Biotech Stock Roundup: Updates From GILD, REGN, GSK, ANAB Down on Study Data, EWTX Gains

It was a busy week in the biotech sector with lots of regulatory and pipeline updates. Among bigwigs, Gilead Sciences, Inc. GILD and GSK plc GSK had a few regulatory updates.Recap of the Week’s Most Important Stories:Updates From Gilead SciencesGilead Sciences announced that the FDA has granted Breakthrough Therapy Designation to breast cancer drug Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy.The designation is based on results from the ES-SCLC cohort of the mid-stage study TROPiCS-03 study. Trodelvy demonstrated promising antitumor activity in both platinum-resistant and platinum-sensitive disease, and the safety profile was consistent with the previous studies. Gilead plans to initiate a phase III study in this patient population.Concurrently, GILD announced entering a strategic collaboration with Terray Therapeutics to discover and develop novel, small molecule therapies across multiple targets.Per the terms of the agreement, Terray will utilize the Terray tNova platform to discover and develop small molecule compounds against a set of targets selected by Gilead. The latter will be responsible for further development and commercialization activities for products resulting from the collaboration if it exercises its option to exclusively license the compounds directed to a target.In exchange, Terray will receive an upfront payment and be eligible to receive milestone payments associated with achieving preclinical, clinical, and sales milestones as well as tiered royalties on net sales of products commercialized by Gilead in connection with the collaboration.The Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended approval of seladelpar. The CHMP adopted a positive opinion recommending seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. A final decision from the European Commission is expected in the first quarter of 2025. The drug is already approved in the United States under the brand name Livdelzi.Gilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Regeneron’s Study Meets GoalsRegeneron Pharmaceuticals REGN announced that the primary endpoint was met in the late-stage QUASAR trial on Eylea HD (aflibercept) injection 8 mg. QUASAR is a global, double-masked, active-controlled phase III study evaluating the efficacy and safety of Eylea HD, compared to Eylea 2 mg, D in patients with macular edema secondary to retinal vein occlusion (RVO), including those with central retinal vein occlusion, branch retinal vein occlusion, or hemiretinal vein occlusion.Eylea HD demonstrated non-inferior vision gains with an 8-week dosing regimen compared to Eylea injection of 2 mg dosed every 4 weeks.  The safety data remains consistent with the known safety profiles of Eylea HD and Eylea.Regeneron plans to submit a supplementary biologics license application to the FDA in the first quarter of 2025.ANAB Stock Down on Study ResultsAnaptysBio, Inc. ANAB announced that the phase IIb study of pipeline candidate, ANB032, a BTLA agonist, was unsuccessful. Shares of this clinical-stage biotechnology company were down on the results.The ARISE-AD study evaluated the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of ANB032 monotherapy in patients with moderate-to-severe atopic dermatitis (AD) or eczema.  Patients were randomized to receive for 12 weeks either 100mg of subcutaneous ANB032 every four weeks (Q4W), 400mg every four weeks (Q4W) or 400mg every two weeks (Q2W), or placebo. The primary and secondary endpoints were assessed at week 14. However, ANB032 did not meet the primary endpoint of the proportion of patients who achieved at least a 75% improvement from baseline in Eczema Area and Severity Index score (EASI-75), irrespective of the patient type.ANB032 did not meet any of the secondary endpoints at week 14, including EASI-90, the mean change in baseline EASI or a 4-point reduction in itch severity as measured by the peak Pruritus Numerical Rating Scale (PNRS), compared with placebo.Due to the disappointing efficacy data from the study, ANAB will discontinue further investment in this asset.Regulatory and Pipeline Updates From GSKGSK’s HIV subsidiary, ViiV Healthcare, announced that the CHMP gave a positive opinion recommending marketing authorization to Vocabria (cabotegravir long-acting injections) in combination with Johnson & Johnson’s Rekambys (rilpivirine long-acting injections) for the treatment of HIV-1 infection in virologically suppressed adolescents aged 12 years and above, weighing at least 35 kg.A decision from the European Commission is expected in the upcoming months.GSK also announced that the CHMP has recommended expanded use of Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of all adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. This population includes patients with mismatch repair proficient/microsatellite stable tumors, who represent 70-75% of patients diagnosed with endometrial cancer with limited treatment options.GSK announced that the FDA has granted Breakthrough Therapy designation to Jemperli for the treatment of patients with locally advanced mismatch repair deficient or microsatellite instability-high rectal cancer.Edgewise Stock Up on Study DataEdgewise Therapeutics EWTX announced positive results from the mid-stage CANYON study on its lead pipeline drug, sevasemten, in patients with a rare genetic disorder called Becker Muscular Dystrophy (“BMD”). Shares gained on the news.The study met its primary endpoint of change from baseline in creatine kinase (CK), a biomarker associated with skeletal muscle damage. Data from the study showed a significant reduction in CK levels in the sevasemten-treated group, with an average decrease of 28% compared to placebo between six and 12 months. The drug was also well-tolerated by study participants.Treatment with sevasemten showed a trend toward improvement in the key secondary endpoint of the North Star Ambulatory Assessment, a scale commonly used to rate motor function.Edgewise remains on schedule to complete recruitment for a pivotal cohort of the CANYON study, called GRAND CANYON, expected to be achieved in the first quarter of 2025. If data from this cohort is also positive, management intends to start discussions with the FDA and EMA for seeking approval for sevasemten in the BMD indication.PerformanceThe Nasdaq Biotechnology Index has declined 1.98% in the past five trading sessions and Regeneron’s shares have lost 4.95%. In the past six months, shares of MRNA have plunged 70.44%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIOA Down on Study Update, QURE, CRDF Gain on Study Data & More)Image Source: Zacks Investment ResearchWhat's Next in Biotech?Stay tuned for more pipeline updates. Free Today: Profiting from The Future’s Brightest Energy SourceThe demand for electricity is growing exponentially. At the same time, we’re working to reduce our dependence on fossil fuels like oil and natural gas. Nuclear energy is an ideal replacement.Leaders from the US and 21 other countries recently committed to TRIPLING the world’s nuclear energy capacities. This aggressive transition could mean tremendous profits for nuclear-related stocks – and investors who get in on the action early enough.Our urgent report, Atomic Opportunity: Nuclear Energy's Comeback, explores the key players and technologies driving this opportunity, including 3 standout stocks poised to benefit the most.Download Atomic Opportunity: Nuclear Energy's Comeback free today.Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report AnaptysBio, Inc. (ANAB): Free Stock Analysis Report Edgewise Therapeutics, Inc. (EWTX): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks