The Daily Biotech Pulse: Mallinckrodt Faces FDA Panel, Reshape's Earnings, Vapotherm To Debut

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. 13)

• AstraZeneca plc (NYSE: AZN)

• Down In The Dumps

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

• Abeona Therapeutics Inc (NASDAQ: ABEO)
• Achieve Life Sciences Inc (NASDAQ: ACHV)
• Aclaris Therapeutics Inc (NASDAQ: ACRS)
• Aduro BioTech Inc (NASDAQ: ADRO)
• Aerie Pharmaceuticals Inc (NASDAQ: AERI)
• Alkermes Plc (NASDAQ: ALKS)
• Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)
• aTyr Pharma Inc (NASDAQ: LIFE)
• Clearside Biomedical Inc (NASDAQ: CLSD)
• Concert Pharmaceuticals Inc (NASDAQ: CNCE)
• DURECT Corporation (NASDAQ: DRRX)
• Edge Therapeutics Inc (NASDAQ: EDGE)
• Endologix, Inc. (NASDAQ: ELGX)
• Eyenovia Inc (NASDAQ: EYEN)
• Foamix Pharmaceuticals Ltd (NASDAQ: FOMX)
• Histogenics Corp (NASDAQ: HSGX)
• Magenta Therapeutics Inc (NASDAQ: MGTA)
• Nemaura Medical Inc (NASDAQ: NMRD)
• Neos Therapeutics Inc (NASDAQ: NEOS)
• Oncolytics Biotech, Inc. (NASDAQ: ONCY)
• Onconova Therapeutics Inc (NASDAQ: ONTX)
• Ophthotech Corp (NASDAQ: OPHT)
• PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS)
• Pieris Pharmaceuticals Inc (NASDAQ: PIRS)
• RA Medical Systems Inc (NYSE: RMED)
• SCYNEXIS Inc (NASDAQ: SCYX)(reported a narrower-than-expected loss for its Q3)
• Stemline Therapeutics Inc (NASDAQ: STML)
• Tenax Therapeutics Inc (NASDAQ: TENX)
• Trillium Therapeutics Inc (NASDAQ: TRIL)
• Vascular Biogenics Ltd (NASDAQ: VBLT)

Stocks In Focus

Merck Begins Rolling Regulatory Submission For Its Investigational Ebola Vaccine

Merck & Co., Inc. (NYSE: MRK) said it has started the submission of a rolling biologic license application to the FDA for V920, its investigational vaccine for Ebola Zaire disease. The application was granted Breakthrough Therapy Designation in July 2016.

This rolling submission would accelerate the regulatory review process for V920, the company said.

Merck expects the rolling submission to be completed in 2019.

CareDx Prices 2M Stock Offering

CareDx Inc (NASDAQ: CDNA) priced its underwritten public offering of 2 million shares at $24.50 per share, a discount to the $25.49 at which they closed Tuesday. The company expects to generate gross proceeds of $49 million from the offering.

The stock fell 2.86 percent to $24.76 in after-hours trading.

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

Earnings

Altimmune Inc (NASDAQ: ALT) reported a decline in Q3 revenues from $4.6 million to $2.6 million. The net loss narrowed from $61.57 to $1.73, with the year-ago loss including an impairment charge.

The stock rallied 5.88 percent to $3.60 in after-hours trading.

aTyr Pharma Inc (NASDAQ: LIFE) reported a loss of 24 cents for Q3'18 compared to a loss of 43 cents per share in Q3 2017, while analysts had estimated a loss of 31 cents per share.

The stock advanced 14.23 percent to $0.63 in after-hours trading.

ImmuCell Corporation (NASDAQ: ICCC), an animal health company, reported Q3 revenues of $2.2 million, up 7 percent year-over-year. The net loss narrowed from 7 cents per share to 5 cents per share.

The stock jumped 19.94 percent to $8.86 in after-hours trading.

Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) reported a solid 66 percent year-over-year increase in Q3 revenues to $10.7 million. The net loss for the quarter narrowed from 28 cents per share to 12 cents per share.

The stock advanced 7.51 percent to $4.15 in after-hours trading.

Atossa Genetics Inc (NASDAQ: ATOS) reported a narrower loss of 64 cents per share for Q3 2018 compared to a loss of $2.11 per share for Q3 2017. The consensus estimate had called for a loss of 65 cents per share.

As of Sep. 30, the company had cash and cash equivalents and restricted cash of $13 million.

The stock slumped 18.60 percent to $1.05 in after-hours trading.

On The Radar

Earnings

• Athenex Inc (NASDAQ: ATNX) (before the market open)
• Aldeyra Therapeutics Inc (NASDAQ: ALDX) (before the market open)
• AIT Therapeutics Inc (OTC: AITB) (after the market close)
• Reshape Lifesciences Inc (NASDAQ: RSLS) (after the market close)
• Edap Tms SA (NASDAQ: EDAP) (after the market close)
• Cesca Therapeutics Inc (NASDAQ: KOOL) (after the market close)
• RXi Pharmaceuticals Corp (NASDAQ: RXII) (after the market close)
• Cytori Therapeutics Inc (NASDAQ: CYTX) (after the market close)
• Precision Therapeutics Inc (NASDAQ: AIPT) (after the market close)
• Titan Pharmaceuticals, Inc. common stock (NASDAQ: TTNP) (after the market close)

Adcom Meeting

Mallinckrodt PLC (NYSE: MNK)'s generic unit SpecGx's NDA for an immediate-release oral tablet formulation of oxycodone - MNK-812 - will be discussed by a joint committee of Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Nov. 14. This pipeline asset is intended to manage pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Clinical Trial Results

TRACON Pharmaceuticals Inc (NASDAQ: TCON) will present Phase 2 data for TRC102 and Temodar, evaluated for Glioblastoma, at the Society for Neuro-Oncology 2018 annual meeting 2018 annual meeting held in New Orleans, Louisiana.

Zymeworks Inc (NYSE: ZYME) is expected to present updated Phase 1 data for ZW25, its candidate for HER2-expressing cancers such as ovarian, breast and gastric, at the 30th European Organisation for Research and Treatment of Cancer, or EORTC, the National Cancer Institute, or NCI, and the American Association for Cancer Research, or AACR symposium held in Dublin, Ireland.

IPO

Vapotherm, which manufactures non-invasive breathing aids to treat respiratory distress, priced its 4-million share initial public offering at $14 per share, the lower end of the estimated price range of $14-$16. Shares are to be listed on the Nasdaq under the ticker symbol VAPO.

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