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 …

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, …

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 …

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 …

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 …

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. …

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 …

GRAFT VERSUS HOST DISEASE (GVHD) INCYTE (INCY) HAS SEVERAL GOOD NEWS. As a matter of fact, Incyte has exciting news coming from innumerable activities strategized by the firm’s dynamic management. The first good news came from the FDA, granting Breakthrough Therapy Designation for Jakafi® (ruxolitinib) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for GVHD. Breakthrough Therapy …

Paratek Pharmaceuticals (PRTK) announced positive results from Phase 3 registration study comparing its once-daily, broad spectrum antibiotic, omadacycline, to linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI). The firm’s press release stated that its antibiotic drug met the FDA-specified primary efficacy endpoint of early clinical response. The study has also met the European Medicines Agency (EMA)-specified co-primary efficacy endpoints for …

ARIAD Pharmaceuticals (ARIA) announced the initiation of a New Drug Application (NDA) submission for brigatinib, the firm’s investigational anaplastic lymphoma kinase (ALK) inhibitor to the FDA. Earlier than expected, ARIAD is seeking U.S. marketing approval of brigatinib for patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib, which has received Breakthrough Therapy designation from the FDA for for this NSCLC condition …

CELATOR PHARMACEUTICALS Good News That Might Go to JAZZ Pharmaceuticals Celator Pharmaceuticals (CPXX): At the European Hematology Association (EHA) 21st Annual Congress, Celator  presented positive response rate results in acute myeloid leukemia (AML) patients with the FLT3 (FMS-like tyrosine kinase-3) mutation.   The results came from Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection in patients with high-risk (secondary) acute myeloid leukemia (AML). Data, …

Additional data from pivotal METEOR trial underscore clinically meaningful benefit of Exelixis’ (EXEL) drug Cabometyx™ for patients with Advanced RCC AT the ASCO Meeting: ABSTRACT #4557, #4558 Cabometyx’™ benefit was robust and consistent regardless of prior treatment, location and extent of tumor metastases Positive data will be presented at the 2016 American Society of Clinical Oncology (ASCO) from subgroup analyses of the pivotal METEOR trial. …

Enrollment has been completed in all the three ongoing clinical trials comprising the firm’s Phase 3 program for Theravance Biopharma’s (TBPH) revefenacin (TD-4208). The drug is an investigational long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD). The three revefenacin Phase 3 program are meant to support the registration of the product in the U.S. More than 2,300 patients have been enrolled and Top-line …

CANCER Everyday something new is discovered that explains cancer behavior, including proliferation, response to treatment, resistance to treatment, metastasis, recurrence, etc. Today we have several news, including one that might have cleared a puzzle regarding a continuous growth of colon cancer after oncologists block a well known signaling molecule recognized as playing a major role in making, not breaking the cancer. We also have news …