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The Latest Breaking News from FDA

Omega Therapeutics Submits IND For Liver Cancer Candidate

Omega Therapeutics, Inc. (NASDAQ: OMGA) submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its lead product candidate, OTX-2002, for the treatment of hepatocellular carcinoma (HCC).

Benzinga

Morning Brief: Top Financial Stories Dominating on Wednesday, June 15

Reuters Warner Bros Discovery To Undergo Major Global Ad Sales Team Restructuring

Benzinga

Pfizer Halts Enrollment In Paxlovid COVID-19 Trial In Standard-Risk Population

Pfizer Inc (NYSE:PFE) shared additional data from the Phase 2/3 EPIC-SR study of Paxlovid (nirmatrelvir and ritonavir tablets) in patients at standard risk for developing severe COVID-19. In previously reported interim analyses, the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met. Non-significant 70% relative…

Benzinga

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FDA Committee Backs Moderna's COVID-19 Shot For Kids, Adolescents: Report

Moderna Inc's (NASDAQ: MRNA) COVID-19 vaccine received unanimous backing from the FDA's committee of independent immunization experts for children ages 6 through 17.

Benzinga

24 Stocks Moving in Wednesday's Pre-Market Session

Gainers Boxed, Inc. (NYSE: BOXD) rose 38.3% to $1.95 in pre-market trading. Boxed reported that Director Andrew Pearson bought 150,000 shares at an average price of $1.82 per share.

Benzinga

82 Biggest Movers From Yesterday

Gainers Comera Life Sciences Holdings, Inc. (NASDAQ: CMRA) gained 126.5% to settle at $2.65 on Tuesday.

Benzinga

Cannabis Reg. Update: FDA To Review CBD Again, DEA Wins In Hemp Extract Case & More

FDA To Review CBD Once Again The U.S. Food and Drug Administration’s Science Board is expected to review the idea of incorporating cannabinoids into dietary supplements on Tuesday at the public advisory committee meeting.

Benzinga

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Fisher-Price issues warning after 13 infant deaths from rockers - what you need to know

No recall has been issued for the product, but parents are advised not to let newborns and toddlers sleep in the rockers

The Independent UK

Benchmark Downgrades AeroClean After Share Price Rallies

Benchmark analyst Robert Wasserman downgraded AeroClean Technologies Inc (NASDAQ:AERC) to Hold from Buy, without a price target. The analyst notes that despite a poor overall market outlook, the company's shares have quickly reached and exceeded earlier price targets. Wasserman downgraded the rating on AERC at this time due to share price and market volatility.…

Benzinga

Here's How Citi Views Amylyx Pharma

Citi Research has raised the price target on Amylyx Pharmaceuticals Inc's (NASDAQ:AMLX) to $33 from $32, with a Buy rating. It says the small market opportunity for the newly approved amyotrophic lateral sclerosis (ALS) drug in Canada (~$100 million peak) bodes well for ongoing FDA review. Availability in Canada and using ALSFRS-R data as the primary basis…

Benzinga

Approval Of Baricitinib For Patchy Baldness Validates Clinical Patch For This Small-Cap Stock

Olumiant (baricitinib), a Janus kinase (JAK) inhibitor, was developed by Incyte Corp (NASDAQ:INCY) and launched in collaboration with Eli Lilly And Co (NYSE:LLY), received FDA approval for hair loss disorder known as alopecia areata (AA). Olumiant was first approved for the treatment of rheumatoid arthritis (RA) in 2018. The above nod is expected to…

Benzinga

Moderna's COVID-19 Shot Likely Related To Higher Heart Inflammation Risk Than Pfizer's: Reuters

Moderna Inc's (NASDAQ:MRNA) COVID-19 vaccine may relate to a higher risk of heart inflammation in some age groups than Pfizer Inc (NYSE:PFE) - BioNTech SE's (NASDAQ:BNTX) shot, Reuters reported citing the Centers for Disease Control and Prevention. Citing recent data, CDC said that the findings on myocarditis and pericarditis, types of heart inflammation linked to both the…

Benzinga

FDA advisers consider Moderna's COVID shots for older kids

A government advisory panel is meeting to decide whether to recommend a second brand of COVID-19 vaccine for school-age children and teens

The Independent UK

FDA OKs Apple Watch To Help Monitor Symptoms Of Parkinson's Disease

A San Francisco-based software company received permission from the U.S. Food and Drug Administration to use Apple Inc. (NASDAQ: AAPL) wearable technology to track Parkinson's symptoms.

