The Daily Biotech Pulse: Regeneron's Bad Cholesterol Drug Aces Late-Stage Trial, Oncolytics 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 Aug. 13)

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

Down In The Dumps

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

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

Stocks In Focus

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

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