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 …

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 …

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 (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 …

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 …

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 …

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 …

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 …

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 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 …

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 …

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 …

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 …

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, …

ANOTHER MISLEADING STORY  This article was corrected after being posted. Read our apology at the end of the article. Forecasting exaggerated impact of negative-looking news has stricken GlaxoSmithKline (GSK) shareholders today, while enchanting Merck’s (MRK) shareholders. GSK said that: “Used as a single therapy”, its checkpoint immunotherapy drug Opdivo has failed a trial for newly diagnosed lung cancer patients. GSK said that the Checkmate-026 study has not met its primary …

EMA’s created Priority Medicines (PRIME) regulatory initiative for products which the European agency rules they are of unmet needs. PRIME makes them eligible for support, possible regulatory applications and potential accelerated reviews. PRIME has accepted Adaptimmune’s (ADAP) drug NY-ESO-targeting T-cell therapy. The drug became the 8th accepted for EMA’s PRIME program. The PRIME status has been awarded to Adaptimmune’s NY-ESO-targeting T-cell therapy for the treatment …

News about approvals or insinuations about almost guaranteed future approvals of products that promise improving the management of chronic and life-threatening diseases are always welcomed with enthusiasm. Of course some approvals are more rewarding than others, which has to be assessed by investors. For the patients, however, any improvement, small or phenomenal is always considered good news. Let’s have a look at one of the …

JUNO   Juno Therapeutics (JUNO), the CAR T developing firm that aims at revolutionizing cancer treatment has gotten the news we anticipated, but significantly faster than we expected. Indeed, the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Phase 2 of the ROCKET clinical trial of its CAR T product JCAR015. The trial was conducted in adult patients with relapsed …

Good news is not always great news that makes a difference. In the drug industry, clinical trial results that demonstrate a drug has fulfilled the requirements of the trials, including the primary and secondary endpoints does not always guarantee that the drug will be successful if and when it hits the market. Experience and follow up on certain firms enables us to see the real …

The Royal Divorce On Sunday, the next day after the announcement of the British referendum’s results, a turbulence in the stock markets was in the making by professionals who cited all kind of pessimistic likelihoods and negative projections that England divorce will cause havoc, devastating the stock markets for months, and maybe for years to come. On Monday, the markets were, indeed, devastated and the …