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Regeneron makes obesity push; Atai, Alto ink brain drug deals
Regeneron makes obesity push; Atai, Alto ink brain drug deals

Yahoo

time3 days ago

  • Business
  • Yahoo

Regeneron makes obesity push; Atai, Alto ink brain drug deals

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving Regeneron and Bluebird bio, as well as updates from Atai Life Sciences, Alto Neuroscience and UniQure that you may have missed. Regeneron Pharmaceuticals on Monday disclosed Phase 2 study results that it claimed suggest the addition of one or two of its experimental medicines to Novo Nordisk's Wegovy might help people with obesity preserve muscle mass. Leerink Partners analyst David Risinger, however, described the results in a research note as "mixed," highlighting how the addition of Regeneron's drug resulted in either numerically lower weight loss with "comparable tolerability" or "greater weight loss with worse tolerability." The effects on muscle function, which haven't yet been disclosed, will be "critical,' Risinger added. Draft guidance published by the Food and Drug Administration has indicated muscle-protecting medicines "need to demonstrate functional benefits" to succeed. — Ben Fidler Regeneron also expanded its portfolio of weight-loss medicines, announcing on Monday a deal for most worldwide rights to a drug developed by Hansoh Pharmaceuticals Group that's currently in late-stage testing in obesity in China. Regeneron paid Hansoh $80 million upfront for the drug, which, like Eli Lilly's Zepbound targets the gut hormones GLP-1 and GIP. It could add nearly $2 billion in additional payouts. In testing, the drug has demonstrated a "potentially similar profile" to Zepbound, Regeneron said. — Ben Fidler Carlyle Group and SK Capital on Monday closed a deal to acquire and take private gene therapy developer Bluebird bio. The two private equity firms said they've provided 'significant primary capital' to support and scale Bluebird's gene therapies for rare blood and brain diseases, and that the company will now prioritize building up its manufacturing capabilities and strengthening relationships with insurers. Bluebird's stock, which will no longer trade on the Nasdaq, last closed at around $5 per share. — Ben Fidler Psychedelics developer Atai Life Sciences is absorbing the rest of a U.K.-based biotechnology company through an all-share transaction announced Monday. Atai last year took a nearly 36% stake in Beckley Psytech, providing it access to an experimental version of the mind-altering compound mebufotenin. Now, the two developers are combining in a deal that values Beckley at $390 million and is expected to close in the back half of this year. Beckley's investors other than Atai will be issued around 105 million new shares as consideration, representing about 31% of the combined company. Additionally, the investment firms Ferring Ventures and Adage Capital Partners are making a concurrent $30 million private placement. Atai said the new entity will have enough cash to keep it running through 'multiple' readouts of important mid-stage clinical trials. — Jacob Bell Alto Neuroscience has, for just under $2 million, acquired a portfolio of dopamine-boosting drugs in development for depression. The deal with Chase Therapeutics, disclosed Tuesday, hands Alto a fixed-dose combination of pramipexole, which is already used to treat Parkinson's disease, and ondansetron, the active ingredient in the nausea medication Zofran. Now code-named ALTO-207, this combination recently succeeded in a mid-stage study of patients with major depressive disorder. Alto plans to start by mid-2026 a Phase 2b trial designed to potentially enable an approval application. The trial would focus on treatment-resistant depression and report high-level data sometime in 2027. — Jacob Bell UniQure, the Belgium-based gene therapy developer, said it has reached an agreement with the FDA on 'several key components' of an approval application for its closely watched treatment for Huntington's disease. Those components include the manufacturing process for the treatment, named AMT-130, as well as updated statistical analysis plans that UniQure expects to submit before the end of June. Looking ahead, the company intends to have another pre-filing meeting with the FDA late this year and then formally submit its application for priority review sometime between January and March of 2026. Analysts at TD Cowen have estimated that peak annual sales of AMT-130 could reach or surpass around $1 billion. — Jacob Bell Recommended Reading Sanofi reaches consumer health deal; Supernus antidepressant fails study Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Leerink Partners Remains a Hold on Amgen (AMGN)
Leerink Partners Remains a Hold on Amgen (AMGN)

Business Insider

time4 days ago

  • Business
  • Business Insider

Leerink Partners Remains a Hold on Amgen (AMGN)

In a report released on June 3, David Risinger from Leerink Partners maintained a Hold rating on Amgen (AMGN – Research Report). The company's shares closed yesterday at $287.01. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Risinger covers the Healthcare sector, focusing on stocks such as Eli Lilly & Co, Pfizer, and Johnson & Johnson. According to TipRanks, Risinger has an average return of 8.3% and a 52.15% success rate on recommended stocks. In addition to Leerink Partners, Amgen also received a Hold from Guggenheim's Vamil Divan in a report issued on May 20. However, on June 3, Piper Sandler reiterated a Buy rating on Amgen (NASDAQ: AMGN).

