Category: Today’s Highlights

Who Will End Up Acquiring Medivation? Abbott Acquires St Jude. See Also: Alnylam

Who Will End Up Acquiring Medivation? Abbott Acquires St Jude. See Also: Alnylam

Medivation is a Target for Acquisition The Question is: Who Will Acquire Medivation? Sanofi has made a bid to acquire Medivation for $9.3 billion (£6.37B). Sanofi is expected to pay $52.50 per share in cash for Medivation. Why Medivation? Sanofi's chief executive Olivier Brandicourt said, "Thanks to Medivation's excellent prostate cancer treatments, we believe that a merger with Medivation would benefit patients and, at the same time, create value …
Agenus First Immune Check Protein Inhibitor in Clinical Trial. See Also: IMGN and EXEL

Agenus First Immune Check Protein Inhibitor in Clinical Trial. See Also: IMGN and EXEL

Biotech NEWS   AGENUS Agenus’ First Checkpoint Inhibitor to reach Clinical Trial The first patient has been dosed in Agenus (AGEN) Phase 1 clinical trial of its checkpoint inhibitor product AGEN1884. The open-label, multicenter trial in patients with advanced or refractory cancer is designed to evaluate the safety of AGEN1884 and determine the estimated maximum tolerated dose. AGEN1884 is an anti-CTLA-4 (cytotoxic T-lymphocyte antigen-4) checkpoint …
TapImmune and Loxo Oncology Have Interesting News

TapImmune and Loxo Oncology Have Interesting News

The AACR 2016 meeting presentations differed substantially from previous meetings. The  2016 meeting has brought near certainty that, indeed, defeating cancer is a reachable objective. The road is lengthy, but the speed in analyzing the data and acting upon them towards improvement is unprecedented. You will find the most important information about the AACR cancer meeting in the upcoming Prohost Letter. In the NEWS TAPIMMUNE …
Why Illumina Might Be Offering a Lucrative Investment Opportunity

Why Illumina Might Be Offering a Lucrative Investment Opportunity

Illumina Showing 6% revenue increase over the same quarter last year, Q1 2016, was not enough as Illumina (ILMN) missed analysts’ expectations and its own projections regarding its revenues. Prior to the announcement of its Q1 results, the giant gene sequencing firm offered investors a comprehensive explanation of the origin of the miss and the actions it has already begun to take to avoid future misses. Illumina pinpointed …
Good News Does Not Always Mean Good Investment Opportunities

Good News Does Not Always Mean Good Investment Opportunities

In the biotech sector, daily stories (news) are not just announced, but mostly edited in ways that project the narrators’ tendencies and wishes rather than the original news. Last week’s headlines comprised positive news from a firm’s drug aimed at treating a chronic progressive disease, muscular dystrophy, which disables children’s by weakening their voluntary and involuntary muscles, while threatening their hearts and lungs and lives. Other headlines …
Gilead Files NDA for HBV Drug. Synta Surprising Merger

Gilead Files NDA for HBV Drug. Synta Surprising Merger

Pursuing its goal in treating hepatitis, Gilead Sciences (GILD) is at the finish line of clinical trials on another virus, this time the Hepatitis B virus. HBV not HCV. Two large Phase 3 trials evaluating once-daily tenofovir alafenamide (TAF) 25 mg in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus (HBV) infection met the primary endpoints of non-inferiority to Gilead’s Viread® (tenofovir disoproxil fumarate (TDF) 300 mg.  …
Regeneron in Gene Editing and New Information About CRISPR/Cas9 Gene Editing Firms

Regeneron in Gene Editing and New Information About CRISPR/Cas9 Gene Editing Firms

Regeneron and Intellia to Discover and Develop CRISPR/Cas Therapeutics Moving forward is Regeneron Pharmaceuticals’ (REGN) strategy based on strong scientific and technological capability that needs no validation by external validators. The quality, i.e., safety and efficacy, of Regeneron’s approved products and the clinical trial outcomes of the firm’s drugs in late phase trials speak for themselves. Good news from the firm is flooding the media. The most recent …
Intercept Drug Ocaliva Passed the Test

Intercept Drug Ocaliva Passed the Test

Another day, another badly needed treatment for a dangerous disease is on its way to be FDA approved. The day was yesterday, Thursday, April 7, 2016. The company is Intercept (ICPT), the disease is primary biliary cirrhosis renamed primary biliary cholangitis (PBC), the drug is called Ocaliva™ (obeticholic acid). The good news came from the FDA's Gastrointestinal Drugs Advisory Committee, which voted 17 to 0to recommend accelerated approval of Ocaliva™.    Now …
The Outcome of the Pfizer/Allergan Marriage. See Also: More News for Incyte

The Outcome of the Pfizer/Allergan Marriage. See Also: More News for Incyte

Pfizer (PF) terminated its acquisition agreement with Allergan Plc (AGN) The new set of rules released by the U.S. Treasury Department to make it difficult for U.S. companies to conduct tax inversions contributed Pfizer’s decision. Analysts noted that the new regulations seem almost directly aimed at Pfizer-Allergan. In one of two major parts of the new rules, the U.S. government would not consider the assets acquired …
Expected and Unexpected Reasons for Pfizer and Intercept Stocks’ Rallies

Expected and Unexpected Reasons for Pfizer and Intercept Stocks’ Rallies

PFIZER Pfizer (PF) announced that its oral drug tofacitinib in doses of 5 mg and 10 mg twice daily  met Phase 3 endpoints on psoriatic arthritis. The trial was conducted on adult patients with active psoriatic arthritis (PsA). The recruited patients had an inadequate response to at least one conventional anti-rheumatic drug (csDMARD) and were tumor necrosis factor inhibitor (TNFi)-naïve. Patients enrolled in the study were …
News from Incyte and Gossip About Medivation

