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Manmohan Singh died on December 26, 2024, at the age of 92; he will be remembered as one of India’s greatest leaders. Not only was he the first Sikh to be Prime Minister, he was also the architect of sweeping economic reforms that transformed India into a global player. During his 10 years in office from 2004 to 2014, he had focused on policies designed to lift people out of poverty and boost the economy’s standing in the world. Liberalization under Singh exposed the world to India, and India to the world, enabling the country to fight for her place as a major economic player. Singh, who was soft-spoken and principled in his leadership, influenced economic growth beyond the realm of the economic. He used these welfare schemes — some of which bettered the lives of millions — to convey his commitment to social justice. Another key achievement of his government, which exists till today, is the National Rural Employment Guarantee Act (NREGA) that assured the rural poor atleast 100 days of wage employment in a financial year to every rural household. Singh rose through the political ranks after assuming the post of Finance Minister in 1991, a period of massive economic turmoil for India. Devaluation of the rupee, reduction of import tariffs and foreign investment were the thrust of his initiatives, laying the foundation for the transformation of India’s economy. He was instrumental in India’s shift from a closed economy to a more open economy connected to the global markets. During his two terms in office as Prime Minister, Singh oversaw a number of landmark achievements, including a strong economy that had an average growth rate of approximately 9% each year between 2005 and 2008, in his first term. His style of leadership involved building consensus and working within coalition governments that had to accommodate many different political interests. Yet, Singh’s second term was plagued with several allegations of corruption and the scandals thus raised overshadowed few initial successes, and led to the Congress party defeat in the 2014 elections. Manmohan Singh’s global dealings also more than a little shape his legacy. He promoted peaceful and diplomatic ties — particularly with Pakistan and China. Under his leadership, there were efforts to engage Pakistan for possible commonality, but this was thwarted on many structural levels through incidents like the 2008 Mumbai attacks. Singh’s approach emphasized collaboration and cooperation over confrontation and this was reflected in his priority of ending conflicts through dialogues. One of the landmark achievements of his regime was the 2008 Indo-US nuclear deal, which changed India’s foreign policy posture, laying the foundation for civilian nuclear relations with America. Singh also helped establish BRICS — the grouping of Brazil, Russia, India, China and South Africa, held up the rising powers of the developing world where much of the economic growth in recent years has been taking place. As news broke about Manmohan Singh passing away, political leaders and citizens expressed their tributes. Describing Singh as one of the “greatest leaders” of the country, Prime Minister Narendra Modi asserted that the former prime minister’s contribution to make a difference in people’s lives was “substantial”. Leaders spanning the political spectrum have praised Singh’s insight, humility, and dedication to the country, underscoring his national influence on Indian politics. In a nation that has changed significantly since he entered national politics in the 1990s, Singh’s legacy is both long-lasting and complex, not least due to the controversies that clamoured around the last years of his political life. His long-term vision of an India which is economically prosperous, but socially inclusive is going to guide many generations of leaders and policymakers who come after jego. Manmohan Singh passed away around the age of 91 and most people remember his prime ministerial role as a crucial period for India. Ultimately, Manmohan Singh moved the needle through both his policies and the collective psyche of a nation from which even at age 92 he has yet to be able to rest. As India looks back on his legacy, may his values of economic reform, honesty, and diplomacy be adopted by all those who take on the mantle that he successfully wore.
