Latest news with #Voquezna
Business Insider
3 days ago
- Business
- Business Insider
Needham sees FDA's positive CP ruling as best-case outcome for Phathom
Needham notes that Phathom Pharmaceuticals (PHAT) is trading up 95%-plus this afternoon, following the company's announcement that the food and drug administration has approved the company's Citizen's Petition regarding Voquezna tablets. FDA has also communicated its intention to correct the Orange Book listing to reflect the full 10-year NCE exclusivity. This extends Voquezna's market exclusivity through 5/3/2032. Needham notes the CP/exclusivity issue had been a massive overhang on the stock since November 2024, but it views the news as clearly a best-case scenario and a significant clearing event for the stock. The firm believes Phathom Pharmaceuticals' shares now have a new support level, and thinks shares will move higher in the coming weeks as investors digest the news and take a fresh look at the story, which Needham believes is quite compelling given the strong Voquezna launch and TRx trends. The firm has a Buy rating on the shares with a price target of $28. Confident Investing Starts Here:
Yahoo
4 days ago
- Business
- Yahoo
Phathom Pharmaceuticals shares soar on FDA exclusivity grant
-- Shares of Phathom Pharmaceuticals Inc. (NASDAQ: PHAT) soared 128% after the FDA granted the company's petition for exclusivity in the Orange Book listing for its drug Voquezna (vonoprazan fumarate). The decision by the Food and Drug Administration to extend the exclusivity period to a full 10 years for Voquezna, under the umbrella of the Generating Antibiotic Incentives Now (GAIN) provisions, has been a significant catalyst for the stock's movement. The FDA's response to Phathom's citizen petition, which was received on December 11, 2024, allows the company to benefit from the extended exclusivity initially granted to Voquezna Triple Pak and Voquezna Dual Pak. These packages, which contain the new chemical entity (NCE) vonoprazan, were designated as qualified infectious disease products (QIDPs) and received an additional 5 years of exclusivity, totaling 10 years under the GAIN provisions. The FDA's decision is in line with its umbrella policy, which aims to encourage the development and improvement of drugs containing the NCE without compromising the innovator's exclusivity period. This FDA ruling is pivotal for Phathom as it ensures that Voquezna will benefit from the remainder of the NCE exclusivity recognized for the Voquezna Paks. The Orange Book will be updated to accurately reflect this extended period of exclusivity, which is a substantial win for the company. This exclusivity extension is particularly important as it protects Voquezna from generic competition and allows Phathom to capitalize on the market potential of its product without immediate threats. Related articles Phathom Pharmaceuticals shares soar on FDA exclusivity grant Neo Performance Materials stock surges on buyback plan BofA sees termination of Owens–Rotech deal as surprising but potentially positive 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
Yahoo
04-04-2025
- Health
- Yahoo
Kenan Thompson Reveals New Health Diagnosis, Recalls ‘Suffering in Silence' as Symptoms ‘Piled Up' (Exclusive)
Kenan Thompson spent months suffering in silence with symptoms of heartburn that disrupted his everyday life The actor and comedian revealed exclusively to PEOPLE that he was diagnosed with gastroesophageal reflux disease — commonly known as GERD He's sharing his story in hopes of encouraging others to feel more comfortable speaking to their doctors and getting proper help For the first time, Kenan Thompson is opening up about a recent health diagnosis. The longtime Saturday Night Live star, 46, tells PEOPLE exclusively that he began struggling with a health issue over two years ago. The actor and comedian was 44 years old when he started experiencing painful heartburn, specifically when eating acidic foods. It became so frequent that he struggled to get through workdays at SNL. 'I noticed that I would get hoarse a lot easier when I'm doing the show. Losing my voice quicker, but also uncomfortable sleepless nights because I'm burping up acid, just kind of hiccuping all night,' he tells PEOPLE. 'And that can definitely add more stress to an already stressful kind of environment doing a live show like that. So all of those factors, I was like whatever, I'll get over it. But it just started to pile up.' Thompson tried to avoid some of his trigger foods and take over-the-counter medications, but nothing brought him significant relief. 'I was able to take something and patch it up for the moment, but I got to a point where that didn't work anymore. That's when it got serious,' he explains. 'It was a suffering-in-silence situation. I don't know if I was necessarily embarrassed to talk to a doctor — I just didn't know if I needed to.' Related: I Was Diagnosed with Colon Cancer at 35. Two Years Later, I'm Running the Boston Marathon with My Doctor (Exclusive) Never miss a story — sign up for to stay up-to-date on the best of what PEOPLE has to offer, from celebrity news to compelling human interest stories. The All That alum says his symptoms were at their 'most extreme' in early 2024. They became so disruptive to his everyday life that finally, he decided to see a doctor. Thompson was immediately diagnosed with GERD. Gastroesophageal reflux disease — commonly known as GERD — occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach (esophagus), according to the Mayo Clinic. This backwash is known as acid reflux, and it can irritate the lining of the esophagus. GERD is one of the most common gastrointestinal disorders, affecting more than 65 million people in the United States. However, it often goes undiagnosed. 'I didn't know there was a real medical term for it,' Thompson admits. Related: I Dreamed of Being a College Athlete. Then Vaping Almost Killed Me (Exclusive) Shortly after his diagnosis, the actor's doctor introduced and prescribed him with Voquezna, a potassium competitive acid blocker and the first and only FDA-approved treatment of its kind to manage the chronic condition. 'I felt relief pretty immediately,' Thompson adds. Now speaking publicly about his health for the first time, the comedian is partnering with Phathom Pharmaceuticals for the GERD IS NO JOKE campaign to raise awareness about GERD and Voquezna, encouraging people to feel comfortable seeing a doctor and getting proper help. For the campaign, Thompson is doing what he does best and using humor to shed light on the important health issue, portraying a chef in a 'Kick Some Acid Cooking Show,' a nod to how the treatment has given him relief. 'It's nice to throw some humor into it because I like to have fun and a little bit of sugar helps the medicine go down,' he says. 'I thought it'd be funny if there was a chef who couldn't eat his own food because he is suffering in silence.' ! 'I've had good training with SNL, just trying to take the comedic approach to tougher topics and make it more palatable to discuss,' he continues. 'Sometimes you have to massage your way into it a little bit and just be like, alright, don't freak out everybody, I'm doing a medication ad, but we need to do a deep dive on this. So if I throw a character in it, there's some familiarity to go along with the messaging.' Today, Thompson tells PEOPLE that he's feeling so much better and has a solid grasp on managing his health. 'God bless, I feel great,' he says. 'I'm in a much healthier kind of space with my daily lifestyle and meal decision-making and all of that good stuff. I'm in a good place.' Read the original article on People
