The Daily Biotech Pulse: EC Approves Roche's Tecentriq For Breast Cancer, Trevena On Track For NDA Resubmission, Edap 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 Aug. 28)

• Turning Point Therapeutics Inc TPTX

Down In The Dumps

(Biotech stocks hitting 52-week lows on Aug. 28)

• Agios Pharmaceuticals Inc AGIO
• Bicycle Therapeutics PLC BCYC
• Cancer Genetics Inc CGIX
• Capricor Therapeutics Inc CAPR
• ContraFect Corp CFRX
• Cumberland Pharmaceuticals, Inc. CPIX
• Esperion Therapeutics Inc ESPR
• Kezar Life Sciences Inc KZR
• Obalon Therapeutics Inc OBLN
• Protalix Biotherapeutics Inc PLX
• ProQR Therapeutics NV PRQR

Stocks In Focus

Judge Rules Amgen's Patent Claims On Cholesterol Drug Invalid

Regeneron Pharmaceuticals Inc REGN and Sanofi SA SNY announced the U.S. District Court of Delaware ruled that Amgen, Inc. AMGN's patent claims for antibodies targeting PCSK9 are invalid based on lack of enablement.

Regeneron and Sanofi have now successfully invalidated all five asserted Amgen patent claims.

Reata Apppoints Manmeet Soni As CFO

Reata Pharmaceuticals Inc RETA announced the appointment of Manmeet Soni as CFO and EVP, effective Aug. 28, as Jason Wilson who served as CFO is transitioning to the role of EVP Operations. Soni was earlier with Alnylam Pharmaceuticals, Inc. ALNY as its CFO.

See Also: Biotech Stock On The Radar: MyoKardia Bets On Precision Medicine For Heart Health

Trevena On Track To Submit Oliceridine NDA By Q1

Updating on activities to resubmit oliceridine NDA, Trevena Inc TRVN said it has completed enrollment for the ongoing healthy volunteer QT study and remains on track to support top-line data readout in the fourth quarter. The company also said it has completed the necessary nonclinical work to further characterize the 9662 inactive metabolite and has also finished the outstanding drug product validation reports identified in the CRL.

Trevena was handed down a CRL November 2018. The company hopes to refile the NDA as early as the first quarter of 2020.

The stock added 2.56% to 83 cents in after-hours trading.

EC Approves Roche's Tecentriq-Chemo Combo For First-line Treatment of Breast Cancer

Roche Holdings AG Basel ADR RHHBY announced the European Commission has approved Tecentriq plus chemotherapy – Abraxane - for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer, or TNBC, whose tumors have PD-L1 expression and who have not received prior chemotherapy.

The German pharma giant also said its Ventana PD-L1 Assay is now CE marked and commercially available in the EU as an aid for identifying patients with TNBC eligible for treatment with the Tecentriq combination.

Earnings

Edap Tms SA EDAP reported 45.1% year-over-year revenue growth to $14 million, and the company reversed to a profit of $1.6 million.

The stock jumped 15.12% to $3.99 in after-hours trading.

Ascendis Pharma A/S ASND's second-quarter revenues increased year-over-year from 18,000 euros in 2018 to 3.2 million euros in 2019. The net loss per share widened from 55 euro cents per share to 1.25 euros per share.

The stock rose 5% to $117.28 in after-hours trading.

On The Radar

PDUFA Dates

The FDA is scheduled to rule on Nektar Therapeutics NKTR's NDA for NKTR-181, a novel mu-opioid analgesic drug candidate, to treat chronic low back pain in adult patients new to opioid therapy.

The company communicated through a late-July filing postponement of a scheduled Adcom meeting, as the FDA continues to consider a number of scientific and policy issues relating to this class of drugs. Although the postponement is not unique to NKTR-181, the FDA said in the communication the PDUFA goal date may not be met.