The FDA approved Array BioPharma’s (ARRY) products Braftovi™ capsules in combination with Mektovi® tablets for unresectable or metastatic skin cancer melanoma with a BRAF or BRAFV mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for the treatment of patients with wild-type BRAF melanoma. The products, which represent a new standard of care for BRAF-mutant melanoma are now available to order through select specialty pharmacies in the U.S. market.  The …

Sarepta Therapeutics (SRPT) has news from preliminary Duchenne muscular dystrophy trials. Although the number of recruited patients was only three, the strong positive data excited the media and Wall Street investors who rushed to buy the stock, making it add over $50 in today’s morning trading. The Story At the Company’s R&D Day, Jerry Mendell, M.D. of Nationwide Children’s Hospital presented positive preliminary results from Phase 1/2a …

– Keytruda becomes the first anti-PD-1 therapy to be approved for PMBCL   – This is the 2nd indication for Keytruda for a hematologic malignancy. – The approval is based on tumor response rate and durability of response. The FDA granted Merck (MRK) approval for its immuno-oncology checkpoint inhibitor Keytruda® for adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or for those who relapsed after two …

ASTRAZENECA AstraZeneca’s (AZN) Checkpoint Inhibitor Imfinzi significantly improved Overall Survival (OS) for Stage III Non-Small Cell Cancer Imfinzi (durvalumab) achieved positive overall survival (OS) results for the Phase III PACIFIC trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose cancer did not progress following platinum-based chemotherapy and radiation. An Independent Data Monitoring Committee concluded that the trial met the second of two primary …

Cara Therapeutics (CARA) develops novel and proprietary class of product candidates, led by Korsuva (CR845/difelikefalin) injection. This product is a first-in-class peripheral kappa opioid receptor (KOR) agonist designed to alleviate pruritus (itching) and pain.  In Phase 2 trials, Korsuva injection demonstrated statistically significant reductions in itch intensity and concomitant improvement in the quality of life in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Additionally, Korsuva has demonstrated statistically …

The U.S. Food and Drug Administration (FDA) approved Amgen’s (AMGN) new once a month drug Aimovig™ (erenumab-aooe) for the prevention and treatment of migraine in adults. Aimovig is the first and only FDA-approved treatment specifically developed to prevent migraine. The drug blocks calcitonin gene-related peptide receptor (CGRP-R) believed to play a critical role in the occurrence of migraine. The drug will be marketed by Amgen and Novartis (NVS).  Aimovig 70 mg is …

Exelixis (EXEL) announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX®(cabozantinib) 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate or poor-risk advanced renal cell carcinoma (RCC) in the European Union. Under the terms of the Collaboration and License Agreement with Ipsen, Exelixis will receive a milestone payment of $50 million for the EC approval, of which approximately $46 million was recognized as collaboration revenue in the first quarter …

Ionis Pharmaceuticals (IONS) and Akcea Therapeutics (AKCA), an affiliate of Ionis Pharmaceuticals, announced that the Advisory Committee of the U.S. Food and Drug Administration’s (FDA) Division of Metabolism and Endocrinology Products voted 12-8 in support of approving the firms’ product WAYLIVRATM (volanesorsen) for familial chylomicronemia syndrome (FCS). The PDUFA date for the FDA review and ruling is August 30, 2018. WAYLIVRA, potentially the first and only treatment for people living with this serious and …

The U.S. Food and Drug Administration (FDA) has approved Portola’s (PTLA) drug Andexxa®, the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Commenting on the approval, Stuart J. Connolly, M.D., ANNEXA-4 Executive Committee chairman and professor in the Department of Medicine of the Faculty of Health Sciences at McMaster University in Hamilton, Ontario said, “Today’s approval represents …

It is obvious that Exelixis’ (EXEL) first quarter results do not justify the selling of EXEL during the whole quarter, but rather condemn it. It is an undeniable fact that Exelixis is doing a great job squeezing the best out of its approved drugs while conducting persistent research and development regarding its investigational pipeline products. The unveiled facts comprise the following: – Strong commercial performance for CABOMETYX in advanced renal cell …

