Category: News & Comments

Gilead Collaboration with Sangamo

Gilead Collaboration with Sangamo

Kite, a Gilead Company, and Sangamo Therapeutics Announce Collaboration to Develop Next-Generation Engineered Cell Therapies for Cancer Kite, a Gilead (GILD) company, and Sangamo Therapeutics (SGMO) announced a worldwide collaboration agreement for using Sangamo’s zinc finger nuclease (ZFN) technology platform for the development of next-generation ex vivo cell therapies in oncology. Kite will use Sangamo’s ZFN technology to modify genes to develop next-generation cell therapies for autologous and allogeneic use in treating …
Nektar Therapeutics: The Best Example of the “Sell Good News” Reckless Habit

Nektar Therapeutics: The Best Example of the “Sell Good News” Reckless Habit

Bristol-Myers Squibb (BMY) and Nektar Therapeutics (NKTR) Announce Global Development & Commercialization Collaboration for Nektar’s Product NKTR-214 The Collaboration is to evaluate the full-potential of NKTR-214 plus Obdivo (nivolumab) across numerous tumors, based on promising early data from ongoing Phase 1/2 PIVOT clinical study. Establishes a broad joint clinical development plan combining NKTR-214 with Opdivo and Opdivo plus Yervoy (ipilmumab) in registration-enabling trials in more than 20 indications across 9 …
The Undiagnosed Market Seizures

The Undiagnosed Market Seizures

We postponed the Prohost Letter we planned to post this past Monday until the market’s fits come to an end, which we believe they will. Indeed, the market unexpectedly acted as if it is suffering from petit mal without being diagnosed with epilepsy. The sudden market switch from rallying to tumbling is unexplainable considering that the usual criteria for a stock market suppression are nonexistent. We remembered, …
The FDA Grants Breakthrough Therapy Designation for Balovaptan – Roche’s Product for Autism Spectrum Disorder (ASD)

The FDA Grants Breakthrough Therapy Designation for Balovaptan – Roche’s Product for Autism Spectrum Disorder (ASD)

Yes, the title is real and correct and the condition is ASD. The US Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for Roche’s (RHHBY) drug balovaptan developed for ASD. Balovaptan has shown the potential to improve social interaction and communication in people with ASD. Balovaptan is an investigational small molecule drug that acts as a vasopressin (V1a) receptor antagonist. Evidence from both human and animal studies implicate …
Celgene Acquires Juno Therapeutics at $9 Billion or $87 a Share. Why Array is Trading Around $15 in Premarket Today.

Celgene Acquires Juno Therapeutics at $9 Billion or $87 a Share. Why Array is Trading Around $15 in Premarket Today.

Celgene (CELG) and Juno (JUNO) announced the signing of a definitive merger agreement upon which Celgene has agreed to acquire Juno. Celgene will pay $87 per share in cash, or a total of approximately $9 billion, net of cash and marketable securities acquired and Juno shares already owned by Celgene (approximately 9.7% of outstanding shares). The transaction was approved by the boards of directors of both companies. Juno …
Juno Therapeutics’ Stock Rally. Exelixis’ Successful Trial for Liver Cancer

Juno Therapeutics’ Stock Rally. Exelixis’ Successful Trial for Liver Cancer

Juno Therapeutics’ (JUNO) stock price orbited the moon after-hours trading yesterday, rising 45%, following a wall street journal report stating that Celgene (CELG) was in discussions to take over Juno and that the negotiations could result in a deal in the coming weeks. Juno was established to create cellular immuno-oncology products- chimeric antigen receptor T cell (CAR T) to treat cancer. Neither Juno nor Celgene would …
Exelixis Strategy: Expanding the Pipeline with Novel Products

Exelixis Strategy: Expanding the Pipeline with Novel Products

As part of its ongoing strategy to build an innovative pipeline beyond its two internally-discovered, commercially available compounds, cabozantinib and cobimetinib, Exelixis (EXEL) entered into an exclusive collaboration and license agreement with StemSynergy Therapeutics. The aim of the collaboration is discovering and developing novel cancer products. targeting Casein Kinase 1 alpha (CK1α), a component of the Wnt signaling pathway implicated in key cancer processes. Exelixis and StemSynergy intend to conduct preclinical …
More Exciting News for Sangamo

More Exciting News for Sangamo

Sangamo’s (SGMO) has abundant positive news since it offered proof of concept and feasibility of its zinc finger protein transcription factor (ZFP-TF)-mediated gene regulation approach and other approaches. The most recent announcement was made early today by Sangamo and Pfizer (PFE) about a new collaboration. The cooperation aimed at developing a potential therapy for amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD) linked to mutations of the C9ORF72 gene. The firms will …
Progenics: The FDA Accepted the NDA for Its Cancer Product Azedra® and Granted It Priority Review

Progenics: The FDA Accepted the NDA for Its Cancer Product Azedra® and Granted It Priority Review

Progenics Pharmaceuticals (PGNX) has good news today. The U.S. Food and Drug Administration (FDA) has accepted for review the firm’s New Drug Application (NDA) for its product Azedra® for recurrent and/or unresectable pheochromocytoma and paraganglioma — rare neuroendocrine tumors. The FDA has also granted Progenics’ request for Priority Review and has set an action date of April 30, 2018, under the Prescription Drug User Fee Act (PDUFA). The NDA is supported by data from a pivotal phase …
The FDA Grants Fast Track Status to DelMar Pharmaceuticals’ Product VAL-083

The FDA Grants Fast Track Status to DelMar Pharmaceuticals’ Product VAL-083

The FDA Grants Fast Track Status to DelMar Pharmaceuticals’ Product VAL-083 Dec.26, 2017 – DelMar Pharmaceuticals (DMPI) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s lead product candidate, VAL-083, in recurrent glioblastoma (rGBM). This Fast Track status applies to two ongoing clinical trials sponsored by DelMar Pharmaceuticals to evaluate VAL-083 as a potential treatment for rGBM.  These trials include: …
The FDA Approved Aerie Pharmaceuticals’ Glaucoma Eye Drops Rhopressa. What’s Next?

