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

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 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 BHVN
• Axsome Therapeutics Inc AXSM
• Fate Therapeutics Inc FATE
• Global Blood Therapeutics Inc GBT
• Masimo Corporation MASI(received FDA nod for Radius PPG, a tetherless sensor solution)
• MediciNova, Inc. MNOV
• MeiraGTx Holdings PLC MGTX
• TransMedics Group Inc TMDX
• Zynerba Pharmaceuticals Inc ZYNE

Down In The Dumps

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

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

Stock In Focus

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

Axovant Gene Therapies Ltd 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 INO and Qiagen NV 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 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 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 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. ACHN will release interim Phase 2 data for ACH-4471 in paroxysmal nocturnal hemoglobinuria.