The Daily Biotech Pulse: SITC Presentations Pick Up Pace, Sandoz' Voluntary Recall

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. 8)

• Amphastar Pharmaceuticals Inc (NASDAQ: AMPH)
• AstraZeneca plc (NYSE: AZN)(reported declines in Q3 revenues and earnings but confirmed its full-year outlook)
• Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL)
• BioTelemetry Inc (NASDAQ: BEAT)
• Gritstone Oncology Inc (NASDAQ: GRTS)
• LogicBio Therapeutics Inc (NASDAQ: LOGC)
• Merck & Co., Inc. (NYSE: MRK)
• Meridian Bioscience, Inc. (NASDAQ: VIVO)(reported bette-than-expected Q4 results)
• Pacific Biosciences of California (NASDAQ: PACB)
• Twist Bioscience Corp (NASDAQ: TWST)
• Wright Medical Group NV (NASDAQ: WMGI)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 8)

• Achaogen Inc (NASDAQ: AKAO)(reported a loss for its Q3, while it revenues missed estimates)
• Avalara Inc (NYSE: AVLR)
• OraSure Technologies, Inc. (NASDAQ: OSUR)
• RA Medical Systems Inc (NYSE: RMED)
• Reshape Lifesciences Inc (NASDAQ: RSLS)(shares started trading on a post-split basis following its reverse stock split)
• Ritter Pharmaceuticals Inc (NASDAQ: RTTR)
• Rockwell Medical Inc (NASDAQ: RMTI)
• Tenax Therapeutics Inc (NASDAQ: TENX)

Stocks In Focus

Novartis' Generic Unit Recalls A Lot of Hypertension Tablet

Novartis AG (NYSE: NVS)' Sandoz unit said it's voluntarily recalling one lot of Losartan Potassium Hydrochloride tablets, USP 100mg/25mg to the consumer level. The tablet is indicated for hypertension. The company attributed the recall to the trace amount of an impurity N-nitrosodiethylamine in the tablets manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd.

Ascendis Forms Chinese Joint Venture For Endocrinology Drugs

Ascendis Pharma A/S (NASDAQ: ASND) announced a 50-50 joint venture named VIEN Pharma, with an investor syndicate led by Vivo Capital to develop and commercialize endocrinology rare disease therapies in China. The investor syndicate has invested $40 million in lieu of the 50 percent stake in the joint venture.

Earnings

Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) reported a decline in it revenues from $4.1 million in Q3 2017 to $1.2 million in Q3 2018, with the company blaming the decline on the timing of activities. The net loss, however, narrowed from 63 cents per share to 37 cents per share, roughly in line with the 36 cents per share loss expected by analysts.

The stock surged up 10.22 percent to $2.48 in after-hours trading.

ICU Medical, Incorporated (NASDAQ: ICUI) said its Q3 revenues declined from $343.2 million a year ago to $327.2 million in Q3. Adjusted earnings per share of $1.85 beat the $1.51 consensus estimate. The company raised its full-year guidance, and issued initial 2019 adjusted EBITDA guidance.

The stock slipped 7.05 percent to $242 in after-hours trading.

Transenterix Inc (NYSE: TRXC) reported Q3 revenues of $5.42 million, with 4 Senhance systems sold during the quarter. The adjusted net loss per share for the quarter narrowed from 9 cents to 6 cents, while the consensus had called for a loss of 7 cents.

The stock pulled back 9.36 percent to $3.10 in after-hours trading.

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

Myovant Sciences Ltd (NYSE: MYOV) reported a wider-than-expected loss for its Q3.

The stock declined 7.28 percent to $19.74 in after-hours trading.

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) reported 16 percent net revenue growth and its net loss narrowed from 21 cents to 10 cents. Analysts had estimated a loss of 14 cents per share for the quarter.

The stock advanced 5.69 percent to $3.90 in after-hours trading.

