Category: News & Comments

Seres Therapeutics: A Novel Approach for Treating Clostridium Difficile Infection

Seres Therapeutics: A Novel Approach for Treating Clostridium Difficile Infection

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: News We Are Anxious to Hear

Kite: News We Are Anxious to Hear

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 Is in Much Better Shape Than Six Months Ago

Inovio Is in Much Better Shape Than Six Months Ago

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 …
Astrazeneca Selects Mirati Therapeutics Drug for Its Cancer Immunotherapy Combination

Astrazeneca Selects Mirati Therapeutics Drug for Its Cancer Immunotherapy Combination

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 …
NantKwest Inc:  A Novel Breathtaking Immunotherapy for Cancer?

NantKwest Inc: A Novel Breathtaking Immunotherapy for Cancer?

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 …
Exelixis: The Importance of the Public Offering. Xoma: What Should We Do Now?

Exelixis: The Importance of the Public Offering. Xoma: What Should We Do Now?

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 …
Amgen: Repatha Approved in Europe

Amgen: Repatha Approved in Europe

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 …
Anacor Pharmaceuticals Ointment for Atopic Dermatitis Passes the Tests. Why Is This Great News?

Anacor Pharmaceuticals Ointment for Atopic Dermatitis Passes the Tests. Why Is This Great News?

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 …
TrovaGene: Overcoming Challenges in Cancer Immunotherapy

TrovaGene: Overcoming Challenges in Cancer Immunotherapy

After decades of attempting, but failing, to harness the immune system power to treat cancer (Cancer immunotherapy), novel approaches based on new discoveries have finally demonstrated they can do the hard job. These treatments, however, are facing challenges which must be dealt with. Will TrovaGene (TROV) succeed in dealing with the challenges? Indeed, using the body’s own immune system to fight cancer is working by …
Unearthing Dynavax Treasures Has Nothing to Do with Greece Troubles

Unearthing Dynavax Treasures Has Nothing to Do with Greece Troubles

Today it is Greece. What About Tomorrow? Can Greece’s crisis devastate the biotech sector? No sane individual would think so and the hysteria cannot be called other than what it is. The biotech sector is not overvalued and its value must not be insulted by unfairly downgrading great biotech revolutionary firms, while they are obviously undervalued. Those who invest their money against biotech stocks regardless …
Biocryst: A Major Game Changing Agreement

Biocryst: A Major Game Changing Agreement

On Thursday June 18, 2015, we posted an article under “Today’s Highlights” at the Prohost website about an important agreement Biocryst Pharmaceuticals (BCRX) signed with CSL We expect the agreement to contribute a great deal into bringing effective treatments of disabling chronic progressive diseases and life-threatening acute diseases to the global market The  news that appealed to us and the market came in the announcement by …
Immunogen: Defeating Advanced Ovarian Cancer and Other Malignancies

Immunogen: Defeating Advanced Ovarian Cancer and Other Malignancies

– Immunogen’s recurrent ovarian cancer drug Mirvetuximab soravtansine (IMGN853) has demonstrated promising results. – The firm succeeded in developing and owning the drug. –  ImmunoGen is doing whatever it takes to get the drug to the patients as quickly as possible and to explore the possibility of treating other cancers with the same drug. – The market showed extreme enthusiasm for the news. ImmunoGen’s (IMGN) …
Xoma: Phase 3 Eyeguard-B Trial Is Good News for Gevokizumab

Xoma: Phase 3 Eyeguard-B Trial Is Good News for Gevokizumab

Xoma (XOMA) announced good news from Phase 3 EYEGUARD-B trial of its monoclonal antibody drug gevokizumab for Behcet’s uveitis. The study, which is sponsored by Xoma’s development partner Servier, reached its target exacerbation event as specified in the study design. The objective of the first part of this study is to demonstrate the superiority of gevokizumab, inreducing the risk of Behcet’s disease uveitis exacerbation and …
Immunotherapy at ASCO. What Do We Want to Hear?

Immunotherapy at ASCO. What Do We Want to Hear?

For those who ask whether immunotherapy will have a dominant presence at ASCO, we confirm that yes; immunotherapy therapeutics will have a presence and a lot of audience, especially oncologists. There is big reason for oncologists’ interest in the subject. Their patients who have exhausted all standard of care treatments and would usually go home to die, did not lose hope this time. Instead, many …
Vertex: The FDA Advisory Committee Recommended Approval for Orkambi

Vertex: The FDA Advisory Committee Recommended Approval for Orkambi

AS WE AND PREDICTED, the FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC), voted in favor of approving Vertex’s (VRTX) drug Orkambi™ (lumacaftor/ivacaftor) for people with Cystic Fibrosis (CF) ages 12 and older who have two copies of the F508del mutation in the CFTR gene. The FDA is expected to make a decision on the approval of Orkambi by July 5, 2015 under the Prescription Drug User …
The FDA Advisory Committee Voted in Favor of Amgen Melanoma Drug T-VEC and More Insight

The FDA Advisory Committee Voted in Favor of Amgen Melanoma Drug T-VEC and More Insight

The FDA Advisory Committee Voted 22-1 In Favor of Approval of Its Melanoma Immunotherapy T-VEC Yesterday’s Prohost’s intelligent prediction that the FDA committee will vote in favor of approving Amgen’s melanoma drug T-VEC has proven to be correct. “Amgen (AMGN) cancer immunotherapy showed enough efficacy in the treatment of melanoma to be given marketing approval” That’s what the independent advisory panel selected by the U.S. …
Celldex: Crossing the Border Towards a Higher Status

Celldex: Crossing the Border Towards a Higher Status

As you would observe when reading the most recent Prohost Letters, our recent enthusiasm for Celldex Therapeutics (CLDX) emanated from its products’ combinationsc with novel immunotherapy drugs. In the past months, yesterday and today CLDX has outperformed for the same reason we mentioned in our most recent Prohost Letters. The reason for the current out-performance was the announcement that Celldex entered into a clinical trial …
Exelixis: On the Road Towards Accomplishments with Faster Steps

Exelixis: On the Road Towards Accomplishments with Faster Steps

Exelixis Announces Acceptance of New Drug Application for Cobimetinib (NDA) in Combination with Vemurafenib for Treatment of Patients with BRAF V600 Mutation-Positive Advanced Melanoma “The FDA Granted Priority Review, Assigns Action Date of August 11, 2015” This is a subtitle in the firm’s news today, which says a lot about Exelixis (EXEL) as an active biotech firm. Exelixis has, indeed, designed, produced and developed a …
Aerie Pharmaceuticals Is Speeding Towards Improving the Magement of Glaucoma

Aerie Pharmaceuticals Is Speeding Towards Improving the Magement of Glaucoma

AERIE PHARMACEUTICALS (AERI) A YOUNG BUT STRONG COMPETITOR IN THE GLAUCOMA HUGE MARKET – Aerie Pharmaceuticals has eye drops that could become a game changer in the management of glaucoma. – The firm’s lead drug, Rhopressa™, is a one drop once-daily having triple action that might bring life to over two decades of paralysis in Glaucoma treatments. – Rhopressa™ inhibits Rho Kinase (ROCK) and the …
Irrational Selloff Adding More Irrational Volatility

Irrational Selloff Adding More Irrational Volatility

They jumped to call the biotech sector a bubble, accentuating its volatility. Instead of saying WOW about Gilead’s (GILD) 3.49 billion net income, calculated as $2.18 a share, they called for a selloff of the stock. The 3.49 billion net income and $2.18 income a share are compared with $791 million, or 47 cents a share, a year earlier. This is big for us, but …