On June 22, 2017, the U.S. Food and Drug Administration (FDA) has approved Genentech’s Rituxan Hycela™. This product is a combination of Genentech’s drug rituximab and Halozyme's hyaluronidase enzyme through Halozymes’s proprietary human ENHANZE® technology. The aim of the combination is changing Rituxan from an intravenously administered product into a subcutaneous (under the skin) injection. The new version Rituxan Hycela is expected to reduce the …

The most important last barrier to cross or dismantle for drug developers is the approval of novel products that amplify the improvement of previous drugs. The approvals of drugs in the U.S. and Europe open the door for the same drugs to be approved and marketed in the rest of the world. For the revenue-generating firms, each and every approval helps grow their revenues. With …

IMPRESSIVE RESULTS?  Bellicum Pharmaceuticals’ (BLCM) drug BPX-501 is described as a safe and effective product that can offer children with cancer and other serious diseases the opportunity to beat their intractable sicknesses. The drug enables the patients who are in desperate need for a bone marrow stem cell transplant to use unmatched donors’ stem cells through lowering their adverse effects. The most recent clinical trial …

Portola (PTLA) announced that the U.S. Food and Drug Administration (FDA) has approved Bevyxxa (betrixaban), the first anticoagulant for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. Bevyxxa’s approval is on …

We examined many explanations about the rallying in the biotech stocks, including the reports stating that the President’s threatening of a crackdown on pricing may have been misinterpreted. A more convincing possibility was the feeling that the newly appointed FDA commissioner, Scott Gottlieb, might have managed to show that he came to bring about a change in the way the FDA tasks have been conducted …

Prohost Letter #411 SOME STOCK RALLYING NEWS - Under normal conditions, some good news should rally the stocks of the firms that the news belong to them. During the past six months, Amgen (AMGN) announced a series of good news that seem to have fallen on deaf ears. Yesterday Amgen announced some positive results from three approved and one experimental products – all the news …

Since Regulus’ (RGLS) lead candidate drug RG101 for HCV was put on clinical hold by the FDA in 2016, the stock has enormously suffered and with it the firm’s value. Finally, we are experiencing a tremendous change as we started hearing from the firm, not about its pipeline products’ clinical updates this time, but about the firm’s made decisions about changes. On June 12, 2017, …

Prohost Letter #410 JUNE PDUFA DAYS This month, the FDA will decide on the approvals of drugs belonging to companies that Prohost has picked for investment. Usually, granting approvals rallies the stocks of the drugs’ developing firms. Sending Complete Response Letters for demands that might delay approvals would cut a substantial percentage of the stocks’ values, while rejections would cause the stocks to falter. Let’s …

Juno’s (JUNO) JCAR017 and JCAR014 are chimeric antigen receptor T cell (CAR-T) product candidates that target CD19, a protein expressed on the surface of almost all B cell malignancies. These malignancies include non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL). The clinical trial results of Juno’s CAR-T product JCAR017 in relapsed and refractory (r/r) aggressive B cell non-Hodgkin lymphoma (NHL) are …

AT ASCO CAR-T Was Created to Stay BlueBird Bio CAR-T Results Bluebird Bio (BLUE) presentation was well received at ASCO after the firm stated results demonstrating that all the 15 evaluable patients in the clinical trial of its chimeric antigen receptor T cell (CAR-T) drug “bb2121 responded to treatment. Data were convincing demonstrating 89% of the patients observed their tumors shrink with 27% seeing their …

As we wrote in Prohost Letter #409, a transformation in this year’s American Society of Clinical Oncology meeting (ASCO) is further elaborating on Checkpoint inhibition and chimeric antigen receptor T-cell (CAR-T) approaches’ limitations. Both are attempts towards making Immunotherapy for cancer a successful treatment. Checkpoint inhibitors have reached the market at the hands of Merck, Bristo-Myers Squibb and Roche, with other firms coming forward with products …

