What’s Going on the Morning of Thursday, August 18, 2016? PORTOLA Portola Pharmaceuticals (PTLA) announced the receipt of a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa). An FDA-designated Breakthrough Therapy, AndexXa is in development for patients treated with a direct (apixaban, rivaroxaban, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is …

GILEAD & GENMAB To Access Genmab’s (GEN) bispecific antibody technology, Gilead (GILD) signed a new agreement with Genmab. The King of HIV treatment objective is to use its exclusive license from Genmab to produce an HIV bispecific monoclonal antibody therapeutic. Gilead is paying around $5 million in upfront payment and up to $277 million in milestones. Genmab will also be entitled to one-digit royalty of …

Gene Editing EDITAS MEDICINE CRISPR gene editing firm Editas Medicine (EDIT) signed a collaboration agreement with a   small cap gene therapy firm called Adverum Biotechnologies (ADVM). The collaboration aims at exploring the delivery of Editas’ genome editing approach with Adverum’s next-generation adeno-associated viral (AAV) vectors to treat up to five inherited retinal diseases that have yet to find treatments or have poor existing remedies. According …

Sequenom (SQNM) is no more there as a separate biotech company, as it is on its way to becoming part of Laboratory Corporation of America® Holdings (LH), which might help it create breakthrough diagnostics without the pain of struggling to survive. LabCorp Holding (LH) announced the commencement of its cash tender offer for all outstanding shares of the common stock of Sequenom for $2.40 per …

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, …

We do expect some selling of Array today after AstraZeneca’s announced negative results from Phase 3 SELECT-1 trial of the MEK inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment for KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC). The results did not meet the trial’s primary endpoint of progression-free survival (PFS), and did not demonstrate overall survival (OS). These results, …

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 …

Investors in the stock market know that stocks yo-yo all the time. Sometimes, the yo-yoing becomes so severe it could trigger the soaring of some stocks and the tumbling of others. This article is about the plummeting of the biotech stocks.  Small development-stage biotech stocks, more than stocks belonging to other industries are subjected to a shredding of their values. Some would lose more than …

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 …

The FDA advisory committee members’ inability to rule for or against the approval of Valeant (VRX) anti plaque psoriasis drug brodalumab was not unexpected. However, more outside observers were expecting the committee to flatly reject the skin disease drug that would subject people to commit suicide or to cardiovascular side effects, including death. Indeed, the discussions were mostly about the drug’s side effects specifically the …

Important news is the news that informs about successful achievements that make a difference in treating life-threatening diseases, chronic diseases and diseases with no available treatments. Sometime you might not have a personal interest in one, or another or even all the mentioned firms in the news. For investors in the biotech sector, however, it is good to know the successful treatments that might be …

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 …

The FDA approved INSIGHTEC firm’s Exablate Neuro system for the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication. Using focused ultrasound waves Exablate Neuro precisely targets and ablates tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement …

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 …

AMGEN Repatha is the human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR). The binding  prevents PCSK9-mediated LDLR degradation, permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs …

Juno Therapeutics (JUNO) announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), known as the “ROCKET” trial. The clinical hold was initiated after patients’ death last week, which followed a recent addition of fludarabine to the pre-conditioning regimen. …

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 …

PsiOxus Therapeutics’ adenovirus product in combination with Opdivo (nivo-lumab) for late-stage cancers.     Bristol-Myers Squibb (BMY) and PsiOxus Therapeutics (PsiOxus) announced an agreement to evaluate PsiOxus’ drug enadenotucirev, a systemically administered oncolytic adenovirus therapeutic, in combination with Bristol-Myers Squibb’s checkpoint inhibitor opdivo (nivolumab) for a range of tumor types in late-stage cancer patients. Enadenotucirev is designed to have immune stimulating effects while Opdivo is designed …

- Tesaro's (TSRO) drug niraparib significantly improved progression-free survival for patients with ovarian cancer in both cohorts of the phase 3 NOVA trial - The NOVA trial successfully achieved its primary endpoint of PFS in the germline BRCA mutant cohort   - The NOVA trial successfully achieved its primary endpoint of PFS in the germline and non-germline BRCA mutant cohort. PFS endpoint is also achieved in …

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 …