The Daily Biotech Pulse: FDA Greenlights Pfizer-Merck KGAa's Kidney Cancer Combo Treatment, Adcom Disappointment For Daiichi

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 May 14)

• Arena Pharmaceuticals, Inc. ARNA
• Avedro Inc AVDR
• Milestone Pharmaceuticals Inc MIST
• Silk Road Medical Inc SILK
• Zynex Inc. ZYXI

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 14)

• Auris Medical Holding Ltd EARS
• Foamix Pharmaceuticals Ltd FOMX
• Myovant Sciences Ltd MYOV (reported positive results for its menstrual bleeding drug, with investors apparently selling on competition concerns)
• Osmotica Pharmaceuticals PLC OSMT
• Sienna Biopharmaceuticals Inc SNNA

Stock In Focus

FDA Approves Pfizer's Inlyta In Combination With Bavencio For Kidney Cancer Drug

Pfizer Inc. PFE and MERCK KGAA/S ADR MKKGY unit EMD Serono announced FDA approval for Bavencio in combination with Inlyta for the first-line treatment of advanced renal cell carcinoma.

"This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC," the companies said.

The approval was based on positive results from the Phase 3 JAVELIN Renal 101 study.

Biogen Says U.K.'s NICE Recommends Funding For Spinraza

Biogen Inc BIIB said U.K.'s National Institute for Health and Care Excellence, or NICE, has recommended funding for its spinal muscular dystrophy, or SMA, drug Spinraza on the National Health Service. The recommendation is for treating infants, children and adults with 5q SMA, including pre-symptomatic and symptomatic SMA Types 1, 2 and 3, the company said.

Dr. Reddy's Launches Generic Version Of Merck's Antibiotic For Skin Infection

Dr.Reddy's Laboratories Ltd RDY announced the U.S. launch of Daptomycin injection, 500mg/vial single-dose vial, a generic version of Merck & Co., Inc. MRK's Cubicin, which is indicated to treat complicated skin and skin structure infection.

Cubicin's branded and generic version fetched sales of $640.8 million in the U.S. in the 12-months ended March 2019, the company said, citing IQVIA.

FDA Panel Votes Against Daiichi's AML Drug

DAIICHI SANKYO/S ADR DSNKY said the FDA's Oncologic Drugs Advisory Committee, which met Tuesday to discuss its NDA for quizartinib for treating adults with relapsed/refractory FLT3-ITD acute myeloid leukemia, or AML, voted 8 to 3 that safety risks outweigh benefits. The PDUFA date has been set for Aug. 5.

Earnings

ENDRA Life Sciences Inc NDRA reported no revenues for the first quarter of 2019 compared to revenues of $6,174 for the year-ago period. The net loss, however, narrowed from 72 cents to 37 cents. The loss was wider than the consensus loss estimate of 30 cents per share.

The stock fell 10.95 percent to $1.22 in after-hours trading.

On The Radar

Clinical Trial Readouts

Online abstracts of data to be presented at the American Society of Clinical Oncology Meeting (May 31-June 4) will be made available at 5 p.m. ET. Some of the key abstracts in focus will be:

Amgen, Inc. AMGN – Phase 1 data for AMG 510 in solid tumors; Mirati Therapeutics Inc MRTX, which has a competing pipeline asset in MRTX849 will also be in focus, although Phase 1/2 data for it not expected until the second half of 2019.

Roche Holdings AG Basel ADR RHHBY – Entrectinib (central nervous system tumors with gene mutations)

Celgene Corporation CELG and Bristol-Myers Squibb Co BMY – Liso-cel (chronic lymphocytic leukemia )

Earnings

• Vascular Biogenics Ltd VBLT (before the market open)
• Rubius Therapeutics Inc RUBY (before the market open)
• Achieve Life Sciences Inc ACHV (after the close)
• Edap Tms SA EDAP (after the close)
• Titan Pharmaceuticals, Inc. common stock TTNP (after the close)
• Precision Therapeutics Inc AIPT (after the close)
• Altimmune Inc ALT