Category: News & Comments

Why Celyad’s stock gained $2.30 today

Why Celyad’s stock gained $2.30 today

Celyad (CYAD) is an immuno-oncology firm, which created CAR T CELL treatments for cancers, including  solid tumors. Celyad announced its consolidated financial results for the six-month period ending 30 June 2018. Celyad’s report is endorsed by Europe. Dr. Christian Homsy, Celyad’s CEO started by expressing the firm’s great enthusiasm towards the progress it has made in the first half of 2018, which include a significant advancement of …
Aerie’s successful new confirmatory study for Rhopressa® was a necessity

Aerie’s successful new confirmatory study for Rhopressa® was a necessity

Aerie Pharmaceuticals (AERI) announced results from a double-masked, randomized, placebo-controlled study designed to evaluate the effect of its glaucoma product Rhopressa® (netarsudil ophthalmic solution) 0.02% on aqueous humor dynamics in patients with open-angle glaucoma or ocular hypertension. This study is the first performed on glaucoma patients to confirm that Rhopressa® lowers intraocular pressure (IOP) primarily through trabecular meshwork outflow facility.  In the trials, the enrolled patients …
Regeneron’s and Bluebird Bio’s collaboration is meant to create advanced immune cell therapy

Regeneron’s and Bluebird Bio’s collaboration is meant to create advanced immune cell therapy

Regeneron Pharmaceuticals (REGN) and bluebird bio, Inc. (BLUE) announced a collaboration to apply their respective technology platforms to the discovery, development, and commercialization of novel immune cell therapies for cancer. The collaborators will specifically leverage Regeneron’s VelociSuite® platform technologies for the discovery of human antibodies as well as T cell receptors (TCRs) directed against tumor-specific proteins and peptides, and bluebird bio will contribute its field-leading expertise in gene transfer and …
A new European approval for Bristol-Myers’ immunotherapy opdivo. The future is starting now

A new European approval for Bristol-Myers’ immunotherapy opdivo. The future is starting now

The Future is Starting Now Recognizing that the future has already started now is important as it makes analysts use different criteria for the fair evaluation of the future growth of biotechnology startups and revenue-generating companies. This is our main topic the Prohost Letter that we are working diligently working on posting at any time now. This is extremely important to know before the hype …
The EU CHMP Recommends Approving Alnylam’s RNAi Therapeutic, ONPATTRO™

The EU CHMP Recommends Approving Alnylam’s RNAi Therapeutic, ONPATTRO™

The Committee for Medicinal Products for Human Use (CHMP) announced a Positive Opinion recommending marketing authorization of Alnylam’s (ALNY) RNAi product Onpattro™ (patisiran). The product is designed to treat hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy. The CHMP opinion is based on conclusive positive results from APOLLO Phase 3 study on patients with hATTR amyloidosis. The results were published in The New England Journal …
Novartis Pleased the Market with Its Q2 Financial Results and Pleased Us with Its Great Scientific Achievements. See Also: The Role AveXis and RegenxBio are Playing Towards the Future Success of Novartis

Novartis Pleased the Market with Its Q2 Financial Results and Pleased Us with Its Great Scientific Achievements. See Also: The Role AveXis and RegenxBio are Playing Towards the Future Success of Novartis

Novartis’ (NVS) financials results exceeded analysts’ expectations. The firm’s research institutions’ strategy, well-designed structure, plans for innovation and accurate execution led to a wealthy and competitive pipeline with more than 200 projects in clinical development. Novartis is flying into the future finding its way to more effective treatments and possible cures. As a matter of fact, Novartis is at the end of the road towards …
The FDA Clears Compugen’s and Bayer’s IND Application for Their Checkpoint Inhibitor Immunotherapy Product

The FDA Clears Compugen’s and Bayer’s IND Application for Their Checkpoint Inhibitor Immunotherapy Product

