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

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 ABEO(reacted to its Q3 earnings and the earnings call)
• Achaogen Inc AKAO
• Aclaris Therapeutics Inc ACRS
• Aduro BioTech Inc ADRO
• Aerie Pharmaceuticals Inc AERI
• Alkermes Plc ALKS
• Alnylam Pharmaceuticals, Inc. ALNY
• Amicus Therapeutics, Inc. FOLD
• Atossa Genetics Inc ATOS
• Biocept Inc BIOC
• Cancer Genetics Inc CGIX
• Clearside Biomedical Inc CLSD
• Dova Pharmaceuticals Inc DOVA
• Endologix, Inc. ELGX
• Evelo Biosciences Inc EVLO
• Histogenics Corp HSGX
• Infinity Pharmaceuticals Inc. 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. IRWD
• Kala Pharmaceuticals Inc KALA
• Kodiak Sciences Inc KOD
• La Jolla Pharmaceutical Company LJPC
• Leap Therapeutics Inc LPTX
• Miragen Therapeutics Inc MGEN
• Neuralstem, Inc. CUR
• Oncomed Pharmaceuticals Inc OMED
• PhaseBio Pharmaceuticals Inc PHAS
• Radius Health Inc RDUS
• Regulus Therapeutics Inc RGLS
• Reshape Lifesciences Inc RSLS
• Rubius Therapeutics Inc RUBY
• RXi Pharmaceuticals Corp RXII
• Sangamo Therapeutics Inc SGMO
• SCYNEXIS Inc SCYX
• Stemline Therapeutics Inc STML
• SUMMIT THERAPEU/S ADR SMMT
• The Medicines Company MDCO
• Unum Therapeutics Inc 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 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.

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

Clinical Trial Results

Galmed Pharmaceuticals Ltd 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.