Alnylam Pharmaceutical (ALNY) calls RNAi (RNA interference) a revolution in biology. The FDA’s just granted the firm’s RNAi therapy breakthrough for a disease nobody has ever dreamed of conquering confirms this reality in spite of spending years of efforts and money towards turning the RNAi molecules into therapeutic molecules that can be used safely and effectively. RNAi-related treatments represent a completely new approach to drug …

It is obvious that the CAR-T approach to cancer treatment is here to stay and to change the way cancer has been managed for decades. Attempts to improve the novel elegant procedure safety profile and efficacy on solid cancers are being pursued by academia as well as by biotechnology and pharmaceutical companies. Kite Pharma’s (KITE) CAR-T therapy axicabtagene ciloleucel is an investigational therapy in which …

Array Biopharma (ARRY) and Bristol-Myers Squibb (BMY) announced a clinical research collaboration to investigate the safety, tolerability and efficacy of Array’s investigational MEK inhibitor, binimetinib in combination with BMY’s checkpoint inhibitor immunotherapy drug Opdivo (nivolumab) and Opdivo Plus Yervoy (ipilimumab). The combinations are for the  potential treatment for metastatic colorectal cancer in patients with microsatellite stable tumors. According to Ron Squarer, CEO Array BioPharma the …

Prohost Letter #409 ASCO The American Society of Clinical Oncology (ASCO) meeting is around the corner. The Meeting, which will begin on Friday June 2, 2017 and will end on Monday 5, 2017 will be different than the past years for many reasons, including the following: -­ Checkpoint inhibition as Immunotherapy for cancer treatment moved from wishful thinking a decade ago, to promising cancer treatments …

GlycoMimetics (GLYN) is a development-stage biotechnology company focused on cancer and sickle cell disease. The firm’s most advanced drug, rivipansel, a pan-selectin antagonist, is being developed for vaso-occlusive crisis in sickle cell disease. The product is in a Phase 3 clinical trial being conducted by GlycoMimetics’ strategic collaborator, Pfizer. But the recent news is about GlycoMimetics’ wholly-owned drug candidate, GMI-1271, an E-selectin antagonist, is being evaluated …

Amgen’s (AMGN) and UCB's drug Evenity (romosozumab), which, in long and large 24 months of clinical investigation has demonstrated superior results in reducing new vertebral, non vertebral and clinical bone fractures, has demonstrated a heart-related side effects. At the weekend Amgen announced results from Phase 3 trials demonstrating that its product Evenity (romosozumab) met the primary and secondary endpoints of the trials, which relate to  reducing the …

As a matter of fact, we consider Incyte’s (INCY) drug epacadostat’s good results extremely important. The reason? Two facts are currently settled in researchers’ and oncologists’ minds. These are: 1. Checkpoint inhibitors require effective combination therapy to boost their limited efficacy, or at least to improve their efficacy, especially in solid tumors. 2. IDO inhibition is recognized as central for immunotherapy success. Both facts have been proven …

PTC THERAPEUTICS Why Buying Emflaza? Buying Emflaza, a steroid approved by the FDA for Duchenne muscular dystrophy (DMD) from Marathon Pharmaceuticals invited an intractable headache to PTC Pharmaceuticals’ shareholders and scrutiny by some law makers. The cause of the law makers’ involvement has been the Marathon’s pricing Emflaza at $89,000, but PTCT shareholders had several question marks revolving around the motive for buying this drug …

AKEBIA THERAPEUTICS? Akebia Therapeutics (AKBA) whose stock trades on the NASDAQ is outperforming. The firm’s drug vadadustat — an oral hypoxia-inducible factor (HIF) stabilizer in Phase 3 trial for anemia associated with chronic kidney disease (CKD) is attracting attention, which led to a lucrative agreement. The enthusiasm towards this firm’s product vadadustat stems from the fact that it is an orally administered drug, which makes …