The Daily Biotech Pulse: Bristol-Myers Squibb's Lung Cancer Readout, Positive News From Masimo, Integra Lifesciences

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 Oct. 6)

• 10X Genomics Inc TXG
• Aclaris Therapeutics Inc ACRS
• Arena Pharmaceuticals, Inc. ARNA
• BioLife Solutions Inc BLFS
• Blueprint Medicines Corp BPMC
• CareDx Inc CDNA
• Castle Biosciences Inc CSTL
• Celldex Therapeutics, Inc. CLDX
• CTI BioPharma Corp CTIC
• CymaBay Therapeutics Inc CBAY
• Eidos Therapeutics Inc EIDX
• Fate Therapeutics Inc FATE
• Inspire Medical Systems Inc INSP
• InVitae Corp NVTA
• Kura Oncology Inc KURA
• Mirati Therapeutics Inc MRTX
• Novocure Ltd NVCR
• Pacific Biosciences of California Inc PACB
• Prelude Therapeutics Inc PRLD
• ProPhase Labs Inc PRPH
• Qiagen NV QGEN
• Repligen Corporation RGEN
• TG Therapeutics Inc common stock TGTX
• Turning Point Therapeutics Inc TPTX
• Twist Bioscience Corp TWST
• Vericel Corp VCEL
• West Pharmaceutical Services Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 6)

• Corbus Pharmaceuticals Holdings Inc CRBP (reacted to negative results for a mid-stage study of lenabasum in cystic fibrosis patients)
• Dyne Therapeutics Inc DYN
• Outset Medical Inc OM
• Teligent Inc TLGT

Stocks In Focus

Integra LifeSciences' Preliminary Q3 Revenues Exceed Estimate

Medtech company Integra Lifesciences Holdings Corp IART preannounced third-quarter results, expecting revenues of $368 million to $370 million, down about 2.7%, but exceeding the company's guidance provided at the second-quarter earnings call in August. Analysts, on average, estimate revenues of $342.51 million for the quarter.

The stock added 5.72% to $51.60 in after-hours trading.

Pluristem Expands Mid-stage European Study of PLX Cells In COVID Patients To Israel

Pluristem Therapeutics Inc. PSTI said it has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for its COVID-19 Phase 2 clinical trial, under the protocol that was approved by the Paul Ehrlich Institute, Germany's regulatory agency.

The company is evaluating PLX cells, which are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system's natural regulatory T cells and M2 macrophages, and thus may potentially reverse the dangerous overactivation of the immune system.

A total of 40 patients hospitalized with severe COVID-19 complicated by Acute Respiratory Distress Syndrome will be enrolled at clinical sites in Israel and Germany, Pluristem said.

Bristol-Myers Squibb's Opdivo-Chemo Combo Found Effective In Neoadjuvant Setting For Treating Non-small Cell Lung Cancer

Bristol-Myers Squibb Co BMY said the Phase 3 CheckMate -816 trial met a primary endpoint of pathologic complete response in resectable non-small cell lung cancer.

In the trial, significantly more patients treated with Opdivo plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone.

"CheckMate -816 is the first and only Phase 3 trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC," the company said.

The stock was up 1.11% to $58.38 in premarket trading.

Masimo Expects Q3, FY20 Revenues Above Consensus

Masimo Corporation MASI announced preliminary third-quarter results, expecting product revenue of $274 million to $278 million, representing 19.7% to 21.4% year-over-year growth. It expects full-year product revenues of $1.124 billion to $1.128 billion.

The consensus estimates call for third-quarter revenues of $246.16 million and full-year revenues of $1.08 billion.

Hologic COVID-19 Test Now Authorized to Test Asymptomatic Individuals

Hologic, Inc. HOLX said its Aptima SARS-CoV-2 assay, which initially received FDA's emergency use auhorization, has been authorized by the FDA now for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.

Abeon's Board Forms Special Committee to Assist Executive Leadership

Abeona Therapeutics Inc ABEO said its board has formed a special committee to oversee and advise the executive leadership team on operations, leveraging the respective medical, business development and financial expertise of its members. The committee, which consists of current board members, is also working closely with the executive leadership team to develop the company's strategic direction and leadership plan, it added.

Additionally, Abeona announced the appointment of Steven Rouhandeh as chairman of its board.

Earnings

Aytu Bioscience Inc's AYTU fourth-quarter revenues climbed 766% year-over-year to $14.9 million, exceeding the consensus estimate of $13.75 million. The company reported a narrower-than-expected loss of 3 cents per share.

The stock was slipping 8.27% to $1.22 in premarket trading.

Offerings

Guardant Health Inc GH announced the commencement of a proposed underwritten public offering of 7 million shares of its common stock being offered for sale by SoftBank Investment Advisers.

The stock slid 6.72% to $102.50 in after-hours trading.

SpringWorks Therapeutics Inc SWTX said it has commenced an underwritten public offering of $150 million worth of shares of its common stock. All of the shares in the offering will be sold by the company.

SpringWorks shares shed 3.95% to $49.82 in after-hours trading.

On The Radar

Clinical Readouts

Eyenovia Inc EYEN is scheduled to present at the American Academy of Optometry's annual meeting updates on the CHAPERONE study that evaluates low-dose atropine for the reduction of pediatric myopia progression and the VISION study that evaluates low-dose pilocarpine for improvement in near vision.