Category: Today’s Highlights

Will NewLink Genetics’ IDO Inhibitor Improve the Efficacy of AstraZeneca’s Checkpoint Inhibitor in Treating Pancreatic Cancer?

Will NewLink Genetics’ IDO Inhibitor Improve the Efficacy of AstraZeneca’s Checkpoint Inhibitor in Treating Pancreatic Cancer?

AstraZeneca’s (AZN) checkpoint PD-L1 inhibitor Imfinzi and NewLink Genetics’ (NLNK) IDO inhibitor indoximod will be combined and tested in Phase 2 randomized, placebo-controlled clinical trials together with the standard of care chemotherapy treatment for metastatic pancreatic cancer. AstraZeneca and NewLink Genetics will jointly fund the phase 2 trial of the combination that  NewLink will be sponsoring  It is a Phase 2  trial that will be …
Exelixis is Still a Favorite

Exelixis is Still a Favorite

EXELIXIS Being called overvalued by one analyst does not mean that Exelixis (EXEL) is, indeed, overvalued. We believe it is not and that’s why we decided to accumulate the stock on any weaknesses in EXEL. We do not intend to sell this stock at this time for what we believe are the wrong reasons. Some bloggers tried to interpret the reasons that led to the …
Two Large Pharma Agreements with Halozyme in One Day. HALO Rallied

Two Large Pharma Agreements with Halozyme in One Day. HALO Rallied

Following the announcement of two new licensing agreements for its ENHANZE® drug-delivery technology, Halozyme Therapeutics (HALO) raised financial guidance for 2017 as follows: - Net revenue of $245 million to $260 million, an increase of $130 million from the prior range of $115 million to $130 million, reflecting the portion of upfront payments from the new agreements expected to be recorded as revenue in 2017; - Operating expenses of $240 million …
Kura Oncology (KURA): Battling Resistant Head & Neck Cancers

Kura Oncology (KURA): Battling Resistant Head & Neck Cancers

Positive Phase 2 Results for Tipifarnib in HRAS Mutant Head and Neck Cancer Four of the first six HRAS Mutant HNSCC Patients enrolled on study achieve confirmed RECIST Partial Responses and Durable Responses Greater than One Year   On September 7, 2017, i.e., five days ago, Kura Oncology (KURA) announced positive results from a Phase 2 trial from its lead product candidate, tipifarnib, in patients with …
Why Marinus Pharmaceuticals’ Stock Rallied Today

Why Marinus Pharmaceuticals’ Stock Rallied Today

Marinus Pharmaceuticals’ (MRNS) stock rallied following its announcement of top-line data from Phase 2 open-label study in patients with the severe epilepsy disorder known as CDKL5. The disease is a rare  severe genetic derived epilepsy that results in seizures, pervasive neuro-developmental delay and disabling behavioral issues. The disease has no approved treatments. The good news that boosted the stock price early today has come out …
Circumventing Cellectis’ UCART123 Severe Adverse Effects

Circumventing Cellectis’ UCART123 Severe Adverse Effects

In the news, the FDA has placed a clinical hold on two phase 1 trials of Cellectis’ (CLLS) off- the-shelf product UCART123 after the death of a 78-year old patient. Cellectis is working with the FDA towards finding ways that help mitigate the risks expected to have caused the fatality. We experienced deaths with other CAR T products with the cytokine release syndrome on the …
Why Our Increased Enthusiasm for Incyte’s Product Baricitinib

Why Our Increased Enthusiasm for Incyte’s Product Baricitinib

Eli Lilly and Company (LLY) and Incyte (INCY) announced that, after discussions with the U.S. Food and Drug Administration (FDA) in late August, Lilly will resubmit the New Drug Application (NDA) for baricitinib before the end of January 2018. That was fast, we mean the re-submission. To remind you, the firms had submitted Baricitinib for review seeking marketing approval for rheumatoid arthritis in the U.S., the …
About Innoviva Inhalers

