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 AZN

• Down In The Dumps

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

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

Stocks In Focus

Merck Begins Rolling Regulatory Submission For Its Investigational Ebola Vaccine

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

Adcom Meeting

Mallinckrodt PLC 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 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 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.