DBV announces additional Phase I data in pertussis toxin study

DBV Technologies, the Geneva University Hospitals and BioNet-Asia presented new data from a Phase I study evaluating the safety and immunogenicity of boosting young adults against pertussis toxin with an investigational epicutaneous patch containing recombinant PT. The new results, which were presented at the European Congress of Immunology in by Dr. Olga Chatzis and Prof. Claire-Anne Siegrist, highlighted data from two additional cohorts showing that following skin preparation with an epidermal laser, anti-PT booster responses elicited by Viaskin-PT were comparable to those elicited by Boostrix dTpa, an injectable approved booster vaccine, DBV said in a statement. In March 2017, data from this study reported no detectable immunogenicity signal following the application of Viaskin-PT on intact skin, it added. Data presented showed favorable safety and immunogenicity responses in healthy adults who received two applications of Viaskin-PT following skin preparation with an epidermal laser, DBV said. No serious adverse events were reported. The company “continues to evaluate these positive

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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