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The Daily Biotech Pulse: NASH Cheer For Intercept, Gilead Layoffs, BioDelivery Licenses Constipation Drug

Shanthi Rexaline

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 April 10)

  • Fulgent Genetics Inc (NASDAQ: FLGT)
  • Intuitive Surgical, Inc. (NASDAQ: ISRG)
  • NeoGenomics, Inc. (NASDAQ: NEO)

Down In The Dumps

(Biotech stocks hitting 52-week lows on April 10)

  • Adamas Pharmaceuticals Inc (NASDAQ: ADMS)
  • Caladrius Biosciences Inc (NASDAQ: CLBS)
  • Helius Medical Technologies Inc (NASDAQ: HSDT)(FDA declined its request for De Novo classification and clearance of its Portable Neuromodulation Stimulator device)
  • Evoke Pharma Inc (NASDAQ: EVOK)
  • Revance Therapeutics Inc (NASDAQ: RVNC)
  • Scpharmaceuticals Inc (NASDAQ: SCPH)
  • Vaxart Inc (NASDAQ: VXRT)
  • Viveve Medical Inc (NASDAQ: VIVE)
  • Teva Pharmaceutical Industries Ltd (NYSE: TEVA)

Stock In Focus Intercept Presents Additional Positive Late-Stage Results For NASH Candidate

Intercept Pharmaceuticals Inc (NASDAQ: ICPT) announced additional positive data from its pivotal Phase 3 trial, dubbed REGENERATE, that is evaluating its obeticholic acid, or OCA, in patients with liver fibrosis due to non-alcoholic steatohepatitis, or NASH.

The new data being presented at the EASL annual meeting in Vienna, based on additional analyses, showed that OCA demonstrated robust efficacy across a range of additional histologic and biochemical parameters.

In February, the company released positive top-line results from the study, sending its shares up by 6 percent on Feb. 19, the day the data was released.

Gilead Presents New Data On NASH Candidates; to Reportedly Cut 150 Jobs

Gilead Sciences, Inc (NASDAQ: GILD) presented new data at the EASL annual meeting, which support its efforts to develop combination therapies to target different aspects of NASH.

A proof-of-concept Phase 2 study dubbed ATLAS showed the combination of non-steroidal farnesoid X receptor agonist cilofexor, or GD-9674, and acetyl-CoA carboxylase inhibitor firsocostat, or GS-0976 resulted in improvements in hepatic steatosis, liver stiffness, liver biochemistry and serum fibrosis markers.

"Baseline data from the STELLAR Phase 3 trials showed significant burden of disease among people with advanced fibrosis due to NASH," the company added.

Gilead reported in mid-February that its Phase 3 STELLAR-4 study that evaluated the safety and efficacy of its candidate selonsertib did not meet its primary endpoint.

Meanwhile, Gilead may be bracing to layoff 20 percent of its salesforce or 150 long-tenured salespeople, STAT reported.

Novartis Generic Unit Secures Commercialization Rights to Shionogi's Opioid-induced Constipation Drug In Europe

Novartis AG (NYSE: NVS)'s Sandoz generic unit signed an agreement with Japan's Shionogi for commercialization of Rizmoic in the key European markets of Germany, the U.K. and the Netherlands, along with the right of first refusal for certain other European markets.

Rizmoic, a once-daily 200 microgram oral tablet developed by the Japanese pharma company is indicated to treat opioid-induced constipation in adult patients, previously treated with a laxative.

The company secured EU marketing authorization for Rizmoic in February.

BioDelivery To Acquire U.S. License to Shionogi's Opioid-induced Constipation Drug For $30M

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) said it has signed an exclusive licensing agreement with Shionogi for commercializing Symproic tablets 0.2mg in the U.S. and Puerto Rico, effective immediately. Symproic is indicated to treat opioid-induced constipation in adults with non-cancer pain.

The agreement calls for BioDelivery paying Shionogi an initial payment of $20 million and an additional $10 million in six months. Additionally, Shionogi is eligible to receive tiered royalty payments based on net sales of Symproic.

Biodelivery said, with the addition of Symproic, it expects long-term net sales potential to be in the range of $325 million to $400 million. The company also reaffirmed its expectation to become cash flow positive by the end of 2019.

The company also announced an offering of common shares.

BioDelivery shares fell 2.18 percent to $4.94 in after-hours trading.

On The Radar PDUFA Date

The FDA is set to rule on Merck & Co., Inc. (NYSE: MRK)'s sBLA for Keytruda as a monotherapy for firstline treatment of locally advanced or metastatic non-small cell lung cancer, or NSCLC, In patients whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations.

Clinical Trial Readouts

Alkermes Plc (NASDAQ: ALKS) is due to release new Phase 3 data for ALKS 3831, which is evaluated in a study dubbed ENLIGHTEN-2 for schizophrenia, at the 2019 Congress of the Schizophrenia International Research Society.

The European Association for the Study of the Liver International Liver Congress 2019 Presentations

Eiger Biopharmaceuticals Inc (NASDAQ: EIGR) – Late-breaker presentation of already-released Phase 2 data for pegylated interferon lambda (hepatitis delta virus)

Assembly Biosciences Inc (NASDAQ: ASMB) – Poster presentation of Phase 1a data for ABI-H2158 (hepatitis B virus)

Intercept Pharmaceuticals Inc (NASDAQ: ICPT) – Full Phase 3 data for Ocaliva from the REGENERATE study (NASH)

Viking Therapeutics Inc (NASDAQ: VKTX) and Ligand Pharmaceuticals Inc. (NASDAQ: LGND) – additional Phase 2 data for VK2809 (hypercholesterolemia and non-alcoholic fatty liver disease)

Madrigal Pharmaceuticals Inc (NASDAQ: MDGL) – Further analyses of Phase 2 data for MGL-3196 in NASH

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