Category: News & Comments

Let’s Go Shopping

Let’s Go Shopping

In today’s news, Incyte’s (INCY) immuno-oncology IDO1 inhibitor product Epacadostat in combination with Merck’s immuno-oncology product Keytruda® did not meet the endpoints of the trial in patients with unresectable or metastatic melanoma. The stock was subjected to a selloff – a market’s reaction pattern that occurs whenever negative news comes out of experimentation without consideration of the extent of their impact. A serious question to ask now would …
An Erroneous Interpretation of an Outstanding Achievement in CRISPR Gene Editing

An Erroneous Interpretation of an Outstanding Achievement in CRISPR Gene Editing

A False Reason for Unwarranted Selling of CRISPR/Cas9 Gene Editing Shares     CRISPRs are bacterial immune systems that contain many defense enzymes such as the Cas9 “molecular scissors,” which scientists have engineered as a powerful DNA-targeting gene-editing tool and created companies specialized in CRISPR gene editing tools. The outstanding revolutionary news, which is wrongly interpreted by Wall Street, which led to a recent selling of the shares of CRISPR gene …
Regeneron Discovers the Therapeutic Target for Non-Viral Chronic Liver Diseases. Alnylam is Assigned to Discover and Create the Targeted RNAi Therapeutic

Regeneron Discovers the Therapeutic Target for Non-Viral Chronic Liver Diseases. Alnylam is Assigned to Discover and Create the Targeted RNAi Therapeutic

Regeneron (REGN) and Alnylam (ALNY) announced a collaborative agreement aimed at identifying RNAi therapeutics for the chronic liver disease nonalcoholic steatohepatitis (NASH) and potentially other related diseases. The agreement is not the first between the two firms, but it would not have occurred if not for Regeneron’s identification of an important and unique therapeutic target that influences the liver debilitating and life-threatening nonviral hepatitis diseases, which affect thousands …
Arena Pharmaceuticals: Positive Results on Ulcerative Colitis

Arena Pharmaceuticals: Positive Results on Ulcerative Colitis

Arena Pharmaceuticals (ARNA) announced positive Phase 2 results from the OASIS trial for etrasimod in ulcerative colitis (UC). The Drug: Etrasimod is a selective sphingosine 1-phosphate (S1P) receptor modulator. Patients receiving the 2 mg dose of the drug achieved statistically significant improvements versus placebo in the primary, all secondary, and clinical remission endpoints. Relative to placebo: there was a statistically significant improvement in a 3-component (stool frequency, rectal bleeding, and findings on endoscopy) Mayo Clinic …
Exelixis: Further Stretching Its Cabozantinib’s Market

Exelixis: Further Stretching Its Cabozantinib’s Market

Exelixis (EXEL) completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Cabometyx® (cabozantinib) tablets for previously treated patients with advanced hepatocellular carcinoma (HCC). The sNDA submission is based on results from the CELESTIAL randomized pivotal phase 3 trial of Cabometyx in patients with advanced HCC who received prior sorafenib. Some History: On October 16, 2017, Exelixis announced that the independent data …
Trogarzo’s FDA Approval Made Possible Managing Multidrug Resistant HIV 1 Infection

Trogarzo’s FDA Approval Made Possible Managing Multidrug Resistant HIV 1 Infection

Extremely important news has come from Montreal, Canada carrying the announcement by Theratechnologies (TSX:TH) and its partner TaiMed Biologics (TaiMed) that the FDA has granted approval of Trogarzo™ (ibalizumab- uiyk) Injection. The approval is for Trogarzo to be used with other ARTs for HIV-1 infection in heavily treated adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. Trogarzo™ is a humanized monoclonal antibody created for multidrug resistant …
Thanks to Aimmune, You Might Be Able to Eat Peanut Butter by Next Year

Thanks to Aimmune, You Might Be Able to Eat Peanut Butter by Next Year

On March 4, 2018, Aimmune Therapeutics (AIMT) – a biopharmaceutical company developing treatments for potentially life-threatening food allergies confirmed the superior news that brings hope to children and adults who are susceptible to peanut allergic reactions. The results from the firm’s pivotal Phase 3 PALISADE trial of its product AR101 for the treatment of peanut allergy were presented at the 2018 American Academy of Allergy, Asthma & Immunology–World Allergy Organization Joint Congress …
The FDA Approves AstraZeneca Checkpoint Inhibitor Imfinzi® for a Lung Cancer. A Probable Partnership Agreement Between Arbutus and Roivant

The FDA Approves AstraZeneca Checkpoint Inhibitor Imfinzi® for a Lung Cancer. A Probable Partnership Agreement Between Arbutus and Roivant

The Food and Drug Administration (FDA) approved AstraZeneca (AZN) Checkpoint inhibitor drug Imfinzi® (durvalumab) for patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT). Explaining the importance of this approval, Scott J. Antonia, M.D., Ph.D., Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida and investigator …
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 …