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The Daily Biotech Pulse: Axovant Doses First Patient In Gene Therapy Trial, Agile Resubmits NDA, ADMA Prices Offering

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 16)

  • Adverum Biotechnologies Inc (NASDAQ: ADVM)(announced lifting of FDA's partial clinical hold on the second cohort of Phase 1 study of its wet age-related macular degeneration drug)
  • Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN)
  • Axsome Therapeutics Inc (NASDAQ: AXSM)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • Global Blood Therapeutics Inc (NASDAQ: GBT)
  • Masimo Corporation (NASDAQ: MASI)(received FDA nod for Radius PPG, a tetherless sensor solution)
  • MediciNova, Inc. (NASDAQ: MNOV)
  • MeiraGTx Holdings PLC (NASDAQ: MGTX)
  • TransMedics Group Inc (NASDAQ: TMDX)
  • Zynerba Pharmaceuticals Inc (NASDAQ: ZYNE)

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 16)

  • Auris Medical Holding Ltd (NASDAQ: EARS)
  • CELLECT BIOTECH/S ADR (NASDAQ: APOP)(announced exploration of strategic alternatives)
  • Enochian Biosciences Inc (NASDAQ: ENOB)
  • NGM Biopharmaceuticals Inc (NASDAQ: NGM)
  • Nuvectra Corp (NASDAQ: NVTR)(announced departure of COO and CFO)
  • Precision Therapeutics Inc (NASDAQ: AIPT)(reacted to its first-quarter results)
  • Sellas Life Sciences Group Inc (NASDAQ: SLS) (reacted to its first-quarter results)
  • Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNX)
  • Xenetic Biosciences Inc (NASDAQ: XBIO)

Stock In Focus Axovant Doses First Patient With Investigational Gene Therapy For Autoimmune Lysosomal Disorder

Axovant Gene Therapies Ltd (NASDAQ: AXGT) said it has dosed the first patient in a clinical study of AXO-AAV-GM1, its investigational gene therapy for the treatment of GM1 gangliosidosis. The company said till-date the patient has experienced no complications related to the intravenous administration of the vector.

The company expects initial data from the program in the second half of 2019, with enrollment expected to continue throughout 2019.

The stock rose 1.45 percent to $7.69 in after-hours trading.

See Also: 5 ASCO Abstracts That Moved Stocks

Inovio, Qiagen Announce Collaboration For HPV Virus Immunotherapy

Inovio Pharmaceuticals Inc (NASDAQ: INO) and Qiagen NV (NYSE: QGEN) announced a collaboration to co-develop a diagnostic test to identify patients most likely to respond to VGX-3100, Inovio's immunotherapy to treat advanced cervical dysplasia associated with the human papillomavirus virus. VGX-3100 is currently in two pivotal Phase 3 trials, with the potential become the first treatment for HPV infection of the cervix and the first non-surgical treatment for precancerous cervical lesions associated with the virus.

The companies did not disclose the financial terms of the deal. Inovio said it plans to make regulatory submissions for the candidate in 2021.

Inovio shares moved up 1.46 percent to $3.47 in after-hours trading.

Mannkind Announces Agreement To Supply Afrezza In Australia

MannKind Corporation (NASDAQ: MNKD) said it has entered into an exclusive marketing and distribution agreement with the AMSL Diabetes division of Australasian Medical & Scientific Ltd for commercialization of Afrezza inhalation powder – a rapid-acting inhaled insulin - in Australia.

The stock added 2.36 percent to $1.30 in after-hours trading.

Agile Resubmits NDA For Hormonal Contraceptive Patch

Agile Therapeutics Inc (NASDAQ: AGRX) said it has resubmitted its NDA for its lead candidate Twirla, an investigational low-dose combined hormonal contraceptive patch. The FDA had issued a complete response to the previous application in Dec. 2017, citing deficiencies related to quality control adhesion test methods, issues with the facility of one of its third-party manufacturers and questions on the in vivoadhesion properties of Twirla.

The stock was last seen up 6.85 percent to $1.56 in pre-market trading.

ADMA Prices Public Offering

ADMA Biologics Inc (NASDAQ: ADMA) announced pricing of its previously-announced underwritten public offering of 11.25 million shares at $4 per share, resulting in gross proceeds of $45 million.

The stock was last seen dipping 1.66 percent to $4.15 in pre-market trading.

On The Radar Clinical Trial Results

Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) will release interim Phase 2 data for ACH-4471 in paroxysmal nocturnal hemoglobinuria.

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