News and Comments

BREAKING NEWS: FDA COMMITTEE RECOMENDS ONYX (ONXX) MM DRUG FOR APPROVAL

  Wednesday, June 20, 2012

The FDA Oncologic Drugs Advisory Committee (ODAC) voted 11-0 with 1 abstention in favor of approval of Onyx (ONXX) multiple myeloma drug Kyprolis™(carfilzomib). The recommendation is for patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD), the benefit-risk assessment is favorable for the use of Kyprolis™.  More...

PHARMACYCLICS: IBRUTINIB, THE NEXT RITUXAN AND MORE

  Wednesday, June 20, 2012

When on February 24, 2012, we wrote that the Pharmacyclics (PCYC) story is one of only a few in which the power of the firm’s product pipeline overshadows the stock market’s technical influence, we were not hallucinating, as some have claimed. With this firm’s drug ibrutinib (PCI-32765) demonstrating safety and efficacy in various blood cancers, negative unsubstantiated speculations failed to persuade investors to cease investing in PCYC. Trial results have confirmed the superiority of ibrutinib in treating B-cell cancers, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and multiple myeloma (MM).  More...

ImmunoGen has good news and any “BUT” is not relevant at this time.

  Monday, June 04, 2012

The media seems to have woken up from its unconsciousness, overlooking good news in favor of perpetrating negative energy that weighs heavily on people’s psyche. When undeniable cheerful realities emerge, the media can no more ignore it. That’s what we see happening at least in the biotechnology sector these days. Years of overlooking breakthrough approaches that demonstrate promise of improving the prognosis of cancers known to resist conventional treatments have ended and the negative media could not hide its admiration of what it is actually witnessing. Some would find a space to put a “BUT” after praising the drug, but investors have developed expertise in interpreting the but that is put in the wrong place. More...

AVEO AND EXELIXIS AT THE FINISH LINE

  Thursday, May 31, 2012

News announcing that small biotech firms are filing for approval of breakthrough drugs targeting deadly diseases is worth admiration, not cynicism. Humans look for miracles; yet, they impassively overlook hundreds of human handmade marvels taking place every second around them. Serendipity does not make miracles. Human curiosity, learning and determination to erase whatever obstacles might block the road to great accomplishments create marvels. Discovering the structure of the DNA is a miracle, mapping the human genome is a miracle, switching genes on and off with a pill is working on a miracle and the advancement in biological sciences in the past two decades is a basket full of miracles. The miracle of miracles, though, was that in spite of labeling the biotechnology industry high risk since its inception, investors never abandoned investing in it. Thousands generated lots of profit on it, especially those who managed to select the best of the best of the stocks and stick to them. Those investors, no doubt, contributed a great deal in creating many of the miracles that are filling what a quarter of a century ago was an empty basket.  More...

REDEFINING "CREATING SHAREHOLDER VALUE"

  Tuesday, May 15, 2012

The time has come for redefining the meaning of “creating shareholders value” in the biotech sector. Pinpointing the real value has become imperative. It is the road to a fair assessment of innovative biotech firms. It helps investors reap the fruits of the real value of excellent firms at the right time, rather than rush to sell extremely promising stocks while still undervalued. It makes investors think twice before throwing their shares of firms that are installing one by one the building blocks of their vision. Creating shareholders value is investing in the future. The cost of this investment shouldn’t be cause for downgrading the stocks because of overspending, which has become a normal pattern. We still see all development-stage biotech stock prices slashed following the announcement of their quarterly results. There is a big difference between spending on the future and spending because the money has been made available. Investors can know the difference. The first thing to look for is whether the firm has any program in development that is worth spending on, including buying firms having a technology that is badly required for the successful outcome of the firm’s program. This kind of investment should not be punished or treated as unnecessary spending. More...

VERTEX: Well-EQUIPPED TO OWN THE FUTURE

  Tuesday, May 08, 2012

On Monday May 7, 2012, Vertex announced an interim analysis of data from an ongoing Phase 2 study of VX-809 in combination with KALYDECO™ (ivacaftor). The analysis demonstrated significant improvements in lung function (FEV1) among adults with cystic fibrosis (CF) who have two copies (homozygous) of the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, F508del.   More...

ILMN AND HGSI: REASONS FOR ATYPICAL REJECTIONS OF TAKEOVERS

  Sunday, April 22, 2012

These days all the focus, the talk, the debates, and the confusion are, and will certainly continue for a while to be, about Illumina’s (ILMN) and Human Genome’s (HGSI) rejection of the acquisitions offers. The truth is that the offers were not as generous as they are said they are. More...

AFFYMAX vs. AMGEN?

  Tuesday, April 03, 2012

Affymax (AFFY) red blood growth factor drug Omontys (peginesatide) was granted FDA approval – good news for the firm. The approval is a remarkable achievement by Affymax. The firm has proven a capability developing biological products and there is no doubt that AFFY will sell the drug Omontys for patients with chronic kidney disease on dialysis, as it is dictated by the FDA.  More...

Ariad's mTOR and the FDA Committee

  Tuesday, March 20, 2012

Ariad’s (ARIA) drug Taltorvic (ridaforolimus) is a novel small-molecule inhibitor of the protein mTOR interferes with cell growth, division, metabolism and angiogenesis. The FDA independent committee will discuss, debate and decide whether this drug should, or should not be approved for metastatic soft tissue sarcoma or bone sarcoma whose disease has not progressed after at least 4 cycles of chemotherapy.  More...

AGENUS: Stimulon Stimulates The Immune System And Investors

  Friday, March 16, 2012

Agenus (AGEN) has outperformed. Of course some profit-taking was expected, but the firm has definitely done a good job rebuilding a new pipeline backed by updated information and more mature understanding of the immune system and the requirements for a successful immunotherapy. Investors might have been missing the transformation but when they got the chance to look deeper into the firm’s programs, they liked what they saw. AGEN’s  price has more than doubled since January 2012 on large trading volume, insinuating that the rally is for real and that investors are expecting good news to finally emerge from the firm’s labs and finances in the same time. A relevant comforting symptom is that Agenus’ partnership with GlaxoSmithKline (GSK) has proven solid like a rock, which might have helped convince the skeptics that Agenus’ QS-21 Stimulon is genuine adjuvant essential for to the efficacy of vaccines both preventive and therapeutic.  More...


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