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The Daily Biotech Pulse: Genfit NASH Drug In China, Conatus Explores Sale, Gilead Stitches Up Immuno-Oncology Partnership

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 June 24)

  • Global Blood Therapeutics Inc (NASDAQ: GBT)
  • Krystal Biotech Inc (NASDAQ: KRYS)(reported positive Phase 2 results for its lead gene therapy candidate to treat an incurable skin blistering condition and securing of regenerative advanced therapy designation for it from the FDA)
  • strong>Zynex Inc. (NASDAQ: ZYXI)
  • Prevail Therapeutics Inc (NASDAQ: PRVL)(IPOed June 20)

Down In The Dumps

(Biotech stocks hitting 52-week lows on June 24)

  • Abeona Therapeutics Inc (NASDAQ: ABEO)
  • AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)(declined despite FDA approval for its drug to boost sexual drive in women)
  • Amneal Pharmaceuticals Inc (NYSE: AMRX)
  • AnaptysBio Inc (NASDAQ: ANAB)
  • Assembly Biosciences Inc (NASDAQ: ASMB)
  • BENITEC BIOPHAR/S ADR (NASDAQ: BNTC)
  • Endo International PLC (NASDAQ: ENDP)
  • Hookipa Pharma Inc (NASDAQ: HOOK)
  • HTG Molecular Diagnostics Inc (NASDAQ: HTGM)
  • Kezar Life Sciences Inc (NASDAQ: KZR)
  • MEREO BIOPHARMA/ADR (NASDAQ: MREO)
  • Myriad Genetics, Inc. (NASDAQ: MYGN)
  • Neos Therapeutics Inc (NASDAQ: NEOS)
  • Rhythm Pharmaceuticals Inc (NASDAQ: RYTM)
  • Spring Bank Pharmaceuticals Inc (NASDAQ: SBPH)
  • Surface Oncology Inc (NASDAQ: SURF)
  • Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP)
  • Trillium Therapeutics Inc (NASDAQ: TRIL)
  • United Therapeutics Corporation (NASDAQ: UTHR)
  • Urogen Pharma Ltd (NASDAQ: URGN)

Stocks In Focus Genfit Licenses Rights To NASH Drug In China For Up To $228M

GENFIT S A/ADR (NASDAQ: GNFT) announced a licensing and collaboration agreement with Terns Pharma under which the former licensed the right to develop and commercialize elafibranor, its proprietary compound for non-alcoholic steatohepatitis and primary biliary cholangitis, to the latter in Greater China. The agreement provides for Genfit receiving an upfront payment of $35 million and the eligibility to receive up to $193 million in potential clinical, regulatory and commercial milestone payments.

The stock rose 8.06% to $21.85 in after-hours trading.

Conatus to Explore Strategic Options

Conatus Pharmaceuticals Inc (NASDAQ: CNAT) has engaged Oppenheimer as its financial advisor to assist in the exploration and evaluation of strategic alternatives to enhance shareholder value. Meanwhile, the company also announced a restructuring plan to extend its resources, including a 40 percent reduction in workforce and pulling the plug on its inflammasome disease candidate CTS-2090.

The stock slumped 59.87% to 37 cents in after-hours trading.

Nabriva's Antibiotic For Pneumonia Accepted For Review In Europe

Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV) said the European Medicines Agency has determined that its Marketing Authorization Application for the intravenous and oral formulation of lefamulin, a semic-synthetic pleuromutilin antibiotic for the treatment of community-acquired pneumonia in adults 18 years and older is valid, which confirms that the submission is sufficiently complete to begin a formal review process. An opinion from the EMA's Medicinal Products for Human Use is expected in the next 12 to 15 months.

The stock rose 2.38% to $2.15 in after-hours trading.

See Also: Minerva Spikes Higher After Novel Insomnia Drug Aces Mid-Stage Trial

Dermira's Licensee Exercises Option For European Rights To Eczema Drug

Dermira Inc (NASDAQ: DERM) said Almirall has exercised its option to license rights to develop and commercialize lebrikizumab for the treatment of atopic dermatitis and certain other indications in Europe. The companies had entered into an option and license agreement in February.

Because of Almirall's decision to exercise the option, it will pay Dermira $50 million, and an initiation of certain late-stage studies will make the latter eligible for receiving a further $30 million in milestone payments.

Gilead To Partner With Carna For Immuno-Oncology Drugs

Gilead Sciences, Inc. (NASDAQ: GILD) and Carna Bioscienses announced a R&D collaboration agreement to develop and commercialize small molecule compounds in immuno-oncology and to access Carna's proprietary lipid kinase drug discovery platform.

Gilead has agreed to pay an upfront payment of $20 million and additional milestone payments up to $450 million. It has also agreed to pay Carna royalties on future net sales.

Jaguar Regains Compliance With Nasdaq Listing Standards

Jaguar Health Inc (NASDAQ: JAGX) has received a letter from the Nasdaq June 21 confirming the bid price deficiency of Jaguar has been rectified and that the company is in compliance with all applicable listing standards.

The stock rose 9.65% to $5 in Tuesday's pre-market trading.

Common Stock Offerings

Gamida Cell Ltd (NASDAQ: GMDA) announced the launch of a proposed follow-on public offering of about $30 million worth of its shares.

View more earnings on IBB

The stock fell 9.03 percent to $6.55 in after-hours trading.

ArQule, Inc. (NASDAQ: ARQL) scommenced an underwritten public offering, subject to market and other conditions, of its common stock. All the shares are to be offered by the company.

The stock slipped 2.10% to $9.80 in after-hours trading.

Krystal Biotech priced its previously-announced underwritten public offering of 2.5 million shares at $40 per shares, which could generate gross proceeds of about $100 million.

The Medicines Company (NASDAQ: MDCO) launched a public offering of $150 million worth of its common stock. The company said it intends to use the net proceeds for the development of inclisiran and for general corporate purposes.

The stock moved down 1.33% to $34.89 in after-hours trading.

CymaBay

CymaBay Therapeutics Inc (NASDAQ: CBAY) found some strength, reportedly on initiation of the shares by Stifel at a Buy with a $14 price target, according to Seeking Alpha.

The stock rose 2.95% to $6.97 in after-hours trading.

PDUFA Dates

Acer Therapeutics Inc (NASDAQ: ACER) awaits FDA verdict on its NDA for Edsivo, which is being evaluated for the treatment of vascular Ehlers-Danlos syndrome, or vEDS, in patients with a confirmed type III collagen (COL3A1) mutation.

Clinical Trial Readout

Aldeyra Therapeutics Inc (NASDAQ: ALDX) is due to release Phase 3 data for ADX-102 in non-infectious anterior uveitis.

Arcus Biosciences Inc (NYSE: RCUS) will present Phase 1 initial safety, pharmacokinetic and pharmacodynamic data and biomarker analysis from the dose escalation portion of its Phase 1 study of AN928 in combination with mFOLFOX in colorectal cancer.

Obseva SA (NASDAQ: OBSV) is set to present Phase 2b data for OBE2109 in endometriosis.

Earnings

AIT Therapeutics Inc (NASDAQ: AITB) (after the close)

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