FDA OKs expanded use of Roche cervical cancer test

The FDA approves expanded use of Roche’s (OTCQX:RHHBY) CINtec PLUS Cytology test to be used as triage for positive cobas HPV tests performed on the automated cobas 6800 and 8800 systems in primary screening or co-testing programs.

The company says CINtec PLUS is more sensitive than a PAP smear and allows physicians to determine which HPV-positive women require further diagnostic procedures to prevent disease progression.

https://seekingalpha.com/news/3614454-fda-oks-expanded-use-of-roche-cervical-cancer-test

FDA accepts Orphazyme arimoclomol application for rare lipid disorder

Under Priority Review status, the FDA accepts Orphazyme A/S’s (ORPH) marketing application seeking approval for lead drug arimoclomol for the treatment of Niemann-Pick disease Type C, a rare inherited disorder in which the body is unable to transport cholesterol and other lipids inside of cells. The fatty substances accumulate in various body tissues, leading to potentially life-threatening nerve and organ damage.

The agency’s action date is March 17, 2021. No advisory committee meeting is planned.

Orally administered arimoclomol amplifies the production of heat-shock proteins, which can rescue defective misfolded proteins, clear protein aggregates and improve the function of lysozymes, naturally occurring enzymes that function as antimicrobial agents.

The company secured the rights to arimoclomol from CytRx in 2011.

https://seekingalpha.com/news/3614460-fda-accepts-orphazyme-arimoclomol-application-for-rare-lipid-disorder

Lilly COVID-19 antibody shows positive effect in mid-stage study

Eli Lilly (NYSE:LLY) announces positive preliminary data from a Phase 2 clinical trial, BLAZE-1, evaluating LY-CoV555, a SARS-CoV-2 neutralizing antibody, in COVID-19 outpatients with mild-to-moderate symptoms.

The change from baseline in viral load at day 11, the primary endpoint, was met in the 2,800 mg dose arm, but not the others (700 mg, 7,000 mg, placebo). Most patients, including those in the control arm, showed near-complete viral clearance by day 11.

Treatment with LY-CoV555 was associated with improved viral clearance at an earlier time point (day 3) and a lower proportion of patients with persistently high viral load at later time points as well as a lower hospitalization rate.

On the safety front, LY-CoV555 was well-tolerated with no treatment-related serious adverse events and a profile similar to placebo. The rate of putative LY-CoV555 resistance variants (source of drug resistance) was 8% in the treatment group compared to 6% in the placebo group.

https://seekingalpha.com/news/3614483-lilly-covidminus-19-antibody-shows-positive-effect-in-mid-stage-study

Arrowhead Pharma +10% on encouraging ARO-AAT data in liver disease

Arrowhead Pharmaceuticals (NASDAQ:ARWR) jumps 10% on positive interim 24-week liver biopsy results in four subjects from AROAAT2002, an open-label Phase 2 study of ARO-AAT, the second generation investigational RNA interference (RNAi) therapeutic being developed as a treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency (AATD). The study assesses ~16 patients.

Serum and total intra-hepatic mutant AAT protein (Z-AAT) decreased in all four patients by up to 93% and 95%, respectively.

Three of four patients demonstrated reductions in intra-hepatic Z-AAT polymer, with a maximum reduction of 97%.

Maximum reductions of 66% in circulating alanine aminotransferase (ALT) and 58% in gamma-glutamyl transferase (GGT) observed in all four patients.

All patients demonstrated improved transient elastography FibroScan values, with three of four patients exhibiting greater than 20% reductions.

“These data are very encouraging and suggest that ARO-AAT may rapidly ameliorate liver injury. It is particularly reassuring to see the decrease in liver enzymes, which suggests that elevations are related to proteotoxic stress that could be addressed with ARO-AAT therapy rather than reflecting co-morbidities,” said Professor Pavel Strnad, M.D., University Hospital Aachen, Germany, and an investigator on the trial.

https://seekingalpha.com/news/3614514-arrowhead-pharmaplus-10-on-encouraging-aro-aat-data-in-liver-disease

Heron Therapeutics’ HTX-011 shows positive action in hernia repair surgery

Heron Therapeutics (NASDAQ:HRTX) announces results from EPOCH 2 follow-on study evaluating the efficacy and safety of locally administered HTX-011 300 mg bupivacaine / 9 mg meloxicam into the surgical site in combination with a postoperative non-opioid multimodal analgesia regimen of over-the-counter oral acetaminophen and ibuprofen in 63 patients undergoing open inguinal hernia repair surgery.

In in this study, more than 90% of patients did not require opioids to manage their postoperative pain during the first 72 hours.

87% of patients were opioid-free through Day 10 and 83% throughout the entire 28-day follow-up period of the study.

Mean pain intensity scores were similar between cohorts and never rose above the mild pain range (NRS <4) throughout the 72-hour postoperative period.

Addition of an intraoperative dose of ketorolac did not provide additional benefit for pain intensity or opioid use.

HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.

https://seekingalpha.com/news/3614551-heron-therapeutics-htxminus-011-shows-positive-action-in-hernia-repair-surgery

Teladoc Health and Livongo issue updates on merger

Teladoc Health (NYSE:TDOC) and Livongo (NASDAQ:LVGO) have filed the joint proxy statement and prospectus with the SEC in connection with the proposed merger of the two companies.

Special meetings will be held on October 29, wherein stockholders will be entitled to vote.

The Teladoc and Livongo Boards of Directors each unanimously recommends their respective stockholders vote “For” the proposed merger set forth in the proxy statement.

As described in the prospectus, each share of Livongo will be exchanged for 0.5920 Teledoc shares plus cash consideration of $4.24.

Additionally, prior to the closing of the merger, LVGO will pay a cash dividend of $7.09/share.

The transaction is on track to close by the end of Q4.

https://seekingalpha.com/news/3614496-teladoc-health-and-livongo-issue-updates-on-merger

Dosing underway in Arena Pharma’s pivotal etrasimod study in ulcerative colitis

Arena Pharmaceuticals (NASDAQ:ARNA) has dosed the first participant in the ELEVATE UC 12 global Phase 3 trial evaluating etrasimod, as the potential treatment of moderately to severely active ulcerative colitis (UC).

ELEVATE UC 12 will assess the efficacy and safety of etrasimod 2 mg once-daily in subjects with moderately to severely active UC. The primary objective of this trial is clinical remission at 12 weeks (similar to the Phase 2 OASIS trial)

“This is a significant milestone for Arena as the progress confirms that the ELEVATE UC registrational program, including ELEVATE UC 12 and UC 52 trials, remains on track for data by year-end 2021.” said Chris Cabell EVP, Head of R&D, and Chief Medical Officer.

Etrasimod is an orally available next-generation sphingosine 1-phosphate receptor modulator. Selected binding to subtype S1PR1 leads to anti-inflammatory activity by its (theorized) interference with the migration of a specific subset of activated lymphocytes to sites of inflammation

https://seekingalpha.com/news/3614555-dosing-underway-in-arena-pharmas-pivotal-etrasimod-study-in-ulcerative-colitis