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Fly News Breaks for April 28, 2016
FE, HOLI, HAL, BHI, TWTR, VRTX
Apr 28, 2016 | 10:19 EDT
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Vertex (VRTX) downgraded to Neutral at Goldman by analyst Terence Flynn, who cited the company's second straight quarterly miss for Orkambi for cystic fibrosis. The analyst now expects shares to be range bound through year-end. 2. Twitter (TWTR) downgraded to Hold at Argus citing the company's slowing revenue growth and weak monthly average user growth. Argus says that the stock could decline further unless the company's user growth accelerates. 3. Baker Hughes (BHI) downgraded to Equal Weight at Stephens by analyst Matthew Marietta, who said he now sees "significant risk" to deal closure with Halliburton's (HAL), given the delay of the Halliburton's earnings call to after April 30 deadline and a fairly ominous report issued by the DOJ. Marietta also noted that Baker Hughes sees continued degradation of its NAM pumping business citing that the product line continues to generate negative cash flows. Baker Hughes (BHI) was also downgraded to Sector Perform at Iberia. 4. Hollysys (HOLI) downgraded to Reduce at Nomura after analyst Patrick Xu lowered estimates for the Industrial Automation segment. The analyst believes shares are expensive with such a low growth rate and sees downside to FY16 revenue guidance of $565M-$600M. 5. FirstEnergy (FE) downgraded to Hold at Jefferies by analyst Anthony Crowdell after the Federal Energy Regulatory Commission rescinded the company's Ohio power purchase agreement. Crowdell views the stock as fairly valued without the PPA. RBC capital also downgraded the company to Sector Perform, saying that FirstEnergy will have to issue around $2B of equity this year to strengthen its balance sheet and remain investment grade. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage,
News For VRTX;TWTR;BHI;HAL;HOLI;FE From the Last 2 Days
VRTX
Apr 18, 2024 | 08:30 EDT
Vertex Pharmaceuticals announced important advancements across its suzetrigine pain program, which has the potential to be the first new class of medicine for acute and neuropathic pain in more than two decades. Suzetrigine is an oral selective NaV1.8 pain signal inhibitor. Following the positive Phase 3 results in acute pain announced in January, the FDA has granted a rolling New Drug Application (NDA) submission for suzetrigine in moderate-to-severe acute pain. Vertex has started the rolling submission process and is on track to complete the submission in the second quarter of 2024. Suzetrigine was previously granted FDA Fast Track and Breakthrough Therapy designations in moderate-to-severe acute pain. In neuropathic pain, Vertex released positive results from its Phase 2 study in December 2023 and recently completed a successful end-of-phase 2 meeting with the FDA. Vertex is now preparing to initiate a Phase 3 pivotal program of suzetrigine in patients with DPN in 2H 2024. In addition, the FDA recently granted suzetrigine Breakthrough Therapy designation for the treatment of pain associated with DPN. The Phase 3 program will include two identical 12-week randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of suzetrigine in patients with DPN. The primary endpoint for both studies will be the change from baseline in weekly average of daily pain intensity on the numeric pain rating scale, or NPRS, assessed at Week 12 compared to placebo. Both studies will also include a key secondary endpoint of change from baseline in the weekly average of daily pain intensity on the NPRS at Week 12 compared to pregabalin. Approximately 1,100 patients are expected to enroll in each Phase 3 study. After completing participation in the randomized controlled studies, patients may roll over into an open-label study to evaluate the long-term safety and effectiveness of suzetrigine in DPN. Additionally, Vertex continues to enroll its Phase 2 study of suzetrigine in patients with lumbosacral radiculopathy, or LSR, which is pain caused by impairment or injury to nerve roots in the area of the lumbar spine. The company is on track to complete enrollment in the Phase 2 LSR study by the end of the year.