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 …

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 …

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 …

MOTIF BIO Antibiotic Motif Bio’s (MTFB) antibiotic drug Iclaprim met the Phase 3 Revive-2 trial’s primary endpoints of non-inferiority against the current standard of care antibiotic, vancomycin in acute bacterial skin and skin structure infections (ABSSSI). The drug demonstrated a 78% clinical skin infection cure. According to Motif Bio, Iclaprim was nearly identical compared to vancomycin. The firm observed, though, that within 48 to 72 hours, a …

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 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 …

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 …

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 …

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 …

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 …

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 …

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 (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 …

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 …

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 …

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’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 (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 …