Another Durable Botulinum Toxin with Many Advantages REVANCE THERAPEUTICS As per its self- described profile, Revance Therapeutics (RVNC) manufactures and develops novel botulinum toxin products for multiple aesthetic and therapeutic indications. The company is leveraging its proprietary portfolio of botulinum toxin compounds combined with its patented TransMTS® peptide delivery system to address unmet needs in the growing markets. Revance’s proprietary TransMTS technology seems to enable …

POSITIVE TOP-LINE RESULTS FROM A PHASE 2 TRIAL OF OMECAMTIV MECARBIL IN PATIENTS WITH CHRONIC HEART FAILURE Data Showed Statistically Significant Improvements in Several Pre-Specified Measures of Cardiac Function Amgen (AMGN) and Cytokinetics (CYTK): Data from the expansion phase of COSMIC-HF – a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, showed statistically significant improvements in several measures of cardiac function, including systolic …

The FDA issued a warning that hepatitis C treatment Viekira Pak and Technivie can cause serious side effects and serious liver injury, mostly in patients with underlying advanced liver disease. The drugs in question belong to AbbVie (ABBV) with some of their  ingredients made by Enanta (ENTA), both were subjected to selloffs after the news, in addition to Express Script (ESRX) Holding, which  operates as a …

– Exelixis submitted rolling NDA for cabozantinib. – Exelixis plans to complete the submission in the next two months. – Positive Results from the METEOR trial with cabozantinib on advanced renal Cell carcinoma led the FDA to grant the drug breakthrough designation. Based on good results from a Phase 3 from the METEOR pivotal trial, Exelixis (EXEL) initiated submission of its rolling New Drug Application (NDA) to …

About Duchenne muscular Dystrophy treatments, bloggers tried to explain the reasons that led the FDA to decide upon reviewing BioMarin’s (BMRN) Duchenne muscular dystrophy (DMD) drug Drisapersen a few weeks earlier than reviewing Sarepta (SRPT) DMD drug Eteplirsen. The real reasons for the FDA decision remain inside the FDA mind. No outsider will be allowed to know anything related to NDA reviews. All the talk and …

Incyte (INCY) and Merck (MRK) announced the expansion of their ongoing clinical collaboration to include a Phase 3 study evaluating the combination of epacadostat,Incyte’s investigational selective IDO1 inhibitor, with Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy. The trial is for the use of the combination as first-line treatment for advanced or metastatic melanoma. The Phase 3 study, which is expected to begin in the first half of 2016, …

Stories from Yesterday’s Market We are not claiming that the market volatility has subsided and the leadership has shown and is in full control of the chaos. But yesterday biotech stock performance made us feel that investors are regaining their common sense and trying to benefit from the catastrophic plummeting of the member firms stock prices. Today’s trading seems negative for the biotech stocks, but …

– Exclusively licenses global rights to its (TGFb) antibody program to Novartis  – Could the lucrative agreement spare Xoma the pain of raising money for developing its programs, or filing bankruptcy?  – Reasons to believe that Xoma’s TGFb therapeutic antibodies might become another cancer immunotherapy used alone or in combination with immune checkpoint protein inhibitors such as PD-1 inhibitors, which are considered game changers in …

Exelixis (EXEL) announced positive results from the METEOR Phase 3 Pivotal Trial of Cabozantinib in advanced renal cell carcinoma, which was presented at the European Cancer Congress 2015. In the study, Cabozantinib met the primary endpoint of improving progression-free survival as compared to Evorulimus. The drug, which has already been approved and marketed for thyroid cancer has also demonstrated a strong trend towards improving overall …

Aerie Pharmaceuticals (AERI), which is specialized in glaucoma treatments reported successful results of its second Phase 3 trial for Rhopressa™ — a novel once-daily, triple-action eye drops for glaucoma. The trial achieved its primary efficacy endpoint demonstrating non-inferiority of Rhopressa™ compared to timolol, the most widely used comparator. Management will host a conference call and provide accompanying slides to discuss these results at 5:00 p.m. …

