U.S. Markets open in 16 mins

The Daily Biotech Pulse: Viking's Fatty Liver And Cholesterol Drug, Cyclacel Loss Narrows, Eton's Debut

Shanthi Rexaline

Here's a roundup of top developments in the biotech space over the last 24 hours.

None of the Nasdaq-listed biotech stocks hit 52-week highs Nov. 12.

Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 12)

  • Abeona Therapeutics Inc (NASDAQ: ABEO)(reacted to its Q3 earnings and the earnings call)
  • Achaogen Inc (NASDAQ: AKAO)
  • Aclaris Therapeutics Inc (NASDAQ: ACRS)
  • Aduro BioTech Inc (NASDAQ: ADRO)
  • Aerie Pharmaceuticals Inc (NASDAQ: AERI)
  • Alkermes Plc (NASDAQ: ALKS)
  • Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)
  • Amicus Therapeutics, Inc. (NASDAQ: FOLD)
  • Atossa Genetics Inc (NASDAQ: ATOS)
  • Biocept Inc (NASDAQ: BIOC)
  • Cancer Genetics Inc (NASDAQ: CGIX)
  • Clearside Biomedical Inc (NASDAQ: CLSD)
  • Dova Pharmaceuticals Inc (NASDAQ: DOVA)
  • Endologix, Inc. (NASDAQ: ELGX)
  • Evelo Biosciences Inc (NASDAQ: EVLO)
  • Histogenics Corp (NASDAQ: HSGX)
  • Infinity Pharmaceuticals Inc. (NASDAQ: INFI)(reacted to data pertaining to the Phase 1 study of its IP1-549 in combination with Opdivo in treatment-resistant cancer patients who failed to respond to anti-PD-1/L1 therapy; The data was presented at the Society For Immunotherapy of Cancer, or SITC, 2018 meeting)
  • Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
  • Kala Pharmaceuticals Inc (NASDAQ: KALA)
  • Kodiak Sciences Inc (NASDAQ: KOD)
  • La Jolla Pharmaceutical Company (NASDAQ: LJPC)
  • Leap Therapeutics Inc (NASDAQ: LPTX)
  • Miragen Therapeutics Inc (NASDAQ: MGEN)
  • Neuralstem, Inc. (NASDAQ: CUR)
  • Oncomed Pharmaceuticals Inc (NASDAQ: OMED)
  • PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS)
  • Radius Health Inc (NASDAQ: RDUS)
  • Regulus Therapeutics Inc (NASDAQ: RGLS)
  • Reshape Lifesciences Inc (NASDAQ: RSLS)
  • Rubius Therapeutics Inc (NASDAQ: RUBY)
  • RXi Pharmaceuticals Corp (NASDAQ: RXII)
  • Sangamo Therapeutics Inc (NASDAQ: SGMO)
  • SCYNEXIS Inc (NASDAQ: SCYX)
  • Stemline Therapeutics Inc (NASDAQ: STML)
  • SUMMIT THERAPEU/S ADR (NASDAQ: SMMT)
  • The Medicines Company (NASDAQ: MDCO)
  • Unum Therapeutics Inc (NASDAQ: UMRX)

See Also: The Week Ahead In Biotech: Earnings, Conferences, PDUFA Dates, Clinical Trial Results And IPOs

Stocks In Focus Viking Presents Positive New Phase 2 Data For Drug to Treat Cholesterol, Liver Fat

Viking Therapeutics Inc (NASDAQ: VKTX) presented results from the 12-week Phase 2 study of VK2809 as a late-breaking oral presentation at the annual meeting of the American Association for the Study of Liver Diseases, with the newly presented data shedding further light on the trial endpoints.

The study achieved its primary endpoint of demonstrating statistically significant reductions in LDL-C compared with placebo following 12 weeks of treatment. It also achieved its secondary endpoint of producing statistically significant reductions in liver fat content, with up to 91 percent of VK2809 treated patients showing more than or equal to 30 percent reduction in liver fat.

View more earnings on IBB

"Newly reported data from a 'super'-responder analysis demonstrated that 67% of VK2809-treated patients demonstrated ≥ 50% reduction in liver fat content at 12 weeks," Viking said.

The stock rallied 14.92 percent to $13.48 in after-hours trading.

Roche's Tecentriq sBLA Granted Priority Review Status

Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) said the FDA accepted its supplemental biologic license application for its Tecentriq in combination with chemotherapy (Abraxane) for the first-line treatment of people with PD-L1-positive, metastatic triple-negative breast cancer. The application has been granted priority review status. The PDUFA date has been set for March 12, 2019.

Earnings

Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC) reported a narrower loss of 18 cents per share for Q3'18 compared to a loss of 91 cents per share last year. Analysts estimated a loss of 17 cents per share for the quarter.

The stock jumped 15.35 percent to $1.39 in after-hours trading.

On The Radar Earnings

Albireo Pharma Inc (NASDAQ: ALBO) (before the market open)
Catabasis Pharmaceuticals Inc (NASDAQ: CATB) (before the market open)
BIOLASE Inc (NASDAQ: BIOL) (before the market open)
Dare Bioscience Inc (NASDAQ: DARE) (before the market open)
Fibrocell Science Inc (NASDAQ: FCSC) (before the market open)
Jounce Therapeutics Inc (NASDAQ: JNCE) (before the market open)
Onconova Therapeutics Inc NASDAQ: (ONTX) (before the market open)
Mersana Therapeutics Inc (NASDAQ: MRSN) (before the market open)
Eyenovia Inc (NASDAQ: EYEN) (before the market open)
OptiNose Inc (NASDAQ: OPTN) (before the market open)
Onconova Therapeutics Inc (NASDAQ: ONTX) (before the market open)
Capricor Therapeutics Inc NASDAQ: CAPR) (after the market close)
Biocept Inc (NASDAQ: BIOC) (after the market close)
OncoCyte Corp (NYSE: OCX) (after the market close)
RA Medical Systems Inc (NYSE: RMED) (after the market close
Synlogic Inc (NASDAQ: SYBX) (after the market close
Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) (after the market close)
MusclePharm Corp (OTC: MSLP) (after the market close)
Rubius Therapeutics Inc (NASDAQ: RUBY)

Clinical Trial Results

Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) is set to present 12-month Phase 2b data for Aramchol, its treatment candidate for NASH, at the AASLD in San Francisco.

IPO

Eton Pharmaceuticals, Inc., a specialty pharma company, announced that it has priced its initial public offering of 3.6 million shares at $6 per share. The shares are to be listed on the Nasdaq under the ticker symbol ETON.

See more from Benzinga

© 2018 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.