U.S. Markets closed

The Daily Biotech Pulse: Regeneron's Bad Cholesterol Drug Aces Late-Stage Trial, Oncolytics Offering

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 Aug. 13)

  • GENMAB A/S/S ADR (NASDAQ: GMAB) (IPOed July 1)
  • NextCure Inc (NASDAQ: NXTC)(reacted to its second-quarter results)
  • Novocure Ltd (NASDAQ: NVCR)
  • Syndax Pharmaceuticals Inc (NASDAQ: SNDX)
  • ResMed Inc. (NYSE: RMD)
  • West Pharmaceutical Services Inc. (NYSE: WST)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Aug. 13)

  • Aclaris Therapeutics Inc (NASDAQ: ACRS)
  • Acorda Therapeutics Inc (NASDAQ: ACOR)
  • Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC)
  • Fulcrum Therapeutics Inc (NASDAQ: FULC)
  • Gamida Cell Ltd (NASDAQ: GMDA)
  • Guardion Health Sciences Inc (NASDAQ: GHSI)(announced $5.2 million common stock offering)
  • Haemonetics Corporation (NYSE: HAE)
  • Hemispherx BioPharma, Inc (NYSE: HEB)
  • Mallinckrodt PLC (NYSE: MNK)
  • Meridian Bioscience, Inc. (NASDAQ: VIVO)
  • Neuralstem, Inc. (NASDAQ: CUR)
  • Nevro Corp (NYSE: NVRO)
  • Obalon Therapeutics Inc (NASDAQ: OBLN)
  • Pfizer Inc. (NYSE: PFE)
  • Plus Therapeutics Inc (NASDAQ: PSTV)
  • Psychemedics Corp. (NASDAQ: PMD)
  • RA Medical Systems Inc (NYSE: RMED)
  • Trillium Therapeutics Inc (NASDAQ: TRIL)(reacted to its second-quarter results)
  • TrovaGene Inc (NASDAQ: TROV)
  • Viking Therapeutics Inc (NASDAQ: VKTX)
  • Viveve Medical Inc (NASDAQ: VIVE)
  • Xenetic Biosciences Inc (NASDAQ: XBIO)

Stocks In Focus Regeneron's Bad Cholesterol Drug Meets Primary Endpoint In Late-Stage Trial

Regeneron Pharmaceuticals Inc (NASDAQ: REGN), which announced a FDA approval for its prefilled Eylea syringe Tuesday, said a pivotal Phase 3 trial evaluating evinacumab in patients with homozygous familial hypercholesterolemia met the primary endpoint, showing that addition of the compound to other lipid-lowering therapies decreased LDL cholesterol by 49% on average, compared to lipid-lowering therapies alone.

Mallinckrodt's Regenerative Tissue Found Effective In Early-Stage Trial

Mallinckrodt announced the publication of positive results of its Phase 1b data of StrataGraft – its investigational regenerative tissue – in the journal of the International Society of Burn Injuries.

The company said the data showed that treatment with a single application of StrataGraft tissue resulted in wound closure by three months in 27 of the 29 study participants.

Also, the efficacy of StrataGraft was comparable to those treated with autograft at 12 months after treatment.

The stock added 2.06% to $4.95 in after-hours trading.

AstraZeneca, Merck's Lynparza Found Effective In First-Line Ovarian Cancer Setting

AstraZeneca plc (NYSE: AZN) and Merck & Co., Inc. (NYSE: MRK) announced positive results from the Phase 3 study dubbed PAOLA-1 that evaluated its Lynparza in combo with the current standard of care bevacizumab compared to bevacizumab alone as a first-line maintenance therapy for advanced ovarian cancer in women with or without BRCA gene mutations.

Oncolytics to Offer Shares

Oncolytics Biotech, Inc. (NASDAQ: ONCY) intends to offer common shares and warrants to purchase common shares in an underwritten public offering. The company said the offering is subject to market conditions as well as Nasdaq and TSX approvals. The company said it would use the net proceeds for R&D and working capital purposes.

Separately, the company reported financial results for the second quarter, showing a narrower loss.

The stock slumped 20.01% to 72 cents in after-hours trading.

Earnings

Genetic testing company Myriad Genetics, Inc. (NASDAQ: MYGN) reported fiscal year, fourth-quarter revenues of $215.4 million, up 11% year-over-year. The adjusted EPS fell from 43 to 41 cents. The results trailed estimates. The company issued a mixed guidance.

The stock plunged 16.95% to $37 in after-hours trading.

Medical cannabis maker Tilray Inc (NASDAQ: TLRY)'s second-quarter revenues climbed 371.1% to $45.9 million but the net loss widened from 17 cents to 36 cents. Analysts expected a loss of 25 cents on revenues of $41.11 million.

The stock declined 10.32% to $41.27 in after-hours trading.

Applied DNA Sciences Inc (NASDAQ: APDN) said its fiscal year third-quarter revenues climbed 102% to $2.1 million, with the increase due to a licensing agreement in the cannabis industry. The net loss narrowed from 10 cents per share to 4 cents per share. The results trailed estimates.

The stock moved down 11.08% to 28 cents in after-hours trading.

Altimmune Inc (NASDAQ: ALT) reported a decline in second quarter revenues from $2.4 million in 2018 to $1.6 million in 2019. The net loss, however, narrowed from $10.29 to 26 cents.

The stock fell 3.30% to $2.05 in after-hours trading.

Cyclacel reported a wider loss for its second quarter and the stock slipped 9.82% to 49 cents in after-hours trading.

On The Radar Earnings

  • Onconova Therapeutics Inc (NASDAQ: ONTX) (before the market open)
  • aTyr Pharma Inc (NASDAQ: LIFE) (after the close)
  • Aethlon Medical, Inc. (NASDAQ: AEMD) (after the close)
  • Dare Bioscience Inc (NASDAQ: DARE) (after the close)
  • OncoCyte Corp (NYSE: OCX) (after the close)
  • Zosano Pharma Corp (NASDAQ: ZSAN) (after the close)
  • Y-mAbs Therapeutics, Inc (NASDAQ: YMAB) (after the close)
  • Misonix, Inc. (NASDAQ: MSON) (after the close)
  • Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) (after the close)
  • Reshape Lifesciences Inc (OTC: RSLS) (after the close)
  • Zyla Life Sciences (OTC: ZCOR) (after the close)

See more from Benzinga

© 2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.