Halozyme, J&J slide as analyst cuts rating on CMS draft guidance
Halozyme, J&J slide as analyst cuts rating on CMS draft guidance

Yahoo

time14-05-2025

  • Business
  • Yahoo

Halozyme, J&J slide as analyst cuts rating on CMS draft guidance

Shares of Halozyme Therapeutics (HALO) and Jonhson & Johnson (JNJ) are under pressure on Tuesday after Leerink downgraded the stocks to Underperform and Market Perform, respectively. This comes after the Centers for Medicare and Medicaid Services issued draft guidance for 2028 Inflation Reduction Act drug price controls, which the firm says creates risk that hyaluronidase combination products may not be protected from IRA price negotiations for 13 years after combo approval. Quickly and easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks straight to you inbox with TipRanks' Smart Value Newsletter DOWNGRADES ON CMS ACTION: On Tuesday, Leerink analyst David Risinger downgraded Halozyme to Underperform from Market Perform with a price target of $47, down from $63, and Leerink downgraded Johnson & Johnson to Market Perform from Outperform with a price target of $153, down from $169. The firm, however, is not making any changes to its revenue projections this time as it awaits final guidance from CMS in the second half of 2025. Leerink explains that the catalyst for its downgrades is that CMS issued draft guidance for 2028 IRA drug price controls that creates risk that hyaluronidase combination products may not be protected from IRA price negotiations for 13 years after combo approval. The 'surprise' is CMS draft guidance language suggests that combination products, which do not enhance efficacy, may be negotiated 13 years after the original active ingredient was approved, rather than 13 years after combination approval. The firm notes that Halozyme could face U.S. revenue pressure from Opdivo SC in 2028, Darzalex Faspro in 2029 and Ocrevus SC in 2031. In addition, CMS action may reduce new business opportunities to license ENHANZE. A caveat is that the Street already anticipates the company's Faspro royalty to decline from 5% to 2.5% in 2029 and go to zero in 2032. Its new investment thesis on Halozyme is that Leerink expects shares to underperform because it will be difficult for investors to assign value to the company's major growth drivers since they could start to roll over in 3-5 years. Regarding Johnson & Johnson, the firm notes Darzalex Faspro may be price controlled in 2029 rather than 2034 as it had been assuming. In the case of Darzalex, it was approved in November 2015, and Darzalex Faspro was approved in 2020. Leerink has been modeling that Darzalex Faspro will generate $10.7B in U.S. sales in 2028, or 16% of J&J Worldwide Pharma sales of $66.4B and 10% of total company sales of $96.8B. The firm believes that U.S. Darzalex's profit contribution could be approximately $8.6B in 2028, or 22% of its total company operating profit estimate of $39.1B. If it is price controlled in 2029, the drug's U.S. profit contribution could take a meaningful hit, it points out. Leerink's new investment thesis is that J&J's 5-year growth prospects are at risk of downward revisions if Darzalex Faspro is price controlled in 2029, and we are not anticipating an upward re-rating of the stock in the near-medium term. The firm also highlights that in its 2028 draft guidance, CMS included a new paragraph suggesting a possible reconsideration of its approach to fixedcombination drug negotiations. It believes this development raises concerns for multiple Halozyme's products and J&J's Darzalex Faspro. PRICE ACTION: In Tuesday morning trading, shares of Johnson & Johnson dropped almost 3% to $149.87, while Halozyme's stock has plunged about 27% and is now trading at $49.02. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on HALO: Disclaimer & DisclosureReport an Issue Coinbase, Caterpillar upgraded: Wall Street's top analyst calls Halozyme downgraded to Underperform from Market Perform at Leerink Cautious Optimism for Halozyme Amid Uncertainties: Hold Rating Maintained Halozyme Therapeutics Reports Strong Earnings and Growth Halozyme's Strong Financial Performance and Strategic Developments Justify Buy Rating with $75 Price Target Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Eli Lilly stock sell-off was 'overreaction': Analysts
Eli Lilly stock sell-off was 'overreaction': Analysts

