Xa inhibitor. Andexanet Alfa Bill Lis, the chief executive officer …

The Week in Review #18 The Market - The stock market recuperated most of its losses while analysts preferred to abstain from forecasting and remain bystanders during the market volatility.  Although the causes of volatility have yet to be delineated, some philosophers in the field dared to attribute it as a market’s own mind’s judgment . . . This content is for paid subscribers. Please …

Seattle Genetics and Pieris pharmaceutical Collaboration Agreement Pieris Pharmaceuticals (PIRS) and Seattle Genetics (SGEN) signed a multi-program immuno-oncology collaboration agreement intended to evaluate novel bi-specific immuno-oncology agents. These agents would combine Pieris’ Anticalin proteins drugs with Seattle Genetics’ targeted antibodies to develop multiple targeted bi-specific immuno-oncology treatments for both solid and blood cancers. The Story Pieris Pharmaceuticals created recombinant engineered Anticalin protein-based therapeutics. These proteins are versions of the human protein lipocalin, which naturally bind, …

Expected or not, we believe that the news announcing that the U.S. Food and Drug Administration (FDA) approval Vertex’s (VRTX) cystic fibrosis combo product Symdeko™ (tezacaftor/ivacaftor and ivacaftor) is good news. It is indeed excellent news for the many cystic fibrosis people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis trans-membrane conductance regulator (CFTR) gene or who have at least one mutation that …

Bristol-Myers Squibb (BMY) and Nektar Therapeutics (NKTR) Announce Global Development & Commercialization Collaboration for Nektar’s Product NKTR-214 The Collaboration is to evaluate the full-potential of NKTR-214 plus Obdivo (nivolumab) across numerous tumors, based on promising early data from ongoing Phase 1/2 PIVOT clinical study. Establishes a broad joint clinical development plan combining NKTR-214 with Opdivo and Opdivo plus Yervoy (ipilmumab) in registration-enabling trials in more than 20 indications across 9 …

The Week in Review #17 A Wild Wild Week - The stock market looked as if it rejected all analysts’ opinions about the stocks they believed were “undervalued” and adopted only their opinion on what they believed are overvalued. As a result, the market decided to dive,... &nbsp . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Prohost Letter #417 Private Lessons - These lessons are overdue and we had to do this homework before we go into further evaluations of our picks and introduction of new companies as we promised in the past issue. We believe that the Prohost readers, the fans and the critics should know how and why we pick our biotech stocks . . . This content is …

A Stanford research team investigating a new immunotherapy approach, which consists of injecting tiny amounts of two immuno-stimulating molecules directly into the cancers themselves, announced good news. The first of the two injections contained a CpG oligonucleotide a short stretch of DNA that promotes the expression of OX40, a protein that resides on the surface of the immune system’s T cells. The second injection comprised an antibody that binds …

We postponed the Prohost Letter we planned to post this past Monday until the market’s fits come to an end, which we believe they will. Indeed, the market unexpectedly acted as if it is suffering from petit mal without being diagnosed with epilepsy. The sudden market switch from rallying to tumbling is unexplainable considering that the usual criteria for a stock market suppression are nonexistent. We remembered, …