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The Latest Breaking News from FDA

The End of Roe? Everything You Need To Know About the Leaked Supreme Court Draft Opinion

Plus: Boston rebuked for rejecting Christian flag, Google will remove more personal information, and more...

Reason · May 3, 2022

The Daily Biotech Pulse: FDA's AdComm For Acadia's Pimavanserin, Review Issues For Spero's Tebipenem Application, Cortexyme Layoffs

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

Benzinga · May 3, 2022

66 Biggest Movers From Yesterday

Gainers Better Therapeutics, Inc. (NASDAQ: BTTX) shares surged 120.4% to close at $2.01 on Monday following a 5% drop on Friday.

Benzinga · May 3, 2022

From analysis to the latest developments in health,
read the most diverse news in one place.

Ipsen - Exelixis' Cabometyx Scores European Approval As Second-Line Treatment For Thyroid Cancer

The European Commission (EC) has approved Ipsen SA's (OTC:IPSEY) Cabometyx (cabozantinib) as monotherapy in differentiated thyroid carcinoma (DTC) setting. The approval covers adult patients with locally advanced or metastatic DTC, refractory or not eligible for radioactive iodine, who have progressed during or after systemic therapy. This EC approval follows the FDA approval announced…

Benzinga · May 3, 2022

ACHV: Topline Data from ORCA-2 Smoking Cessation Trial

By John Vandermosten, CFA NASDAQ:ACHV READ THE FULL ACHV RESEARCH REPORT

Benzinga · May 3, 2022

Here's Why This Analyst Is On Sidelines Despite European Approval Of Myovant's Relugolix For Prostate Cancer

Myovant Sciences Ltd (NYSE:MYOV) received European approval for Orgovyx (relugolix, 120 mg) for advanced hormone-sensitive prostate cancer, and SVB Securities think Orgovyx could be a ~$1 billion product in advanced prostate cancer long term. But the surprise Myfembree setback in endometriosis has sparked uncertainty and new investor questions for Myovant's 2nd program. Hence, SVB remains on the…

Benzinga · May 2, 2022

Here's Why This Analyst Cut Price Target On Regeneron

RBC Capital Markets has lowered Regeneron Pharmaceuticals Inc's price target (NASDAQ:REGN) from $679 to $647 and maintained a Sector Perform rating. Checks suggest that Dupixent (dupilumab) growth/durability should remain strong in new and existing indications, maintaining positive sentiment. The analysts also believe that the concerns about near-term Eylea competition may be overblown. However, high-dose…

Benzinga · May 2, 2022

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Transcript: Jason Raznick's Conversation with Mr. Wonderful Kevin O'Leary At The Benzinga Psychedelics Conference

On this special edition of the RazReport, Benzinga Founder & CEO Jason Raznick sits down with Kevin O'Leary AKA Mr. Wonderful at the Benzinga Psychedelics Capital Conference to discuss why he's investing in psychedelics.

Benzinga · May 2, 2022

The FDA Uses Its New Authority To Close Off the Last Remaining Legal Option for Vapers Who Like Flavor Variety

In a move that is likely to undermine public health, the agency warns that products containing synthetic nicotine "will be subject to FDA enforcement."

Reason · May 2, 2022

Why HC Wainwright Is Bullish On This Stock's Hepatitis-B Pipeline

Recently, Vir Biotechnology Inc (NASDAQ:VIR) announced updates on its expansive hepatitis portfolio, including VIR-2218 which is part of a collaboration with Alnylam Pharmaceuticals Inc (NASDAQ:ALNY), and VIR-3434, a monoclonal antibody (mAb). The key highlight of the event was the initial data presented from the Phase 2 MARCH trial of VIR-2218 + VIR-3434 in patients with…

Benzinga · May 2, 2022

Moderna Bullish On COVID-19 Vaccine For Younger Kids To Be Ready Next Month: Reuters

Moderna Inc's (NASDAQ:MRNA) chief medical officer said that its COVID-19 vaccine for children under six years old would be ready for review by the FDA panel when it meets in June. "I think the FDA now has all of the core fundamental data they need to be able to begin an application review.…

Benzinga · May 2, 2022

Vertex Pharma's Stem Cell Derived Diabetes Treatment Trial Put On Hold

The FDA has instituted a clinical hold on Vertex Pharmaceuticals Incorporated's (NASDAQ:VRTX) VX-880 Phase 1/2 study due to a determination that there is insufficient information to support dose escalation with the product. VX-880 is an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for type 1 diabetes (T1D). Three patients have been…

