The Daily Biotech Pulse: Mallinkckrodt's Terlipressin, Deciphera Offering, Sellas Reboots On Earnings

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. 14)

• GENMAB A/S/S ADR GMAB (announced first-half results and raised 2019 guidance)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Aug. 14)

• Acer Therapeutics Inc ACER (reacted to second-quarter results)
• Acorda Therapeutics Inc ACOR
• Adaptimmune Therapeutics PLC – ADR ADAP
• Akorn, Inc. AKRX
• Amneal Pharmaceuticals Inc AMRX
• aTyr Pharma Inc LIFE (reacted to second-quarter results)
• Bicycle Therapeutics PLC BCYC
• BioMarin Pharmaceutical Inc. BMRN
• Cancer Genetics Inc CGIX
• Cellectis SA CLLS
• DelMar Pharmaceuticals Inc DMPI(announced $6.5 million common stock offering)
• DiaMedica Therapeutics Inc DMAC(reacted to second-quarter results)
• Ekso Bionics Holdings Inc EKSO
• Fulcrum Therapeutics Inc FULC
• GENFIT S A/ADR GNFT
• Kiniksa Pharmaceuticals Ltd KNSA
• Medigus ADR MDGS
• Meridian Bioscience, Inc. VIVO
• Mersana Therapeutics Inc MRSN
• Neuralstem, Inc. CUR(reacted to second-quarter results)
• Neurometrix Inc NURO
• Nuvectra Corp NVTR
• Obalon Therapeutics Inc OBLN
• Oncolytics Biotech, Inc. ONCY(priced $3.7 million worth of common stock offering)
• Oragenics Inc OGEN
• Pfizer Inc. PFE
• Pluristem Therapeutics Inc. PSTI
• Prothena Corporation PLC PRTA
• Rubius Therapeutics Inc RUBY
• Sierra Oncology Inc SRRA
• Sonoma Pharmaceuticals Inc SNOA
• Supernus Pharmaceuticals Inc SUPN
• Tetraphase Pharmaceuticals Inc TTPH
• Teva Pharmaceutical Industries Ltd TEVA(lawmakers accused the company of obstructing price-fixing probe)
• Trillium Therapeutics Inc TRIL
• TrovaGene Inc TROV
• Xenetic Biosciences Inc XBIO

Stocks In Focus

Mallinkckrodt's Hepatorenal Syndrome Drug Aces Late-Stage Trial

Mallinckrodt PLC MNK announced positive top-line results from the pivotal Phase 3 study dubbed CONFIRM that evaluated the efficacy and safety of terlipressin in 300 adults with hepatorenal syndrome type 1, or HRS-1. The study met the primary endpoint of verified HRS-1 reversal, including three components: renal function improvement, avoidance of dialysis and short-term survival.

The company said it expects to submit an NDA to the FDA for the indication in early 2020.

The stock was seen rising 8.84% to $5.05 in pre-market trading Thursday.

Deciphera To Offer Shares

Deciphera Pharmaceuticals Inc DCPH, which announced positive clinical trial results for its gastrointestinal stromal tumor drug candidate earlier this week, priced its previously announced underwritten public offering of 10.81 million shares of its common stock at $37 per share, likely raising $40 million in gross proceeds for the company. The offering would close Aug.19.

The stock rose 0.84% to $38.19 in after-hours trading.

Earnings

Ritter Pharmaceuticals Inc RTTR announced quarterly results for the second quarter, which showed a loss of 31 cents per share, narrower than the year-ago loss of 71 cents per share. Cash and cash equivalents fell from $7.8 million at the end of Dec. 2018 to $4.4 million at the end of June 2019. Analysts expected a loss of 49 cents per share.

The stock gained 8.80% to 95 cents in after-hours trading.

Fibrocell Science Inc FCSC reported second-quarter revenues of $20.98 million in 2019 compared to no revenues last year, with the revenues stemming from the sale of an exclusive license to commercialize FCX-007 in the U.S.. The company reversed to a profit of $1.12 per share from a loss of 49 cents per share.

The stock rose 8.26% to $1.90 in after-hours trading.

Sellas Life Sciences Group Inc SLS's second quarter loss narrowed from $1.26 in 2018 to 13 cents in 2019. Cash and cash equivalents totaled $12.8 million at the end of June 2019.

Analysts expected a loss of 18 cents per share for the quarter.

The company had initiated a review of strategic options earlier this year.

The penny stock jumped 21.77% to 17.9 cents in pre-market trading.

Medical device maker Misonix, Inc. MSON's second-quarter revenues increased from $8.64 million in 2018 to $9,75 million in 2019. The net loss, however, widened from $1.78 million to $2.35 million.

The stock moved down 7.68% to $19.60 in after-hours trading.

OncoCyte Corp OCX reported a net loss per share of 10 cents for the second quarter of 2019, narrower than the net loss per share of 12 cents for the second quarter of 2018.

The stock plunged 15.31% to $1.77 in after-hours trading.

On The Radar

Earnings

Auris Medical Holding Ltd EARS (before the market open)
Bio-Path Holdings Inc BPTH (before the market open)