Category: News & Comments

Sarepta vs. Biomarin: Trying to Make an Educated Guess

Sarepta vs. Biomarin: Trying to Make an Educated Guess

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 and Merck Agree to Expand Their Agreement Regarding Their Immunotherapy Combination Drugs

Incyte and Merck Agree to Expand Their Agreement Regarding Their Immunotherapy Combination Drugs

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, …
Yesterday’s Market Performance Brings Back Hope to Normalcy.  Compugen Announced Some Encouraging News

Yesterday’s Market Performance Brings Back Hope to Normalcy. Compugen Announced Some Encouraging News

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 …
Xoma: A New Chance for Resurrection?

Xoma: A New Chance for Resurrection?

– 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: The Stream of Good News Continues to Flow

Exelixis: The Stream of Good News Continues to Flow

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: Another Step Forward Towards the Approval of a Promising Glaucoma Drug

Aerie Pharmaceuticals: Another Step Forward Towards the Approval of a Promising Glaucoma Drug

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. …
Huge Improvement in the Differential Diagnosis of Diseases and More

Huge Improvement in the Differential Diagnosis of Diseases and More

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 …
Why Switzerland Approval of Exelixis and Roche Drug Combination for Melanoma Is a Big Deal

Why Switzerland Approval of Exelixis and Roche Drug Combination for Melanoma Is a Big Deal

– 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 …
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) …