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 (NASDAQ: AGRX (announced the appointment of healthcare industry veteran Kimberly Whelan as VP, Market Access, as it prepares for a potential Twirla commercial launch)
- Aimmune Therapeutics Inc (NASDAQ: AIMT)
- Applied Therapeutics Inc (NASDAQ: APLT)
- Ascendis Pharma A/S (NASDAQ: ASND)
- Biondvax Pharmaceuticals Ltd – ADR (NASDAQ: BVXV)
- Cassava Sciences Inc (NASDAQ: SAVA)
- ChemoCentryx Inc (NASDAQ: CCXI)
- DBV TECHNOLOGIE/S ADR (NASDAQ: DBVT)
- Epizyme Inc (NASDAQ: EPZM)
- Esperion Therapeutics Inc (NASDAQ: ESPR)
- Fortress Biotech (NASDAQ: FBIO)
- INNATE PHARMA S/S ADR (NASDAQ: IPHA)(announced EMA acceptance of regulatory application for drug to treat hairy cell leukemia)
- The Medicines Company (NASDAQ: MDCO)
- Mesoblast limited (NASDAQ: 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 (NASDAQ: MRTX)
- Nevro Corp (NYSE: NVRO)
- NuVasive, Inc. (NASDAQ: NUVA)
- Otonomy Inc (NASDAQ: OTIC)
- Syneos Health Inc (NASDAQ: SYNH)
- Urovant Sciences Ltd (NASDAQ: UROV)
- Veru Inc (NASDAQ: VERU)
- West Pharmaceutical Services Inc. (NYSE: WST)
- Zoetis Inc (NYSE: ZTS)
Down In The Dumps
(Biotech stocks hitting 52-week lows on Jan. 2)
- Alterity Therapeutics Ltd (NASDAQ: ATHE)
- Evelo Biosciences Inc (NASDAQ: EVLO)
- Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI)
- Stealth BioTherapeutics Corp (NASDAQ: MITO)
- Wave Life Sciences Ltd (NASDAQ: WVE)
- Xeris Pharmaceuticals Inc (NASDAQ: XERS)
Stocks In Focus Acorda Gains After Hedge Fund Hikes Stake
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 (NASDAQ: 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.
Illumina, Pacific Biosciences Terminate $1.2B Merger Agreement
Illumina, Inc. (NASDAQ: ILMN) and Pacific Biosciences of California (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NYSE: 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 (NYSE: 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.
See more from Benzinga
- The Daily Biotech Pulse: Canadian Approval For Amarin's Vascepa, Innate Pharma's Blood Cancer Drug Accepted For Review In Europe
- Week Ahead In Biotech: PDUFA Date Ahead For Astra Zeneca, Merck's Lynparza, Pending Clinical Readouts In Focus
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