Eisai, Merck announce China approval of liver cancer med

Eisai (ESALY) and Merck (MRK) announced that the China National Medical Products Administration, or NMPA, approved the kinase inhibitor Lenvima as a single agent for the treatment of patients with unresectable hepatocellular carcinoma, or HCC who have not received prior systemic therapy. In China, the application of Lenvima was submitted in October 2017 and was designated for priority review by the NMPA due to Lenvima’s significant clinical benefit compared to existing treatments, leading to approval in approximately 10 months. This approval marks the first for Lenvima in China, where the incidence of HCC is high, and the first new systemic therapy approved for the first-line treatment of unresectable HCC in China in ten years. The approval was based on results from the REFLECT study, an open-label, Phase 3 trial where Lenvima demonstrated a treatment effect on overall survival by statistical confirmation of non-inferiority when compared with the standard of care, sorafenib, in 954 patients with previously untreated unresectable HCC; patients randomized to the Lenvima arm did not have a statistically significant improvement in overall survival compared to those in the sorafenib arm.
https://thefly.com/landingPageNews.php?id=2785705

Bio-Rad initiated at Barclays

Bio-Rad initiated with an Equal Weight at Barclays. Barclays analyst Jack Meehan started Bio-Rad Laboratories with an Equal Weight rating and $345 price target. The analyst views the investment thesis and valuation as balanced at current share levels. He sees a lot of long-term opportunity at Bio-Rad, but also near-term challenges, including Diagnostics pricing.
https://thefly.com/landingPageNews.php?id=2785709

Barclays downgrades Hologic on more cautious near-term outlook

Barclays analyst Jack Meehan downgraded Hologic to Equal Weight from Overweight and lowered his price target for the shares to $43 from $50. The analyst is more cautious around the near-term outlook for Hologic’s Diagnostics segment and potential for “heightened competitive activity” in 2019. Meehan also has “limited conviction” in CynoSure’s ability to accelerate and support mid-single digit growth overall. He views Hologic’s investment thesis and valuation as balanced at current share levels.
https://thefly.com/landingPageNews.php?id=2785711

Barclays downgrades Myriad to Underweight near 18-year high

Barclays analyst Jack Meehan downgraded Myriad Genetics to Underweight from Equal Weight and cut his price target for the shares to $30 from $38. With the stock near an 18-year high, several company risks create an unfavorable risk/reward profile, Meehan tells investors in a research note. He sees “several risks” around the GeneSight Randomized Control Trial, which he thinks present risks for payor coverage. Further, the analyst is cautious around the sustainability of hereditary cancer testing pricing longer term.
https://thefly.com/landingPageNews.php?id=2785713

BioCryst price target raised to $16 from $12 at JMP Securities

JMP Securities analyst Liisa Bayko raised her price target on BioCryst to $16 from $12 after data from the Phase 2 ZENITH-1 trial showed the liquid formulation of 750 mg BCX7353 was superior to placebo in multiple clinical outcomes measuring hereditary angioedema attacks. The data for BCX7353 opens the door to the acute treatment setting, Bayko tells investors. She maintains her Outperform rating on BioCryst shares
https://thefly.com/landingPageNews.php?id=2785743

MediWound receives marketing authorization for NexoBrid in Russia

MediWound announced receipt of authorization from the Ministry of Health in Russia to market and distribute NexoBrid for the removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. Genfa Medica, MediWound’s exclusive distribution partner in Russia, received the marketing authorization and intends to launch NexoBrid in Russia in the first half of 2019. This regulatory approval builds upon NexoBrid’s marketing authorization from the European Medicines Agency for the same indication and again validates MediWound’s strategy of using the EMA approved registration file for seeking approval in different international markets around the globe.
https://thefly.com/landingPageNews.php?id=2785747

Abivax Bolstered by Positive Mid-Stage Results from Ulcerative Colitis Treatment

Shares of Paris-based Abivax have shot up more than 8 percent this morning after the company posted positive mid-stage results for its ulcerative colitis treatment, ABX464.

This morning the company released topline results from its Phase IIa trial showing treatment with the experimental drug resulted in “statistically significant efficacy based on both clinical and endoscopic endpoints in this study.” Abivax’s ABX464 has a mechanism of action that is triggered by an increased expression of miR124, a potent anti-inflammatory microRNA, the company said.

Final eight-week topline data from the Phase IIa study showed 35 percent of patients on the Abivax treatment saw clinical remission, compared to 11 percent of placebo patients. When it came to mucosal healing, 50 percent of ABX464 patients saw a positive response, compared to 11 percent of patients on placebo. Abivax’s ABX464 yielded an overall 70 percent clinical response rate, compared to 30 percent for placebo, results show.

Additionally, the company noted that calprotectin, the best-studied biomarker in ulcerative colitis, was markedly reduced in patients who received ABX464 in comparison to placebo after four weeks of treatment.

For ulcerative colitis patients treated with ABX464 the onset of therapeutic effect was rapid, the company said. Efficacy could be observed following two weeks of treatment and the results “became significant” at eight weeks.

Ulcerative colitis is a debilitating inflammatory bowel disease in adults and children, with limited therapeutic management options for many patients. It is estimated that close to 1 million patients with ulcerative colitis live in the United States.

Jean-Marc Steens, chief medical officer of Abivax, said the results of the Phase IIa trial have exceeded the company’s expectations given the “statistically significant, strong efficacy” that was already observed in the study.

“They validate our hypothesis that ABX464 novel mechanism of action would result in potent anti-inflammatory properties in patients. Like other chronic inflammatory diseases, ulcerative colitis is a debilitating disease that greatly affects patients’ quality of life and warrants expensive innovative therapies. We look forward to developing and potentially market ABX464 as a well-tolerated oral treatment for this large patient population,” Steens said in a statement.

No severe adverse events attributed to ABX464 were reported in the trial. Full clinical trial data will be presented at upcoming international scientific conferences, the company said.

Hartmut Ehrlich, chief executive officer at Abivax, called the Phase II a data impressive. He said it indicates the potential for ABX464 to bring relief to UC patients who “are not adequately helped by currently available therapeutics and are struggling from the devastating consequences of this inflammatory disease.” Based on the results, Abivax will initiate a Phase IIb dose-ranging study for ABX464. Ehrlich added that the data is also leading the company to pursue mid-stage trials in other inflammatory indications, such as Crohn’s disease.

https://www.biospace.com/article/-cp8r-abivax-bolstered-by-positive-mid-stage-results-from-ulcerative-colitis-treatment/