Category: News & Comments

Interpreting Portola Pharmaceuticals’ News

Interpreting Portola Pharmaceuticals’ News

The FDA’s Center for Drug Evaluation and Research (CDER) informed Portola (PTLA) that it does not plan to hold an Advisory Committee meeting for its Product betrixaban. What is betrixapan? Betrixapan is a small molecule oral, once-daily, Factor Xa inhibitor anticoagulant. The drug directly inhibits the activity of Factor Xa, which is a validated target in the blood coagulation pathway. Why it is used? Betrixapan …
Companies Targeted for Takeover Yet Can Thrive on their Own

Companies Targeted for Takeover Yet Can Thrive on their Own

It seems that the global Takeda (TKPYY) has guessed well what it should pick in order to bring the most effective targeted treatments to cancer patients allover the globe. Cancer management has unreservedly changed. What seems now to have become the best treatment choices are those that would accommodate the new wave of extremely promising immunotherapy approaches. To reach its ultimate success, immunotherapy drugs require …
Welcoming Jounce Therapeutics (JNCE) as a Public Company

Welcoming Jounce Therapeutics (JNCE) as a Public Company

Today, Jounce Therapeutics has begun trading on the NASDAQ under the ticker symbol (JNCE).  The Company, which focuses on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced the pricing of its initial public offering of 6,365,000 shares of common stock at a public offering price of $16.00 per share for aggregate gross proceeds of $101,840,000. In addition, Jounce granted the underwriters …
Vertex and Merck KGaA Agreement Suits Both Firms

Vertex and Merck KGaA Agreement Suits Both Firms

Vertex (VRTX) entered into a licensing agreement with Merck KGaA, Darmstadt, Germany for the worldwide development and commercialization of four research and development programs that the firm believes represent novel approaches to cancer treatment Merck KGaA will license two clinical-stage programs targeting DNA damage and repair, along with two additional novel pre-clinical programs. Upon the agreement Vertex will receive an upfront payment of $230 million, …
Takeda Acquires Ariad for $5.2 Billion

Takeda Acquires Ariad for $5.2 Billion

ARIAD Pharmaceuticals’ (ARIA) stock jumped 75% today. The oncology firm entered into a definitive agreement to be acquired by Takeda Pharmaceutical Company Limited under which Takeda will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, or a total enterprise value of approximately $5.2 billion, representing a premium of approximately 75 percent over ARIAD’s closing price on January 6, 2017. Under …
Halozyme’s PEGPH20 Trial Results Are Worth Appreciating Not Doubting

Halozyme’s PEGPH20 Trial Results Are Worth Appreciating Not Doubting

Extremely important, not just exciting, were the results of Halozyme Therapeutics’s (HALO) Phase 2 randomized, multi-center clinical trial of its PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer. The results demonstrated a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving …
The FDA Manufacturing Issues. Why Portola Rallied but is Still Way Undervalued

The FDA Manufacturing Issues. Why Portola Rallied but is Still Way Undervalued

MANUFACTURING ISSUES?!  Why PORTOLA Stock Rallied? On Aug. 17, 2016, we learned that the FDA sent a Complete Response Letter (CRL) to Portola Pharmaceuticals (PTLA) regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa), which is an antidote important for the safety use of several new Factor Xa inhibitors anticoagulants aimed at replacing Coumadin (warfarin). The Factor Xa inhibitors anticoagulants have many advantages over …
Prohost Take on What’s Going on in the Drug Sector

Prohost Take on What’s Going on in the Drug Sector

President Elect Trump was quoted in a Time person of the year as saying “I am going to bring down drug prices.” The President Elect did not say he is going to bring down the drug producing and developing firms. Mr. Trump did not say he will bring down medical research, which is mostly conducted by the biotech and pharmaceutical firms. He did not say …
Cempra Stock has Been Cremated. Will Today’s Good News Resurrect It?

Cempra Stock has Been Cremated. Will Today’s Good News Resurrect It?

The nature the Presidential Election this time is weighing on investors’ chests and minds and mood and decisions. The stocks are typically reflecting investors’ inability to reason or make rational selection. Many are waiting for the election results to see whether they sell their portfolios or add to them. Negativity is the outcome fuelled by pessimism and by the simultaneous surfacing of articles and biographies …
Regeneron and Sanofi Rheumatoid Arthritis Drug is Still Extremely Promising

Regeneron and Sanofi Rheumatoid Arthritis Drug is Still Extremely Promising

Regeneron (REGN) and Sanofi informed that the FDA has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sarilumab. The drug  is an investigational interleukin-6 receptor (IL-6R) antibody for adult patients with moderately to severely active rheumatoid arthritis (RA). Nothing in the CRL contents insinuates that sarilumab is not safe, or not effective, or that the clinical trial data were not …
Why We Are Ignoring the Temporary Selling of NKTR. See Also: Agenus Adjuvant in GSK Successful Shingles Vaccine

Why We Are Ignoring the Temporary Selling of NKTR. See Also: Agenus Adjuvant in GSK Successful Shingles Vaccine

