The Daily Biotech Pulse: Tonix Gets European Patent, EC Nod For Roche, Insys Earnings

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks hitting 52-week highs on March 7)

• CareDx Inc CDNA (reacted to its fourth-quarter results released ahead of the market open)
• Stealth BioTherapeutics Corp MITO
• Uniqure NV QURE

Down In The Dumps

(Biotech stocks hitting 52-week lows on March 7)

• AMAG Pharmaceuticals, Inc. AMAG
• Aptevo Therapeutics Inc APVO(priced its common stock offering of 22 million shares and warrantS)
• Aptinyx Inc APTXAGN reporting disappointing results for its major depressive disorder drug, which it had purchased from Aptinyx)
• Chimerix Inc CMRX
• CytomX Therapeutics Inc CTMX
• DelMar Pharmaceuticals Inc DMPI
• Enochian Biosciences Inc ENOB(reported a patient in London was successfully treated with its investigational curative drug for HIV)
• Harpoon Therapeutics Inc HARP
• Hoth Therapeutics Inc HOTH
• Evolent Health Inc EVH
• MEDNAX Inc MD
• Novavax, Inc. NVAX
• Soligenix, Inc. Common Stock SNGX
• Sorrento Therapeutics Inc SRNE
• Unity Biotechnology Inc UBX
• Urogen Pharma Ltd URGN
• Viveve Medical Inc VIVE

Related Link: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

Stock In Focus

FDA Accepts Sanofi's sBLA For Expanded Use of Dupixent to Treat Sinus

Sanofi SA SNY and Regeneron Pharmaceuticals Inc REGN said the FDA has accepted for priority review their sBLA for Dupixent, which is being evaluated as an add-on maintenance therapy in adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps. The PDUFA date has been set for June 26.

Dupixent has already been approved for eczema and moderate-to-severe asthma.

Roche's Gets EC Nod For Tecentriq-Avastin-Chemo Combo For First-line Treatment of Lung Cancer

Roche Holdings AG Basel ADR RHHBY said the European Commission approved its Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with metastatic non-small cell lung cancer, or NSCLC. This combination has already been approved for people with EGFR mutant or ALK-positive NSCLC, only after the failure of appropriate targeted therapies.

See Also: Bio-Path Jumps Nearly 600% In 2 Days: What You Need To Know

Tonix Gets European Patent For Use of Its TNX-601

Tonix Pharmaceuticals Holding Corp TNXP said the European Patent Office issued a patent to the use of its TNX-601, or tianeptine oxalate, and other salts for treating neurocognitive dysfunction associated with corticosteroid treatment.

The patent is expected to bestow Tonix with market exclusivity until April 2029.

The stock jumped 19.16 percent to $2.55 in after-hours trading.

Ardelyx Announces Publication of Positive Data for End-stage Renal Disease Drug

Ardelyx Inc ARDX announced the publication in the Journal of the American Society of Nephrology results from the first of two Phase 3 pivotal trials for tenapanor to treat hyperphosphatemia in patients with end-stage renal disease who are on dialysis. The published results showed that 164 patients, who completed treatment in one of the three randomized dosing groups, demonstrated a significant decrease in serum phosphate, with mean reduction of 1.0-1.2 mg/dL over 8 weeks.

The company said it expects to receive results from a second monotherapy Phase 3 trial, dubbed, PHREEDOM, in the fourth quarter of 2019. It also expects to receive results from a Phase 3 trial, dubbed AMPLIFY, that is evaluating a combination regimen of tenapanor with phosphate binders in the second half of 2019.

The stock moved up 8.02 percent to $3.50 in after-hours trading.

Immutep Reports Positive Preclinical Data For Autoimmune Disorder Drug

IMMUTEP LTD/S ADR IMMP announced positive results from its preclinical study of IMP761, a novel LAG-3 agonist antibody being developed for the treatment of autoimmune diseases. The results were presented at the 14th Congress of European Crohn's and Colitis Organisation Conference in Denmark.

The stock gained 4.80 percent to $2.40 in after-hours trading.

Earnings

T2 Biosystems Inc TTOO reported a 6 percent year-over-year increase in fourth-quarter revenues to $1.8 million. The net loss per share narrowed from $1.94 to $1.26. For 2019, the company expects revenues to double from the $10.5 million in 2018.

The stock retreated 8.28 percent to $2.88 in after-hours trading.

AcelRx Pharmaceuticals Inc ACRX reported a fourth-quarter loss of 18 cents per share compared to the year-ago loss of 20 cents per share. Analysts had expected a wider loss of 20 cents per share.

The company increased its expected number of formulary approval wins by the end of 2019 from 100 to 125. The company also announced the commercial launch of its pain management medication Dsuvia, which was approved in November.

The stock declined 7.98 percent to $3.46 in after-hours trading.

Syndax Pharmaceuticals Inc SNDX reported a fourth-quarter loss of 70 cents, wider than the 67 cents per share loss expected by analysts.

The stock slipped 11.48 percent to $5.55 in after-hours trading.

Insys Therapeutics Inc INSY reported a wider-than-expected loss for its fourth-quarter and a year-over-year decline in its revenues from $31.5 million to $16.4 million, with the drop attributed to declines in the TIRF market.

Meanwhile, the Reuters reported that Insys has hired Lazard to advise it on its plan to explore strategic options. The company also said it is in talks with multiple parties for the potential divestiture of Subsys.

The stock fell 12.15 percent to $4.99 in after-hours trading.

HTG Molecular Diagnostics Inc HTGM reported a 46 percent jump in fiscal year 2018 revenues to $21.5 million. The net loss per share narrowed from $1.79 to 60 cents. The company guided first-quarter revenues to $2.5 million to $3 million and full-year 2019 revenues to $23 million to $28 million.

The stock slumped 12.64 percent to $2.28 in after-hours trading.

On The Radar

Earnings

• Allogene Therapeutics Inc ALLO
• Eloxx Pharmaceuticals Inc ELOX
• PLx Pharma Inc PLXP
• Aldeyra Therapeutics Inc ALDX
• Conatus Pharmaceuticals Inc CNAT
• Mersana Therapeutics Inc MRSN