Transenterix Gets FDA Clearance For Senhance Indication Expansion

Transenterix Inc TRXC 10.54% announced Tuesday that its laparoscopic Senhance Surgical System was approved by the FDA for two additional indications.

What Happened 

The Senhance Surgical System received regulatory clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy, or gallbladder removal, procedures.

Why It’s Important

With about 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures in the U.S. annually, the indication expansion more than doubles the device’s total addressable domestic market beyond 3 million annual operations.

“These expanded procedures are commonly performed at over 95 percent of hospitals in the United States,” President and CEO Todd Pope said in a press release. “We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice.”

Transenterix’s stock popped 27.2 percent premarket on the news.

What’s Next

Pope alluded in the press release to a regulatory strategy to expand indications beyond laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgery.

https://bit.ly/2GZfQEI

T2Biosystems Announces FDA Approval For Sepsis Test: ‘This Is A Game-Changer’

T2 Biosystems Inc TTOO 9.92% announced Tuesday that it received FDA approval for a blood test to detect sepsis; the stock is down more than 11 percent in morning trading.

What Happened

T2 Biosystems announced the FDA’s market clearance for its T2Bacteria Panel. The panel is meant to directly detect bacterial species in human whole blood specimens from patients with suspected bloodstream infections.

Why It’s Important

The panel sensitively detects sepsis-causing bacterial pathogens directly from a whole blood specimen in about five hours, about 2 1/2 days faster than blood culture-dependent tests.

“This is an important breakthrough, as bacterial infections are a major cause of poor patient outcomes and high hospital costs. This is a game-changer,” Frank Peacock, a professor and associate chair at the Baylor College of Medicine, said in a statement.

The FDA-cleared T2Bacteria Panel identifies five of the most common and deadly sepsis-causing species of bacteria: enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa  and Staphylococcus aureus, the company said in the release.

Bacterial and fungal bloodstream infections are a leading cause of sepsis, a life-threatening illness affecting 1.6 million U.S. patients per year, resulting in over 250,000 deaths — or about 50 percent of all deaths of U.S. hospitalized U.S. patients.

https://bit.ly/2xroc8A

Astellas gets FDA priority review for leukemia med

 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, the company’s New Drug Application (NDA) for gilteritinib for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. Currently, there are no FLT3-targeting agents approved for the treatment of relapsed or refractory FLT3 mutation-positive (FLT3mut+) AML.

“FLT3 mutations impact approximately 30 percent of AML patients and are often associated with poor survival outcomes. Many with this condition relapse after treatment or don’t respond to currently available treatments. Simply put, they need more options,” said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. “The FDA’s acceptance of this NDA, with Priority Review, represents a significant milestone for gilteritinib and Astellas in our mission to help AML patients and the physicians who treat them.”

The NDA is based on the ongoing Phase 3 ADMIRAL trial investigating gilteritinib for the treatment of adult patients with FLT3mut+ relapsed or refractory AML. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is November 29, 2018.

The FDA grants Priority Review designation to applications for drugs that, if approved, may offer significant improvements in the safety and effectiveness of the treatment of serious conditions when compared to standard applications. Under Priority Review, the FDA aims to take action on an application within six months of NDA filing, as compared to ten months under standard review.

Previously, gilteritinib was granted both Orphan Drug designation and Fast Track designation by the U.S. FDA. Gilteritinib also received Orphan Designation from the European Commission (EC) and Orphan Drug Designation from the Japan Ministry of Health, Labor and Welfare (MHLW). The MHLW also granted SAKIGAKE designation to gilteritinib for relapsed/refractory AML.

https://bit.ly/2LEwEEB

Axovant Completes Reorganization, Adds to Management Team

After Axovant Sciences’ spectacular clinical trial failure in September 2017, the company has been reorganizing. Today it announced it had completed that reorganization by adding to its executive team and Scientific Advisory Board.