The Independent Data Monitoring Committee (IDMC) decided that ImmunoGen (IMGN) Phase 3 registration trial evaluating mirvetuximab soravtansine as a single-agent therapy for platinum-resistant ovarian cancer will continue as planned without modification. ImmunoGen has completed full enrollment of the trial two months ahead of schedule and expects top-line results from FORWARD I during the first half of 2019. Enrollment was initially planned to be completed by the end of June. FORWARD I is …

The Market The Stock Market is Still under pressure, which is frightening common investors, pressuring them to sell. We see no real reasons for the stock market to be acting as a Bear when the criteria of bullishness are obvious and several. We see no need for us to be scared, overreact and unwillingly contribute to the selloff. In the News ALNYLAM Alnylam (ALNY) announced positive …

Bellicum Pharmaceuticals (BLCM): The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events. Bellicum will be working with U.S. clinical sites to resume patient recruitment based on the amended protocols. The FDA clinical hold did not affect the BP-004 …

In today’s news, Incyte’s (INCY) immuno-oncology IDO1 inhibitor product Epacadostat in combination with Merck’s immuno-oncology product Keytruda® did not meet the endpoints of the trial in patients with unresectable or metastatic melanoma. The stock was subjected to a selloff – a market’s reaction pattern that occurs whenever negative news comes out of experimentation without consideration of the extent of their impact. A serious question to ask now would …

A False Reason for Unwarranted Selling of CRISPR/Cas9 Gene Editing Shares     CRISPRs are bacterial immune systems that contain many defense enzymes such as the Cas9 “molecular scissors,” which scientists have engineered as a powerful DNA-targeting gene-editing tool and created companies specialized in CRISPR gene editing tools. The outstanding revolutionary news, which is wrongly interpreted by Wall Street, which led to a recent selling of the shares of CRISPR gene …

Regeneron (REGN) and Alnylam (ALNY) announced a collaborative agreement aimed at identifying RNAi therapeutics for the chronic liver disease nonalcoholic steatohepatitis (NASH) and potentially other related diseases. The agreement is not the first between the two firms, but it would not have occurred if not for Regeneron’s identification of an important and unique therapeutic target that influences the liver debilitating and life-threatening nonviral hepatitis diseases, which affect thousands …

Arena Pharmaceuticals (ARNA) announced positive Phase 2 results from the OASIS trial for etrasimod in ulcerative colitis (UC). The Drug: Etrasimod is a selective sphingosine 1-phosphate (S1P) receptor modulator. Patients receiving the 2 mg dose of the drug achieved statistically significant improvements versus placebo in the primary, all secondary, and clinical remission endpoints. Relative to placebo: there was a statistically significant improvement in a 3-component (stool frequency, rectal bleeding, and findings on endoscopy) Mayo Clinic …

Exelixis (EXEL) completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Cabometyx® (cabozantinib) tablets for previously treated patients with advanced hepatocellular carcinoma (HCC). The sNDA submission is based on results from the CELESTIAL randomized pivotal phase 3 trial of Cabometyx in patients with advanced HCC who received prior sorafenib. Some History: On October 16, 2017, Exelixis announced that the independent data …

Extremely important news has come from Montreal, Canada carrying the announcement by Theratechnologies (TSX:TH) and its partner TaiMed Biologics (TaiMed) that the FDA has granted approval of Trogarzo™ (ibalizumab- uiyk) Injection. The approval is for Trogarzo to be used with other ARTs for HIV-1 infection in heavily treated adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. Trogarzo™ is a humanized monoclonal antibody created for multidrug resistant …

On March 4, 2018, Aimmune Therapeutics (AIMT) – a biopharmaceutical company developing treatments for potentially life-threatening food allergies confirmed the superior news that brings hope to children and adults who are susceptible to peanut allergic reactions. The results from the firm’s pivotal Phase 3 PALISADE trial of its product AR101 for the treatment of peanut allergy were presented at the 2018 American Academy of Allergy, Asthma & Immunology–World Allergy Organization Joint Congress …