The Daily Biotech Pulse: Nabriva Stumbles At FDA Hurdle, Gilead CFO To Retire, Eisai Ends Collaboration With Purdue

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

Scaling The Peaks

(Biotech stocks hitting 52-week highs on April 30)

• VolitionRX Ltd VNRX
• ZEALAND PHARMA/S ADR ZEAL
• Zynerba Pharmaceuticals Inc ZYNE

Down In The Dumps

(Biotech stocks hitting 52-week lows on April 30)

• Acorda Therapeutics Inc ACOR
• Gamida Cell Ltd GMDA
• KemPharm Inc KMPH
• Meridian Bioscience, Inc. VIVO(announced an agreement to acquire the business of GenePOC, a Canadian provider of molecular diagnostic instruments and assays)
• Outlook Therapeutics Inc OTLK
• Unum Therapeutics Inc UMRX

Stock In Focus

FDA Hands Out Complete Response Letter For Nabriva's Urinary Tract Infection Drug

Nabriva Therapeutics PLC – ADR NBRV received a complete response letter, or CRL, from the FDA for its NDA for Contepo, chemically fosfomycin, injection for treating complicated urinary tract infections, including acute pyelonephritis.

The company said the CRL pertains to issues related to facility inspections and manufacturing deficiencies at one of its contract manufacturers, and that it will seek a Type a meeting with the FDA to discuss the findings.

Shares, which had advanced in the run up to the decision, were seen tumbling 43.14 percent to $1.70 in pre-market trading.

Gilead's CFO To Retire After A More Than 10-Year Stint

Gilead Sciences, Inc. GILD said its CFO Robin Washington has announced her plan to retire, effective March 1, 2020. Washington will remain in an advisory capacity through the completion of the company's reporting of 2019 financial results to ensure a smooth transition, the company said. She will join the board at Alphabet.

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

ArQule's Chinese Licensee Gets Regulatory Nod For Commencing Clinical Trial For Liver Cancer Drug

ArQule, Inc. ARQL said its Chinese partner Sinovant Sciences announced that its Clinical Trial Application, or CTA, for derazantinib has been accepted by the Chinese regulatory agency, enabling of a registrational clinical trial in patients with second-line intrahepatic cholangiocarcinoma in the second half of 2019.

The stock climbed 5.53 percent to $6.30 in after-hours trading.

Eisai Buys Out Full Development Rights to Sleep Disorder Drug

Eisai Co., Ltd ESALY said it will buy out Purdue Pharma's rights to the worldwide collaboration for the development and commercialization of lemborexant, an investigational sleep-wake regulation agent being studied for the treatment of multiple sleep-wake disorders in patients with Alzheimer's Disease.

The original agreement signed in August 2015 required that both companies share the costs of global clinical studies and commercialization. Following Eisai's buyout of the stake, it will provide a one-time payment to Purdue, and assume the sole responsibility for the conduction all future development and commercialization activities globally.

The PDUFA date for the investigational drug has been set for Dec. 27, 2019.

Earnings

Tandem Diabetes Care Inc TNDM reported 142 percent sales growth and 232 percent jump in pump shipments. The company's net loss per share narrowed, and it raised its 2019 revenue guidance.

The stock climbed 7.47 percent to $66 in after-hours trading.

Twist Bioscience Corp TWST reported first-quarter revenues that more than doubled to $13.6 million and orders nearly doubled. The net loss per share narrowed from 93 cents to $6.32. The company raised its full-year guidance.

The stock rose 5.71 percent to $25.01 in after-hours trading.

Veracyte Inc VCYT's first-quarter revenues climbed 47 percent to $29.5 million. Genomic test volume climbed 33 percent. The loss per share narrowed from 27 cents to 5 cents. Veracyte raised its 2019 revenue guidance

The stock gained 5.16 percent to $24.05 in after-hours trading.

Pulse Biosciences Inc PLSE reported a loss of 49 cents per share for its first quarter, wider than the 44 cents per share loss expected by analysts.

The stock fell 11.67 percent to $14.15 in after-hours trading.

Evolus Inc EOLS reported a net loss of 40 cents per share compared to a loss of 30 cents per share a year ago. Analysts expected a wider loss of 79 cents per share.

The stock moved up 4.59 percent to $25.50 in after-hours trading.

Offerings

Repligen Corporation RGEN priced its previously announced underwritten public offering of 2.734 million shares at $64 per share.

The stock fell 2.80 percent to $65.49 in after-hours trading.

On The Radar

PDUFA Dates

Sanofi SA SNY dengue vaccine Dengvaxia will come before the FDA scanner, with the regulatory agency scheduled to announce its verdict.

Clinical Trial Readouts

Aldeyra Therapeutics Inc ALDX is due to present Phase 2 data for ADX-102, which is being studied, for dry eye syndrome at the Association for Research In Vision and Ophthalmology, or ARVO, annual meeting.

Audentes Therapeutics Inc BOLD will present Phase 1/2 data for AT132 in X-linked myotubular myopathy at the American Society of Gene and Cell Therapy annual meeting.

Earnings

• Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
• ArQule (before the market open)
• United Therapeutics Corporation UTHRV
• Syros Pharmaceuticals Inc SYRS (before the market open)
• Strongbridge Biopharma plc SBBP (before the market open)
• United Therapeutics Corporation UTHR (before the market open)
• Lexicon Pharmaceuticals, Inc. LXRX (before the market open)
• ACADIA Pharmaceuticals Inc. ACAD (after the market close)
• Exelixis, Inc. EXEL (after the market close)
• PRA Health Sciences Inc PRAH (after the market close)
• SurModics, Inc. SRDX (after the market close)
• LeMaitre Vascular Inc LMAT (after the market close)
• MacroGenics Inc MGNX (after the market close)
• Vanda Pharmaceuticals Inc. VNDA (after the market close)
• Nuvectra Corp NVTR (after the market close)
• Hologic, Inc. HOLX (after the market close)