Axovant is one of Vivek Ramswamy’s biotech companies. It was built around the drug intepirdine for Alzheimer’s disease, which it acquired for $5 million from GlaxoSmithKline. The drug had a favorable safety and tolerability profile, and in a Phase IIb clinical trial, showed immediate and sustained efficacy over placebo. But it had been abandoned by GSK after four failed clinical trials. Ramaswamy believed the company could revitalize the drug in a narrower patient population.

However, the drug failed to meet its co-primary efficacy endpoints in the Phase III trial, with the company stating there was “essentially no difference between the intepirdine and placebo arms in change from baseline in activities of daily living.”

In April 2017, David Hung, the founder, president and chief executive officer of Medivation,took over Axovant as chief executive officer. He had sold Medivation to Pfizer in September 2016 for $14 billion.

Not long after the clinical trial failure, Hung stepped down, replaced by Pavan Cheruvu in February 2018.

As part of today’s announcement, Gavin Corcoran will join Axovant as executive vice president of Research & Development. Michael Hayden has been appointed senior scientific advisor and chairman of the newly established Scientific Advisory Board.

Corcoran is currently chief medical officer at Allergan. He was previously chief medical officer of Actavis. Hayden most recently was president of Global R&D and chief scientific officer at Teva.Prior to Teva, he founded Aspreva Pharmaceuticals and several other biotech companies.

“I am pleased to welcome Gavin and Michael to the Axovant team,” Cheruvu said in a statement. “Since starting as CEO in February, I have been focused on transforming Axovant into a leaner organization, introducing heightened standards of quality and excellence throughout the business, and establishing a new pipeline strategy. We are now poised for growth, and I am excited to have Gavin and Michael join us as we look forward to expanding our pipeline in the coming months.”

Axovant began its reorganization in February 2018 with the goal of simplifying its structure, cutting costs and streamline business processes. It cuts its internal headcount by about 43 percent and “increased the use of the Roivant platform to supplement internal capabilities,” whatever that means. Most of the staffers affected by the cuts transferred to other positions at the Roivant family of companies.

“Roivant supports Axovant’s plans for pipeline expansion and organizational transformation,” Ramaswamy said in a statement. “We are committed to hiring and developing high-caliber talent, and we were pleased to support many of Axovant’s employees in finding new roles within the Vant family. I am excited about the new direction that Axovant is taking.”

Axovant currently has two compounds it is developing. They are nelotanserin, a highly selective inverse agonist of the 5HT2A receptor and RVT-104, an early-stage asset. Nelotanserin is being evaluated in patients with Dementia with Lewy bodies (DLB) or Parkinson’s Disease Dementia (PDD) who are experiencing REM sleep behavior disorder (RBD). RVT-104 is a proposed combination of a higher than presently approved dose of cholinesterase inhibitor rivastigmine and a peripherally active muscarinic receptor antagonist. It is being studied as a possible treatment for Alzheimer’s disease and dementia with Lewy bodies.

https://bit.ly/2shfynT

Genmab and Johnson & Johnson Halt Lung Cancer Study

Genmab A/S, based in Copenhagen, Denmark, and U.S.-based Johnson & Johnson’s Janssendivision have pulled the plug on the Phase Ib/II trial of daratumumab in combination withRoche’s Tecentriq (atezolizumab) in patients with advanced or metastatic non-small cell lung cancer.

The action followed a planned review by a Data Monitoring Committee (DMC). In addition, a Phase I MMY2036 trial of daratumumab plus JNJ-63723283, an anti-PD-1 antibody in multiple myeloma is being discontinued.

The committee decided there was no observed benefit in the combination treatment arm, daratumumab with atezolizumab over atezolizumab alone. The DMC also observed a numerical increase in mortality-related events in the combination arm.

In the trial, CALLISTO/LUC2001, daratumumab in combination with atezolizumab was being compared to atezolizumab monotherapy alone. Genma granted Janssen the exclusive worldwide license to develop, manufacture and commercialize daratumumab in August 2012.