Yahoo

time02-05-2025

  • Business
  • Yahoo

Eli Lilly stock sell-off was 'overreaction': Analysts

Despite beating on its earnings Thursday, pharma giant Eli Lilly (LLY) suffered a nearly 12% loss in its stock, losing more than $90 billion in market cap in a single day. The move, some analysts say, was an overreaction to the news that GLP-1 competitor Novo Nordisk (NVO) locked up a preferred listing deal with CVS (CVS) on its formulary for obesity drug Wegovy to the exclusion of Eli Lilly's drug Zepbound. "We think the market reaction was overdone and are thus reiterating our OP [Outperform] rating on LLY," Leerink Partners analyst David Risinger wrote in a note to clients Friday. Risinger also lowered Eli Lilly's price target from $989 to $944 on the formulary news, calling it a negative in a note Thursday. Read more about Eli LIlly's stock moves and today's market action. The deal with CVS is the latest this week as Novo Nordisk pushes for more access points for Wegovy, which has been overtaken in weekly prescription fillings by Eli Lilly's Zepbound, including deals with telehealth platforms like Hims & Hers (HIMS). It's a key reason why Novo Nordisk's stock is down more than 25% in the past two months. "LLY is taking ~75% share on new branded obesity scripts," Jefferies analyst Akash Tewari wrote in a note to clients Thursday. He questioned whether Novo Nordisk's move was the right one. This also sparked concern that Novo Nordisk's moves could hamper Eli Lilly's momentum — and launch a price war — which pressured Eli Lilly's stock Thursday. Eli Lilly's stock looked to be slightly reversing its losses in trading Friday, up more than 4% at market open. "The move today reminds of what we say frequently: expect volatility, take advantage of moment of weakness, as long as there is not a new, fundamental crack in the story — no such cracks surfaced today, in our opinion," BofA Securities analyst Tim Anderson wrote in a note to clients Thursday. The overarching concern with the CVS/Novo Nordisk deal is whether this starts a race to the bottom on pricing between the two GLP-1 market leaders. The stock action Thursday assumed the CVS move would drive down price, and therefore profits, for both companies in the GLP-1 market, driven by a "desperate" Novo Nordisk, BofA's Anderson said. Eli Lilly CEO David Ricks signaled he was not interested in such a race and instead is focusing on near-term wins with next-generation GLP-1s and the highly anticipated orforglipron, an obesity pill that could hit the markets mid-next year. "We're not interested in exclusive deals. We think innovation and choice is very important. And we're well into the product replacement cycle, and there's more coming," Ricks told Yahoo Finance. That sentiment was reflected in some analyst notes late Thursday. Jefferies' Tewari wrote in a note that Lilly still "has one of the most sustainable growth stories in the next 5-10 years." He expressed doubt that the impacted pool of patients would be significant and shrugged off the idea that this was the starting gun of a price war. "We're skeptical that NVO is making irrational pricing decisions & that a single formulary will lead to a race to the bottom on pricing," he wrote. JPMorgan's Chris Schott similarly wrote, "We do not see the CVS announcement as portending an acceleration in price declines across the space," and he does not see this as "leading to a price war." BofA's Anderson had a slightly different take. "It's not to say that there's not going to be erosion in price, I mean there is, each and every year. This is not a sudden step-change. I think it's being taken out of proportion," he said. But time will tell if the move is a desperate one on the part of either CVS or Novo Nordisk, with broader impacts, or one that doesn't move the needle at all. "I do think Novo, they are trying to prove to their shareholders that they're going to see inflection of their franchise and return to growth later in the year. That's why they signed that Hims deal, that's why they can talk about the CVS deal. I think this is free advertising for CVS and Novo," BofA's Anderson said. "I think Novo is trying to convey ... there's always negotiations with payers, but they're not out there undermining a market. And that's how Lilly's stock is reacting," he said, adding CVS may have been overstating the impact of the formulary decision on the call. Most analysts said the impact on Eli Lilly should be limited and that a key indicator would be employer-sponsored insurance plans and how they react to the formulary option. "It remains to be seen how attractive this change will be to employers given differences in product profiles while patients could also look to go through exemption processes to keep their prescriptions," Schott wrote. He added, "LLY noted that the change primarily impacts smaller employers, who likely have lower employer opt-in rates on average (while larger employers largely utilize more customized formularies)." Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee as AnjKhem on social media platforms X, LinkedIn, and Bluesky @AnjKhem. Sign in to access your portfolio

Eli Lilly stock sell-off was 'overrreaction': Analysts
Eli Lilly stock sell-off was 'overrreaction': Analysts

