The Daily Biotech Pulse: FDA Nod For Sanofi's Dengue Vaccine, Veracyte Offering, Biogen Reports Positive Data

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 1)

• Alcon AG ALC (announced presentation of new clinical data and innovative technology at the Cataract Refractive Suite during the American Society of Cataract and Refractive Surgery)

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 2)

• Acorda Therapeutics Inc ACOR
• Aptevo Therapeutics Inc APVO
• Athenex Inc ATNX
• Auris Medical Holding Ltd EARS(began to trade on a reverse stock-split adjusted basis)
• Caladrius Biosciences Inc CLBS
• Eyegate Pharmaceuticals Inc EYEG
• Heron Therapeutics Inc HRTX(stymied by a CRL issued for its post-operative pain medication)
• KemPharm Inc KMPH
• Opiant Pharmaceuticals Inc OPNT
• Psychemedics Corp. PMD
• Strongbridge Biopharma plc SBBP (reacted to its first quarter results)

Related Link: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates

Stock In Focus

FDA Okays Sanofi's Dengue Vaccine With Restrictions

Sanofi SA SNY said the FDA approved its Dengvaxia for the prevention of dengue disease caused by serotypes 1-4 of the virus in individuals 9 through 16 years of age living in endemic areas of the U.S. with a lab-documented prior infection.

The stock rose 1.36 percent to $44 in after-hours trading.

Biogen's Rare Neurological Disease Drug Shows Efficacy In Mid-Stage Trial

Biogen Inc BIIB announced interim results of a Phase 1/2 study of tofersen, an antisense oligonucleotide, being evaluated for the treatment of amyotrophic lateral sclerosis in adults with a confirmed superoxide dismutase 1 mutation, with the investigational compound achieving proof-of-biology and proof-of-concept. The study showed a statistically significant reduction in SOD1 protein and a numerical trend towards slowing of clinical decline in SOD1-ALS patients treated with tofersen.

The company said the results support the initiation of a Phase 3 clinical trial to confirm the efficacy and safety of the asset and further demonstrate the potential of antisense oligonucleotides to treat genetic driver of disease.

Biogen said it will present the data as a late breaking presentation at the American Academy of Neurology Annual Meeting.

AstraZeneca Strikes Collaboration Agreement For Oncolytic Immunotherapies

AstraZeneca plc AZN announced a collaboration and exclusive licensing agreement with French biotech Transgene for co-developing five armed oncolytic vaccinia virus candidates, which will use the latter's proprietary next-gen viral platform Invir.IO. The U.K. pharma company will pay Transgene $10 million upon signing and additional preclinical milestones of up to $3 million.

Transgene is also eligible to receive an option exercise payment on each candidate in the event AstraZeneca exercises its license option, as well as development and commercial milestones and royalties.

Novavax To Present Results Of Respiratory Tract Infection Vaccine At Conference

Novavax, Inc. NVAX said it will present Phase 3 results of ResVax, its respiratory syncytial virus fusion protein recombinant nanoparticle vaccine, at the 37th Annual Meeting of the European Society for Pediatric Infectious Diseases in Ljubljana, Slovenia, on May 7.

The online abstract showed that the investigational vaccine offered via maternal immunization was well tolerated and may protect against medically significant RSV-associated LRTI and hospitalization in the first six months of life.

The results released in February showed that the vaccine candidate did not meet its primary endpoint, sending its shares into penny stock territory.

The stock rose 2.99 percent to 53 cents in after-hours trading.

Earnings

Neurostimulation medical device company Nuvectra Corp NVTR reported first-quarter revenues of $11.1 million, up 17 percent year-over-year, with Algovita revenues accounting for $11 million. The net loss per share narrowed from 84 cents to 83 cents. For 2019, the company expects Algovita revenues of $57 million to $62 million. The results trailed expectations.

The stock slumped 13.74 percent to $8.10 in after-hours trading.

Offerings

Magenta Therapeutics Inc MGTA priced its previously-announced public offering of 4.25 million shares at $13.25 per share, raising gross proceeds of $56.3 million.

The stock rose 0.22 percent to $13.73 in after-hours trading.

Veracyte Inc VCYT commenced an underwritten public offering of 5 million shares of its common stock. All shares are to be offered by the company.

The stock fell 2.66 percent to $24.50 in after-hours trading.

On The Radar

Clinical Trial Readouts

BioTime, Inc. BTX is scheduled to present updated Phase 1/2 data for OpRegen, which is being evaluated for dry age-related macular degeneration, at the Association for Research In Vision and Ophthalmology annual meeting.

Adaptimmune Therapeutics PLC – ADR ADAP will present full summary of SPEAR program that is evaluating its MAGE-for solid tumors. The presentation is due to be done at the American Society of Gene and Cell Therapy annual meeting.

Earnings

• ABIOMED, Inc. ABMD (before the market open)
• Acorda Therapeutics Inc ACOR (before the market open)
• Agios Pharmaceuticals Inc AGIO (before the market open)
• Antares Pharma Inc ATRS (before the market open)
• Evelo Biosciences Inc EVLO (before the market open)
• Pacira Biosciences Inc PCRX (before the market open)
• SAGE Therapeutics Inc SAGE (before the market open)
• GlycoMimetics Inc GLYC (before the market open)
• Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
• Intellia Therapeutics Inc NTLA (before the market open)
• Concert Pharmaceuticals Inc CNCE (before the market open)
• Anika Therapeutics Inc ANIK (after the market close)
• Novocure Ltd NVCR (after the market close)
• T2 Biosystems Inc TTOO (after the market close)
• Harvard Bioscience, Inc. HBIO (after the market close)
• Endologix, Inc. ELGX (after the market close)
• Gilead Sciences, Inc. GILD (after the market close)
• Ligand Pharmaceuticals Inc. LGND (after the market close)
• Viking Therapeutics Inc VKTX (after the market close)
• Novavax, Inc. NVAX (after the market close)
• PTC Therapeutics, Inc. PTCT (after the market close)
• Insulet Corporation PODD (after the market close)
• Alder Biopharmaceuticals Inc ALDR (after the market close)
• Emergent Biosolutions Inc EBS (after the market close)
• Globus Medical Inc GMED (after the market close)