The Daily Biotech Pulse: Acorda Surges As Point72 Hikes Stake, Novan Sinks On Failed Study, Illumina-Pac Bio Terminate Merger

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 Jan. 2)

• Agile Therapeutics Inc AGRX Market Access, as it prepares for a potential Twirla commercial launch)
• Aimmune Therapeutics Inc AIMT
• Applied Therapeutics Inc APLT
• Ascendis Pharma A/S ASND
• Biondvax Pharmaceuticals Ltd – ADR BVXV
• Cassava Sciences Inc SAVA
• ChemoCentryx Inc CCXI
• DBV TECHNOLOGIE/S ADR DBVT
• Epizyme Inc EPZM
• Esperion Therapeutics Inc ESPR
• Fortress Biotech FBIO
• INNATE PHARMA S/S ADR IPHA(announced EMA acceptance of regulatory application for drug to treat hairy cell leukemia)
• The Medicines Company MDCO
• Mesoblast limited MESO(announced submission of safety and efficacy data as part of rolling BLA submission for remestemcell-L for the treatment of children with steroid-refractory acute graft versus host disease)
• Mirati Therapeutics Inc MRTX
• Nevro Corp NVRO
• NuVasive, Inc. NUVA
• Otonomy Inc OTIC
• Syneos Health Inc SYNH
• Urovant Sciences Ltd UROV
• Veru Inc VERU
• West Pharmaceutical Services Inc. WST
• Zoetis Inc ZTS

Down In The Dumps

(Biotech stocks hitting 52-week lows on Jan. 2)

• Alterity Therapeutics Ltd ATHE
• Evelo Biosciences Inc EVLO
• Spectrum Pharmaceuticals, Inc. SPPI
• Stealth BioTherapeutics Corp MITO
• Wave Life Sciences Ltd WVE
• Xeris Pharmaceuticals Inc XERS

Stocks In Focus

Acorda Gains After Hedge Fund Hikes Stake

Acorda Therapeutics Inc ACOR shares gained after hedge fund Point72 Asset Management led by Steven Cohen raised its stake in the company to 9.8%.

The stock gained 20.41% to $2.36 in after-hours trading.

Incyte's Graft-Versus-Host Disease Drug Fails to Meet Primary & Key Secondary Endpoints In Late-stage Study

Incyte Corporation INCY said a Phase 3 study dubbed GRAVITAS-301 that evaluated its itacitinib in combination with corticosteroids in patients with treatment-naïve graft-versus-host disease did not meet the primary endpoint of improving overall response rate at Day 28 compared to placebo plus corticosteroids.

The study also did not meet the key secondary endpoint, with no difference shown in non-relapse mortality at Week 6, the company added.

The stock slipped 10.08% to $77.30 in after-hours trading.

See Also: Attention Biotech Investors: Mark Your Calendar For These January PDUFA Dates

Illumina, Pacific Biosciences Terminate $1.2B Merger Agreement

Illumina, Inc. ILMN and Pacific Biosciences of California PACB said they have mutually agreed to terminate their $1.2 billion all-cash merger agreement announced Nov. 2018. The companies cited the lengthy regulatory process and continued uncertainty of the ultimate outcome as reasons for the snapping of the deal.

Illumina said it would pay Pac Bio a termination fee of $98 million.

Nuvasive Appoints New CFO, Reaffirms FY19 Guidance

Nuvasive said it has appointed Matthew Harbaugh as EVP and CFO, effective immediately, following the incumbent Rajesh Asarpota transitioning from the company. The company also reaffirmed its full-year guidance.

Chembio Expects FDA Approval For its HIV, Syphilis Screening Test In Q1'20

Chembio Diagnostics Inc CEMI said it anticipates FDA approval for its DPP HIV-Syphilis System, which includes the DPP HIV-Syphilis test and DPP Micro Reader, during the first quarter of 2020. The company added its clinical study demonstrated that the system met the performance requirements established with the FDA.

DPP HIV-Syphilis System is a single-use, 15-minute screening test for the simultaneous detection of antibodies to HIV types 1 and 2 and the bacteria that causes syphilis, Treponema pallidum.

The stock rallied 19.30% to $5.44 in after-hours trading.

Novan's Viral Skin Infection Treatment Fails In Late-Stage Trial

Novan Inc NOVN released top-line efficacy results from the Phase 3 B-SIMPLE program that evaluated SB206 for the treatment of molluscum contagiosum, which showed that statistical significance was not achieved for the primary endpoint in either B-SIMPLE1 or B-SIMPLE2.

However, the company said sensitivity analyses are supportive and consistent across both studies, supporting a path forward. The company now awaits 24-week safety data from the two trials.

The stock plunged 72.67% to 85 cents in after-hours trading.

DBV Appoints Ramzi Benamar as CFO

DBV announced the appointment of Ramzi Benamar as its CFO, effective Jan. 6, taking over the responsibility from Sebastien Robitaille, who was holding the role on an interim basis since Aug. 2019.

OncoCyte Announces $7.6M Registered Common Stock Offering

OncoCyte Corp OCX has entered into a definitive agreement with Pura Vida Investments and another institutional investor to purchase about $7.6 million of its common shares in a registered offering. In connection with the offering, the company said it will sell 3.524 million shares at $2.156 apiece. The offering is expected to close during the week of Jan. 6.

Transenterix Appoints Brett Farabaugh as Interim CFO

Transenterix Inc TRXC said it has appointed Brett Farabaugh as interim CFO, effective Jan. 2, replacing Joe Slattery, who retired Dec. 31.

The stock slipped 0.66% to $1.50 in after-hours trading.