Yahoo

time02-05-2025

  • Business
  • Yahoo

Eli Lilly stock sell-off was 'overrreaction': Analysts

Despite beating on its earnings Thursday, pharma giant Eli Lilly (LLY) suffered a nearly 12% loss in its stock, losing more than $90 billion in market cap in a single day. The move, some analysts say, was an overreaction to the news that GLP-1 competitor Novo Nordisk (NVO) locked up a preferred listing deal with CVS (CVS) on its formulary for obesity drug Wegovy to the exclusion of Eli Lilly's drug Zepbound. "We think the market reaction was overdone and are thus reiterating our OP [Outperform] rating on LLY," Leerink Partners analyst David Risinger wrote in a note to clients Friday. Risinger also lowered Eli Lilly's price target from $989 to $944 on the formulary news, calling it a negative in a note Thursday. Read more about Eli LIlly's stock moves and today's market action. The deal with CVS is the latest this week as Novo Nordisk pushes for more access points for Wegovy, which has been overtaken in weekly prescription fillings by Eli Lilly's Zepbound, including deals with telehealth platforms like Hims & Hers (HIMS). It's a key reason why Novo Nordisk's stock is down more than 25% in the past two months. "LLY is taking ~75% share on new branded obesity scripts," Jefferies analyst Akash Tewari wrote in a note to clients Thursday. He questioned whether Novo Nordisk's move was the right one. This also sparked concern that Novo Nordisk's moves could hamper Eli Lilly's momentum — and launch a price war — which pressured Eli Lilly's stock Thursday. Eli Lilly's stock looked to be slightly reversing its losses in trading Friday, up more than 4% at market open. "The move today reminds of what we say frequently: expect volatility, take advantage of moment of weakness, as long as there is not a new, fundamental crack in the story — no such cracks surfaced today, in our opinion," BofA Securities analyst Tim Anderson wrote in a note to clients Thursday. The overarching concern with the CVS/Novo Nordisk deal is whether this starts a race to the bottom on pricing between the two GLP-1 market leaders. The stock action Thursday assumed the CVS move would drive down price, and therefore profits, for both companies in the GLP-1 market, driven by a "desperate" Novo Nordisk, BofA's Anderson said. Eli Lilly CEO David Ricks signaled he was not interested in such a race and instead is focusing on near-term wins with next-generation GLP-1s and the highly anticipated orforglipron, an obesity pill that could hit the markets mid-next year. "We're not interested in exclusive deals. We think innovation and choice is very important. And we're well into the product replacement cycle, and there's more coming," Ricks told Yahoo Finance. That sentiment was reflected in some analyst notes late Thursday. Jefferies' Tewari wrote in a note that Lilly still "has one of the most sustainable growth stories in the next 5-10 years." He expressed doubt that the impacted pool of patients would be significant and shrugged off the idea that this was the starting gun of a price war. "We're skeptical that NVO is making irrational pricing decisions & that a single formulary will lead to a race to the bottom on pricing," he wrote. JPMorgan's Chris Schott similarly wrote, "We do not see the CVS announcement as portending an acceleration in price declines across the space," and he does not see this as "leading to a price war." BofA's Anderson had a slightly different take. "It's not to say that there's not going to be erosion in price, I mean there is, each and every year. This is not a sudden step-change. I think it's being taken out of proportion," he said. But time will tell if the move is a desperate one on the part of either CVS or Novo Nordisk, with broader impacts, or one that doesn't move the needle at all. "I do think Novo, they are trying to prove to their shareholders that they're going to see inflection of their franchise and return to growth later in the year. That's why they signed that Hims deal, that's why they can talk about the CVS deal. I think this is free advertising for CVS and Novo," BofA's Anderson said. "I think Novo is trying to convey ... there's always negotiations with payers, but they're not out there undermining a market. And that's how Lilly's stock is reacting," he said, adding CVS may have been overstating the impact of the formulary decision on the call. Most analysts said the impact on Eli Lilly should be limited and that a key indicator would be employer-sponsored insurance plans and how they react to the formulary option. "It remains to be seen how attractive this change will be to employers given differences in product profiles while patients could also look to go through exemption processes to keep their prescriptions," Schott wrote. He added, "LLY noted that the change primarily impacts smaller employers, who likely have lower employer opt-in rates on average (while larger employers largely utilize more customized formularies)." Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee as AnjKhem on social media platforms X, LinkedIn, and Bluesky @AnjKhem.

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