The Daily Biotech Pulse: Vivus Extends Supply Deal With Sandoz, Applied Genetic Snaps Ties With Biogen

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

No biotech stock hit 52-week high in Wednesday's session.

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 12)

• Achieve Life Sciences Inc ACHV
• Aileron Therapeutics Inc ALRN
• Bellicum Pharmaceuticals Inc BLCM
• Bioanalytical Systems, Inc. BASI
• BIOLASE Inc BIOL
• Biomerica, Inc. BMRA
• Bio-Path Holdings Inc BPTH
• Epizyme Inc EPZM
• Evogene Ltd EVGN
• IntelliPharmaCeutics Intl IncIPCI
• Melinta Therapeutics Inc MLNT
• MOTIF BIO PLC/S ADR MTFB
• Nemaura Medical Inc NMRD(announced acceptance of SugarBEAT Clinical Performance Data Abstract presentation at Advanced Technologies and Treatments for Diabetes Conference in Feb. 2019)
• Neurotrope Inc NTRP
• Oncomed Pharmaceuticals Inc OMED
• Ophthotech Corp OPHT
• OptiNose Inc OPTN(announced that Avanir Pharma has terminated the license agreement it had with OptiNose for developing Onzetra XSAIL in the U.S., Canada and Mexico)
• Ovid Therapeutics Inc OVID
• Pluristem Therapeutics Inc. PSTI
• SCYNEXIS Inc SCYX
• Sierra Oncology Inc SRRA
• Synergy Pharmaceuticals Inc SGYP((filed for Chapter 11 bankruptcy protection, NYSE:BHC) now emerging as the stalking horse bidder in a court approved auction and sales process)
• TherapeuticsMD Inc TXMD
• Trillium Therapeutics Inc TRIL
• Unum Therapeutics Inc UMRX
• Urovant Sciences Ltd UROV
• Vaccinex Inc VCNX
• Wright Medical Group NV WMGI

See Also: The Week Ahead In Biotech: Conferences, Clinical Trials And Earnings

Stocks In Focus

VIVUS Extends Supply Agreement With Sanofi

VIVUS, Inc. VVUS announced an amended supply deal with Novartis AG NVS's Sanofi Chimie, which provides for the latter manufacturing and supplying API for Vivus' avanafil, on an exclusive basis, beginning Jan. 1, 2019. The amendment also provides for adjustment of the yearly minimum quantities of API that Vivus must purchase, as well as pricing and payment terms, beginning Jan. 1.

The supply agreement has been extended until Dec. 31, 2023. The original deal was struck in July 2013.

The stock rallied 8.42 percent to $3.07 in after-hours trading.

Applied Genetic's Gene Therapy Not Effective, Snaps Ties With Biogen

Applied Genetic Technologies Corp AGTC said interim six-month data from the Phase 1/2 trial of rAAV2tYF-CB-hRS1, an investigational AAV-based gene therapy, delivered via intravitreal injection for X-linked retinoschisis clinical study, showed the gene delivery platform did not demonstrate signs of clinical activity. The platform, however, was found safe and tolerable.

The company also said it has terminated its collaboration agreement with Biogen Inc BIIB effective March 8, 2018, and consequently regained full rights to the X-linked retinoschisis and X-linked retinitis pigmentosa programs and the three other partnered discovery programs.

Despite the snapping of ties with Biogen, Applied Genetic Tech said its previous guidance is unchanged.

The stock slumped 38.72 percent to $4.02 in after-hours trading.

EC Okays Novartis' Injectable Asthmatic Allergy Biologic Drug

Novartis said the European Commission has approved its Xolair prefilled syringe for self-administration by patients with severe allergic asthma and chronic spontaneous urticaria.

Xolair is administered via injection every two or four weeks.

Zynerba's Cannabinoid Drug Produces Sustained Improvement In Fragile X Syndrome

Zynerba Pharmaceuticals Inc ZYNE reported new 12-month open label clinical trial data that explains the long term impact of ZYN002, a transdermal cannabinoid gel, on emotional and behavioral symptoms of Fragile X Syndrome, which showed sustained improvement over a period of 12 months.

After 12 months of treatment with ZYN002, patients experienced a 77 percent improvement in aberrant behaviors associated with social avoidance compared to the baseline.

The data is to be presented in the form of a poster at the 57th Annual Meeting of the American College of Neuropsychopharmacology held in the Diplomat Beach Resort in Hollywood, Florida.

Zynerba shares rallied 9.11 percent to $5.15 in after-hours trading.

Zoetis to Buy Back $2B Shares

Zoetis Inc ZTS said its board has authorized a $2 billion multi-year share repurchase program as part of its long-tern capital allocation plans. The previous $1.5 billion buyback program announced Dec. 2016 is expected to be completed in the first-half of 2019.

The company's board also approve a 30 percent increase its quarterly dividend to 16.4 cents per share.

Offerings

Tocagen Inc TOCA said it has priced its underwritten public offering of 3 million shares at $10 per share, which would generate gross proceeds of about $30 million. The offering is expected to close on or about Dec. 17.

The stock pulled back 5.08 percent to $10.66 in after-hours trading.

VBI Vaccines Inc VBIV announced the commencement of an underwritten public offering of its common shares, although it did not specify the size of the offering. The company intends to use the net proceeds, primarily to fund its clinical programs.

The stock plunged 10.78 percent to $1.49 in after-hours trading.

Marinus Pharmaceuticals Inc MRNS said it has priced its previously announced public offering of 12 million shares at $3.75 per share, with the total size of the offering at $45 million.

The stock slipped 2.85 percent to $4.09 in after-hours trading.

On The Radar

Earnings

Pure Bioscience, Inc. PURE (after the market close)

Clinical Trial Results

Imv Inc IMV will host a webcast and conference call to discuss its ESMO Immuno-oncology conference poster presentation of updated Phase 1b/2 data for its ovarian cancer pipeline candidate DPX-Survivac, which is low dose cyclophosphamide, along with epacadostat. The poster presentation is scheduled for Dec. 14-15.