The Daily Biotech Pulse: FDA Nod For Mallinckrodt's Pain Drug, AbbVie-Neurocrine Report Positive Elagolix Results

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peak

(Biotech stocks hitting 52-week highs on Nov. 14)

• Vapotherm, Inc. VAPO(listed following its IPO)

• Down In The Dumps

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

• Abeona Therapeutics Inc ABEO
• Achieve Life Sciences Inc ACHV
• Aclaris Therapeutics Inc ACRS
• Adaptimmune Therapeutics PLC – ADR ADAP
• Adial Pharmaceuticals Inc ADIL
• Aerie Pharmaceuticals Inc AERI
• Alkermes Plc ALKS
• Alnylam Pharmaceuticals, Inc. ALNY
• AnaptysBio Inc ANAB
• Athenex Inc ATNX(reported wider loss for its Q3)
• aTyr Pharma Inc LIFE( reported a narrower loss for Q3)
• Biocept Inc BIOC(reported a narrower Q3 loss but a decline in revenues)
• Blueprint Medicines Corp BPMC
• Celgene Corporation CELG
• Clearside Biomedical Inc CLSD
• Concert Pharmaceuticals Inc CNCE
• Cue Biopharma Inc CUE
• Cytokinetics, Inc. CYTK
• Dova Pharmaceuticals Inc DOVA
• Endologix, Inc. ELGX
• Epizyme Inc EPZM
• Evelo Biosciences Inc EVLO
• Genprex Inc GNPX
• GlycoMimetics Inc GLYC
• Histogenics Corp HSGX
• Ironwood Pharmaceuticals, Inc IRWD
• Iterum Therapeutics PLC ITRM(reported higher revenues and a narrower loss for Q3)
• Kala Pharmaceuticals Inc KALA
• Magenta Therapeutics Inc MGTA
• Neos Therapeutics Inc NEOS
• Neuronetics Inc STIM
• Onconova Therapeutics Inc ONTX
• Ophthotech Corp OPHT
• Ovid Therapeutics Inc OVID
• Pernix Therapeutics Holdings Inc PTX
• PhaseBio Pharmaceuticals Inc PHAS
• Radius Health Inc RDUS
• Regulus Therapeutics Inc RGLS
• Revance Therapeutics Inc RVNC
• RXi Pharmaceuticals Corp RXII
• Sangamo Therapeutics Inc SGMO(JP Morgan downgraded the stock to Neutral and lowered its price target)
• Stemline Therapeutics Inc STML
• SUMMIT THERAPEU/S ADR SMMT
• Sunesis Pharmaceuticals, Inc. SNSS
• Tetraphase Pharmaceuticals Inc TTPH
• The Medicines Company MDCO
• Trillium Therapeutics Inc TRIL(reported Q3 results)
• Vascular Biogenics Ltd VBLT
• VIVUS, Inc. VVUS

Stocks In Focus

AbbVie-Neurocine's Elagolix Found Effective and Safe For Treating Uterine Fibroids

AbbVie Inc ABBV and Neurocrine Biosciences, Inc. NBIX presented positive additional results from two replicate Phase 3 trials that evaluated the efficacy and safety of elagolix in women with uterine fibroids at the 47th American Association of Gynecologic Laparoscopists Global Congress on Minimally Invasive Gynecology in Las Vegas, Nevada.

At month six of the six-month treatment period, elagolix 300mg twice a day in combination with low-dose hormone therapy reduced heavy menstrual bleeding related to uterine fibroids compared to placebo.

The data will support regulatory submission for elagolix in uterine fibroids – a likely mid-2019 event, the company said.

See Also: The Week Ahead In Biotech: Earnings, Conferences, PDUFA Dates, Clinical Trial Results And IPOs

FDA Panel Recommends Approval of Mallinckrodt Unit's Pain Drug

Mallinckrodt PLC MNK said a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 10 to 7 in favor of approving its SpecGx generic unit's investigative abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The committees also voted 12-5 for labeling the drug as an abuse-deterrent product by the nasal route of abuse. Also, the committees voted 10-7 for not labeling the drug as an abuse-deterrent product by the intravenous route of abuse.

The stock rose 1.55 percent to $31.39 in after-hours trading.

European Commission Approves Exelixis-Ispen's Caometyx For Liver Cancer

Exelixis, Inc. EXEL said its partner Ispen has received European Commission approval for its Cabometyx tablets as a monotherapy for hepatocellular carcinoma in adults who have previously been treated with sorafenib.

The approval allows the marketing of the drug in all 28 EU member states, Norway and Iceland.

This kicks in a milestone payment of $40 million due to Exelixis within the next 70 days.

Earnings

Aptevo Therapeutics Inc APVO reported a 132 percent increase in Ixinity sales to $5.8 million. Ixinity is the company's recombinant factor IX treatment for hemophilia B. Total revenues however fell year-over-year, as the year-ago results included $3.7 million in collaboration revenues. The company's loss narrowed from $1.77 to 56 cents per share, which was also narrower than the consensus estimate of 57 cents per share.

The stock slumped 13.23 percent to $2.69 in after-hours trading.

Reshape Lifesciences Inc RSLS reported Q3 revenues of $350,236, lower than $360,020 in the year-ago period. The net loss narrowed to $27.46 per share.

The stock fell 1.09 percent to $1.81 in after-hours trading.

Neovasc Inc NVCN's Q3 revenues fell 65 percent to $480,540. Sales of its Reducer rose 44 percent to $489,540. The company reported a loss of 6 cents per share, roughly in line with estimates.

The stock plunged 18.99 percent to $1.45 after-hours trading.

On The Radar

Earnings

• Auris Medical Holding AG EARS (before the market open)
• PAVmed Inc PAVM (after the market close)
• NantHealth Inc NH (after the market close)

Clinical Trial Results

Blueprint Medicines Corp BPMC will present updated Phase 1 data for Avapritnib BLU-285 that is being evaluated for PDGFRα driven gastrointestinal stromal tumors at the Connective Tissue Oncology Society, or CTOS, 2018 Annual Meeting held in Rome, Italy.