On the business side of things, this was welcomed news by the manufacturer. After the inspection results were made public, the corporation’s stock grew over 6% on April 3rd. Piramal Pharma has a 5-year loss of almost 75%* but the short-term boost and the positive report from the FDA could indicate things are looking up for the international company.
Also on Monday, April 3rd, a report from the FDA had the opposite impact for another company in the medicinal field, a Denmark company called Ascendis Pharma. The US federal agency reported that “deficiencies” were observed when studying the application of a possible treatment, developed by Ascendis, for a condition known as hypoparathyroidism. The pending drug under scrutiny is named TransCon PTH. Although the report did not go into detail regarding the deficiencies, the FDA did note that the findings were not reflective of a “final regulatory decision.” The company’s stock, which is traded on the NASDAQ, fell over 30% in a day* after the news became public on Friday March 31st. Over the past years, however, Ascendis has posted a gain of almost 25% over that last five years*.
* as of 4:30 PM EST on 4/3/23
—-
Until Next Time,
The information has been obtained from sources considered reliable but we do not guarantee that the foregoing material is accurate or complete. Any opinions are those of Serving Those Who Serve writers and not necessarily those of RJFS or Raymond James. Any information is not a complete summary or statement of all available data necessary for making an investment decision and does not constitute a recommendation. Investing involves risk and you may incur a profit or loss regardless of strategy suggested. Every investor’s situation is unique and you should consider your investment goals, risk tolerance, and time horizon before making any investment or financial decision. Prior to making an investment decision, please consult with your financial advisor about your individual situation. While we are familiar with the tax provisions of the issues presented herein, as Financial Advisors of RJFS, we are not qualified to render advice on tax or legal matters. You should discuss tax or legal matters with the appropriate professional. **
For two companies, Ascendis and Piramal, findings from the Food and Drug Administration (FDA) directly impact short-term performance of stocks.
At the beginning of the pandemic, some in-person inspections of drug manufacturing facilities were paused by the FDA – especially those conducted internationally. Over the past few months, these “Good Manufacturing Practices” (GMP) evaluations have resumed. In Digwal, India, the FDA conducted one of these physical surveys from March 27th to the 31st at a factory owned by Piramal Pharma LTD. The FDA found that the building’s operations were compliant as there were no “form-483 observations” – which represent failures to comply with industry standards.
On the business side of things, this was welcomed news by the manufacturer. After the inspection results were made public, the corporation’s stock grew over 6% on April 3rd. Piramal Pharma has a 5-year loss of almost 75%* but the short-term boost and the positive report from the FDA could indicate things are looking up for the international company.
Also on Monday, April 3rd, a report from the FDA had the opposite impact for another company in the medicinal field, a Denmark company called Ascendis Pharma. The US federal agency reported that “deficiencies” were observed when studying the application of a possible treatment, developed by Ascendis, for a condition known as hypoparathyroidism. The pending drug under scrutiny is named TransCon PTH. Although the report did not go into detail regarding the deficiencies, the FDA did note that the findings were not reflective of a “final regulatory decision.” The company’s stock, which is traded on the NASDAQ, fell over 30% in a day* after the news became public on Friday March 31st. Over the past years, however, Ascendis has posted a gain of almost 25% over that last five years*.
* as of 4:30 PM EST on 4/3/23
—-
Until Next Time,
The information has been obtained from sources considered reliable but we do not guarantee that the foregoing material is accurate or complete. Any opinions are those of Serving Those Who Serve writers and not necessarily those of RJFS or Raymond James. Any information is not a complete summary or statement of all available data necessary for making an investment decision and does not constitute a recommendation. Investing involves risk and you may incur a profit or loss regardless of strategy suggested. Every investor’s situation is unique and you should consider your investment goals, risk tolerance, and time horizon before making any investment or financial decision. Prior to making an investment decision, please consult with your financial advisor about your individual situation. While we are familiar with the tax provisions of the issues presented herein, as Financial Advisors of RJFS, we are not qualified to render advice on tax or legal matters. You should discuss tax or legal matters with the appropriate professional. **
For two companies, Ascendis and Piramal, findings from the Food and Drug Administration (FDA) directly impact short-term performance of stocks.
At the beginning of the pandemic, some in-person inspections of drug manufacturing facilities were paused by the FDA – especially those conducted internationally. Over the past few months, these “Good Manufacturing Practices” (GMP) evaluations have resumed. In Digwal, India, the FDA conducted one of these physical surveys from March 27th to the 31st at a factory owned by Piramal Pharma LTD. The FDA found that the building’s operations were compliant as there were no “form-483 observations” – which represent failures to comply with industry standards.
On the business side of things, this was welcomed news by the manufacturer. After the inspection results were made public, the corporation’s stock grew over 6% on April 3rd. Piramal Pharma has a 5-year loss of almost 75%* but the short-term boost and the positive report from the FDA could indicate things are looking up for the international company.
Also on Monday, April 3rd, a report from the FDA had the opposite impact for another company in the medicinal field, a Denmark company called Ascendis Pharma. The US federal agency reported that “deficiencies” were observed when studying the application of a possible treatment, developed by Ascendis, for a condition known as hypoparathyroidism. The pending drug under scrutiny is named TransCon PTH. Although the report did not go into detail regarding the deficiencies, the FDA did note that the findings were not reflective of a “final regulatory decision.” The company’s stock, which is traded on the NASDAQ, fell over 30% in a day* after the news became public on Friday March 31st. Over the past years, however, Ascendis has posted a gain of almost 25% over that last five years*.
* as of 4:30 PM EST on 4/3/23
—-
Until Next Time,
The information has been obtained from sources considered reliable but we do not guarantee that the foregoing material is accurate or complete. Any opinions are those of Serving Those Who Serve writers and not necessarily those of RJFS or Raymond James. Any information is not a complete summary or statement of all available data necessary for making an investment decision and does not constitute a recommendation. Investing involves risk and you may incur a profit or loss regardless of strategy suggested. Every investor’s situation is unique and you should consider your investment goals, risk tolerance, and time horizon before making any investment or financial decision. Prior to making an investment decision, please consult with your financial advisor about your individual situation. While we are familiar with the tax provisions of the issues presented herein, as Financial Advisors of RJFS, we are not qualified to render advice on tax or legal matters. You should discuss tax or legal matters with the appropriate professional. **
The FedLife Podcast is your in-depth, biweekly deep dive into the world of federal benefits and retirement planning. Hosted by federal benefits expert Ed Zurndorfer and Dan Sipe of Serving Those Who Serve, each 30-minute episode unpacks the complexities of FERS and CSRS retirement, FEHB and Medicare, survivor benefits, tax planning, and more. Designed for federal employees and retirees who want more than just the basics, FedLife goes beyond the headlines to explore the rules, nuances, and strategies that can make a meaningful difference in your retirement. Remember: it’s your Fed life, make it a great one.
The Fed15 Podcast is your weekly 15(ish)-minute briefing on federal benefits and financial planning, built specifically for federal employees and retirees. Hosted by Dan Sipe and Katelyn Murray of Serving Those Who Serve, each episode delivers clear, actionable guidance on topics like FERS and CSRS retirement, TSP strategies, FEHB, survivor benefits, tax planning, and more! Whether you’re five years from retirement or already there, The Fed15 helps you cut through the noise, avoid costly mistakes, and make confident decisions about your federal benefits.