The FDA Approved Aerie Pharmaceuticals’ Glaucoma Eye Drops Rhopressa. What’s Next?

Two months ahead of the PDUFA date scheduled for February 28, 2018, the Food and Drug Administration (FDA) approved Aerie Pharmaceuticals’ (AERI) ophthalmic solution) 0.02% Rhopressa® (netarsudil for the lowering of elevated intraocular pressure (IOP) in open-angle glaucoma. Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie said that the firm will hire a sales force of 100 sales representatives early in the first quarter of …
Portola: The FDA Approves Bevyxxa

Portola: The FDA Approves Bevyxxa

After years of spending efforts in creating and developing its pipeline products, Portola (PTLA) has just been granted a U.S. Food and Drug Administration’s (FDA) approval of its Prior Approval Supplement (PAS) for the anticoagulant product Bevyxxa® (betrixaban). The product is approved ahead of its scheduled January 30th action date, which enables the release and distribution of its product inventory. Bevyxxa® is a factor Xa inhibitor approved on June 23, 2017 as a single-drug regimen for …
Cellectis: Offering Proof of Concept is What Led to the Stock Rally

Cellectis: Offering Proof of Concept is What Led to the Stock Rally

UCART19 UCART19 is one of the Cellectis’ (CLLS) lead allogeneic anti-CD19 CAR T-cell products. The word allogeneic is important as it makes the difference between Cellectis’ CAR T products and the two approved chimeric antigen receptor (CAR T) products and some of the investigational CAR T immuno-oncology products. Except for Cellectis’ and a few other  biotechs including  Celyad’s (CYAD)  products all other CAR T treatments are non-allogeneic (autologous) treatments. Being allogeneic, Cellectis’ products …
Practicing More Personalized Medicine

Practicing More Personalized Medicine

All the necessities, including future plans, are being taken care of by institutions, academia and biotech companies that are increasingly offering the medical community what they need to treat diseases based on their genetic mutations, if any. In recent news, a publicly-traded biotech firm called Foundation Medicine (FMI) has offered the medical community what could bring hope for change in the the treatment of diseases, …
The FDA New Guidelines to Speed the Approval of Gene Therapy. See Also: The Gene Editing Effect

The FDA New Guidelines to Speed the Approval of Gene Therapy. See Also: The Gene Editing Effect

Important news has come from the FDA, which issued new guidelines to speed the introduction of treatments with human cells and tissues, including gene therapy. Cracking down on rogue clinics offering dangerous or unproven versions of gene therapy or stem cell therapy is also included in the report. Scott Gottlieb, the commissioner of the FDA stated that regenerative medicine and other important gene therapy treatments …
Nektar Therapeutics: Speeding Its Flight Towards the Moon

Nektar Therapeutics: Speeding Its Flight Towards the Moon

Nektar Therapeutics (NKTR) stock rallied, reaching all-time high with positive results in every aspect of the firm’s fundamentals from reported finances, to reported products’ results, etc.,  Cash and investments in marketable securities at September 30, 2017, were $412.2 million as compared to $389.1 million at December 31, 2016. The cash includes the $150.0 million upfront payment by Eli Lilly & Company for the development and commercialization of NKTR-358. As Howard W. Robin, President and CEO of …
Must Read News. See Also: A New Immunotherapy Combination by Incyte and AstraZeneca

Must Read News. See Also: A New Immunotherapy Combination by Incyte and AstraZeneca

Amgen (AMGN) and Kirin Holdings (Kirin) announced an agreement upon, which Kirin-Amgen, a joint venture between the two companies, will redeem Kirin’s shares in the joint venture and as a result, Kirin-Amgen will become a wholly-owned subsidiary of Amgen. The Kirin-Amgen joint venture was established in 1984 as a 50-50 joint venture between Amgen and Kirin to fund the global development of Epogen® (epoetin alfa). The scope of …
Gilead’s CAR T Drug, Yescarta, is Approved for NHL Resisting Previous Treatments

Gilead’s CAR T Drug, Yescarta, is Approved for NHL Resisting Previous Treatments

As expected by those who welcome good news from publicly-traded firms, the Food and Drug Administration (FDA) has given the green light to a second CART immuno-oncology product with the trade name Yescarta.  This drug, which has been developed by Kite Pharma is now belonging to Gilead Sciences (GILD) together with the rest of Kite’s CAR T wealthy pipeline after Gilead acquired Kite less than …
Exelixis: A Day for Celebrating and Learning

Exelixis: A Day for Celebrating and Learning

Two game changing news has come together on October 16, 2017, both indicating that  Exelixis (EXEL) is on its way to reach its goal becoming the leader in the current oncology discovery and development field.  THE FIRST GOOD NEWS announced that the U.S. Food and Drug Administration (FDA) determined that Exelixis’ supplemental New Drug Application (sNDA) for the approval of Cabometyx® in patients with previously …