FDA Roundup: December 6, 2024 [Yahoo! Finance]
Merus N.V. - Common Shares (MRUS)
Last merus n.v. - common shares earnings: 8/19 04:01 pm
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US:NASDAQ Investor Relations:
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Source: Yahoo! Finance
On Thursday, the FDA published the draft guidance, " Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics ," which proposes updates to certain agency policies and procedures regarding accelerated approval. Topics addressed by this guidance include how FDA determines which products are candidates for accelerated approval, standards for granting accelerated approval (including postmarketing requirements), and the statutory procedures for withdrawing a product approved under the accelerated approval program. The draft guidance is largely consistent with the information on accelerated approvals contained in the FDA's 2014 guidance, Expedited Programs for Serious Conditions , with some clarifications and updates to address changes introduced by the 2023 Consolidated Appropriations Act. On Thursday, the FDA updated the outbreak advisory, Outbreak Investigation of Salmonella: Cucumbers ( November 2024 ) to include additional downstream recalls. See the ou
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MRUS
News
- Merus announces First Patient Dosed in Phase 2 Trial of Petosemtamab in 3L+ mCRCGlobeNewswire
- Merus (MRUS): FDA Approval and Speculative Future in Cancer Therapy [Yahoo! Finance]Yahoo! Finance
- Merus (NASDAQ: MRUS) had its price target raised by analysts at Citigroup Inc. from $89.00 to $97.00. They now have a "buy" rating on the stock.MarketBeat
- Merus (NASDAQ: MRUS) had its "buy" rating re-affirmed by analysts at Needham & Company LLC. They now have a $85.00 price target on the stock.MarketBeat
- Merus' Petosemtamab Monotherapy Interim Data Continues to Demonstrate Clinically Meaningful Activity in 2L+ r/m HNSCC [Yahoo! Finance]Yahoo! Finance
MRUS
Earnings
- 8/1/24 - Miss
MRUS
Sec Filings
- 12/16/24 - Form SCHEDULE
- 12/5/24 - Form 8-K
- 12/2/24 - Form 8-K
- MRUS's page on the SEC website