There is nothing wrong with Nektar Therapeutics (NKTR). The stock is temporarily underperforming as traders are practicing their conviction that they must sell when a firm finances through dilution. The traders practice this law of thumb regardless of whether the financing aims at bringing wealth or invites for a catastrophe. We believe Nektar is walking the road towards creating wealth and growth through continued development …
Senator Sanders and Ariad

Senator Sanders and Ariad

Shares of Ariad Pharmaceuticals declined following Senator Bernie Sanders’ criticism of the high price of the firm’s drug Iclusig (ponatinib) on Twitter. Ariad said, “our pricing reflects our significant investment in R&D, our commitment to the very small, ultra orphan cancer patient populations that we serve and the associated risk with research and development.” The Senator meant well we know. However, it looks as if …
A Promising Strategic Agreement Between a Large and a Small Biotech Firms

A Promising Strategic Agreement Between a Large and a Small Biotech Firms

When plenty of news comes out of the biotech sector, we are left with no option but prioritizing. Connecting the dots also might serve some purpose, including smelling take-over possibilities that make sense or contribute to improvements of the treatments and of firms’ finances. Prioritizing comprises selecting as much as possible the most concrete subjects that are safe to explore. In the upcoming Prohost Letter …
Alnylam: Some Acted Without Listening and Some Listened But Did Not Believe

Alnylam: Some Acted Without Listening and Some Listened But Did Not Believe

Following recent reports of new onset or worsening peripheral neuropathy in patients with ATTR amyloidosis with cardiomyopathy (hATTR-CM) treated with Alnylam’s (ALNY) RNAi –based drug revusiran, The firm requested that the Data Monitoring Committee (DMC) review the reports and the Clinical trial data on an unblinded basis. After reviewing the reports, the DMC advised suspending the dosing of revusiran. However, the DMC stated that It …
Why Aerie Pharmaceuticals’ Stock Rallied Today. What About Now?

Why Aerie Pharmaceuticals’ Stock Rallied Today. What About Now?

As we expected in our previous articles, Today, Aerie Pharmaceuticals (AERI) came up with great news about its glaucoma treatment. The stock surged ….   On February 18, 2016, Under News & Comments, we wrote an article titled “Aerie Pharmaceuticals: Novel Glaucoma Eye Drops Confirm their Superiority”. The article also referred to a Prohost previous article written on February 4, 2015 and tittled “Aerie Pharmaceuticals …
Another CRISPR Gene Editing Company Decided to Go Public. What’s Investors’ Decision?

Another CRISPR Gene Editing Company Decided to Go Public. What’s Investors’ Decision?

Another gene editing firm, CRISPR Therapeutics decided to become publicly traded. On Friday, the private firm filed with the SEC planning for a $90 million initial public offering (IPO). CRISPR Therapeutics is headquartered in Switzerland, but also exists in Cambridge. It was cofounded by Emmanuelle Charpentier, who, together with Jennifer Doudna claim discovering CRISPR/Cas9 gene editing recipe. The firm aim is to use CRISPR/Cas9 genome-editing …
Nektar Therapeutics: Crossing the Barriers and Sailing into the Future

Nektar Therapeutics: Crossing the Barriers and Sailing into the Future

Filled with high hopes and great enthusiasm, we are following up on Nektar’s (NKTR) immunotherapy product NKTR-214, which is in trials by Mayo Clinic and MD Anderson cancer center. The product is a CD122-biased agonist designed to stimulate the patient’s own immune system to kill tumor cells. The technology behind the molecule “targeted polymer conjugate technology” has been validated time and time again in clinical …
A New Option for Osteoporosis Treatment That Would Prevent Bone Fractures

A New Option for Osteoporosis Treatment That Would Prevent Bone Fractures

AMA Publishes Positive Phase 3 Data for Abaloparatide in Postmenopausal Women with Osteoporosis The Company is Radius Health (RDUS) and the new expected to be soon approved drug, abaloparatide, is an investigational therapy for the potential treatment of women with postmenopausal osteoporosis who are at an increased risk for a fracture. It is a novel synthetic peptide that engages the parathyroid hormone receptor (PTH1 receptor) and was selected for …
Is Advaxis Finally Running on the Right Track?

Is Advaxis Finally Running on the Right Track?

Advaxis (ADXS) is a small clinical-stage biotech producing and developing cancer immunotherapy products based on its proprietary Lm Technology. The technology uses bioengineered live attenuated Listeria monocytogenes (Lm) bacteria. It is said that Adraxis therapeutics cancer immunotherapy agents are the first to generate cancer fighting T cells against cancer antigens in early testing. They could also neutralize myeloid-derived suppressor cells (MDSCs), which protect the tumor …
Biotech Firms with Approaches Born To Stay and Succeed

Biotech Firms with Approaches Born To Stay and Succeed

Immunotherapy Engineered T-Cell Therapy Is Here to Stay Articles aimed at undermining the value of the firms’ chimeric antigen receptor T (CAR T) cells as immunotherapy for cancer are less and less convincing to savvy investors. Most of the bloggers who attack the procedure admit at the end of their articles that the approach is promising, but still needs this or that for the sake of perfection, …