The Daily Biotech Pulse: FDA Nod For Novocure, Dynavax Restructures, Therapix Receives Nasdaq Notice

The following is a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs May 23.)

• ArQule, Inc. ARQL
• Turning Point Therapeutics Inc TPTX (went public April 17)

Down In The Dumps

(Biotech stocks that hit 52-week lows May 23.)

• Abeona Therapeutics Inc ABEO
• Adamis Pharmaceuticals Corp ADMP
• Aethlon Medical, Inc. AEMD
• Alkermes Plc ALKS
• Allena Pharmaceuticals Inc ALNA
• ANCHIANO THERAP/S ADR ANCN
• Arbutus Biopharma Corp ABUS
• Bellicum Pharmaceuticals Inc BLCM
• Biopharmx Corp BPMX
• Capricor Therapeutics Inc CAPR
• Heat Biologics Inc HTBX
• Minerva Neurosciences Inc NERV
• Myriad Genetics, Inc. MYGN
• OncoSec Medical Inc ONCS
• Organovo Holdings Inc ONVO (reacted to fourth-quarter results and an extended timeline for its liver tissue patch)
• Osmotica Pharmaceuticals PLC OSMT
• T2 Biosystems Inc TTOO
• Teva Pharmaceutical Industries Ltd TEVA
• Teligent Inc TLGT
• TherapeuticsMD Inc TXMD
• Theravance Biopharma Inc TBPH
• Tocagen Inc TOCA
• Xenetic Biosciences Inc XBIO

Stock In Focus

Novocure's Cancer Treatment System For Pleural Mesothelioma Passes FDA Muster

Novocure Ltd NVCR said the FDA has approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic pleural mesothelioma, or MPM — a cancer of the pleura, the protective lining of the lung.

NovoTTF-100L is a non-invasive, antimitotic cancer treatment that delivers tumor treating fields to the region of the tumor. It uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.

"NovoTTF-100L is the first treatment for MPM approved by the FDA in more than 15 years," Novocure said.

The stock rallied 5.46 percent to $51.99 in after-hours trading.

Dynavax To Restructure Operations To Focus On Vaccine Business, Trim 82 Jobs

Dynavax Technologies Corporation DVAX announced a strategic restructuring to prioritize its vaccine business, with a focus on its first commercial product: Heplisav, a hepatitis B vaccine.

As part of the restructuring action, the company said it will explore strategic options for its immuno-oncology portfolio and  eliminate 82 jobs, or 37 percent of its U.S. workforce.

CEO Eddie Gray also announced his plan to retire as CEO and a director of the board effective Aug. 1.

Dynavax's board created an interim office of president and appointed David Novack, a senior vice president of operations and Ryan Spencer, a senior vice president for commercial, as co-presidents effective immediately. The company is initiating a search for a new CEO.

The stock fell 8.66 percent to $5.80 in after-hours trading.

Therapix Receives Nasdaq Notification For Flouting Continued Listing Standards Rule

THERAPIX BIOSCI/S ADR TRPX, a specialty pharma company focused on cannabinoid-based treatment, said it has received a written notification from the Nasdaq informing the company that the stockholders' equity does not comply with the minimum $2.5-million stockholders' equity requirement for continued listing.

The company said it has until July 5 to resolve the issue. The company is eligible for a 180-day period extension from the date of notification for providing evidence of compliance.

The stock slipped 9.09 percent to $3 in after-hours trading.

MiMedx Says Independent Audit Committee Confirms Malpractice

Following the conclusion of a 15-month investigation by an independent audit committee on certain sales and distribution practices, MiMedx Group Inc MDXG said it concluded that, as previously announced, the financial statements for fiscal years 2012-2016 and three quarters of 2017 will need to be restated.

The former executive team — including former COO Parker Petit, former CFO Michael Senken and former Controller John Cranston — were in the know of improprieties in the company's dealings with its largest distributor made material restatements and omissions to key stakeholders, according to MiMedx. 

Petit was also found to order the recording of interviews and employee discussions without their consent to penalize potential whistleblowers, the company said. 

The stock rose 0.88 percent to $2.30 in after-hours trading.

On The Radar

PDUFA Dates

The FDA is set to rule on Incyte Corporation INCY and Novartis AG NVS's sNDA for Jakafi for the expanded indication of treating patients with acute graft-versus-host disease, or GVHD, who have had an inadequate response to corticosteroids.

Related Links:

Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates

The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trial Readouts And IPOs