Latest news with #AkashTewari
Yahoo
15-05-2025
- Business
- Yahoo
Jefferies not seeing significant impact to Merck, Bristol from draft guidance
Jefferies analyst Akash Tewari notes that new Medicare Part B & D draft guidance has been released and that Merck (MRK) and Bristol Myers (BMY) are trading down due to updated language on single source qualifying drugs. The updated language on single source qualifying fixed dose combo products in the draft makes it seem as if subcutaneous Keytruda/Opdivo will be eligible for negotiation in 2028, but 'We're not sure this is true,' says the analyst, who is not seeing a significant impact to Merck and Bristol. The firm thinks subQ Keytruda/Opdivo may be exempt from IRA negotiation on biosimilar entry, similar to HD Eylea, and believes changes may create an opening for Merck to settle with some biosimilars before Keytruda's '28 loss of exclusivity and 'therefore be EXCLUDED from IRA negotiation.' Since subQ and IV Keytruda are now both 'considered the same drug,' theoretically subQ Keytruda 'may never get IRA negotiated,' the analyst added. 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 Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on MRK: Disclaimer & DisclosureReport an Issue UnitedHealth, Wayfair downgraded: Wall Street's top analyst calls SCHD ETF News, 5/14/2025 U.S. biotech companies debate relocating trials outside U.S., Reuters reports Merck downgraded to Neutral from Buy at Citi Merck & Company: Navigating Medicare Drug Price Negotiation Challenges with Potential Upside
Japan Times
18-04-2025
- Business
- Japan Times
Weight-loss pill orforglipron shines in study, boosting Lilly and Chugai
Eli Lilly & Co. shares surged after its experimental pill helped patients shed weight and control blood sugar about as well as Ozempic, an advance that could turbocharge what's already one of the fastest-growing markets in medicine. Shares of the drug's originator Chugai Pharmaceutical Co. also soared. The triumph of Ozempic, the blockbuster diabetes shot from Novo Nordisk A/S, and related drugs including Zepbound and Mounjaro from Lilly, has set off an all-out push to develop a pill that's easier to take and less expensive to make. While rivals including Pfizer Inc. have suffered setbacks, analysts said success is critical to creating the $130 billion market they predict by the end of the decade. Results of the Lilly-funded study provide a promising first look. Diabetics given the pill called orforglipron lost 16 pounds, or 7.9% of their body weight, over a 40-week period. That was more than similar patients shed in earlier studies of Ozempic. Those getting the pill hadn't hit a weight plateau when the study ended, suggesting they may lose even more, the company said in a statement. Blood sugar levels fell by an average of 1.3%, slightly underperforming rival injections. "The data presents a best-case scenario for a blockbuster launch out of the gate,' Jefferies analyst Akash Tewari wrote in a note to investors. Jared Holz, a health-care specialist at Mizuho, said Lilly "will remain the preeminent player in this category for a while as its lead over peers, both in Pharma and Biotech, widens on the back of this data.' Lilly surged 14% in New York trading Thursday, its largest gain in more than a year. Chugai jumped as much as 16% in Tokyo trading Friday, the largest intraday gain in more than four years. The trial isn't definitive, however. It's one of several that Lilly is running in diabetes, obesity and other related conditions like sleep apnea. Its main obesity trial won't wrap until at least July, according to a clinical trial database, and those results are among the most anticipated of the year. Lilly could launch the medicine as soon as early 2026, according to Chief Executive Officer Dave Ricks. Obesity shots made by Novo and Lilly have been wildly popular, generating billions of dollars in sales. But drugs that can be taken by mouth, rather than injected, are considered the next frontier. The science, however, can be daunting. Pfizer, which once angled for second place, was forced to abandon its most advanced candidate after one patient in a clinical trial developed signs of liver injury. Smaller biotechnology companies, and large pharmaceutical rivals including AstraZeneca Plc, are still working on their own weight-loss pills, with varying degrees of success. Lilly, which was second to the market that Novo created more than a decade ago with the introduction of Saxenda and then Wegovy, has quickly closed the gap and made prescient moves that may help it pull ahead of its Danish rival. It licensed orforglipron from Japanese drugmaker Chugai in 2018, and negotiated a royalty rate "from mid single digits to low teens,' less than analyst expectations. The company is moving quickly: It expects to submit orforglipron for weight management to regulators by the end of this year, with the application for type 2 diabetes anticipated to come in 2026, the company said in the statement. The data supports "potential blockbuster status,' Bloomberg Intelligence's John Murphy wrote in a note, with competitive effectiveness and no apparent safety signals. The results were toward the top-end of expectations and the limited safety data suggest good tolerability, he said. A pill, which is normally easier to make than an injection, may also help Lilly with supply issues. Both Lilly and Novo struggled to produce enough of their weight-loss shots to meet market demand for the past several years, which allowed compounding drugmakers to legally craft less expensive versions they could sell to patients. Lilly said it's confident it will be able to launch orforglipron worldwide without supply constraints if the medicine is approved. The longer-term results of the study and additional trials may provide better information on what patients could eventually expect from the pills. People with diabetes typically have a harder time shedding pounds, and Lilly executives have warned that results from this trial shouldn't be used to directly assess the drug's weight-loss potential. Its safety profile was consistent with existing therapies, said Lilly. The most common side effects were gastrointestinal issues, which were "generally mild to moderate in severity,' the company said. Treatment discontinuation rates were 8% at the highest dose and 6% at the lowest one. There were no signs of liver damage.
