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Benzinga's Daily Biotech Pulse: Chinese Cheer For Gilead, Immutep Presents Positive Phase 1 Data, FDA Accepts Exelixis sNDA

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 May 29)

  • Ascendis Pharma A/S (NASDAQ: ASN)
  • ASLAN PHARMACEUTICALS ADR REP 5 ORD (NASDAQ: ASLN) (ahead of IPO quiet period expiry)
  • BioLife Solutions Inc (NASDAQ: BLFS)
  • Chembio Diagnostics Inc (NASDAQ: CEMI)
  • Globus Medical Inc (NYSE: GMED)
  • GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH)(upcoming PDUFA catalyst for its Epidiolex)
  • Horizon Pharma PLC (NASDAQ: HZNP)
  • ICU Medical, Incorporated (NASDAQ: ICUI)
  • Mirati Therapeutics Inc (NASDAQ: MRTX)
  • Neurotrope Inc (NASDAQ: NTRP)
  • SurModics, Inc. (NASDAQ: SRDX)

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 29)

  • Agile Therapeutics Inc (NASDAQ: AGRX)
  • Cesca Therapeutics Inc (NASDAQ: KOOL)
  • Eagle Test Systems Common Stock (NASDAQ: EGLT)
  • Fibrocell Science Inc (NASDAQ: FCSC) (announces $6 million registered direct offering priced at-the-market)
  • KINIKSA PHARMACEUTICALS CL A ORD (NASDAQ: KNSA)(listed its shares on Nasdaq on May 24)
  • Nemaura Medical Inc (NASDAQ: NMRD)
  • Soligenix, Inc. Common Stock (NASDAQ: SNGX)

Related Link: The Week Ahead In Biotech: ASCO Presentations In The Spotlight

Stocks In Focus FDA Grants Priority Review Status For Novartis' Anemia Drug

Novartis announced the FDA expedited review of its sNDA for its promacta in combination with standard immunosuppressive therapy for treating first-line severe aplastic anemia by giving its priority review status. The status was granted based on data showing 52 percent complete response and 85 percent overall response rate when added to standard immunosuppressive therapy.

This reduces the review period from the standard 10 months to six months.

China Approves Gilead's HCV Therapy

Gilead Sciences, Inc. (NASDAQ: GILD) said the China Drug Administration, or CDA, has approved its epclusa for treating adults with genotype 1-6 chronic hepatitis C virus infection. The CDA has also approved epclusa in combination with ribavirin for adults, with HCV and decompensated cirrhosis,

Immutep's Skin Cancer Drug Produces Encouraging Results In Early-stage Study

IMMUTEP LTD/S ADR (NASDAQ: IMMP) announced new data from its ongoing TACTI-mel Phase I trial, which evaluated the combination of eftilagimod alpha, its lead compound, with Merck & Co., Inc. (NYSE: MRK)'s Keytruda in unresectable or metastatic melanoma patients, who have had a suboptimal response or had disease progression with keytruda monotherapy.

The results showed long-lasting and durable responses in a subset of patients and overall response rate of 61 percent, with 2 complete responses out of 18 patients.

Shares rallied 11.02 percent to $2.72 after hours, Tuesday.

FDA Accepts Exelixis' sNDA For Cabometyx to Treat Liver Cancer

Exelixis, Inc. (NASDAQ: EXEL) said the FDA has accepted its sNDA for cabometyx tablets to treat patients with advanced hepatocellular carcinoma. The PDUFA action date is set for January 14, 2019.

The stock rose 1.33 percent to $20.58 after hours.

T2 Biosystems Announces Common Stock Offering

T2 Biosystems Inc (NASDAQ: TTOO) announced it would offer 5.65 million shares in a common stock offering, with all shares offered being sold by the company.

T2 Biosystems stock fell 5.83 percent to $7.59 after hours after slumping 9 percent in the regular session.

Acorda Adds Onto Its Regular Session Gains

Acorda Therapeutics Inc (NASDAQ: ACOR) announced that the European Medicines Agency, or EMA, has validated its MAA submission for inbrija, an investigational inhaled levodopa treatment for symptoms of OFF periods in Parkinson's disease patients taking carbidopa/levodopa regimen. The decision is expected within 210 days. The U.S. FDA is currently reviewing the NDA for the pipeline candidate, with the PDUFA date set for October 5, 2018.

Rigel Reverses Regular Session Losses

Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) announced tavalisse, approved by the FDA in April for treating patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment, is available for prescription.

The stock jumped 5 percent to $3.89 after hours after slipping 5.88 percent in the regular session.

On The Radar

Madrigal Pharmaceuticals Inc (NASDAQ: MDGL) is likely to release biopsy data of the Phase 2 study for its MGL-3196, which is being evaluated for non-alcoholic fatty liver disease. Top-line data released in December 2017 showed that primary endpoint was met.

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