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The Latest Breaking News from CHMP

Sarepta Gets Thumbs Down From Regulators Regarding Elevidys Gene Therapy

On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional marketing authorisation (CMA) for Elevidys (delandistrogene moxeparvovec) for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy (DMD).

Benzinga

Sarepta Therapeutics' Brutal Week Continues With Bad News Out Of Europe

Sarepta Therapeutics' brutal week continued Friday after European officials rejected the company's controversial gene therapy, Elevidys.

Investors Business Daily

Apellis Stock Hammered After Eye Drug Gets A Third European Rejection

European regulators rejected Apellis Pharmaceuticals' embattled eye drug, Syfovre, and Apellis stock tumbled to a month-low.

Investors Business Daily

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PTC's Journey Of 'Twist And Doubt' Continues With Another Rejection; Shares Tumble

European regulators rejected PTC Therapeutics' Duchenne muscular dystrophy drug — again — sending PTC stock into free fall early Friday.

Investors Business Daily

5 Blue Chip Stocks to Help You Beat the Market Slump

Rising concerns over stubbornly-high inflation and the Fed’s commitment to bring it down to its desired level have kept equities under pressure lately. Amid increasing recessionary concerns, investing in blue-chip stocks such as Procter & Gamble (PG), AbbVie (ABBV), Pfizer (PFE), Dow (DOW), and Walgreens Boots Alliance (WBA) could help…

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Daily Biotech Pulse: KKR Invests In Medicine Start-Up, Revelation Bio Aces Allergic Rhinitis Study, Tonix Pharma Ends COVID-19 Antiviral Pact

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

Benzinga

The Daily Biotech Pulse: CHMP Backs AstraZeneca's Breast Cancer Therapies, Ipsen Buys Epizyme, FDA Holds For Nuvation Bio, Astellas Studies

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

Benzinga

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Raymond James Says PTC Therapeutics' CHMP Backing Is 'Under Exceptional Circumstances' What's Next

Last week, PTC Therapeutics Inc's (NASDAQ:PTCT) Upstaza (PTC-AADC; AAV2-based DDC gene therapy) received a CHMP opinion for approval under exceptional circumstances, says Raymond James. It maintains Outperform rating on the stock. The CHMP recommended Upstaza for AADC deficiency (AADCD) patients aged 18 months and older with a severe phenotype. According to the analysts, with the…

Benzinga

EMA's Advisory Committee Recommends Eiger's Zokinvy In Premature Aging Disorder

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending Eiger BioPharmaceuticals Inc's (NASDAQ:EIGR) Zokinvy for Hutchinson-Gilford progeria syndrome (HGPS) and processing-deficient progeroid laminopathies (PL). HGPS and PL are ultra-rare and fatal pediatric diseases that cause dramatically accelerated aging and premature death. The CHMP…

Benzinga

CHMP Supports Approval Of Merck's Keytruda As Adjuvant In Post Surgery Melanoma Setting

European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending Merck & Co Inc (NYSE:MRK) Keytruda in melanoma setting. The opinion covers Keytruda as a monotherapy adjuvant treatment for adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have…

Benzinga

Europe's CHMP Backs Approval Of PTC Therapeutics' Gene Therapy In Rare Neurometabolic Disorder

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of PTC Therapeutics Inc's (NASDAQ:PTCT) Upstaza (eladocagene exuparvovec, PTC-AADC). Once ratified by the European Commission, Upstaza will be the first approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency for patients 18 months and older…

Benzinga

Why Eli Lilly Shares Are Rising Today

Eli Lilly And Co (NYSE: LLY) shares are trading higher by 3.58% at $296.48 after the company announced the CHMP has issued a positive opinion for OLUMIANT for the treatment of adults with severe alopecia areata.

Benzinga

The Daily Biotech Pulse: Valneva's COVID-19 Vaccine Filing Accepted By EMA, Enanta's RSV Candidate Fails, Orphan Drug Tag For Mersana's Gastric Cancer Candidate

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

Benzinga

EMA' Advisory Committee Recommends Approval For Roche's Two Cancer Drugs

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval for Roche Holdings AG's (OTC:RHHBY) mosunetuzumab for relapsed or refractory (R/R) follicular lymphoma (FL). The opinion covers mosunetuzumab for adult patients who have received at least two prior systemic therapies. The CHMP recommendation is based on…

Benzinga

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5 Healthcare Stocks Likely to Withstand a Recession

The healthcare industry has attracted massive investor interest since the onset of the COVID-19 pandemic and could remain in the limelight as COVID cases surge again and necessitate the need for more COVID shots. In addition, the healthcare sector is known to withstand recessions relatively well. So, with several analysts…

Benzinga

Novartis Receives Positive CHMP Opinion For Kymriah In Follicular Lymphoma, Jakavi In GvHD

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Novartis AG's (NYSE: NVS)

Benzinga

EMA's CHMP Clears Janssen, Legend's Multiple Myeloma CAR-T Therapy

The European Medicines Agency's CHMP

Benzinga

EMA's Advisory Group Backs Approval For Merck's Keytruda In Various Cancer Settings

The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Merck & Co Inc (NYSE: MRK) for

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Benzinga

EMA Recommends Approval Of AstraZeneca's COVID-19 Therapy, Evusheld

EMA's human medicines committee (CHMP) has

Benzinga

Calliditas Expects EMA's CHMP Opinion For Nefecon In Q2

Calliditas Therapeutics AB (NASDAQ:CALT) says that the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2 of 2022. In its review of the marketing authorization application (MAA) for Nefecon, the CHMP has informed us that they will issue an…

Benzinga

European Recommendation On Valneva's COVID-19 Shot Pushed Into April

Valneva SE (NASDAQ:VALN) now expects a positive recommendation from the European Medicines Agency (EMA) for its VLA2001 COVID-19 candidate vaccine in April. Earlier, the Company expected the European recommendation by the end of March. As announced in February, Valneva received a list of questions as part of the CHMP's initial assessment, to which…

Benzinga

Why Bristol Myers' Shares Are Trading Higher Today

Bristol Myers Squibb & Co (NYSE: BMY) has received positive CHMP opinion for Opdivo (nivolumab) plus chemotherapy for first-line treatment of unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.

Benzinga

EMA's Advisory Committee Does Not Back Orphazyme's Arimoclomol Application

Orphazyme A/S (NASDAQ: ORPH) has been notified by the Committee for Medicinal Products for Human Use (CHMP) of a

Benzinga

EMA's Advisory Committee Recommends Approval Of Bristol-Myers' Breyanzi In Lymphoma

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP)

Benzinga

EMA's Advisory Committee Recommends Approval Of Blueprint Medicines' Avapritinib In Blood Disorder

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has

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