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Texas' abortion pill lawsuit against New York doctor marks new challenge to interstate telemedicine Texas has sued a New York doctor for prescribing abortion pills to a Texas woman via telemedicine. It appears to be the first challenge in the U.S. to a state shield law that's intended to protect prescribers in Democratic-controlled states from being punished by states with abortion bans. Prescriptions like these, made online and over the phone, are a key reason that the number of abortions has increased across the U.S. even after state bans started taking effect. Most abortions in the U.S. involve pills rather than procedures. Anti-abortion groups are increasingly focusing on the rise of pills. Syrians cheer end of 50 years of Assad rule at first Friday prayers since government fell DAMASCUS (AP) — Exuberant Syrians observed the first Friday prayers since the ouster of President Bashar Assad, gathering in the capital’s historic main mosque, its largest square and around the country to celebrate the end of half a century of authoritarian rule. The newly installed interim prime minister delivered the sermon at the Umayyad Mosque, declaring that a new era of “freedom, dignity and justice” was dawning for Syria. The gatherings illustrated the dramatic changes that have swept over Syria less than a week after insurgents marched into Damascus and toppled Assad. Amid the jubilation, U.S. Secretary of State Antony Blinken met with allies around the region and called for an “inclusive and non-sectarian” interim government. US military flies American released from Syrian prison to Jordan, officials say WASHINGTON (AP) — The U.S. military has brought an American who was imprisoned in Syria for seven months out of the country. That's according to two U.S. officials, who said Friday that Travis Timmerman has been flown to Jordan on a U.S. military helicopter. The 29-year-old Timmerman told The Associated Press earlier Friday he had gone to Syria on a Christian pilgrimage and was not ill-treated while in a notorious detention facility operated by Syrian intelligence. He said he was freed by “the liberators who came into the prison and knocked the door down (of his cell) with a hammer.” New Jersey governor wants more federal resources for probe into drone sightings TOMS RIVER, N.J. (AP) — New Jersey Gov. Phil Murphy has asked the Biden administration to put more resources into the ongoing investigation of mysterious drone sightings being reported in the state and other parts of the region. Murphy, a Democrat, made the request in a letter Thursday, noting that state and local law enforcement remain “hamstrung” by existing laws and policies in their efforts to successfully counteract any nefarious drone activity. Murphy and other officials say there is no evidence that the drones pose a national security or a public safety threat. A state lawmaker says up to 180 aircraft have been reported to authorities since Nov. 18. Nancy Pelosi hospitalized after she 'sustained an injury' from fall on official trip to Luxembourg WASHINGTON (AP) — Former House Speaker Nancy Pelosi has been hospitalized after she “sustained an injury” during an official engagement in Luxembourg, according to a spokesman. Pelosi is 84. She was in Europe to mark the 80th anniversary of the Battle of the Bulge in World War II. Her spokesman, Ian Krager, did not describe the nature of her injury or give any additional details, but a person familiar with the incident said that Pelosi tripped and fell while at an event with the other members of Congress. The person requested anonymity to discuss the fall because they were not authorized to speak about it publicly. Russia targets Ukrainian infrastructure with a massive attack by cruise missiles and drones KYIV, Ukraine (AP) — Russia has launched a massive aerial attack against Ukraine. Ukrainian President Volodymyr Zelenskyy says Russia fired 93 cruise and ballistic missiles and almost 200 drones in Friday's bombardments. He says it is one of the heaviest bombardments of the country’s energy sector since Russia’s full-scale invasion almost three years ago. He says Ukrainian defenses shot down 81 missiles, including 11 cruise missiles that were intercepted by F-16 warplanes provided by Western allies earlier this year. Zelenskyy renewed his plea for international unity against Russian President Vladimir Putin. But uncertainty surrounds how the war might unfold next year. President-elect Donald Trump has vowed to end the war and has thrown into doubt whether vital U.S. military support for Kyiv will continue. Trump’s lawyers rebuff DA's idea for upholding his hush money conviction, calling it 'absurd' NEW YORK (AP) — President-elect Donald Trump’s lawyers are again urging a judge to throw out his hush money conviction. In a court filing Friday, they balked at the prosecution’s “absurd” idea for preserving the verdict by treating the case the way some courts do when a defendant dies before sentencing. The Manhattan district attorney’s office is asking Judge Juan M. Merchan to “pretend as if