Benzinga · May 2, 2022

Kala Pharmaceuticals Posts KPI-012 Data In Healing Impaired Ocular Diseases

Kala Pharmaceuticals Inc (NASDAQ:KALA) reported data from a Phase 1b trial of KPI-012, a cell-free secretome therapy for severe ocular diseases driven by impaired healing. As previously disclosed, KPI-012 was well tolerated and resulted in significant improvements in various persistent corneal epithelial defect (PCED) etiologies. The data will be presented at the 2022…

Benzinga · May 2, 2022

Horizon Therapeutics' Inebilizumab Scores European Approval For Spinal Cord Inflammation

The European Commission has approved Horizon Therapeutics plc's (NASDAQ:HZNP) Uplizna (inebilizumab) as monotherapy for neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+). NMOSD is an autoimmune disease that attacks the optic nerve, spinal cord, brain, and brain stem. In the N-MOmentum pivotal clinical trial, Uplizna demonstrated a significant reduction…

Benzinga · May 2, 2022

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Benzinga · May 2, 2022

FDA Approves Expanded Use Of Supernus' Viloxazine In Adult ADHD Patients

The FDA approved an expanded indication for Supernus Pharmaceuticals Inc's (NASDAQ:SUPN) Qelbree (viloxazine extended-release capsules) for attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older. The FDA has now approved Qelbree for ADHD in children (starting at age 6), adolescents, and adults. Qelbree is a novel non-stimulant taken once daily for…

Benzinga · May 2, 2022

Sage Therapeutics, Biogen Start Rolling Submission For Zuranolone In Major Depressive Disorder

Sage Therapeutics Inc (NASDAQ:SAGE) and Biogen Inc (NASDAQ:BIIB) have initiated a rolling submission of a marketing application to the FDA for zuranolone in major depressive disorder (MDD). Zuranolone is an investigational two-week, once-daily oral drug developed for MDD and postpartum depression (PPD). The companies have submitted the nonclinical module and plan to submit the remaining…

Benzinga · May 2, 2022

31 Stocks Moving In Monday's Mid-Day Session

Gainers Redbox Entertainment Inc. (NASDAQ: RDBX) climbed 64.9% to $9.86. Redbox recently reported CFO transition.

Benzinga · May 2, 2022

Vaxxinity Gets Fast Track designation from FDA For Alzheimer's disease Candidate UB-311

Vaxxinity, Inc. (NASDAQ: VAXX) announced that UB-311 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer's disease.

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Benzinga · May 2, 2022

FDA Issues Complete Response Letter (CRL) to Axsome Therapeutics for AXS-07 In Acute Migraine

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Axsome Therapeutics, Inc. (NASDAQ: AXSM) regarding its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.

Benzinga · May 2, 2022

Mid-Morning Market Update: Markets Mostly Lower; US Factory Growth Slows In April

U.S. stocks traded mostly lower this morning, with the Dow Jones tumbling around 100 points on Monday.

Benzinga · May 2, 2022

Coherus and Junshi Biosciences Receive CRL from FDA for Toripalimab in combination with Gemcitabine and Cisplatin In metastatic nasopharyngeal carcinoma (NPC)

Shanghai Junshi Biosciences and Coherus BioSciences, Inc. (NASDAQ: CHRS) received a complete response letter (CRL) from the U.S.

Benzinga · May 2, 2022

FDA Rejects Junshi - Coherus' Toripalimab For Rare Head & Neck Cancer

The FDA has issued a complete response letter (CRL) to Junshi Biosciences Co Ltd and Coherus BioSciences Inc's (NASDAQ:CHRS) toripalimab application for advanced recurrent or metastatic nasopharyngeal carcinoma (NPC). NPC is a rare tumor of the head and neck which originates in the nasopharynx, located behind the nose and above the back of the throat. The…

Benzinga · May 2, 2022

As Expected, FDA Rejects Axsome Therapeutics' Migraine Candidate

The FDA has issued a Complete Response Letter (CRL) to Axsome Therapeutics Inc's (NASDAQ:AXSM) AXS-07 for the acute treatment of migraine. The CRL did not identify or raise any concerns about the clinical efficacy or safety data in the NDA, and the FDA did not request any new clinical trials to support the approval…

Benzinga · May 2, 2022

Myovant Sciences' Relugolix For Hormone-Sensitive Prostate Cancer Approved In Europe

The European Commission (EC) has approved Myovant Sciences Ltd's (NYSE:MYOV) Orgovyx (relugolix, 120 mg) for advanced hormone-sensitive prostate cancer. This approval was supported by data from the Phase 3 HERO study. In the HERO study, Orgovyx met the primary endpoint and achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48…

Benzinga · May 2, 2022

Why Vertex Pharmaceuticals Shares Are Falling

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) shares are trading lower by 3.42% to $263.88 during Monday’s pre-market session after the company announced VX-880 Phase 1/2 has been placed on clinical hold by the FDA due to “a determination that there is insufficient information to support do

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