Abbott 2019 guidance raised

Abbott Laboratories (ABT) Q2 results: Revenues: $7,979M (+2.7%); Nutrition: $1,875M (+0.9%); Diagnostics: $1,905M (+1.7%); Established Pharmaceuticals: $1,108M (-1.8%); Medical Devices: $3,075M (+6.4%).

Net Income: $1,006M (+40.1%); EPS: $0.56 (+40.0%); Non-GAAP Net Income: $1,465M (+13.1%); Non-GAAP EPS: $0.82 (+12.3%).

2019 Guidance: GAAP EPS: $2.06 – 2.12 from $1.95 – 2.05; Non-GAAP EPS: $3.21 – 3.27 from $3.15 – 3.25.

Q3 Guidance: GAAP EPS: $0.53 – 0.55; Non-GAAP EPS: $0.83 – 0.85.

Shares are up 1% premarket.

https://seekingalpha.com/news/3478361-abbott-1-percent-q2-beat-2019-guidance-raised

Seattle Genetics upped to Overweight from Neutral by Piper

Target to $75 from $64

https://www.benzinga.com/stock/SGEN/ratings

J&J target hiked to $147 from $146 by Raymond James

Maintains Outperform

https://www.benzinga.com/stock/JNJ/ratings

Astellas in-licenses rights to hearing loss candidate

Astellas Pharma (OTCPK:ALPMF) inks an agreement with Woburn, MA-based Frequency Therapeutics to co-develop and commercialize a regenerative therapeutic candidate, FX-322, for the treatment of sensorineural hearing loss.

Frequency will be responsible for development and commercialization in the U.S. while Astellas will have the same responsibilities ex-U.S. They will jointly conduct global clinical trials and will coordinate commercial launch activities.

Under the terms of the deal, Astellas will pay Frequency $80M upfront, up to $545M in milestones and royalties on net ex-U.S. sales.

A Phase 2a study should launch in Q4.

FX-322 is a proprietary combination of small molecule drugs designed to restore hearing function by activating inner ear progenitor cells already present in the body to induce hair cell regeneration. Sensorineural hearing loss is the result of damage to and/or loss of sensory hair cells in the inner ear. These inner ear hair cells do not spontaneously regenerate once damaged, although progenitor cells capable of regenerating hair cells remain present in the ear in an inactive state.

https://seekingalpha.com/news/3478333-astellas-licenses-rights-hearing-loss-candidate

FDA accepts Allergan Bimatoprost SR application to lower intraocular pressure

The FDA accepts for review Allergan’s (NYSE:AGN) marketing application for Bimatoprost Sustained-Release (SR) for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The agency’s action will be in late H1 2020.

https://seekingalpha.com/news/3478356-fda-accepts-allergans-bimatoprost-sr-application-reducing-intraocular-pressure

Anixa Bio teams up with Cleveland Clinic to investigate breast cancer vaccine

Anixa Biosciences (NASDAQ:ANIX) inks a strategic alliance and license agreement with Cleveland Clinic aimed at developing a vaccine against triple negative breast cancer (TNBC), its most aggressive and treatment-resistant form.

A Cleveland Clinic researcher, Dr. Vincent Tuohy, has identified a protein that he says becomes inactive after a women gives birth but reappears in many forms of cancer. Studies have shown that vaccinating against this protein completely prevents breast cancer in mice.

In November 2017, the U.S. Department of Defense awarded a $6.2M grant to Dr. Tuohy and Cleveland Clinic to fund preclinical studies and the completion of two Phase 1 trials in humans.

The company will host a conference call tomorrow, July 18, at 4:30 pm ET to discuss the agreement.

https://seekingalpha.com/news/3478366-anixa-bio-teams-cleveland-clinic-investigate-breast-cancer-vaccine

FDA OKs Merck’s triplet antibiotic

The FDA approves Merck’s (NYSE:MRK) RECARBRIO (imipenem, cilastatin, relebactam) for injection, 1.25 gm for the treatment of patients at least 18 years old with complicated urinary tract infections, including pyelonephritis, and complicated intra-abdominal infections caused by certain Gram-negative bacteria who have limited or no alternative treatment options.

The agency reviewed the application under Qualified Infectious Disease Product and Priority Review status.

Imipenem is a penem antibacterial drug, cilastatin sodium is renal dehydropeptidase inhibitor and relebactam is a beta lactamase inhibitor. Cilastatin limits the renal metabolism of imipenem and has no antibacterial activity. Relebactam has no intrinsic antibacterial activity either but protects imipenem from degradation by certain beta lactamase enzymes.

Market launch should commence later this year.

https://seekingalpha.com/news/3478339-fda-oks-mercks-triplet-antibiotic

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