The Daily Biotech Pulse: Nektar Withdraws Opioid Pain Drug NDA, Galapagos Takes Stake In Fibrocor, Integra Lifesciences Lowers Q4 Guidance

The following is a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs on Jan. 14.)

• Adaptimmune Therapeutics PLC – ADR ADAP: announced an oncology stem cell therapy pact with Astellas Pharma Inc. ALPMY.
• Applied Therapeutics Inc APLT
• Arvinas Inc ARVN
• AtriCure Inc. ATRC
• AVITA MED LTD/S ADR RCEL
• Biondvax Pharmaceuticals Ltd – ADR BVXV
• Calithera Biosciences Inc CALA
• Editas Medicine Inc EDIT
• Eli Lilly And Co LLY
• Epizyme Inc EPZM
• Fate Therapeutics Inc FATE
• Frequency Therapeutics Inc FREQ
• Halozyme Therapeutics, Inc. HALO (provided 2020 guidance)
• Hologic, Inc. HOLX
• Medpace Holdings Inc MEDP
• Momenta Pharmaceuticals, Inc. MNTA
• Myokardia Inc MYOK
• NeoGenomics, Inc. NEO
• Novo Nordisk A/S NVO
• NuVasive, Inc. NUVA
• Profound Medical Corp PROF
• Repligen Corporation RGEN
• Replimune Group Inc REPL
• Revance Therapeutics Inc RVNC
• Syneos Health, Inc. SYNH
• TG Therapeutics Inc common stock TGTX
• Varian Medical Systems, Inc. VAR
• Viela Bio Inc VIE
• West Pharmaceutical Services Inc. WST
• XBiotech Inc XBIT (announced a tender offer to buy up to $420 million worth of its shares)
• Zai Lab Ltd ZLAB
• Zoetis Inc ZTS

Down In The Dumps

(Biotech stocks that hit 52-week lows on Jan. 14.)

• GenMark Diagnostics, Inc GNMK
• Novan Inc NOVN
• Portola Pharmaceuticals Inc PTLA
• Sellas Life Sciences Group Inc SLS
• Stemline Therapeutics Inc STML (issued a negative pre-announcement)

See also: The Week Ahead In Biotech: JPMorgan Healthcare Conference, FDA Panel Reviews Opioid Pain Drugs, I-Mab's IPO

Stocks In Focus

Nektar Withdraws NDA For Opioid Pain Drug 

Nektar Therapeutics NKTR said an FDA panel that discussed its NDA for oxycodegol did not recommend its approval.

The company said it is withdrawing the NDA and is making no further investment into the program.

The stock was down 14.7% at $23.85 at the time of publication in Wednesday's premarket session. 

Galapagos Expands Collaboration With Fibrocor, Takes Equity Stake

GALAPAGOS NV/S ADR GLPG announced an expansion of its collaboration agreement with the Canadian biotech Fibrocor Therapeutics, with the former taking an equity stake in the latter.

The original agreement signed in January 2019 was intended for a small molecule inhibitor program focused on an undisclosed fibrotic target. The expanded collaboration gives Galapagos an exclusive option to in-license a total of four additional novel target programs.

Fibrocor specializes in the development of tissue-specific therapeutics to treat fibrotic diseases of the kidney, liver, lung and other organs.

Rockwell Out-Licenses Indian Rights For Triferic To Sun Pharma

Rockwell Medical Inc RMTI said it has signed licensing and supply agreements with Sun Pharma for the rights to commercialize Triferic in India. Rockwell will receive an upfront fee and is also be eligible for milestone payments and royalties on net sales.

Triferic is an approved drug to replace iron and maintain hemoglobin in hemodialysis patients via dialysate during each dialysis treatment.

Integra Lifesciences Lowers Q4 Guidance, Sees Below-Consensus FY20 Revenue 

Integra Lifesciences Holdings Corp IART lowered its fourth-quarter revenue guidance to be at or near the low end of its previously communicated guidance range of $395 million to $400 million. The company guided to full-year 2020 revenue of $1.55 billion to $1.57 billion and earnings per share growth in the double digits. Analysts project revenue of $1.6 billion and EPS growth of 9.5%.

Athersys Announces New CFO

Athersys, Inc. ATHX announced the appointment of pharma industry veteran Ivor Macleod as its CFO, effective Jan. 31, ahead of the potential approval of its Multistem cell therapy.

The stock was rising by 4.48% to $1.40 in Wednesday's premarket session. 

On The Radar

Adcom Meeting

A joint meeting of the FDA's AADPAC and DSRMAC will discuss IntelliPharmaCeutics International Inc. IPCIF's NDA for an extended-release oral tablet formulation of oxycodone. The investigational candidate is being evaluated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Related Link: Attention Biotech Investors: Mark Your Calendar For These January PDUFA Dates