Monopar Therapeutics sets terms of downsized IPO

Monopar Therapeutics (MNPR) has filed a preliminary prospectus for an IPO of ~1.1M common shares at $8-10 per share.

Underwriters’ over-allotment will be an additional ~167K shares.

In September, it filed for an offering of ~4.4M shares at the same price range.

https://seekingalpha.com/news/3526260-monopar-therapeutics-sets-terms-of-downsized-ipo

FDA advisory committee backs Horizon’s teprotumumab

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 12-0 that the benefits of Horizon Therapeutics’ (NASDAQ:HZNP) teprotumumab outweigh the risks for the treatment of thyroid eye disease (TED).

The FDA’s action date is March 8, 2020.

Teprotumumab is a fully human monoclonal antibody that binds to (inhibits) a protein called insulin-like growth factor 1 receptor (IGF-1R). TED is a rare autoimmune disorder in which IGF-1R is overexpressed in the eye.

https://seekingalpha.com/news/3526261-fda-advisory-committee-backs-horizons-teprotumumab

Amarin shares halted pending news

Nasdaq has suspended trading in Amarin (AMRN +4.9%) pending the release of news. In this, probably the expected FDA nod for a CV benefit claim for Vascepa (icosapent ethyl). The agency’s action date is December 28.

https://seekingalpha.com/news/3526234-amarin-shares-halted-pending-news

FDA approves Tandem’s predictive insulin pump software

The U.S. Food and Drug Administration on Friday granted approval for Tandem Diabetes Care’s software program that uses readings from a continuous glucose monitor to predict and deliver corrective doses of insulin to patients using the company’s t:slim X2 insulin pump.

Tandem’s Control IQ algorithm is the first insulin dosing software approved under the FDA’s new “interoperability” approval pathway. This allows companies to develop components of so-called artificial pancreas systems that can be used with products sold by other companies that have gone through the same approval process.

“That’s a really big deal for the industry,” Tandem Chief Executive John Sheridan said in a phone interview.

https://www.reuters.com/article/us-tandem-diabetes/u-s-fda-approves-tandems-predictive-insulin-pump-software-idUSKBN1YH21P

SI-BONE: CIGNA Establishes Positive Coverage for MIS SI Joint Fusion

SI-BONE, Inc.,  (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announced today that CIGNA has established a positive coverage policy for minimally invasive SI joint fusion.

The new policy specifies that coverage will be exclusive for FDA cleared implants that are placed across the SI joint and intended to promote bone fusion. This decision follows an extensive amount of published clinical evidence demonstrating the safety and effectiveness of the iFuse Implant System, including a recent publication of 5-year results from a long-term prospective study called LOIS (Long Term Outcomes from INSITE and SIFI).

Cigna is the fourth largest commercial health plan in the United States with 14.6 million members. Its new policy, available at this link: (https://cignaforhcp.cigna.com/public/content/pdf/coveragePolicies/medical/mm_0303_coveragepositioncriteria_lumbar_fusion_degenerative_conditions.pdf), became effective December 10, 2019.

“As a result of this positive coverage decision, CIGNA’s members will have access to the iFuse procedure when deemed medically necessary by their surgeons,” said Jeffrey Dunn, President, CEO and Chairman at SI-BONE. “CIGNA’s decision to cover MIS SI joint fusion is a significant milestone in the continuing adoption of this important treatment for patients with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.”

https://www.biospace.com/article/releases/si-bone-inc-announces-cigna-establishes-positive-coverage-for-mis-si-joint-fusion-using-the-ifuse-implant-systemnew-positive-coverage-policy-is-specific-for-fda-cleared-implants-placed-across-the-si-joint-and-intended-to-promote-bone-fusion/

Boehringer, Lilly update on Jardiance phase 3 exercise ability in heart failure

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials related to functional endpoints with Jardiance® (empagliflozin) in adults with chronic heart failure with reduced and preserved ejection fraction, respectively. In both trials, there was no significant change from baseline to week 12 in exercise ability with Jardiance versus placebo, as measured by the six-minute walk test, which was the primary endpoint of the studies. The safety profile seen in the EMPERIAL trials was similar to the currently known safety profile of Jardiance and no new safety risks were identified.

The EMPERIAL trials, which included people with and without diabetes, deliver novel safety data for Jardiance in non-diabetic patients with heart failure. In addition, EMPERIAL-Preserved is the first trial to deliver safety data for Jardiance in heart failure with preserved ejection fraction.

“Our large heart failure clinical program underscores our dedication to researching new options for people living with this condition,” said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “The EMPERIAL trials set a high bar for Jardiance to demonstrate an improvement in exercise ability in people with chronic heart failure, and we continue to believe in its potential to improve clinical outcomes. The ongoing EMPEROR trials—which are investigating outcomes including cardiovascular death, hospitalization for heart failure and quality of life—remain the cornerstone of our heart failure program, and we look forward to sharing initial results in 2020.”

The EMPERIAL trials used the six-minute walk test, which measures the distance a person can walk in six minutes, to evaluate changes in exercise ability over 12 weeks. For other heart failure guideline-recommended therapies, there have been divergent results between studies examining clinical outcomes and symptom improvement, with some showing improvements in outcomes such as mortality, but neutral or inconsistent results in exercise ability and patient-reported outcomes.

The ongoing empagliflozin heart failure program also includes the EMPEROR-Preserved, EMPEROR-Reduced, EMPULSE and EMPA-VISION studies. The program, which will include more than 10,000 adults, investigates the effects of empagliflozin on heart failure-related outcomes and patient-related outcomes in people with heart failure. The EMPERIAL studies were initiated based on data obtained from the EMPA-REG OUTCOME® trial, in which Jardiance showed a 38% relative risk reduction in cardiovascular death and a 35% relative risk reduction in hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease, compared to placebo.

https://www.biospace.com/article/releases/boehringer-ingelheim-and-lilly-provide-update-on-jardiance-phase-iii-exercise-ability-studies-in-chronic-heart-failure/

Tenet to divest Memphis-area facilities

Tenet Healthcare (THC +0.6%) has agreed to sell two hospitals, including its associated physician practices, and six MedPost urgent care centers in the Memphis area to Methodist Le Bonheur Healthcare for an undisclosed sum.

The hospitals are St. Francis in Memphis and St. Francis in Bartlett.

The transaction should be completed in 2020.

https://seekingalpha.com/news/3526199-tenet-to-divest-memphis-area-facilities