Theravance Biopharma (TBPH) and Mylan N.V. (MYL) announced positive results from a 12-month Phase 3 safety study of revefenacin (TD-4208). The drug is an investigational long-acting muscarinic antagonist (LAMA) - a proposed once-daily, NEBULIZED bronchodilator for chronic obstructive pulmonary disease (COPD). The study demonstrated that revefenacin was generally well-tolerated, and no new safety issues were identified. Rates of adverse events (AEs) and serious adverse events …

Yesterday, Wednesday July 19, Vertex’s (VRTX) stock added over 20% to its value, recording a new all time high. Why? On Tuesday the firm announced a better than technical analysts’ and its own expectations’ results in three trials testing its cystic fibrosis (CF) drugs VX-152, VX-440 and VX-659 combined with two the its cystic fibrosis drugs. The positive data came from Phase 1 and Phase …

IMPROVING ON CAR IMMUNOTHERAPY APPROACH  When we stated that chimeric antigen receptor CAR immunotherapy process was created to remain and improve, we aimed at demonstrating our conviction that the CAR approach will eventually be improved and become the gold standard for the treatment of many cancers. We observed that many research and medical institutions are using all advanced information, state-of-the-art techniques and technologies in order …

A BIG YES for Novartis CAR-T product has come from the  Food and Drug Administration (FDA) advisory committee. The committee recommended FDA approval for Novartis product CTL019 for pediatric acute lymphoblastic leukemia. The Vote: The panel voted 10-0 in favor of approval. Chimeric antigen receptor T-cell therapy, (CAR-T- Cell therapy) is an immunotherapy that enables the immune system T cells to seek, reach and attack cancer …

Arena (ARNA) announced positive Phase 2 clinical trial results for its drug ralinepag1 for pulmonary arterial hypertension (PAH). In the 61-patient study, the primary efficacy analysis demonstrated a statistically significant absolute change from baseline in pulmonary vascular resistance (PVR) compared to placebo. Ralinepag also demonstrated numerical improvement in 6-minute walk distance (6MWD). Additionally, adverse events observed in the study were consistent with other prostacyclin treatments for …

FROM ARRAY Array’s Drug Binimetinib in Combination Therapy with Merck’s Drug Keytruda for METASTATIC FOR COLORECTAL CANCER   On May 8, 2017, Array BioPharma and Merck announced entering into a clinical trial collaboration to investigate the safety and efficacy of Array's MEK inhibitor, binimetinib, with Merck's anti-PD-1 therapy, Keytruda® (pembrolizumab), in metastatic colorectal cancer patients with microsatellite stable tumors (MSS CRC). The decision on this …

As we wrote yesterday, immunotherapy checkpoint inhibitors represent a great advancement and big changes in the management of cancer. It is pertinent, though, to keep in mind that these immuno-oncology products will not be successful with all cancers. Immune checkpoint inhibitors Keytruda (Merck) and Obdivo, Bristol-Myers Squibb and others are already approved around the world for several cancers. We also know that these immunotherapy products …

Merck’s (MRK) anti-PD-1 drug Keytruda® (pembrolizumab) is approved for many, many cancers. Yet, it is fair to say that this checkpoint inhibitor drug will not be effective in all cancers. This is especially true now that yesterday, the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of Keytruda® with Celgene’s products Pomalyst Pomalidomide and …

Additional Combination Treatment with Vectibix  for Metastatic Colorectal Cancer (mCRC) The Old Drug: VECTIBIX                   The Company: AMGEN Colon cancer is easy to cure when discovered early. Missing the diagnosis of early colon cancer could result in cancer growth, direct spread, distal metastasis and death. In spite of the tremendous improvement of treatments, advanced colon cancer is still …

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 …