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The Daily Biotech Pulse: Lilly Reports Positive Long-Term Efficacy Data For Psoriasis Drug, Provention Bio Offering

The Daily Biotech Pulse: Lilly Reports Positive Long-Term Efficacy Data For Psoriasis Drug, Provention Bio 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 June 10)

  • Abbott Laboratories (NYSE: ABT)
  • Stellar Biotechnologies Inc (NASDAQ: EDSA)
  • EXACT Sciences Corporation (NASDAQ: EXAS)
  • Iovance Biotherapeutics Inc (NASDAQ: IOVA)
  • Kodiak Sciences Inc (NASDAQ: KOD)
  • Provention Bio Inc (NASDAQ: PRVB)(announced positive results for its PRV-031 in at-risk Type 1 diabetes patient)

Down In The Dumps

(Biotech stocks hitting 52-week lows on June 10)

  • Abeona Therapeutics Inc (NASDAQ: ABEO)
  • Axovant Gene Therapies Ltd (NASDAQ: AXGT)
  • Cyclerion Therapeutics Inc (NASDAQ: CYCN)
  • Endo International PLC (NASDAQ: ENDP)
  • Insys Therapeutics Inc (NASDAQ: INSY)(filed for bankruptcy protection)
  • Novavax, Inc (NASDAQ: NVAX)(reacted to the news of FDA requiring an additional Phase 3 study for its respiratory syncytial virus vaccine ResVax)
  • Sensus Healthcare Inc (NASDAQ: SRTS)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA)
  • T2 Biosystems Inc (NASDAQ: TTOO)
  • Teligent Inc (NASDAQ: TLGT)

Stock In Focus

Eli Lily Presents Positive Long-term Efficacy Data For Psoriasis Treatment

Eli Lilly And Co (NYSE: LLY) said it will present at the World Congress of Dermatology positive five-year Phase 3 data for Taltz in patients with moderate-to-severe plaque psoriasis. The company noted that the patients who continued to receive Taltz maintained high levels of skin clearance with no unexpected safety outcomes for up to five years of treatment.

Lily said it plans to announce the results from IXORA-R, a clinical trial that intends to evaluate superiority between Taltz and Johnson & Johnson (NYSE: JNJ)'s Janssen unit's Tremfya, in adult patients with moderate-to-severe plaque psoriasis.

Veracyte's Genomic Sequencing Test Helps Identify Benign Thyroid Nodules

Veracyte Inc (NASDAQ: VCYT) said findings from a new real world study showed that its Afirma Genomic Sequencing Classifier, or GSC, helps identify significantly more benign thyroid nodules, obviating the need for unnecessary surgeries in thyroid cancer diagnosis, as compared to the original Afirma test. The clinical utility study was conducted by researchers at The Ohio State University.

The stock rose 3.23 percent to $27.15 in after-hours trading.

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trial Readouts

J&J Signs Option Agreement With Genmab For New Lymphoma Treatment Candidate

GENMAB A/S/S ADR (OTC: GMXAY) said it has entered into an exclusive worldwide license and option agreement with J&J's Janssen unit to develop and commercialize HexaBody-CD38, a next-gen human CD38 monoclonal antibody that incorporates the former's proprietary HexaBody technology.

The agreement provides for Genmab collaborating exclusively with Janssen on HexaBody-CD38, with Genmab funding R&D until completion of clinical proof of concept studies in multiple myeloma and diffuse large B-cell lymphoma.

Based on data from the study, Janssen may exercise option and receive worldwide license to develop HexaBody-CD38, and if this occurs, Janssen is liable to pay Genmab $150 million option exercise fee and up to $125 million in development milestones as well as a flat royalty rate of 20% on sales of HexaBody-CD38 until a specified time in 2031, followed by 13-20 percent tiered royalties on sales thereafter.

Roche's Kidney Inflammation Drug Aces Mid-Stage Trial

Roche Holdings AG Basel ADR (OTC: RHHBY)'s Genentech unit announced positive results for a Phase 2 study dubbed NOBILITY, that is evaluating the safety and efficacy of Gazyva for adults with proliferative lupus nephritis. The study met the primary endpoint of Gazyva in combination with the standard-of-care demonstrating enhanced efficacy compared to placebo, plus, the standard-of-care.

Zealand's Glucagon Analogue Rapidly Increased Blood Pressure In Type 1 Diabetes Patients

ZEALAND PHARMA/S ADR (NASDAQ: ZEAL) presented at the 79th Scientific Sessions of the American Diabetes Association Phase 3 data that showed that a single dose of dasiglucagon rapidly increased blood glucose levels in Type 1 diabetes patients with low plasma glucose. The median time to plasma glucose recovery was 10 minutes following dasiglucagon injection, with 99% of patients having recovered within 15 minutes, the company said.

The stock was seen rising 1.70 percent to $21.56 in pre-market trading Tuesday.

Provention Bio To Offer 5.5M Shares

Following its 200-percent gain Monday, Provention Bio stock saw incremental strength in after-hours trading. The company said it has a filed a registration statement on Form S-1 with the SEC for offering 5.5 million shares. The company said it intends to use the net proceeds for clinical and regulatory development, as well as for working capital and other general corporate purposes.

Advaxis Reports Wider-Than-expected Q2 Loss

Advaxis, Inc. (NASDAQ: ADXS) reported fiscal second-quarter results, reporting revenues of $1.2 million compared to $1.7 million in the year-ago period, with the decline attributed to the termination of the licensing agreement with Amgen, Inc. (NASDAQ: AMGN). The net loss, however, narrowed from $4.03 per share to $1.59 per share amid a decline in expenses, while analyst expected a narrower loss of $1.20 per share.

The stock fell 8.21 percent to $2.57.

On The Radar

Novus Therapeutics Inc (NASDAQ: NVUS) is due to present Phase 1 data for OP0201 in healthy volunteers.


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