The Daily Biotech Pulse: Intuitive Surgical Earnings, Paratek Pulls Out European Application For Antibiotic, Amgen's Evenity In Europe

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 Oct. 17)

• Applied Therapeutics Inc APLT
• Arrowhead Pharmaceuticals Inc ARWR
• Celgene Corporation CELG
• Kodiak Sciences Inc KOD
• The Medicines Company MDCO
• Reata Pharmaceuticals Inc RETA

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 17)

• Aileron Therapeutics Inc ALRN
• Alpine Immune Sciences Inc ALPN
• Diffusion Pharmaceuticals Inc DFFN
• Fulcrum Therapeutics Inc FULC
• Homology Medicines Inc FIXX
• ITAMAR MED LTD/S ADR ITMR
• Kiniksa Pharmaceuticals Ltd KNSA
• Mirum Pharmaceuticals Inc MIRM
• Neurometrix Inc NURO (reacted to its third-quarter results)
• Puma Biotechnology Inc PBYI
• Rigel Pharmaceuticals, Inc. RIGL
• Spring Bank Pharmaceuticals Inc SBPH
• Theratechnologies Inc THTX
• Titan Pharmaceuticals, Inc. TTNP

Stocks In Focus

Intuitive Surgical Q3 Tops Expectations

Intuitive Surgical, Inc. ISRG reported third-quarter earnings per share of $3.43 on revenues of $1.13 billion. This compares to consensus estimates, which called for earnings per share of $2.99 on revenues of $1.06 billion.

The stock added 3% to $545.30 in after-hours trading.

See Also: Biotech Stock On The Radar: Assessing Mirati's Oncology Franchise With An Eye On Multiple Readouts

Paratek Withdraws EU Regulatory Filing For Antibiotic To Maximize Value Upon Launch

Paratek Pharmaceuticals Inc PRTK said it has withdrawn its submission to the European Medicines Agency, or EMA, of the Marketing Authorization Application for its antibiotic Nuzyra.

The EMA had recommended approval of Nuzyra for acute bacterial skin and skin structure infections, or ABSSSI, but not for community-acquired pneumonia, or CAB. For the second indication, the EMA wanted another study, in line with the norms of mandatory requirement for two Phase 3 studies per indication for approval.

The decision to withdraw is to maximize the value of Nuzyra upon a EU launch, as the 10-year market exclusivity will begin with the first approval.

The stock rose 2.89% to $3.56 in after-hours trading.

J&J Reports Positive Long-term Efficacy Data For Psoriasis Drug

Johnson & Johnson JNJ's Janssen unit announced new long-term data from the open-label period of the Phase 3 VOYAGE-1 clinical trial, which showed that 82% of patients receiving its psoriasis drug Tremfya in the combined group of patients initially randomized to Tremfya or to placebo with crossover to Tremfya at Week 16 achieved a 90% improvement in the Psoriasis Area Severity Index, or PASI, response and an Investigator's Global Assessment score of cleared or minimal disease at Week 204.

"These findings demonstrated maintenance of PASI 90 and IGA 0/1 response rates for four years in adults with moderate-to-severe plaque psoriasis," the company said.

Amgen-UCB's Bone Building Drug Recommended For Approval In EU

Amgen, Inc. AMGN and UCB said following a re-examination procedure, the Committee for Medicinal Products for Human Use, or CHMP, of the EMA has adopted a positive opinion, recommending Marketing Authorization for Evenity to treat severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke.

In June, the CHMP had recommended against approval of the drug, citing heart risks.

Evenity is a bone building drug that has a two-pronged effect – increasing bone formation as well as reducing bone loss. The CHMP's opinion will be reviewed by the EC, and a decision is expected by year-end 2019.

On The Radar

PDUFA Dates

The FDA is likely to rule on Amgen's Nplate, which is being evaluated for treating adult patients with immune thrombocytopenia, for 12 months or less.