Benzinga

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The Daily Biotech Pulse: FDA Nod For Lilly-Incyte's Patchy Hair Loss Treatment, First Regulatory Submission For EQRx, Soleno's Promising Data From Prader-Willi Candidate

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

Morning Brief: Top Financial Stories Dominating on Tuesday, June 14

CNBC

Benzinga

Why Outset Medical Shares Are Trading Lower Today

Outset Medical Inc (NASDAQ:OM) implemented a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending the FDA review and clearance of a 510(k). The company submitted for changes made since the device's original March 2020 clearance. Outset has not identified any safety issues with Tablo. It will continue…

Tribune News Service

Editorial: Needed action on menthol cigarette ban

Three generations of LaTrisha Vetaw's family have smoked menthol cigarettes. It might even be four, since Vetaw knows that her great-grandfather smoked but isn't sure what brand he lit up.

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Benzinga

Lilly-Incyte Snag FDA Nod For Patchy Hair Loss Treatment — Smaller Rival's Stock Shoots Up In Sympathy

Alopecia areata, an autoimmune disorder that causes patchy hair loss, now has a new treatment that has been approved by the Food and Drug Administration.

Los Angeles Times

Editorial: The FDA is right to ban menthol cigarettes

Take a deep breath, America. We’ve made serious progress against cigarette smoking. According to the U.S. Centers for Disease Control and Prevention, 23% of adults were smokers in 2000. By 2020, the rate had fallen to 12.5%. Teen use of traditional cigarettes has plummeted from 22.5% in 2002 to 6%…

Benzinga

Alnylam's Stock Gains Following FDA Nod For hATTR Amyloidosis Candidate

The U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’ (NASDAQ: ALNY) lead drug candidate AMVUTTRA (Vutrisiran) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

Benzinga

Read Why Forma Therapeutics' Current Price Level Is 'Attractive Entry Point'

During the European Hematology Association (EHA) conference, Forma Therapeutics Holdings Inc (NASDAQ:FMTX) presented updated results from the 12-week open-label extension (OLE) of etavopivat's Phase 1 trial in sickle cell disease. Treatment with etavopivat 400mg QD elicited a >1g/dL hemoglobin (Hb) increase in 73% of the 15 patients and an average maximal Hb increase of…

Benzinga

Analysts Remain Bullish Despite Caribou's Allogeneic CAR-T Hit By Durability

Caribou Biosciences Inc (NASDAQ:CRBU) announced the presentation of additional initial clinical data from its ANTLER Phase 1 trial for CB-010 in relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). Following a single dose at the initial dose level of 40 million CAR-T cells, a 100% complete response (CR) rate (6 of 6…

Benzinga

Canada Approves Amylyx's ALS Drug; FDA To Consider Approval In September

The Canadian government has given its approval to AMX0035, a new drug from Cambridge, Massachusetts-based Amylyx Pharmaceuticals Inc.

Benzinga

Novavax' Sees Conditional Approval Of COVID-19 Vaccine Booster In Australia As US FDA Delays Its Decision

The Australian regulatory authority has conditionally approved Novavax Inc's (NASDAQ:NVAX) Nuvaxovid (NVX-CoV2373) COVID-19 vaccine as a booster in individuals aged 18 and over. The provisional registration was based on data from Novavax's Phase 2 trial conducted in Australia, wherein a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after…

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