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The Daily Biotech Pulse: Neurocrine's Parkinson's Drug Accepted For Review, Sunesis Offering, No Headaches For Biohaven's Migraine Drug

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The Daily Biotech Pulse: Neurocrine's Parkinson's Drug Accepted For Review, Sunesis Offering, No Headaches For Biohaven's Migraine Drug

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 July 10)
  • CONMED Corporation (NASDAQ: CNMD)
  • Eidos Therapeutics Inc (NASDAQ: EIDX)
  • Enlivex Therapeutics Ltd (NASDAQ: ENLV)
  • GALAPAGOS NV/S ADR (NASDAQ: GLPG)
  • Penumbra Inc (NYSE: PEN)

Down In The Dumps

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

  • Abeona Therapeutics Inc (NASDAQ: ABEO)
  • Amneal Pharmaceuticals Inc (NYSE: AMRX) (announced a restructuring plan, and also reduced full-year adjusted EBITDA guidance)
  • Atara Biotherapeutics Inc (NASDAQ: ATRA)
  • Jaguar Health Inc (NASDAQ: JAGX)
  • VERONA PHARMA P/S ADR (NASDAQ: VRNA)

See Also: Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates

Stocks In Focus

Neurocrine Says FDA Accepts Regulatory Filing For Parkinson's Drug

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) said the FDA has accepted its NDA for opicapone, a once-daily, oral, selective catechol-O-methyltransferase inhibitor as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes. The PDUFA date has been set for April 26, 2020.

The shares rose 3.31% to $90 in after-hours trading.

MacroGenics Licenses Rights to Cancer Drug to I-Mab In Greater China

MacroGenics Inc (NASDAQ: MGNX) and I-Mab Pharma announced an exclusive collaboration and licensing agreement to develop and commercialize enoblituzumab – an immune-optimized, anti B7-H3 monoclonal antibody that uses MacroGenics' proprietary Fc Optimization technology platform.

The agreement vests I-Mab with the development and commercialization rights in mainland China, Hong Kong, Macau and Taiwan. MacroGenics will receive an upfront payment of $15 million and an additional $135 million in development and regulatory milestone payments, while it will also get tiered double-digit royalties based on annual net sales from I-Mab in its territories.

MacroGenics said it plans to initiate a Phase 2 study of enoblituzumab in combination with MGA012 in patients with squamous cell carcinoma of head and neck in the second half of 2019.

The stock added 2.30% to $16.46 in after-hours trading.

Biohaven Publishes Positive Phase 3 Results For Migraine Drug In NEJM

Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) announced that positive results from a Phase 3 trial of its migraine drug rimegepant are published in the New England Journal of Medicine. Rimegepant is a small molecule calcitonin gene-related peptide receptor antagonist.

The data showed that patients treated with a single dose of oral rimegepant 75 mg experienced superior, rapid pain freedom and freedom from the most bothersome migraine-associated symptom, compared to placebo.

The stock gained 3.41% to $45.20 in after-hours trading.

Offerings

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) said it intends to sell, subject to market and other conditions, shares of its common stock and Series F Convertible Preferred stock in underwritten public offerings. The company said it intends to use the net proceeds to fund the ongoing development of vecabrutinib, ongoing R&D and general corporate purposes.

The stock slumped 26.26% to 62 cents in after-hours trading.

Eyenovia Inc (NASDAQ: EYEN) announced plans for an underwritten public offering. The company indicated that the offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size of the offering.

Posted-In: Biotech News Offerings Contracts FDA Top Stories Pre-Market Outlook Trading Ideas Best of Benzinga

 

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