one of the assassination attempts against President Trump had been successful,” Trump’s lawyers wrote in a blistering 23-page response. In court papers made public Tuesday, District Attorney Alvin Bragg’s office proposed an array of options for keeping the historic conviction on the books after Trump’s lawyers filed paperwork earlier this month asking for the case to be dismissed. Some in seafood industry see Trump as fishermen's friend, but tariffs could make for pricier fish PORTLAND, Maine (AP) — The incoming administration of President-elect Donald Trump is likely to bring big changes to seafood, one of the oldest sectors of the U.S. economy. Some in the industry believe the returning president will be more responsive to its needs. Economic analysts paint a more complicated picture, as they fear Trump’s pending trade hostilities with major trading partners Canada and China could make an already pricy kind of protein more expensive. Conservationists also fear Trump’s emphasis on deregulation could jeopardize fish stocks already in peril. But many in the commercial fishing and seafood processing industries said they expect Trump to allow fishing in protected areas and crack down on offshore wind expansion. OpenAI's legal battle with Elon Musk reveals internal turmoil over avoiding AI 'dictatorship' A 7-year-old rivalry between tech leaders Elon Musk and Sam Altman over who should run OpenAI and best avoid an artificial intelligence ‘dictatorship’ is now heading to a federal judge. The development comes as Musk seeks to halt the ChatGPT maker’s ongoing conversion into a for-profit company. Musk was an early OpenAI investor and board member. But he sued the artificial intelligence company earlier this year. He has since escalated the dispute, adding new claims and asking for a court order that would stop OpenAI’s plans to convert itself into a for-profit business more fully. OpenAI filed its response in court Friday. Paula Abdul settles lawsuit alleging sexual assault by 'American Idol' producer Nigel Lythgoe LOS ANGELES (AP) — Paula Abdul and former “American Idol” producer Nigel Lythgoe have agreed to settle a lawsuit in which she alleged he sexually assaulted her in the early 2000s when she was a judge on the show. Abdul filed a notice of settlement in a Los Angeles court Thursday. The lawsuit filed nearly a year ago had also accused Lythgoe of sexually assaulting Abdul after she left “American Idol” and became a judge on Lythgoe’s other show “So You Think You Can Dance.” Lythgoe said at the time that the allegations were “an appalling smear.” Both sides said in statements Friday that they were glad to put the case behind them.
CLEVELAND (AP) — The NFL has closed an investigation into sexual assault allegations against Cleveland Browns quarterback Deshaun Watson, who is ending the season on injured reserve for the second year in a row. The league has been reviewing the case for months , trying to determine whether Watson should be punished. “The matter is closed,” league spokesman Brian McCarthy said Friday in an email to The Associated Press. “There was insufficient evidence to support a finding of a violation of the personal conduct policy.” Watson, who served an 11-game suspension in 2022, was accused of assault in Texas by a woman in September. She was seeking more than $1 million in damages before the sides reached a confidential settlement. Watson strongly denied the allegations through his attorney, Rusty Hardin. The 29-year-old Watson suffered a season-ending Achilles tendon rupture in October. He's been rehabbing the injury in hopes of returning next season. The Browns still owe Watson $46 million in each of the next two seasons after they traded three first-round picks to Houston and signed him to a five-year, fully guaranteed $230 million contract that has backfired. Watson has only played in 19 games over three seasons due to the suspension and injuries. He was acquired by the Browns, who were comfortable with his character despite Watson being accused of sexual assault and inappropriate conduct during massage therapy sessions while he played for the Texans. While he's in the clear with the league, Watson's future with Cleveland isn't so certain. His massive contract — and its salary-cap ramifications — has put the Browns in a bind in terms of trying to improve their roster. Cleveland has had a disappointing season after making the playoffs a year ago and could move on from Watson, but the cost would be exorbitant if the team just releases him. The Browns signed Jameis Winston for one season to be Watson's backup. Winston has gone 2-3 as a starter since taking over and he's put some life into Cleveland's offense, which didn't score 20 points or gain 300 yards