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

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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. (NYSE: VAPO)(listed following its IPO)
  • Down In The Dumps

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

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

Stocks In Focus

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

AbbVie Inc (NYSE: ABBV) and Neurocrine Biosciences, Inc. (NASDAQ: 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 (NYSE: 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. (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: EARS) (before the market open)
  • PAVmed Inc (NASDAQ: PAVM) (after the market close)
  • NantHealth Inc (NASDAQ: NH) (after the market close)

Clinical Trial Results

Blueprint Medicines Corp (NASDAQ: 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.

Posted-In: Biotech Earnings News FDA Top Stories Trading Ideas Best of Benzinga

 

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