Benzinga's Daily Biotech Pulse: AstraZeneca's Q1, Novartis-Amgen Migraine Drug Approved

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling the Peaks

(Stocks hitting 52-week highs on May 17)

• Abaxis Inc ABAX (rallying for second straight session after announcement of buyout deal)
• AMAG Pharmaceuticals, Inc. AMAG
• Arena Pharmaceuticals, Inc. ARNA
• ArQule, Inc. ARQL
• BioLife Solutions Inc BLFS
• Crispr Therapeutics AG CRSP
• CTI BioPharma Corp CTIC
• Cytosorbents Corp CTSO
• Eiger Biopharmaceuticals Inc EIGR
• Eloxx Pharmaceuticals Inc ELOX
• Endocyte, Inc. ECYT(ASCO abstract)
• Haemonetics Corporation HAE
• Heron Therapeutics Inc HRTX
• ICU Medical, Incorporated ICUI
• Immunomedics, Inc. IMMU (ASCO abstract)
• Karyopharm Therapeutics Inc KPTI
• Loxo Oncology Inc LOXO (ASCO abstract)
• Merit Medical Systems, Inc. MMSI
• Momenta Pharmaceuticals, Inc. MNTA
• Vericel Corp VCEL

Down In The Dumps

(Stocks hitting 52-week lows on May 17)

• Anthera Pharmaceuticals Inc ANTH
• Calithera Biosciences Inc CALA
• Celgene Corporation CELG(FDA listed it among companies thwarting generic competition)
• CELYAD SA/ADR CYAD(announced pricing of its $47.3 million global share offering)
• Dr.Reddy's Laboratories Ltd (ADR) RDY
• Unity Biotechnology Inc UBX

Stocks In Focus

Arqule Files For Common Stock Offering

Arqule filed a S-3 registration with the SEC to offer 10.63 million shares, with all shares being sold by selling stockholders.

The stock slipped 6.61 percent to $3.39 after hours Thursday.

Adverum Presents Data on Wet AMD Treatment at Conference

Adverum Biotechnologies Inc ADVM announced poster presentation of long-tern efficacy data from a pre-clinical study of ADVM-022 in wet-age related macular degeneration at the American Society of Gene and Cell Therapy 21st annual meeting. The company said a single administration of ADVM-022 has the potential to provide long-term protection against choroidal neovascularization associated with vision loss in wet AMD.

The company said it is on track to submit an investigational new drug application, or IND, in the second-half of 2018.

Amgen-Novartis Migraine Treatment Approved

Novartis AG (ADR) NVS and Amgen, Inc. AMGN announced FDA approval for the BLA for their migraine treatment Aimovig (Erenumab).

The companies expect the treatment to be made available in the U.S. within a week.

Amgen rose 1.33 to $176.98 in after-hours trading.

See Also: Jounce Therapeutics Stock Slides On Disappointing Data, Wells Fargo Downgrades

Voyager Presents Multiple Pre-clinical Data at Conference

Voyager Therapeutics Inc VYGR presented new data for VY-SOD101l, its gene therapy to treat amyotrophic lateral sclerosis, at the ASGCT annual meeting. The data showed that one-time administration of VY-SOD101 lowered SOD1 mRNA levels by 78 percent in the spinal cord motor neurons of non-human primates.

The company also presented tolerability data in non-human primates for VY-HTT01 for Huntingon's disease, and already-released data with VY-HTT01 that demonstrated a 54 percent suppression of huntingtin (HTT) mRNA in the non-human primate putamen after a single administration.

The stock rose 3.05 percent to $20.95 after hours.

On The Radar

The following companies report earnings on Friday:

AstraZeneca plc (ADR) AZN – Revenues fell 4 percent and core earnings per share trailed estimates

Other Events

• Rocket Pharmaceuticals Inc RCKT will release updated Phase 1/2 data for its Fanconi anemia treatment at the American Society of Gene & Cell Therapy meeting.
• RXi Pharmaceuticals Corp RXII will present Phase 2 data on its cutaneous wart treatment Samcyprone.
• GTx, Inc. GTXI is scheduled to release updated Phase 2 open-label data for enobosarm, being evaluated for stress urinary incontinence, at the American Urological Association meeting.

FDA Tidbits

FDA Commissioner Scott Gottlieb discussed the steps the agency has taken to address the practice of brand companies obstructing the purchase of samples of brand drugs by generic developers. This is in a bid to help make drugs more affordable and accessible.

In a separate communication, as part of the Youth Tobacco Prevention Plan, the FDA said it has sent official requests for information to four e-cigar manufacturers, seeking important documents that can help it understand better the youth appeal of these products.