with Watson before his injury. His 2023 season was ended by a broken bone in his shoulder, requiring surgery. Winston has indicated he would come back, and he could be a viable option as a starter even if the Browns draft a young QB. AP NFL: https://apnews.com/hub/NFLJennison Associates LLC acquired a new position in shares of Myriad Genetics, Inc. ( NASDAQ:MYGN – Free Report ) in the 3rd quarter, according to the company in its most recent filing with the SEC. The fund acquired 24,162 shares of the company’s stock, valued at approximately $662,000. A number of other hedge funds and other institutional investors also recently bought and sold shares of MYGN. Hexagon Capital Partners LLC increased its position in shares of Myriad Genetics by 75.3% during the second quarter. Hexagon Capital Partners LLC now owns 1,143 shares of the company’s stock worth $28,000 after purchasing an additional 491 shares in the last quarter. Innealta Capital LLC purchased a new position in Myriad Genetics during the 2nd quarter worth $36,000. GAMMA Investing LLC increased its position in Myriad Genetics by 34.1% during the 3rd quarter. GAMMA Investing LLC now owns 1,620 shares of the company’s stock valued at $44,000 after buying an additional 412 shares in the last quarter. Point72 DIFC Ltd purchased a new stake in Myriad Genetics in the second quarter valued at about $60,000. Finally, Point72 Asia Singapore Pte. Ltd. acquired a new stake in Myriad Genetics in the second quarter worth about $82,000. Hedge funds and other institutional investors own 99.02% of the company’s stock. Insider Buying and Selling at Myriad Genetics In other Myriad Genetics news, Director Colleen F. Reitan sold 46,012 shares of the company’s stock in a transaction dated Tuesday, September 3rd. The shares were sold at an average price of $27.95, for a total value of $1,286,035.40. Following the completion of the transaction, the director now owns 42,533 shares in the company, valued at approximately $1,188,797.35. This represents a 51.96 % decrease in their ownership of the stock. The sale was disclosed in a legal filing with the SEC, which is accessible through this link . Also, CEO Paul J. Diaz sold 15,000 shares of the firm’s stock in a transaction dated Friday, October 11th. The shares were sold at an average price of $22.93, for a total value of $343,950.00. Following the sale, the chief executive officer now owns 962,378 shares in the company, valued at $22,067,327.54. This trade represents a 1.53 % decrease in their ownership of the stock. The disclosure for this sale can be found here . Over the last ninety days, insiders sold 71,012 shares of company stock valued at $1,900,485. 2.10% of the stock is owned by company insiders. Analyst Ratings Changes Read Our Latest Stock Analysis on MYGN Myriad Genetics Stock Up 2.4 % Shares of MYGN opened at $15.49 on Friday. The company has a market capitalization of $1.41 billion, a price-to-earnings ratio of -11.92 and a beta of 1.93. Myriad Genetics, Inc. has a 52 week low of $14.72 and a 52 week high of $29.30. The stock’s 50-day moving average price is $22.26 and its 200-day moving average price is $24.48. The company has a quick ratio of 1.73, a current ratio of 1.90 and a debt-to-equity ratio of 0.05. Myriad Genetics Profile ( Free Report ) Myriad Genetics, Inc, a genetic testing and precision medicine company, develops genetic tests in the United States and internationally. The company offers molecular diagnostic tests for use in oncology, and women's and pharmacogenomics. It also provides MyRisk Hereditary Cancer Test, a DNA sequencing test for assessing the risks for hereditary cancers; BRACAnalysis CDx Germline Companion Diagnostic Test, a DNA sequencing test to help determine the therapy for patients with metastatic breast, ovarian, metastatic pancreatic, and metastatic prostate cancer with deleterious or suspected deleterious germline BRCA variants; and MyChoice CDx Companion Diagnostic Test, a tumor test that determines homologous recombination deficiency status in patients with ovarian cancer. Featured Articles Receive News & Ratings for Myriad Genetics Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Myriad Genetics and related companies with MarketBeat.com's FREE daily email newsletter .
