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The Latest Breaking News from FDA

The Daily Biotech Pulse: Kezar Life's Lead Asset Fails, Brickell Biotech Offloads Late-Stage Asset, Connect Biopharma Ulcerative Colitis Trial Disappoints

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

Benzinga

$FDA Grants Fast Track designation To Aptose Biosciences for HM43239 in Relapsed/Refractory AML Patients and FLT3 Mutation$

FDA Grants Fast Track designation To Aptose Biosciences for HM43239 in Relapsed/Refractory AML Patients and FLT3 Mutation

Aptose Biosciences Inc. (NASDAQ: APTO) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to HM43239, an oral, myeloid kinome inhibitor, for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with FLT3 mutation.

Benzinga

Brickell Biotech Shares Surge After Offloading Late-Stage Asset To Australia-Based Firm

Brickell Biotech Inc (NASDAQ:BBI) agreed to sell sofpironium bromide rights to Australia-based Botanix Pharmaceuticals Limited. Brickell will receive upfront and potential near-term regulatory milestone payments over the next 18 months of up to $9 million. Brickell also is eligible to receive additional milestone payments of up to $168 million and tiered earn-out payments ranging from high-single…

Benzinga

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AstraZeneca's Imfinzi/Chemo Combo Goes Under Priority FDA Review For Bile Duct Cancer

The FDA has accepted AstraZeneca plc’s (NASDAQ) supplemental marketing application seeking approval for Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, for locally advanced or metastatic biliary tract cancer (BTC). Under the Priority Review status, the FDA action date is during the third quarter of 2022. BTC is a group of rare and aggressive…

Benzinga

80 Biggest Movers From Yesterday

Gainers Blue Water Vaccines, Inc. (NASDAQ: BWV) shares jumped 93.1% to close at $6.45 on Tuesday on above-average volume.

Benzinga

Elon Musk claims his Neuralink brain chip could 'cure' tinnitus in 5 years. But don't hold your breath

The human brain is said to be the most complex biological structure ever to have existed. And while science doesn’t fully understand the brain yet, researchers in the expanding field of neuroscience have been making progress.

The Conversation

US abortion advocates vow to fight expected Roe v Wade decision

In Georgia, advocates brace for six-week abortion ban if Supreme Court strikes down landmark Roe v Wade decision.

Al Jazeera

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The Impact of Overturning Roe v. Wade Will Be Less Dramatic Than Abortion-Rights Advocates Fear

Abortion is likely to remain legal in most states, and workarounds will mitigate the effects of bans.

Reason

Mid-Afternoon Market Update: Kymera Therapeutics Drops After Q1 Results; Belite Bio Shares Spike Higher

U.S. stocks traded slightly higher toward the end of trading on Tuesday.

Benzinga

Why Kymera Therapeutics Shares Are Falling Today

In its Q1 earnings release, Kymera Therapeutics Inc (NASDAQ:KYMR) announced the selection of the equivalent of 100 mg, in the fed state, as the dose for the Phase 1 patient cohort (Part C). The cohort is expected to enroll up to 20 patients with hidradenitis suppurativa (HS) and atopic dermatitis (AD). In…

Benzinga

Pfizer hopes to submit little-kid vaccine data by early June

Pfizer now hopes to tell U.S. regulators how well its COVID-19 vaccine works in the littlest kids by early June

The Independent UK

Mid-Day Market Update: Dow Jumps 100 Points; Spero Therapeutics Shares Plunge

U.S. stocks traded higher midway through trading, with the Dow Jones gaining over 100 points on Tuesday.

Benzinga

41 Stocks Moving In Tuesday's Mid-Day Session

Gainers SoundHound AI, Inc. (NASDAQ: SOUN) shares jumped 47.4% to $16.13. The company recently completed a SPAC merger deal last week and began trading on Thursday.

Benzinga

FDA Identifies Review Issues For Spero's Tebipenem Application, Shares Plunge

Spero Therapeutics Inc (NASDAQ:SPRO) will defer current commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting (LCM) with the FDA. The discussion suggested that the data package may be insufficient to support approval during this review cycle. In evaluating the efficacy of tebipenem HBr in Phase 3 (ADAPT-PO)…

Benzinga

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Reason

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...

Benzinga

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

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

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…

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Benzinga

ACHV: Topline Data from ORCA-2 Smoking Cessation Trial

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

Benzinga

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

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

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.

Reason

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."

Benzinga

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

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.…

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