Friday, January 4, 2019
Hologic downgraded to Market Perform from Outperform at Cowen
https://thefly.com/landingPageNews.php?id=2843627
Epizyme announces registration path for tazemetostat for follicular lymphoma
Epizyme announced a comprehensive set of pipeline updates, including that the company has identified a path to submission for accelerated approval of tazemetostat for patients with relapsed and/or refractory follicular lymphoma, both with and without EZH2 activating mutations. The company recently conducted a productive meeting with the U.S. FDA to discuss the FL registration strategy based on the current patient population in its ongoing Phase 2 clinical trial. Following the discussion, Epizyme has defined a registration strategy for tazemetostat in both EZH2 mutant and wild type FL patient populations, where patients’ disease has progressed following two or more lines of therapy. Based on this, the company anticipates submitting a New Drug Application for this indication in the fourth quarter of 2019. In addition, the company provided an update on its clinical and preclinical pipeline and anticipated milestones for 2019.
Healthcare IT pullbacks create ‘great’ opportunities, says Oppenheimer
Oppenheimer analyst Mohan Naidu says that recent pullbacks are creating some “great” opportunities in Healthcare IT and believes, in particular, Evolent Health (EVH), Omnicell (OMCL), Tabula Rasa HealthCare (TRHC) and Teledoc (TDOC) stand out. In a research note to investors, Naidu contends that Evolent will gain from the finalized CMS regulations and increased push to risk-based models, and says Omnicell’s story is significantly de-risked with traction in XT implementations. He also adds that Tabula Rasa should deliver on multiple growth drivers brewing in 2019 including PACE. and that despite the near-term distractions, Teledoc’s story remains intact with significant telehealth adoption and utilization focus.
Emergent BioSolutions CEO Abdun-Nabi to retire, Kramer to succeed
https://thefly.com/landingPageNews.php?id=2843682
Flex Pharma, Salarius Pharmaceuticals announce merger agreement
Flex Pharma and Salarius Pharmaceuticals announced that the companies have entered into a definitive merger agreement under which privately-held Salarius will merge with a wholly-owned subsidiary of Flex Pharma. Management believes that the proposed transaction will position the combined company to recognize multiple value inflection points based on Salarius’ clinical pipeline, which targets rare, orphan cancers with no targeted treatments and cancers that have a high unmet need. Salarius recently completed a $6.4M private placement, which combined with cash from Flex Pharma is expected to fund the combined company to mid-2020, allowing it to report early cohort data from an ongoing Phase 1 Ewing sarcoma trial. Upon the closing of the transaction, Flex Pharma stockholders will own approximately 19.9% of the combined company and current Salarius investors will own approximately 80.1% of the combined company. Flex Pharma stockholders will also receive a right to receive warrants, six months and one day following the closing date of the transaction, allowing them to purchase additional shares. The total value of these warrants will be calculated such that upon exercise Flex Pharma stockholders would own an additional 2.4%, or a total of 22.3%, of the value of the combined entity, subject to adjustment based on Flex Pharma’s net cash at closing. Upon closing of the transaction, Flex Pharma is expected to be renamed Salarius Pharmaceuticals and be under the leadership of Salarius’ current management team, led by CEO David Arthur. The Salarius clinical pipeline will become the lead assets of the company following the transaction. Flex Pharma President and CEO William McVicar, Ph.D., is expected to join the Board of Directors of the combined company following the closing of the transaction. Salarius’ lead compound, Seclidemstat, targets the epigenetic dysregulation underlying Ewing sarcoma, a devastating pediatric, adolescent and young adult bone cancer for which no targeted therapies currently exist. Seclidemstat is a differentiated, reversible inhibitor of the lysine-specific demethylase 1 enzyme, or LSD1, which is a widely studied epigenetic enzyme and a validated drug target for clinical development. The company is currently enrolling patients in an open-label Phase 1 dose escalation/dose expansion study, which is expected to conclude in 2020. Salarius is also preparing to initiate additional studies in advanced solid tumors, including prostate, breast and ovarian cancers. The transaction has been approved unanimously by the Board of Director of Flex Pharma and Board of Managers of Salarius. The proposed transaction is expected to close in the first half of 2019, subject to the approval of Flex Pharma stockholders at a special stockholder meeting and other customary conditions, including approval by Salarius’ members.
Sesen Bio downgraded to Neutral from Buy at H.C. Wainwright
H.C. Wainwright analyst Ramakanth downgraded Sesen Bio to Neutral and lowered his price target for the shares to $1 from $3. While the Phase 3 Vista results “appear decent in isolation,” the failure to improve on the Phase 2 results despite a more rigorous treatment schedule introduces additional uncertainties on the regulatory and commercial prospects of Vicinium, Ramakanth tells investors in a research note. The full Vista results are not expected until mid-2019, which could potentially render the stock range-bound until then, says the analyst.
AngioDynamics backs FY19 adj. EPS view of 82c-86c, consensus 84c
Backs FY19 revenue guidance of $354M-$359M, consensus $356.09M.
Subscribe to:
Posts (Atom)