| Over a week ago | ||||
Jefferies assumed… Jefferies assumed coverage of Verona Pharma with a Buy rating and a price target of $38, up from $35. Lead asset ensifentrine has "compelling" Phase 3 efficacy and safety data in COPD lung disease that supports the firm's "high" 90-95% conviction of an FDA approval in the first half of 2024 for the twice-daily nebulizer, the analyst tells investors. | ||||
Societe Generale analyst… Societe Generale analyst Delphine Le Louet upgraded Inventiva (IVA) to Buy from Sell with a price target of EUR 4.50, up from EUR 4.40. Inventiva's investment case is now "anchored" to one late-stage asset, lanifibranor in nonalcoholic steatohepatitis, or NASH, and it is "time to reconsider the NASH marathon" with the space "finally regaining some traction" ahead of expected approval for Madrigal Pharmaceuticals' (MDGL) resmetirom and the FDA conducting an advisory committee meeting Friday to discuss Intercept's (ICPT) Ocaliva for NASH, the analyst tells investors. | ||||
Stifel raised the… Stifel raised the firm's price target on Viking Therapeutics (VKTX) to $30 from $25 and keeps a Buy rating on the shares following "positive" top-line results from the Phase 2b VOYAGER trial for VK2809 in biopsy-confirmed non-alcoholic steatohepatitis, or NASH. These data "compare well" with competitor resmetirom from Madrigal Pharmaceuticals (MDGL) at similar stages and the firm thinks Viking's data confirm VK-2809 as a "potentially best-in-class product," the analyst added. | ||||
Oppenheimer analyst Jay… Oppenheimer analyst Jay Olson raised the firm's price target on Madrigal Pharmaceuticals to $350 from $300 and keeps an Outperform rating on the shares. The firm notes the company reported Q1 results with OpEx of $78.3M and EPS of ($4.23), and highlighted key progress and catalysts, including resmetirom NDA for NASH to be filed in Q2 based on Phase 3 MAESTRO-NASH results; ICER recently published a draft evidence report indicating resmetirom has potential as a cost-effective treatment for NASH priced at $31.7K annually; achieving both efficacy endpoints clarifies the European regulatory path while increasing the probability of success in compensated NASH cirrhosis with NASH outcomes trial enrolling; and multiple resmetirom abstracts accepted at EASL. | ||||
TD Cowen analyst Ritu… TD Cowen analyst Ritu Baral raised the firm's price target on Madrigal Pharmaceuticals to $396 from $309 and keeps an Outperform rating on the shares. The analyst said they reported 1Q23 and remains on track to submit its subpart H NDA for resmetirom in NASH in 2Q23. | ||||
Canaccord raised the… Canaccord raised the firm's price target on Verona Pharma to $33 from $31 and keeps a Buy rating on the shares. The analyst said we are increasing our 12- month price target primarily related to progression of the ensifentrine program moving closer to the terminal year of our model and our assumed pricing for ensifentrine which is in line with current nebulized drugs for COPD. | ||||
Paul Friedman, M.D.,… Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, "In the first quarter of 2023, the Madrigal team made significant progress advancing our regulatory preparations, disease education initiatives, and market access strategy. Additionally, we continue to execute against our clinical development objectives, and have completed enrollment of the MAESTRO-NASH trial. We are working diligently on the resmetirom approval process and recently announced that we obtained Breakthrough Therapy designation for resmetirom, reinforcing our confidence in our regulatory strategy and the planned NDA filing in Q2 2023." | ||||
| Over a month ago | ||||
Oppenheimer analyst Jay… Oppenheimer analyst Jay Olson raised the firm's price target on Viking Therapeutics (VKTX) to $35 from $30 and keeps an Outperform rating on the shares ahead of the company's Q1 update. The firm is encouraged by positive read-across from Madrigal Pharmaceuticals' (MDGL) Phase 3 MAESTRO-NASH 52-week results, which reached statistical significance on both primary endpoints at 52-weeks. | ||||
Madrigal Pharmaceuticals… Madrigal Pharmaceuticals announced that resmetirom has received Breakthrough Therapy designation, BTD, from the U.S. Food and Drug Administration for the treatment of patients with NASH with liver fibrosis. The Company also announced that the outcomes portion of the Phase 3 MAESTRO-NASH biopsy trial has completed enrollment. Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, "The Breakthrough Therapy designation for resmetirom reflects the FDA's recognition of resmetirom's potential in the treatment of NASH as a serious, life-threatening condition and an important area of investigational drug development. It also reinforces our confidence in our regulatory strategy as we approach the new drug application (NDA) filing for resmetirom, which remains on track for Q2 2023. The filing is supported by the positive outcomes on reduction of liver fibrosis and resolution of NASH from the 52-week serial liver biopsy portion of MAESTRO-NASH." | ||||
Meeting to be held in… Meeting to be held in Boston on April 11-12 hosted by Piper Sandler. | ||||