Laurentian Bank reports profits up for the quarter but down for the yearSAN DIEGO , Dec. 13, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved CRENESSITYTM (crinecerfont) capsules and oral solution as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with classic congenital adrenal hyperplasia (CAH), a rare, serious and lifelong genetic condition involving the adrenal glands. CRENESSITY, a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF 1 ) antagonist, is the first and only classic CAH treatment that directly reduces excess adrenocorticotropic hormone (ACTH) and downstream adrenal androgen production, allowing for glucocorticoid dose reduction. It is a breakthrough in the treatment landscape for classic CAH. "For the last three decades, Neurocrine Biosciences, together with our late founder, Wylie W. Vale , has conducted groundbreaking research uncovering the critical role of corticotropin-releasing factor and its receptor, CRF 1 , in the pathophysiology of congenital adrenal hyperplasia," said Kyle W. Gano , Ph.D., Chief Executive Officer, Neurocrine Biosciences. "The approval of CRENESSITY is a significant milestone for the CAH community, and we are grateful to the individuals who participated in our clinical trials, including their families and caregivers, and to the clinical investigators who helped advance a new therapy and class of medicines." "Patients and families struggle to achieve balance between managing the symptoms of CAH and the side effects or complications of treatment with high-dose steroids, which may impact quality of life," said Dina Matos , Executive Director, CARES Foundation. "We are grateful to Neurocrine Biosciences for engaging with our community throughout the drug development process to understand our needs and ultimately providing this new medication that can help reduce excess adrenal androgens and the need for high-dose steroid treatment for individuals living with CAH." CRENESSITY is expected to be commercially available in approximately one week. The medication will be provided through PANTHERx Rare, a specialty pharmacy, to centralize and simplify CRENESSITY prescription fulfillment. Neurocrine Biosciences is committed to supporting patients in obtaining treatment with CRENESSITY by offering Neurocrine Access Support, a free, comprehensive assistance program created for patients, caregivers and healthcare providers. It offers a range of options to make sure patients have everything they need to begin and continue taking CRENESSITY. A dedicated Care Coordinator, backed by a team, is available to help patients and caregivers navigate the insurance process and identify appropriate financial assistance options. Most patients will pay $10 or less per month for CRENESSITY*. For more information, visit www.NBIaccess.com/crenessity or call 1-855-CRNSITY (276-7489) Monday-Friday 8 am-8 pm ET . *Additional terms and conditions apply. CAHtalyst TM Clinical Program Overview: The FDA approval is supported by the largest-ever clinical trial program of classic CAH, the CAHtalyst Pediatric and Adult Phase 3 global registrational studies. CAHtalyst Phase 3 data results in pediatric and adult patients with classic CAH were published in The New England Journal of Medicine . "The clinical results across both CAHtalyst studies support the efficacy and safety profile of CRENESSITY and its ability to reduce the overproduction of adrenal androgens, allowing for a meaningful reduction in glucocorticoid dosage, while maintaining or enhancing control of these androgens," said Richard Auchus , M.D., Ph.D., Professor, University of Michigan Health, Principal Investigator. "Chronic treatment with supraphysiologic glucocorticoids can cause a number of short- and long-term health consequences, such as obesity, hypertension and osteoporosis, so the ability for patients with CAH to lower their glucocorticoid dose to a more physiologic level can have profound benefits." In both CAHtalyst studies, CRENESSITY enabled lower steroid doses and decreased androgen levels. Phase 3 CAHtalyst Pediatric Study: Phase 3 CAHtalyst Adult Study: CRENESSITY was well tolerated with few treatment-related adverse events in both CAHtalyst studies. Pediatric and adult patients taking CRENESSITY had no treatment-related serious adverse events. Adrenal insufficiency and crisis are risks of living with CAH that CRENESSITY does not address and can occur when a patient's GC dose is too low. In the CAHtalyst Pediatric study, there were no cases of adrenal crisis among patients taking CRENESSITY or placebo. In the CAHtalyst Adult study, two patients (1.6%) taking CRENESSITY experienced adrenal crisis. No patients on placebo experienced adrenal crisis. However, one patient (1.7%) on placebo experienced adrenal insufficiency. Patients should work with their healthcare provider to manage GC dosing while taking CRENESSITY. For more information about CRENESSITY, visit Crenessity.com . About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens, which are essential for life. Approximately 95% of CAH cases are caused by variants of the CYP21A2 gene that leads to deficiency of the enzyme 21-hydroxylase (21-OH). Severe deficiency of this enzyme leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in salt wasting, dehydration and even death. Historically, exogenous glucocorticoids (GCs) have been used not only to correct the endogenous cortisol deficiency, but doses used are higher than cortisol replacement needed (supraphysiologic) to lower the levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at high doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with high-dose GCs may have psychological and cognitive impact, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, testicular rest tumors in males and fertility issues in both sexes. About The CAHtalystTM Studies The Phase 3 CAHtalystTM global registrational studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY in children and adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The CAHtalyst studies were the largest-ever clinical trial program in classic CAH, including 285 pediatric and adult patients. The CAHtalyst Pediatric study included 103 pediatric patients aged four to 17 years. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional 24 weeks of CRENESSITY treatment enabled customized glucocorticoid (GC) down-titration while androstenedione levels were maintained or improved. The CAHtalyst Adult study included 182 adult patients aged 18 to 58 years. Similarly, the first question of the study evaluated whether four weeks of CRENESSITY treatment could improve androgen control, and the second question evaluated whether an additional 20 weeks of CRENESSITY treatment enabled GC reduction to physiologic range while androstenedione levels were maintained or improved. Data from the CAHtalyst Phase 3 studies supported approval of CRENESSITY by the U.S. Food and Drug Administration in December 2024. The open-label extension treatment portions of both studies are ongoing. About CRENESSITYTM (crinecerfont) CRENESSITYTM is a potent and selective, oral corticotropin-releasing factor type 1 receptor (CRF 1 ) antagonist developed to reduce and control excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF 1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol. CRENESSITY comes in capsules and an oral solution. The capsule formulation is available in 50 mg and 100 mg doses. The oral solution is available as a 50 mg/mL strength formulation. For adults 18 years and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients four to 17 years of age weighing less than 55 kg (121 lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121 lbs), the recommended dosage is 100 mg twice daily taken orally with a meal. Healthcare providers can work with patients to determine the appropriate formulation for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement. Important Information Approved Uses CRENESSITY (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH). IMPORTANT SAFETY INFORMATION Do not take CRENESSITY if you: Are allergic to crinecerfont, or any of the ingredients in CRENESSITY. CRENESSITY may cause serious side effects, including : Allergic Reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY. Risk of Sudden Adrenal Insufficiency or Adrenal Crisis With Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine. Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take , including prescription and over-the counter medicines, vitamins, and herbal supplements. The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain. The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nose bleeds. These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules and as an oral solution of 50 mg/mL. Please see full Prescribing Information About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X (formerly Twitter) and Facebook . (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo Lockup and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. CRENESSITY and CAHtalyst are trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency; the value and benefits CRENESSITY brings to patients with CAH; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY; and whether the results from our clinical trials of CRENESSITY are indicative of real-world results. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; the degree and pace of market uptake of CRENESSITY; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2024 . Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2024 Neurocrine Biosciences, Inc. All Rights Reserved. CP-CFT-US-0070 12/2024 View original content to download multimedia: https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-fda-approval-of-crenessity-crinecerfont-a-first-in-class-treatment-for-children-and-adults-with-classic-congenital-adrenal-hyperplasia-302331772.html SOURCE Neurocrine Biosciences, Inc.
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