“While we are disappointed that the studies will be discontinued, Genmab fully supports Janssen’s decision as patient safety is paramount in drug development,” said Jan van de Winkel, Genmab’s chief executive officer, in a statement. “We look forward to gaining a better understanding of the data upon further analysis. We are pleased that the development program for daratumumab remains expansive and continues to benefit patients with multiple myeloma.”

Genmab shares dropped as much as 25 percent in early trading as a result of the announcement.

Reuters noted, “The potential to use Darzalex, a key treatment in multiple myeloma, in solid tumors was eagerly awaited and some analysts had seen the outcome of the study as this year’s biggest price trigger for the stock.”

“Investors should not hope for a further adventure for Darzalex in solid tumors,” Soren Lontoft,an analyst with Sydback wrote, reported Reuters.

Daratumumab is marketed under the trade name Darzalex. It is dosed as an intravenous infusion. In the U.S., it is prescribed in combination with bortezomib, melphalan and prednisone to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant. It is also indicated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, to treat MM in patients who have received at least one prior therapy, in combination with pomalidomide and dexamethasone to treat MM patients who have received at least two previous therapies, including lenalidomide and a proteasome inhibitor. It is also indicated as a monotherapy for patients with MM who have received at least three previous lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.

MorphoSys, a primary competitor in the space, is suing both companies, alleging that daratumumab infringes on the company’s patent for a drug targeting the same antigen. The trial is scheduled for August in the state of Delaware. Last year, GenMab and J&J also discontinued developing daratumumab for non-Hodgkin’s lymphoma after it did not improve patient health in a Phase II clinical trial.

However, in a Phase III trial wrapped up last year, daratumumab with chemotherapy cut the progression of MM and deaths from the disease by 50 percent compared to chemotherapy on its own.

https://bit.ly/2LFmGCW

Evolus Appoints Veteran Healthcare Executive Lauren Silvernail CFO

Evolus, Inc. (EOLS) (“Evolus” or the “Company”), a premiere aesthetics company, today announced the appointment of Lauren Silvernail as Chief Financial Officer and Executive Vice President, Corporate Development. Mrs. Silvernail joins Evolus from Revance Therapeutics where she most recently served as Chief Financial Officer and Chief Business Officer. At Revance she successfully led multiple capital raises and executed a number of the company’s pre-commercial strategies.

Prior to her time at Revance Therapeutics, Mrs. Silvernail was Chief Financial Officer and Vice President, Corporate Development at ISTA Pharmaceuticals Inc. working to grow the business from development stage through commercialization and into profitability until its acquisition by Bausch + Lomb. Prior to ISTA, Mrs. Silvernail served in various operating and corporate development positions for Allergan, most recently as Vice President of Business Development, where she led and closed acquisitions, licensing and commercial co-promotion transactions.

David Moatazedi, President and Chief Executive Officer of Evolus, stated, “I welcome Lauren to Evolus as her appointment further strengthens our executive leadership team and represents a critical milestone for the Company ahead of commercialization. Lauren brings extensive category experience and deep financial, operational, commercial, and corporate development expertise as we prepare to bring our first product candidate to market.”

Lauren Silvernail, Chief Financial Officer and Executive Vice President, Corporate Development of Evolus, said, “I am excited to join Evolus at this critical juncture in the evolving competitive landscape of the neurotoxin market. I am confident that my diverse background in healthcare will meaningfully complement the team as we move to execute on the Evolus vision to build a dynamic and customer centric dedicated aesthetics platform company.”

Earlier in her career Mrs. Silvernail was a partner in a seed venture capital fund and held marketing roles of increasing responsibility at Bio-Rad Laboratories and Varian Associates. She holds an MBA in Finance and Accounting from Anderson Graduate School of Management at UCLA and a BA in Biophysics from University of California, Berkeley.

https://yhoo.it/2ISM3Dw

Quest upped to buy by Morgan Stanley

Quest Diagnostics upgraded to Overweight from Equal Weight at Morgan Stanley

https://bit.ly/2smhQkZ