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Regulatory

AQST

Aquestive Therapeutics announced that Anaphylm has met all predefined primary and secondary pharmacokinetic endpoints and reaffirmed its goal of filing a New Drug Application (NDA) before the end of 2024. The company also successfully completed a Type C meeting with the FDA, addressing previous concerns by modifying administration instructions and providing additional information for its NDA submission.

Portfolio Pulse from Benzinga Newsdesk

March 14, 2024 | 9:26 pm

JPM

JP Morgan Chase & Co. (NYSE:JPM) has been fined nearly $350 million by the Federal Reserve and the OCC for deficiencies in its trade surveillance program, failing to monitor billions of trading activities across global venues. The OCC issued a cease and desist order for JPM to improve its surveillance program. Despite the fines, JPM shares have increased by 43.76% over the past year, with a current RSI of 80.72 indicating overbought conditions.

Portfolio Pulse from Erica Kollmann

March 14, 2024 | 9:10 pm

GERN

Geron Corp (NASDAQ:GERN) shares surged in after-hours trading following a positive vote from the FDA's Oncologic Drugs Advisory Committee on the clinical benefit/risk profile of imetelstat for treating transfusion-dependent anemia. The ODAC's 12 to 2 vote in favor of imetelstat, a novel telomerase inhibitor developed by Geron for hematologic malignancies, comes after the Merge Phase 3 trial showed significant improvement in patients achieving red blood cell transfusion independence. The FDA has set a target action date of June 16, 2024, for Geron's New Drug Application for imetelstat.

Portfolio Pulse from Adam Eckert

March 14, 2024 | 9:03 pm

MDGL

Madrigal Pharmaceuticals' stock is trading higher following the FDA approval of Rezdiffra, a treatment for noncirrhotic NASH with moderate to advanced liver fibrosis.

Portfolio Pulse from Benzinga Newsdesk

March 14, 2024 | 8:53 pm

ISRG

Intuitive Surgical's stock is trading higher following the announcement that the FDA has cleared its da Vinci 5 surgical system.

Portfolio Pulse from Benzinga Newsdesk

March 14, 2024 | 8:51 pm

ISRG

Intuitive has received FDA 510(k) clearance for its fifth-generation robotic system, da Vinci 5, expanding its da Vinci product line which includes da Vinci X, da Vinci Xi, and da Vinci SP. This clearance allows Intuitive to offer a broader range of surgical solutions.

Portfolio Pulse from Benzinga Newsdesk

March 14, 2024 | 8:31 pm

BGNE

BeiGene has received FDA approval for TEVIMBRA for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy. TEVIMBRA will be available in the U.S. in the second half of 2024. Additionally, the FDA is reviewing applications for tislelizumab for other cancer treatments, with decisions expected in July and December 2024.

Portfolio Pulse from Benzinga Newsdesk

March 14, 2024 | 8:29 pm

GERN

Geron's stock price increased following the announcement that the FDA Oncologic Drugs Advisory Committee voted in favor of imetelstat's clinical benefit/risk profile for treating transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes.

Portfolio Pulse from Benzinga Newsdesk

March 14, 2024 | 8:28 pm

MDGL

Madrigal Pharmaceuticals has received accelerated FDA approval for Rezdiffra (resmetirom) for treating noncirrhotic NASH with moderate to advanced liver fibrosis. The approval is conditional on further verification from ongoing trials. Rezdiffra, which does not require a liver biopsy for diagnosis, has dosages based on body weight and will be available in the U.S. in April through a specialty pharmacy network.

Portfolio Pulse from Benzinga Newsdesk

March 14, 2024 | 8:22 pm

JNJ

LLY

MRK

WXXWY

WuXi AppTec and its affiliates face a setback as the Biotechnology Innovation Organization (BIO) cuts ties amid Congressional scrutiny over national security concerns. This decision affects U.S. industry giants like Eli Lilly, Merck, and Johnson & Johnson, all members of BIO. WuXi AppTec's shares fell significantly in Hong Kong and Shanghai, as did those of its sister companies, WuXi Biologics and WuXi XDC Cayman. The scrutiny stems from proposed bills aiming to restrict federal engagement with certain Chinese biotech firms. WuXi AppTec denies allegations related to national security risks.

Portfolio Pulse from Vandana Singh

March 14, 2024 | 8:03 pm