The Daily Biotech Pulse: J&J Intensifies Efforts On COVID-19 Cure, Adamas Reports Positive, Long-Term Gocovri Data

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. 11)

• AbbVie Inc ABBV
• Acceleron Pharma Inc XLRN
• Agile Therapeutics Inc AGRX(announced securing of loan facility)
• Allergan plc AGN
• Akebia Therapeutics Inc AKBA
• Alnylam Pharmaceuticals, Inc. ALNY
• Ascendis Pharma A/S ASND
• AtriCure Inc. ATRC
• AVITA MED LTD/S ADR RCEL
• ChemoCentryx Inc CCXI
• Cue Biopharma Inc CUE
• Cytokinetics, Inc. CYTK
• Deciphera Pharmaceuticals Inc DCPH
• DexCom, Inc. DXCM
• Esperion Therapeutics Inc ESPR
• Fulgent Genetics Inc FLGT
• GALAPAGOS NV/S ADR GLPG
• Insulet Corporation PODD
• Masimo Corporation MASI
• Medpace Holdings Inc MEDP
• Momenta Pharmaceuticals, Inc. MNTA
• Nevro Corp NVRO
• Novartis AG NVS(announced priority review for its lung cancer drug)
• Pacira Biosciences Inc PCRX
• PAVmed Inc PAVM(PAVmed's EsoGuard Esophageal DNA test was accorded Breakthrough Device designation)
• Penumbra Inc PEN
• Principia Biopharma Inc PRNB
• PTC Therapeutics, Inc PTCT
• Seattle Genetics, Inc. SGEN(announced positive data readout for ADC in bladder cancer)
• Syneos Health Inc SYNH
• Vertex Pharmaceuticals Incorporated VRTX
• West Pharmaceutical Services Inc. WST
• Zai Lab Ltd ZLAB
• ZEALAND PHARMA/S ADR ZEAL
• Zoetis Inc ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Feb. 11)

• ADDEX THERAPEUT/ADR ADXN
• Brickell Biotech Inc BBI
• Endologix, Inc. ELGX
• Enzo Biochem, Inc. ENZ( received New York State approval for its gynecological tests on GenFlex platform)
• Evolus Inc EOLS
• GenMark Diagnostics, Inc GNMK
• Happiness Biotech Group Ltd HAPP
• Pacific Biosciences of California PACB
• PDS Biotechnology CorpPDSB (reacted to a common stock offering)
• Phio Pharmaceuticals Corp PHIO(priced its common stock offering of 2 million units at $4 per unit)
• Stealth BioTherapeutics Corp MITO
• Xeris Pharmaceuticals Inc XERS (announced a common stock offering of 6 million shares)

Stocks In Focus

J&J Steps Up Efforts to Develop COVID-19 Treatments and Vaccine

Johnson & Johnson JNJ said its Janssen unit will further expedite the development of its investigational COVID-19 vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority at the U.S. Department of Health & Human Sciences.

Apart from Janssen's efforts to develop a vaccine candidate, J&J said the unit will also work closely with global partners to screen its library of antiviral molecules to accelerate the discovery of potential COVID-19 treatments.

Adamas Announces Publication of Positive Results For Parkinson's Study

Adamas Pharmaceuticals Inc ADMS announced publication of final results from a two-year, open-label study of Gocovri extended release capsules in Parkinson's disease, showing a sustained improvement in levodopa-induced dyskinesia, or LID.

"This study further demonstrates that the only FDA-approved medicine for dyskinesia may help people with PD who are struggling to manage these levodopa-related motor complications over this long period of time," the company said.

The results were published online in the Journal of Parkinson's Disease.

The stock gained 4.28% to $5.85 in after-hours trading.

Lily-Incyte's Eczema Drug Aces Late-Stage Study

Eli Lilly And Co LLY and Incyte Corporation INCY announced baricitinib, an oral selective JAK inhibitor, met the primary endpoint in a Phase 3 study dubbed BREEZE-AD5 that evaluated the investigational therapy for the treatment of adults with moderate-to-severe atopic dermatitis.

The primary endpoint was the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index, or EASI, at Week 16.

FDA Accepts For Review FibroGen's Drug To Treat Chronic Kidney Disease-Related Anemia

FibroGen Inc FGEN said the FDA has accepted its NDA for roxadustat for the treatment of anemia of chronic kidney disease in both non-dialysis dependent and dialysis-dependent patients. The FDA has set a PDUFA date of Dec. 20, 2020.

The stock added 4.41% to $46.60 in after-hours trading.

Earnings

EXACT Sciences Corporation EXAS reported fourth-quarter revenues of $295.58 million, up from $142.98 million a year ago. Screening revenues climbed 60% to $229.4 million and test volume was up 63% to 477,000. The company reversed to a profit of 54 cents per share from a loss of 44 cents per share, while analysts estimated a loss of 35 cents per share.

For 2020, the company guided to revenues of $1.61 billion to $1.645 billion, ahead of the $1.59 billion consensus estimate.

The stock slipped 0.83% to $94.

Offerings

PDS Biotechnology said it has priced its underwritten public offering of 9.23 million shares at $1.30 per share. The company expects to raise gross proceeds of $12 million, with the offering expected to close Friday.

The stock plunged 24.16% to $1.35 in after-hours trading.

Zosano Pharma Corp ZSAN announced the commencement of an underwritten public offering of units comprising shares of its common stock and warrants to purchase its common stock. All the units are to be sold by the company.

The stock slipped 21.78% to 75 cents in after-hours trading.

On The Radar

Clinical Readouts

At the 2020 WORLDSymposium, Regenxbio Inc RGNX will make poster presentation of interim data from the Phase 1/2 trial of its investigational gene therapy RGX-121 for the treatment of Mucopolysaccharidosis Type II. The presentation is scheduled at the WORLDSymposium for Wednesday between 4:30 and 6:30 p.m. ET.

Avrobio Inc AVRO is due to present at the WORLDSymposium updated Phase 2 data for AVR-RD-01 in Fabry disease.

Earnings

Kala Pharmaceuticals Inc KALA (before the market open)
Veru Inc VERU (before the market open)