The Daily Biotech Pulse: FDA Snub For Merck, Priority Review For Roche's Tecentriq sBLA

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 Feb. 18)

• Adverum Biotechnologies Inc ADVM
• Anavex Life Sciences Corp AVXL
• Aptose Biosciences Inc APTO
• AtriCure Inc. ATRC
• Bellerophon Therapeutics Inc BLPH ( reported positive mid-stage results for its hypertension drug)
• Bicycle Therapeutics PLC BCYC
• BioXcel Therapeutics Inc BTAI(announced initiation of Phase 2 study to measure biomarkers associated with agitation in patients with schizophrenia and the response to treatment with BXCL501)
• Bio-Rad Laboratories, Inc. BIO
• Cytokinetics, Inc. CYTK
• DexCom, Inc. DXCM
• Fate Therapeutics Inc FATE
• Fulgent Genetics Inc FLGT
• GALAPAGOS NV/S ADR GLPG
• Grifols SA - ADR ADR Class B GRFS(announced signing of non-binding term sheet with the public investment fund of Saudi Arabia to develop a plasma collection network, a plasma fractionation facility and a purification plant)
• Halozyme Therapeutics, Inc. HALO
• Insulet Corporation PODD
• Momenta Pharmaceuticals, Inc. MNTA
• NeoGenomics, Inc. NEO
• Nevro Corp NVRO
• PAVmed Inc PAVM
• Penumbra Inc PEN
• PTC Therapeutics, Inc. PTCT
• ResMed Inc. RMD
• Scpharmaceuticals Inc SCPH
• Syneos Health Inc SYNH
• Tandem Diabetes Care Inc TNDM
• TELA Bio Inc TELA
• TG Therapeutics Inc TGTX

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Feb. 18)

• Enzo Biochem, Inc. (NYSE: ENZ
• AcelRx Pharmaceuticals Inc ACRX
• ADDEX THERAPEUT/ADR ADXN
• AngioDynamics, Inc. ANGO
• GenMark Diagnostics, Inc GNMK
• Lantheus Holdings Inc LNTH
• Medigus Ltd. MDGS
• Revolution Medicines Inc RVMD(IPOed Thursday)
• Sellas Life Sciences Group Inc SLS
• Tonix Pharmaceuticals Holding Corp TNXP

Stocks In Focus

FDA Rejects Merck's Application For Keytruda Dosing Frequency Updation

Merck & Co., Inc. MRK said the FDA handed down a complete response regarding its sBLAs, seeing updation of dosing frequency for its anti-PD-1 therapy Keytruda, to include a 400mg dose infused over 30 minutes every-six-weeks option in multiple indications.

The company said it's reviewing the letter and will discuss the next steps with the FDA.

Roche sBLA for Tecentriq Label Expansion to Treat Lung Cancer Accepted For Priority Review

Roche Holdings AG Basel ADR Common Stock RHHBY said the FDA has accepted its sBLA, granting Priority Review for Tecentriq as a first-line monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.

The company said the FDA is expected to make a decision on approval by June 19.

Mereo Announces $3M Investment By Institutional Investor

MEREO BIOPHARMA/ADR MREO has entered into a securities purchase agreement with new U.S.-based institutional health care investor, which has agreed to make a $3 million investment in the company by purchasing 2.45 million ADSs at a price equivalent to 18.8 pence per share, representing a 20% discount over Mereo's closing price of 23.5 pence on AIM Feb. 18.

Immutep's Lead Drug Shows Promise In Midstage Study of Lung Cancer and Head & Neck Cancer

IMMUTEP LTD/S ADR IMMP announced imterim data from its ongoing Phase 2 TACTI-002 study that evaluated its lead product candidate eftilagimod alpha in combination with Keytruda, showing encouraging overall response rates, or ORR, from stage 1 Parts A and C in first-line non-small cell lung cancer. The data was to be presented at the German Cancer Congress.

In second-line head and neck squamous cell carcinoma, the initial response rate was 33%, which the company termed as encouraging.

Earnings

10X Genomics Inc TXG reported a 49% year-over-year increase in fourth-quarter revenues to $50.6 million. The net loss per share narrowed from $5.40 to 7 cents. Analysts estimated a loss of 11 cents per share. The company guided full-year 2020 revenues to $350 million to $360 million, ahead of the $346.18 million consensus estimate.

The stock slipped 4.90% to $85.80 in after-hours trading.

ImmuCell Corporation ICCC said its fourth-quarter product sales climbed 24% to $3.63 million and the net loss per share narrowed from 19 cents to 6 cents.

The stock rose 4.67% to $5.60 in after-hours trading.

bluebird bio Inc's BLUE fourth-quarter revenues fell steeply and its loss per share widened.

The stock slipped 2.01% to $86.45 in after-hours trading.

Offerings

Twist Bioscience Corp TWST intends to offer up to $100 million shares of its common stock in an underwritten public offering.

The stock declined 3.47% to $29.50 in after-hours trading.

Catalent Inc CTLT said its wholly owned subsidiary Catalent Pharma Solutions intends to offer, subject to market conditions, 450 million euros in aggregate principal amount in a private offering.

On The Radar

Clinical Readouts

Cellectar Biosciences Inc CLRB will release updated Phase 2 data on CLR 131, which is being evaluated for various lymphoma. The company will also issue an update on Phase 1 data for the same asset in multiple myeloma.

Earnings

Elanco Animal Health Inc ELAN (before the market open)
Integra Lifesciences Holdings Corp IART (before the market open)
Endologix, Inc. ELGX (after the market close)
Anika Therapeutics Inc ANIK
Masimo Corporation MASI (after the market close)
InVitae Corp NYSE: (NVTA (after the market close)
OraSure Technologies, Inc. OSUR (after the market close)
Reata Pharmaceuticals Inc RETA (after the market close)