News from Incyte and Gossip About Medivation

Incyte (INCY) and Eli Lilly (LLY): The New England Journal of Medicine published detailed results of RA-BEACON — a pivotal phase 3 global study of baricitinib, a once-daily oral treatment for moderate-to-severe rheumatoid arthritis (RA). The study met its primary endpoint of ACR 20 response for baricitinib compared with placebo at week 12. ACR 20 response rates were (P≤0.001 for each baricitinib dose versus placebo): 55 percent for baricitinib 4 mg; 49 percent …
The FDA Says Yes to Acadia Drug Nuplazid and More

The FDA Says Yes to Acadia Drug Nuplazid and More

The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2 that the benefits outweigh the risks of Acadia’s (ACAD) drug Nuplazid™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease. The Prescription Drug User Fee Act (PDUFA) action date for the FDA decision is May 1, 2016.  Nuplazid’s NDA was granted a breakthrough designation and Priority Review status for the treatment …
Portola Is Still a Favorite

Portola Is Still a Favorite

It is an ingenuous decision made by investors who rushed to consider betrixaban Phase 3 APEX study a failure. Betrixaban is a once-daily orally administered Factor Xa inhibitor anticoagulant.  The Phase 3 AREX study was evaluating the superiority of oral betrixaban’s extended-duration anticoagulation vs. the injectable standard-of-care anticoagulation for the prevention of venous thromboembolism (VTE) in acute medically ill patients. The 7,513-subject study designed to assess the relative risk …
Amgen: Positive Data from Osteoporosis Trial. Aerie Pharmaceuticals: More Data on Glaucoma Drug Safety.

Amgen: Positive Data from Osteoporosis Trial. Aerie Pharmaceuticals: More Data on Glaucoma Drug Safety.

Amgen (AMGN) and UCB (Euronext Brussels: UCB) announced positive results from the BRIDGE pivotal Phase 3 placebo-controlled study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis.  The study met the primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine in men with osteoporosis treated with romosozumab compared with placebo at 12 months. All secondary endpoints comparing romosozumab with placebo …
Immunokinases Attract Roche to Blueprint Medicine. Spectrum Granted FDA Approval.

Immunokinases Attract Roche to Blueprint Medicine. Spectrum Granted FDA Approval.

Immunotherapy for Cancer Blueprint Medicines Blueprint Medicines (BPMC) entered into a worldwide collaboration and exclusive license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (collectively, Roche) for the discovery, development and commercialization of up to five small molecule therapeutics targeting kinases believed to be important in cancer immunotherapy. Under the terms of the agreement, Blueprint Medicines will receive an upfront cash payment of $45 million …
Celator: Improving on AML Standard of Care Treatment. The Stock Rallied.

Celator: Improving on AML Standard of Care Treatment. The Stock Rallied.

First therapy to demonstrate statistically significant improvement in overall survival and induction response rate in a pivotal Phase 3 trial in high-risk Acute Myeloid Leukemia (AML)   NDA submission for VYXEOS planned for later this year   Celator Pharmaceuticals (CPXX) announced positive results from Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML) compared to the standard …
Xoma: The Considered Dead is Alive and Kicking. Gilead is Way Undervalued

Xoma: The Considered Dead is Alive and Kicking. Gilead is Way Undervalued

The Diagnosed Dead Is Far from Dying Xoma (XOMA): Stock rallied following report announcing an upfront payment from Novartis, which multiplied the firm’s revenues 10 times over 2014. Novartis paid Xoma $37 million, Novo Nordisk paid $5 million and Pfizer paid the firm a little less than $4 million. CEO John Varian said, “Novel antibodies and technologies created by XOMA scientists to target diseases such as …
Jazz Pharmaceuticals: The Expected Good News on March 31, 2016

Jazz Pharmaceuticals: The Expected Good News on March 31, 2016

Of the Upcoming Game-Changing Actions THE EXPECTED FDA APPROVAL OF JAZZ DRUG DEFIBROTIDE On March 31, the FDA is expected to decide on the approval of Jazz Pharmaceuticals’ (JAZZ) drug defibrotide. The drug is for patients with hepatic veno-occlusive (VOD), also known as sinusoidal obstruction syndrome (SOS), with multi-organ failure (MOF) post-hematopoietic stem-cell transplantation (HSCT). Optimism about the FDA decision is prevailing among analysts and observers as the results of the …
Illumina: A Great Transformation and Transition

Illumina: A Great Transformation and Transition

As we kept describing it, Illumina’s (ILMN) is the engine behind the biological revolution reflected in the current existence of treatments, which aim at targets that were unknown before this firm enabled discovering them. Illumina’s establishing and launching the independent company, Grail, will speed the successful outcome of the war against cancer. It will contribute to advancing the diagnosis of cancer through a tremendous increase in the sensitivity …
Immune Design: Encouraging News About Treating Allergic Diseases

Immune Design: Encouraging News About Treating Allergic Diseases

Preparing a Prohost Letter dedicated to immunotherapy and the firms that are behind the promising novel approaches towards enabling the immune system to treat, or cure diseases if possible, we fell on other genius approaches. In recent Prohost Letters, we discussed the CAR T immunotherapy approach for the management of advanced, or metastatic cancers and in the upcoming Issue, which was due two days ago, …