Finally, we are hearing what we were constantly expecting to hear coming out of Compugen’s (CGEN) technological capability. Yesterday, the U.S. Food and Drug Administration (FDA) has cleared Bayer AG’s investigational new drug (IND) application for BAY 1905254, a first-in-class immuno- oncology therapeutic antibody targeting ILDR2. The target ILDR2 is a novel immune checkpoint protein discovered by Compugen through its predictive computational capabilities, which enable …
The FDA approved a combination of two products. Both belong to Array Biopharma

The FDA approved a combination of two products. Both belong to Array Biopharma

The FDA approved Array BioPharma’s (ARRY) products Braftovi™ capsules in combination with Mektovi® tablets for unresectable or metastatic skin cancer melanoma with a BRAF or BRAFV mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for the treatment of patients with wild-type BRAF melanoma. The products, which represent a new standard of care for BRAF-mutant melanoma are now available to order through select specialty pharmacies in the U.S. market.  The …
Sarepta announced successful results from a preliminary trial for Duchenne Muscular Dystrophy

Sarepta announced successful results from a preliminary trial for Duchenne Muscular Dystrophy

Sarepta Therapeutics (SRPT) has news from preliminary Duchenne muscular dystrophy trials. Although the number of recruited patients was only three, the strong positive data excited the media and Wall Street investors who rushed to buy the stock, making it add over $50 in today’s morning trading. The Story At the Company’s R&D Day, Jerry Mendell, M.D. of Nationwide Children’s Hospital presented positive preliminary results from Phase 1/2a …
The FDA Approves Keytruda for primary Mediastinal Large B-Cell Lymphoma (PMBCL)

The FDA Approves Keytruda for primary Mediastinal Large B-Cell Lymphoma (PMBCL)

– Keytruda becomes the first anti-PD-1 therapy to be approved for PMBCL   – This is the 2nd indication for Keytruda for a hematologic malignancy. – The approval is based on tumor response rate and durability of response. The FDA granted Merck (MRK) approval for its immuno-oncology checkpoint inhibitor Keytruda® for adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or for those who relapsed after two …
AstraZeneca and Genentech Checkpoint Inhibitors improve survival in two different Lung Cancers

AstraZeneca and Genentech Checkpoint Inhibitors improve survival in two different Lung Cancers

ASTRAZENECA AstraZeneca’s (AZN) Checkpoint Inhibitor Imfinzi significantly improved Overall Survival (OS) for Stage III Non-Small Cell Cancer Imfinzi (durvalumab) achieved positive overall survival (OS) results for the Phase III PACIFIC trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose cancer did not progress following platinum-based chemotherapy and radiation. An Independent Data Monitoring Committee concluded that the trial met the second of two primary …
CARA Therapeutics has good news

CARA Therapeutics has good news

Cara Therapeutics (CARA) develops novel and proprietary class of product candidates, led by Korsuva (CR845/difelikefalin) injection. This product is a first-in-class peripheral kappa opioid receptor (KOR) agonist designed to alleviate pruritus (itching) and pain.  In Phase 2 trials, Korsuva injection demonstrated statistically significant reductions in itch intensity and concomitant improvement in the quality of life in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Additionally, Korsuva has demonstrated statistically …
Amgen: The FDA approves Aimovig™. The first specific migraine drug

Amgen: The FDA approves Aimovig™. The first specific migraine drug

The U.S. Food and Drug Administration (FDA) approved Amgen’s (AMGN) new once a month drug Aimovig™ (erenumab-aooe) for the prevention and treatment of migraine in adults. Aimovig is the first and only FDA-approved treatment specifically developed to prevent migraine. The drug blocks calcitonin gene-related peptide receptor (CGRP-R) believed to play a critical role in the occurrence of migraine. The drug will be marketed by Amgen and Novartis (NVS).  Aimovig 70 mg is …
Exelixis: The European Commission approves Cabometix for first line treatment of poor-risk advanced renal cell carcinoma