The biotechnology industry is proving to be the most innovative and the most growing among Wall Street industries. Individual biotech companies’ achievements complement each other. Some are evolving the sequencing of genes and genetic analysis, while others are excelling in designing drugs based on the tremendous amount of facts they are getting on root causes of the diseases and the interaction of proteins. The biotech …

– The second approval of a cancer drug for Exelixis – The approval of Exelixis/Roche drugs combination will save lives. – The melanoma the combination drugs treat is a killer with bad prognosis  – The terms of Exelixis/Roche agreement are favorable Reiterating our enthusiastic feeling about the future of Exelixis (EXEL), our feeling has transformed into reality and here we are, Swissmedic, the Swiss licensing …

but first: Here is some good news from  SAREPTA Yesterday we wrote about BioMarin (BMRN) being granted FDA “Rare Pediatric Disease Designation for its Duchenne potential muscular dystrophy (DMD) drug drisapersen.Today, Sarepta Therapeutics (SRPT) also a developer of RNA-targeted therapeutics has been granted the same for its drug eteplirsen, also a potential treatment for DMD patients who are amenable to skipping exon 51. The Rare …

Kite Pharma (Kite) stock was sliding, raising concern about the firm and all the biotech firms that are designing and developing CAR T Cell immunotherapy treatments for cancer. Many investors are wondering about the plummeting of the stock and obviously others have learned about one death that occurred during clinical trial, which caused Kite selloff. Finally, Kite provided an update from its ongoing Phase 1/2 clinical …

INOVIO Inovio Pharmaceuticals (INO) is much worth looking at now than 6 months ago. The deal signed between MedImmune, AstraZeneca’s development arm, and Inovio Pharmaceuticals says something. The DEAL MedImmune acquired exclusive rights to Inovio’s INO-3112 immunotherapy against cancers caused by human papillomavirus (HPV) types 16 and 18, which account for more than 70 percent of cervical pre-cancers and cancers. INO-3112 is in Phase 1/2 clinical …

In The NEWS IMMUNOTHERAPY MIRATI THERAPEUTICS Mirati Therapeutics (MRTX) is an oncology company focusing on genetic and epigenetic drivers of cancer. The firm’s clinical stage product candidates include MGCD265, a multi-targeted kinase inhibitor that is in Phase 1b clinical development trials for the treatment of solid tumors, including lung, head and neck, and gastric cancers; MGCD516, a kinase inhibitor, which is in Phase 1 clinical …

The moment the new IPO NantKwest (NK) landed in the town of publicly traded firms, some called it the “New Golden Boy”. During the IPO, investors who knew about this firm and were waiting for that day seemed confident that the stock would surge. As a matter of fact, the stock did surge. On July 27, NantKwest, Inc. (formerly Conkwest, Inc.), Issued a press release …

Why the financing through a secondary public offering was a must for Exelixis. The outcome of the public offering is putting in Exelixis’ (EXEL) coffers around $128 million, which we know the firm will definitely need for the development of its programs, but more important, is for the firm to be able to meet its obligations in case the FDA approves its drug cobimetinib combination with …

The European Commission Approves Amgen’s New Cholesterol-Lowering Medication Repatha™ (evolocumab). The First PCSK9 Inhibitor to Be Approved in the World for Treatment of High Cholesterol. A Critical Milestone for Patients with Uncontrolled Cholesterol Who Require Additional Intensive LDL-C Reduction. Amgen (AMGN): The European Commission (EC) has granted marketing authorization for Repatha™ (evolocumab), the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in …

An Effective Non-Steroid Atopic Dermatitis Ointment Anacor Pharmaceuticals (ANAC) Announces Positive Top-Line Results From Two Phase 3 Pivotal Studies of Crisaborole Topical Ointment, 2% in Patients With Mild-to-Moderate Atopic Dermatitis Crisaborole is a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. In both Phase 3 studies, crisaborole achieved statistically significant results on …