About Innoviva Inhalers

Earlier this month, on Aug. 24, 2017, Propeller Health announced the expansion of its 2015 collaboration with GlaxoSmithKline (GSK), enabling both companies to prepare for and undertake commercial activities using the Propeller clip-on sensor and software platform for use with  ELLIPTA Inhaler. The inhaler, which is marketed by GSK, is produced by Innoviva (INVA) and approved by the FDA in other countries around the world. …
CRISPR Therapeutics’ Worthwhile Deal

CRISPR Therapeutics’ Worthwhile Deal

CRISPR Therapeutics (CRSP) and Massachusetts General Hospital Cancer Center (MGHCC) have entered into a two-year research collaboration and license option agreement to develop Novel T cell therapies for cancer. As part of the collaboration, CRISPR/Cas9 gene editing technology will be utilized to improve upon current T cell therapies in development addressing unmet needs in both hematologic and solid tumors.  This improvement is expected to occur by combining the …
Why Sangamo Rallied

Why Sangamo Rallied

About Our New Section On Sunday, August 20, 2017 we will post our first “The Week in Review” article. This current week has carried bad news, political hypocrisy and a catastrophic terrorist attack on the people of Spain. The week started following war threatening words between the U.S. and North Korea; between the politicians around the world and in the U.S.; and between everybody and …
Stocks’ Declines That Offer Real Opportunities for Accumulation at Bargain Prices

Stocks’ Declines That Offer Real Opportunities for Accumulation at Bargain Prices

AFTER MANY OF THE PROHOST PICKED STOCKS NEARED REACHING THE PROHOST NEAR-TERM TARGETS, recently, external circumstances and exaggerated delaying news, some of our rallied stocks gave back some of their gains. Two reasons were behind the decline in some precious picked stocks, which occurred one after the other in a very short period of time. The first reason for the declines came through traders’ practice …
Reasons for Vertex’s & Illumina’s Outperformance

Reasons for Vertex’s & Illumina’s Outperformance

Synopsis Most of the Prohost picked stocks gained momentum and closed higher at the end of the week. Some rallied because that’s what they were supposed to do after the quarterly financial when most biotech stocks are subjected to selloffs, including those that have clearly outperformed in real life. The most outperforming of our picked stocks in July and continue to outperform are Illumina (ILMN) …
Amgen Outperformed and Will Continue to Outperform

Amgen Outperformed and Will Continue to Outperform

Amgen’s (AMGN) stock outperformed in the past 6 months for significant reasons and these reasons are still there as we observed listening to the firm’s quarterly results. The firm’s results surpassed analysts’ expectations. The stock outperformed because the firm outperformed, never letting its accomplishments emanate from the past successes, but through updating its technologies and products to where the scientific knowledge has reached. That’s the …
Theravance Biopharma Has Good News for COPD Patients

Theravance Biopharma Has Good News for COPD Patients

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 …
Vertex: A Cystic Fibrosis Institution with a Bright Future

Vertex: A Cystic Fibrosis Institution with a Bright Future

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 …
Arena’s Successful Pulmonary Arterial Hypertension Drug. Novartis CAR-T Product Review for Approval Tomorrow

Arena’s Successful Pulmonary Arterial Hypertension Drug. Novartis CAR-T Product Review for Approval Tomorrow

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 …
Targeted Drugs That Would Improve on Immunotherapy Treatments’ Outcomes. See Array and Exelixis

Targeted Drugs That Would Improve on Immunotherapy Treatments’ Outcomes. See Array and Exelixis

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 …
Celgene and Immunotherapy: An Unfolding Story

Celgene and Immunotherapy: An Unfolding Story

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 …
About Old Drugs and New Drugs, Large Companies and Small Companies

About Old Drugs and New Drugs, Large Companies and Small Companies

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 …
Halozyme’s Approved Drug, Promising News and Ongoing Pancreatic Cancer Trials

Halozyme’s Approved Drug, Promising News and Ongoing Pancreatic Cancer Trials

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 …