| Today | ||||
Precision BioSciences… Story temporarily locked. | ||||
| Yesterday | ||||
Pfizer (PFE) and BioNTech… Pfizer (PFE) and BioNTech (BNTX) announced the Food and Drug Administration expanded emergency use authorization to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children five through 11 years of age. The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-microgram dose of the Pfizer-BioNTech COVID-19 Vaccine. The companies have already submitted an application to the European Medicines Agency for a booster dose in this age group and are planning to file with other regulatory agencies around the world. | ||||
The U.S. Food and Drug… The U.S. Food and Drug Administration amended the emergency use authorization for the Pfizer (PFE) BioNTech (BNTX) COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine. Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said, "Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations. The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups." Reference Link | ||||
BMO Capital analyst Gary… BMO Capital analyst Gary Nachman lowered the firm's price target on Scholar Rock (SRRK) to $55 from $74 but keeps an Outperform rating on the shares. The company's Q1 results were better-than-expected on lower operating expenditure, while collaboration with Gilead (GILD) concluded and final collaborative revenue was recognized, the analyst tells investors in a research note. Nachman adds that his reduced price target reflects additional conservatism on timelines while also incorporating lower spending from restructuring. | ||||
Xilio Therapeutics (XLO)… Xilio Therapeutics (XLO) announced that Stacey Davis has been appointed as chief business officer, CBO, to further the company's corporate and business development strategy that will be central to its next stage of growth. Davis brings 25 years of experience in entrepreneurial roles building teams and leading corporate and portfolio strategy. She joins Xilio from Novartis Oncology (NVS), and most recently served as vice president, lung and immuno-oncology franchise, U.S. Oncology. | ||||
Talaris Therapeutics… Talaris Therapeutics (TALS) announced the appointment of independent director Karen Smith, M.D., Ph.D., MBA, LLM to the Company's Board of Directors. Dr. Smith currently serves as the Chief Medical Officer at Novosteo and as a member of the Board of Directors of Sangamo Therapeutics (SGMO), Capstan Therapeutics and Antares Pharma (ATRS). Talaris also announced that Nicholas Galakatos, Ph.D., has retired from its Board. |
| Monday | ||||
Piper Sandler analyst Do… Piper Sandler analyst Do Kim lowered the firm's price target on Gilead to $69 from $73 and keeps a Neutral rating on the shares. The analyst updates his model after the company announced that the FDA lifted clinical hold on injectable enacapavir, allowing clinical study activity in HIV treatment and PrEP to resume. Kim adds that he expects pipeline studies to resume in next few weeks, pending manufacturing of new vials and delivery to trial sites, stating that he sees the long-term opportunity of lenacapavir remaining intact. | ||||
Meeting to be held in New… Meeting to be held in New York on May 19 hosted by Oppenheimer. | ||||
Mirati Therapeutics… Mirati Therapeutics (MRTX) the appointment of Laurie Stelzer as the Company's CFO effective May 16. Laurie will report to the Company's CEO, David Meek. Laurie joins the Company most recently from Arena Pharmaceuticals, acquired by Pfizer (PFE), where she served as Executive Vice President and CFO since 2020. She brings 25 years of biopharma industry experience to her role in leading the company's finance functions. Prior to joining Arena, Laurie was the CFO at Halozyme Therapeutics where she led the finance, information technology, business development, project management and site operations organizations. Prior to joining Halozyme, Laurie held senior management roles at Shire, acquired by Takeda (TAK), including Senior Vice President of Finance, Division CFO for the Regenerative Medicine Division, and Head of Investor Relations. Previously she held positions of increasing responsibility during her fifteen-year career at Amgen, spanning the areas of finance, treasury, global accounting, and international/emerging markets. | ||||
Bilead Sciences announced… Bilead Sciences announced the U.S. Food and Drug Administration has lifted the clinical hold placed on the company's Investigational New Drug Application to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis. As previously announced, the FDA had placed a clinical hold on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue. FDA removed the clinical hold following the agency's review of Gilead's comprehensive plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative vial made from aluminosilicate glass. Following today's decision from the FDA, all activity can resume in the clinical studies evaluating injectable lenacapavir for HIV treatment and HIV PrEP. During the clinical hold, screening and enrollment of study participants and the dosing of injectable lenacapavir were not permitted across all lenacapavir studies. Other study activities, including the monitoring of participants, the dosing of participants in comparator arms, and the dosing of oral formulations of lenacapavir continued according to the relevant study protocol. Gilead will now work with study site investigators to fully resume the lenacapavir clinical development programs as quickly as possible. | ||||
