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The Daily Biotech Pulse: Safety Board Clears Eisai's Alzheimer's Study, Positive Trial Results For Galapagos-Gilead

Shanthi Rexaline

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 March 28)

  • Baxter International Inc (NYSE: BAX)
  • Constellation Pharmaceuticals Inc (NASDAQ: CNST)
  • GENFIT S.A. (NASDAQ: GNFT) (IPOed on Wednesday)
  • Krystal Biotech Inc (NASDAQ: KRYS)
  • Novartis AG (NYSE: NVS)

Down In The Dumps

(Biotech stocks hitting 52-week lows on March 28)

  • Achaogen Inc (NASDAQ: AKAO)
  • Aerpio Pharmaceuticals Inc (NASDAQ: ARPO)
  • Conatus Pharmaceuticals Inc (NASDAQ: CNAT)
  • KemPharm Inc (NASDAQ: KMPH)
  • Osmotica Pharmaceuticals PLC (NASDAQ: OSMT) (reacted to Q4 results reported after the close Wednesday)
  • Proteon Therapeutics Inc (NASDAQ: PRTO) (reported its Phase 3 trial of vonapanitase in patients with chronic kidney disease undergoing creation of a radiocephalic fistula for hemodialysis did not meet the co-primary endpoints)

Stock In Focus Chiasma to Offer Common Shares

Chiasma Inc (NASDAQ: CHMA) commenced an underwritten public offering of its common stock. The company said the shares are being offered pursuant to the shelf registration statement on Form S-3 it filed with the SEC March 22.

The stock slumped 17.53 percent to $4.75 in after-hours trading.

AC Immune Reports Positive Data For PET Tracer to Detect Parkinson's Disease

Swiss biotech AC Immune SA (NASDAQ: ACIU), which focuses on therapies for neurodegenerative disorders, presented new data on its positron emission tomography tracer demonstrating a high-affinity binding to human Parkinson's disease-brain derived alpha-synuclein, facilitating accurate detecting and monitoring of Parkinson's disease in humans. The presentation was made at the 14th International Conference on Alzheimer's and Parkinson's Diseases, being held in Lisbon.

Eisai Given the Go-ahead for Late-stage Study of Early Alzheimer's Drug By Safety Monitoring Board

Eisai said the Data Safety Monitoring Board, or DSMB, which reviewed the safety data from the global Phase 3 study of its investigational oral BACE inhibitor elenbecestat recommended continuation of the studies.

Eisai is codeveloping elenbecestat with Biogen Inc (NASDAQ: BIIB).

The Phase 3 trial consists of two studies dubbed MISSION AD1 and MISSION AD2, which are meant to assess the efficacy and safety of elenbecestat for the treatment of patients with mild cognitive impairment due to AD or mild AD dementia. Eisai said it expects to complete enrollment into the two studies in March.

Blueprint Medicine Prices Its Offering

Blueprint Medicines Corp (NASDAQ: BPMC) priced its common stock offering of 4.054 million shares at $74 per share.

The stock fell 0.99 percent to $74.96 in after-hours trading.

Amarin Submits Regulatory Filing For Expanded Indication For Vascepa Capsules

Amarin Corporation plc (NASDAQ: AMRN) said it has submitted a sNDA for an expanded indication for its lead product Vascepa capsules to be used as an add-on to statins in patients with high cardiovascular risk, who despite stable statin therapy, had elevated triglyceride levels.

The stock fell 1.41 percent to $18.18 in after-hours trading.

See Also: 6 Gene Therapy M&A Targets On The Radar

Essa's New Prostate Cancer Drug More Effective, Names It as Lead Candidate

ESSA Pharma Inc (NASDAQ: EPIX) announced the nomination of EPI-7368 as the lead candidate for the treatment of metastatic castration-resistant prostate cancer. The asset is a novel drug candidate that inhibits the N-terminal domain of the androgen receptor.

The company noted that EPI-7368 is significantly more potent, metabolically stable and more effective in preclinical studies than its first-gen product ralaniten acetate.

The company expects to enter clinical studies with EPI-7386 in the first quarter of 2020.

Daiichi Expedites BLA Filing Schedule For Breast Cancer Drug, Strikes Collaboration With AstraZeneca

Japanese pharma company DAIICHI SANKYO/S ADR (OTC: DSNKY) plans to accelerate filing for its BLA for [fam-] trastuzumab deruxtecan, or DS-8201, that is being evaluated for HER2 positive metastatic breast cancer previously treated with trastuzumab emtansine. As against the original filing schedule of 2020, the company plans BLA submission in the first half of 2019.

View more earnings on IBB

Separately, the company announced a global development and commercialization agreement with AstraZeneca plc (NYSE: AZN) for DS-8201.

Gilead and Galapagos Ace Late-stage Study For Rheumatoid Arthritis Drug

Gilead Sciences, Inc. (NASDAQ: GILD) and GALAPAGOS NV/S ADR (NASDAQ: GLPG) announced that a Phase 3 study, dubbed FINCH3, of its investigational, oral, selective JAK1 inhibitor filgotinib in adults with moderately-to-severely active rheumatoid arthritis achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20 percent response at Week 24. The pipeline asset was evaluated as a monotherapy and in combination with methotrexate in MTX-naïve patients.

Gilead shares rose 0.80 percent to $64.20 in after-hours trading, while Galapagos rallied 10.27 percent to $106.

Earnings

Achaogen reported fourth-quarter Zemdri revenues of $0.5 million following its commercial launch in July 2018, and contract revenues of $1.5 million, down from $1.9 million last year. Total revenues rose from $1.869 million in the fourth quarter of 2017 to $2.025 million in the fourth quarter of 2018. The company's net loss widened from 98 cents per share to $1.01 per share.

Analysts estimated a loss of 75 cents per share on revenues of $2.85 million.

The stock declined 8.70 percent to 42 cents in after-hours trading.

Aridis Pharmaceuticals Inc (NASDAQ: ARDS) reported fourth-quarter revenues of $1.39 million compared to $794,000 in the year-ago period. The loss per share narrowed from $34.34 to 67 cents.

The stock jumped 8.90 percent to $11.50 in after-hours trading.

TapImmune Inc. (NASDAQ: MRKR) provided a business and clinical update, wherein it said it plans to advance a Phase 2 Company-sponsored clinical trial in post-transplant acute myeloid leukemia, as it looks forward to finalize its clinical protocol by the end of the second quarter of 2019 and submit an IND in the third quarter.

Based on its current cash resources, the company said it has adequate cash to meet its operating requirements into the fourth quarter of 2020.

The stock soared 13.43 percent to $6.84 in after-hours trading.

On The Radar Clinical Trial Results

Aptinyx Inc (NASDAQ: APTX) is due to present preclinical data for NYX-458 at the International Conference on Alzheimer's & Parkinson's Diseases.

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