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☆ This little-known biotech stock is primed to surge nearly 50%, Canaccord says
▼ + stars: | 2024-06-20 | by ( Lisa Kailai Han | ) www.cnbc.com time to read: +1 min

Positive data from Intra-Cellular Therapies ' latest study could herald further success for the biotechnology stock, according to Canaccord Genuity. The updated forecast implies that shares of Intra-Cellular Therapies could soar nearly 50% from their Tuesday close at $75.48. "We believe the solidity of the Phase 3 data means an approval for luma in MDD is more of a when, not if." Shares of Intra-Cellular Therapies have risen less than 4% this year. But the analyst believes the stock has been "somewhat constrained" due to investors' overly cautious nature with luma's potential patent runway, he wrote.

Persons: Canaccord, Sumant Kulkarni, Kulkarni, —, Fred Imbert Organizations: Therapies, Cellular Locations: MDD

☆ Buy this 'game-changer' biotech stock with more than 50% upside, BofA says
▼ + stars: | 2023-10-10 | by ( Lisa Kailai Han | ) www.cnbc.com time to read: +1 min

Analyst Geoff Meacham's $18 price objective implies a potential upside of 51% from the stock's $11.94 closing price Monday. Meacham cited the firm's strong pipeline of novel drugs and treatments as a catalyst. Specifically, Neumora's navacaprant drug could be a "game-changer for major depressive disorder," Meacham said. "Overall, the diverse pipeline and targets provide multiple opportunities for Neumora to potentially become one of the largest neuro-focused biotech companies." While the company is currently unprofitable, Meacham expects this to change in 2027, or one year after the company officially commercializes navacaprant for major depressive disorders.

Persons: Geoff Meacham's, Meacham, — CNBC's Michael Bloom Organizations: Bank of America

REUTERS/Andrew Kelly/File PhotoAug 7 (Reuters) - The U.S. drug regulator's approval of Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) first-of-its-kind postpartum depression (PPD) pill is unlikely to allay the drugmakers' growth concerns, analysts said on Monday. Adverse commentary after their PPD drug was approved by the U.S. Food and Drug Administration (FDA) on Friday sent Sage shares tumbling 40%, while Biogen dropped 3% in premarket trading. Zurzuvae's use as a clinical depression treatment represents a more than $1 billion sales opportunity compared with $250 million to $500 million potential for postpartum depression, said Jefferies analyst Michael Yee. "Postpartum depression is not necessarily where a big commercial opportunity is," Biogen CEO Christopher Viehbacher said last month. The U.S. FDA said last week that additional studies might be required to support the drug's approval for major depressive disorder (MDD), or clinical depression.

Persons: Andrew Kelly, Sage, Biogen, Baird, Brian Skorney, Skorney, Zurzuvae, Jefferies, Michael Yee, Christopher Viehbacher, Yee, Mariam Sunny, Bhanvi, Manas Mishra, Vinay Dwivedi Organizations: Food and Drug Administration, FDA, REUTERS, Sage Therapeutics, U.S . Food, Drug Administration, U.S, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

☆ FDA approves oral pill for postpartum depression for first time
▼ + stars: | 2023-08-05 | by ( ) www.reuters.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo/File PhotoAug 4 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder (MDD), or clinical depression, as well as postpartum depression, which affect millions of people. Analysts have anticipated that the stocks of both companies would fall if the drug was approved only for postpartum depression, due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an intravenous injection.

Persons: Andrew Kelly, Zurzuvae, Biogen, Sage, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler, William Mallard Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, U.S . Drug Enforcement Administration, Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ The top doctor at a $2.7 billion pharma company developing a new depression drug says we may be 'on the cusp' of a new wave of mental-health treatments
▼ + stars: | 2023-02-13 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +6 min

Most depression treatments don't work quickly and are meant to be taken for long periods of time. Sage Therapeutics is developing a fast-acting drug that patients take for two weeks. That's according to Laura Gault, the chief medical officer at Sage Therapeutics, a Massachusetts-based company working to develop a new antidepressant drug, called zuranolone. Sage's stock has climbed 7.9% in the past 12 months, giving the company a market value of about $2.7 billion. Unlike most other antidepressants, zuranolone is designed to be taken for a short period of timeIn trials, zuranolone has improved symptoms of major depressive disorder and postpartum depression.

☆ Depression treatments haven't changed much in decades. Here are the promising new drugs that could be more precise, work faster, and help more people.
▼ + stars: | 2023-02-02 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +6 min

Advances in depression treatment have been rare over the past few decades. But treatments for mental-health illnesses, like depression, haven't changed much over the past few decades. Insider put together a roundup of the most promising depression treatments today, both those that have won approval and those that are in the later stages of the research process. Unlike most depression treatments on the market, Auvelity is rapid-acting, which means it offers faster relief for patients. MDD is also known as clinical depression and is defined by persistent depressive symptoms.

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