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Ionis Pharmaceuticals (IONS) announced that GSK (GSK) has initiated two randomized, double-blind, placebo-controlled Phase 3 studies evaluating the safety and efficacy of bepirovirsen, an investigational antisense medicine for the treatment of patients with chronic hepatitis B infection. Ionis earned a $15M milestone payment from GSK associated with the progression of bepirovirsen into the Phase 3 clinical studies.
Ionis Pharmaceuticals announced that the U.S. FDA has granted olezarsen Fast Track designation for the treatment of familial chylomicronemia syndrome. Ionis fully enrolled its global Phase 3 BALANCE study of olezarsen in adult patients with FCS last year. The company plans to share data from the BALANCE study in the second half of 2023.
Loop Capital analyst Jeffrey Stevenson raised the firm's price target on Azek to $24 from $18 but keeps a Hold rating on the shares as part of a broader research note on Building Products. The firm's quarterly composite decking survey reported a number of improving industry dynamics being offset by a slowing demand environment, the analyst tells investors in a research note, stating that while channel destocking was completed at the end of the December quarter, 2023 sales expectations also declined for the majority of respondents compared with 90 days ago. The worst is likely behind for decking names after a challenging 2022 however, even though half of the contacts in the survey do not have backlogs beyond Q1, Loop Capital added.
As previously reported, BofA analyst Rafe Jadrosich downgraded Azek to Neutral from Buy with a price target of $25, up from $20. Shares have increased 32% since the company reported fiscal Q3 results on November 28, noted the firm, which notes that FY23 earnings guidance already implies record EBITDA margins in the second half. The firm also expects destocking to continue through calendar Q1 and noted that its channel checks with decking distributors indicate some competitor discounts have been extended into 2023.
Ionis (IONS) issued the following statement about the FDA advisory committee meeting on tofersen: "On Jan. 23, the Federal Register published a notice that the U.S. Food and Drug Administration will convene a virtual meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review data supporting the New Drug Application for tofersen, an investigational medicine for the treatment of superoxide dismutase 1 amyotrophic lateral sclerosis - SOD1-ALS. The advisory committee meeting is scheduled for March 22, 2023. SOD1-ALS is an ultra-rare genetic form of ALS that affects approximately 330 people in the U.S.1 It is progressive, leads to the loss of everyday functions and is uniformly fatal. The NDA for tofersen has a Prescription Drug User Fee Act action date of April 25, 2023. Additional details about the advisory committee meeting can be found in a separate statement by Biogen which is available on their website." Reference Link
Piper Sandler analyst Do Kim raised the firm's price target on Ionis Pharmaceuticals to $62 from $60 and keeps an Overweight rating on the shares. Eplontersen, the company's investigational medicine to treat transthyretin amyloidosis, continues to be a key driver of share value, Kim tells investors. FDA acceptance of eplontersen is expected in Q1. The company is expected to reveal data from the drug's NEURO study in mid-2023 and this should be a catalyst, the analyst said. Kim adds olezarsen should be Ionis' next commercial product and Phase 3 data is expected in the second half of this year.
Deutsche Bank analyst Joe Ahlersmeyer raised the firm's price target on Azek (AZEK) to $28 from $24 and keeps a Buy rating on the shares. Within the repair and remodel sector, the analyst believes low-ticket products and projects could soften in the near term as excess savings "evaporate," impacting demand. He believes inflation's effect on the end consumer will ultimately weaken manufacturer pricing power across channels as well. This view, along with valuation considerations, drives his downgrade of Fortune Brands Innovations (FBHS) to Hold from Buy and Masco (MAS) to Sell from Hold. On the other hand, high-ticket remodeling may "counterintuitively" hold up better as locked-in homeowners, largely secure in post-pandemic home equity gains, look to make improvements that can improve the eventual selling price of their home, Ahlersmeyer tells investors in a research note.
Within the repair and remodel sector, Deutsche Bank analyst Joe Ahlersmeyer believes low-ticket products and projects could soften in the near term as excess savings "evaporate," impacting demand. He believes inflation's effect on the end consumer will ultimately weaken manufacturer pricing power across channels as well. This view, along with valuation considerations, drives his downgrade of Fortune Brands Innovations (FBHS) to Hold from Buy and Masco (MAS) to Sell from Hold. On the other hand, high-ticket remodeling may "counterintuitively" hold up better as locked-in homeowners, largely secure in post-pandemic home equity gains, look to make improvements that can improve the eventual selling price of their home, Ahlersmeyer tells investors in a research note. In keeping with this theme, Ahlersmeyer maintains Buy ratings on Trex Company (TREX), Azek (AZEK), Beacon (BECN) and PGT Innovations (PGTI), and he also upgraded Pool Corp. (POOL) to Buy from Hold.
Citi analyst Anthony Pettinari downgraded Azek to Neutral from Buy with a price target of $23, up from $21. The downgrade reflects expectations for discretionary weakness in 2023 and an updated view on the stock's valuation, Pettinari tells investors in a research note. The analyst thinks Azek has become more fairly valued on a relative basis.