CareDx Inc (NASDAQ: CDNA) reported a 74 percent year-over-year increase in total revenues, with testing revenues more than doubling to $21.2 million. The net loss narrowed from 15 cent per share fr 1 cent per share. The consensus had called for a loss of 3 cents per share for the quarter.

The stock moved up 5.44 percent to $29.25 in after-hours trading.

Tocagen Inc (NASDAQ: TOCA) reported license revenues of $18.01 million for its Q3. The company's net loss was $1.47 per share compared to a loss of $2.19 per share reported for the year-ago period. The company revised its cash burn guidance for 2018, expecting the total cash used to fund operations and capex to be about $50 million, resulting in a year-end cash balance of about $70 million compared to the $40 million it estimated in Jan. 2018,

The stock rallied 13.73 percent to $14 in after-hours trading.

Omeros Corporation (NASDAQ: OMER) reported total Q3 revenues of $4.6 million, down from the $21.7 million reported for last year. The company attributed the drop to the significant reduction in OMIDRIA usage by ASCs and hospitals due to the absence of transitional pass-through reimbursement, which expired for Omidra on Jan. 1. The company's net loss was 81 cents per share, wider than the year-ago loss of 10 cents per share and the consensus of 77 cents per share.

Separately, the company announced plans to offer $210 million worth of convertible senior noted due 2023.

The stock fell 8.86 percent to $14.60 in after-hours trading.

On The Radar

PDUFA Dates

Merck & Co., Inc. (NYSE: MRK), which recently announced FDA approval for its Keytruda in combination with chemotherapy drugs for metastatic squamous non-small cell lung cancer, or NSCLC, has another tryst with the FDA. The regulatory body will announce its verdict on Keytruda as a monotherapy for hepatocellular carcinoma. The sBLA was submitted based on the KEYNOTE-224 study.

Clinical Trial Presentations

Society For Immunotherapy Of Cancer, or SITC, 2018 Meeting Presentations

Iovance Biotherapeutics Inc (NASDAQ: IOVA) – update on Phase 2 program for LN-144 for treating refractory metastatic melanoma
Aduro BioTech Inc (NASDAQ: ADRO) – initial Phase 1b data for its ADU-S100 for treating solid tumors as well as lymphoma
TESARO Inc (NASDAQ: TSRO) – Phase 1 data for its solid tumor treatment combo TSR-022 + TSR-042
Nektar Therapeutics (NASDAQ: NKTR) – Updated Phase 1/2 data for NKTR-214+ Bristol-Myers Squibb Co (NYSE: BMY)'s Opdiva for treating melanoma, renal cell carcinoma and NSCLC
Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP) – Phase 1/2 data for NY-ESO T-cell therapy to treat Myxoid round cell liposarcoma
Celldex Therapeutics, Inc. (NASDAQ: CLDX) – interim Phase 1 data for CDX-1140 to treat solid tumors
NewLink Genetics Corp (NASDAQ: NLNK) – Initial Phase 1 data for NLG802, tested for treating solid tumors
Oncomed Pharmaceuticals Inc (NASDAQ: OMED) – Phase 1a data for Anti-TIGIT being evaluated for solid tumors
MacroGenics Inc (NASDAQ: MGNX) – Phase 1 data for Enoblituzumab as a treatment option for solid tumors
Curis, Inc. (NASDAQ: CRIS) – Updated Phase 1 data for CA170 that is being evaluated for solid tumor and lymphoma
Alkermes Plc (NASDAQ: ALKS) – Initial Phase 1 data for its solid tumor treatment candidate ALKS 4230

Earnings

SurModics, Inc. (NASDAQ: SRDX) (before the market open)
PLx Pharma Inc (NASDAQ: PLXP) (before the market open)
Axsome Therapeutics Inc (NASDAQ: AXSM) (before the market open)
BioXcel Therapeutics Inc (NASDAQ: BTAI) (before the market open)
Omeros Corporation (NASDAQ: OMER) (before the market open)
Neos Therapeutics Inc (NASDAQ: NEOS) (before the market open)
TG Therapeutics Inc common stock (NASDAQ: TGTX) (before the market open)

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