Exelixis: The European Commission approves Cabometix for first line treatment of poor-risk advanced renal cell carcinoma

Exelixis (EXEL) announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX®(cabozantinib) 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate or poor-risk advanced renal cell carcinoma (RCC) in the European Union. Under the terms of the Collaboration and License Agreement with Ipsen, Exelixis will receive a milestone payment of $50 million for the EC approval, of which approximately $46 million was recognized as collaboration revenue in the first quarter …
An FDA Advisory Committee Voted in Favor of Approving Akcea Therapeutics’ Product, WAYLIVRA, for FCS Syndrome.

An FDA Advisory Committee Voted in Favor of Approving Akcea Therapeutics’ Product, WAYLIVRA, for FCS Syndrome.

Ionis Pharmaceuticals (IONS) and Akcea Therapeutics (AKCA), an affiliate of Ionis Pharmaceuticals, announced that the Advisory Committee of the U.S. Food and Drug Administration’s (FDA) Division of Metabolism and Endocrinology Products voted 12-8 in support of approving the firms’ product WAYLIVRATM (volanesorsen) for familial chylomicronemia syndrome (FCS). The PDUFA date for the FDA review and ruling is August 30, 2018. WAYLIVRA, potentially the first and only treatment for people living with this serious and …
The FDA Approves Portola Pharmaceuticals’ Andexxa®. The First and ONLY Antidote for the Reversal of Factor Xa Inhibitors

The FDA Approves Portola Pharmaceuticals’ Andexxa®. The First and ONLY Antidote for the Reversal of Factor Xa Inhibitors

The U.S. Food and Drug Administration (FDA) has approved Portola’s (PTLA) drug Andexxa®, the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Commenting on the approval, Stuart J. Connolly, M.D., ANNEXA-4 Executive Committee chairman and professor in the Department of Medicine of the Faculty of Health Sciences at McMaster University in Hamilton, Ontario said, “Today’s approval represents …
A Gratifying Exelixis Quarterly Results

A Gratifying Exelixis Quarterly Results

It is obvious that Exelixis’ (EXEL) first quarter results do not justify the selling of EXEL during the whole quarter, but rather condemn it. It is an undeniable fact that Exelixis is doing a great job squeezing the best out of its approved drugs while conducting persistent research and development regarding its investigational pipeline products. The unveiled facts comprise the following: – Strong commercial performance for CABOMETYX in advanced renal cell …
ImmunoGen Stock Flied on Ovarian Cancer Drug News

ImmunoGen Stock Flied on Ovarian Cancer Drug News

The Independent Data Monitoring Committee (IDMC) decided that ImmunoGen (IMGN) Phase 3 registration trial evaluating mirvetuximab soravtansine as a single-agent therapy for platinum-resistant ovarian cancer will continue as planned without modification. ImmunoGen has completed full enrollment of the trial two months ahead of schedule and expects top-line results from FORWARD I during the first half of 2019. Enrollment was initially planned to be completed by the end of June. FORWARD I is …
Alnylam’s RNAi Product Patisiran Has More Positive News

Alnylam’s RNAi Product Patisiran Has More Positive News

The Market The Stock Market is Still under pressure, which is frightening common investors, pressuring them to sell. We see no real reasons for the stock market to be acting as a Bear when the criteria of bullishness are obvious and several. We see no need for us to be scared, overreact and unwillingly contribute to the selloff. In the News ALNYLAM Alnylam (ALNY) announced positive …
Bellicum Pharmaceuticals: The FDA Lifted the Clinical Hold on BPX-501 Clinical Trial

Bellicum Pharmaceuticals: The FDA Lifted the Clinical Hold on BPX-501 Clinical Trial

Bellicum Pharmaceuticals (BLCM): The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events. Bellicum will be working with U.S. clinical sites to resume patient recruitment based on the amended protocols. The FDA clinical hold did not affect the BP-004 …