The Jefferies Biotechnology team, led by Brian Abrahams, believes most of the significant downside in Biotechnology shares has already occurred with the iShares NASDAQ Biotechnology Index (IBB) down 22% year-to-date. Nonetheless, volatility in the space could persist with funds flowing out of healthcare and negative drug pricing rhetoric, the analysts tell investors in a research note. They view any weakness in the space as "excellent" long-term buying opportunities for companies with "concrete" earnings outlooks and "promising" pipelines. The analysts highlight Vertex (VRTX), BioMarin (BMRN), The Medicines Co. (MDCO), Ultragenyx (RARE) and Vanda (VNDA) as names to focus on.

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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.

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Get caught up quickly on the top news and calls moving stocks with these five Top Five lists. 1... To see the rest of the story go to thefly.com. See Story Here