Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus Aeglea Shares Additional Phase 3 Data In Inherited Metabolic Disease Aeglea BioTherapeutics Inc (NASDAQ: AGLE) shared additional data from the PEACE Phase 3 study in Arginase 1 Deficiency at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting.
In an analysis of individual patients, clinically significant differences between the pegzilarginase treated patients (n=17), and placebo (n=9) were observed in motor function.
Aeglea submitted an FDA marketing application for pegzilarginase in Arginase 1 Deficiency.
The stock was trading 31.7% higher at $3.20 in premarket trading.
Novartis Highlights Early Data From KRAS Inhibitor At AACR Meeting Novartis AG (NYSE: NVS) shared clinical data for JDQ443, an investigational selective, covalent and orally bioavailable KRASG12C inhibitor.
Preliminary Phase 1b data showed that JDQ443 demonstrated anti-tumor activity, high systemic exposure at its recommended dose and a favorable safety profile in KRAS G12C-mutated solid tumors.
FDA Identifies Labeling Deficiency In Pfizer-Myovant's Myfembree Supplemental Application The FDA identified deficiencies that preclude discussion of labeling and/or post-marketing requirements related to Myovant Sciences Inc (NYSE: MYOV) and Pfizer Inc's (NYSE: NYSE:PFE) Myfembree for endometriosis-associated pain.
The agency did not provide additional detail.
Myovant and Pfizer will continue to work with the FDA to determine the next steps with the application.
Related Link: The Week Ahead In Biotech (April 10-April 16): Regeneron FDA Decision, Cancer Conference Presentations, And More.
FDA Green Lights Gilead's Magrolimab Studies In MDS, AML The agency has lifted the partial clinical hold placed on Gilead Sciences Inc 's (NASDAQ: NASDAQ:GILD) studies of magrolimab combined with azacitidine.
Enrollment in the U.S. can resume for magrolimab plus azacitidine studies in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
Gilead is also working with the FDA regarding the remaining partial clinical hold on magrolimab studies in diffuse large B-cell lymphoma and multiple myeloma.
Revive Therapeutics Issues Update On Phase 3 COVID-19 Trial The Data Safety and Monitoring Board (DSMB) will meet this quarter to evaluate Revive Therapeutics Ltd's (OTC: RVVTF) Bucillamine Phase 3 trial in mild to moderate COVID-19.
The DSMB can either make recommendations or ask to potentially halt the study early due to positive efficacy based on other clinical outcomes evaluated.
IsoPlexis Cuts Workforce To Streamline Operating Structure IsoPlexis Corporation (NASDAQ: ISO) initiated a reorganization of its workforce. It will retain approximately 80% of its prior workforce.
The company expects first-quarter FY22 sales of $4.8 million-$4.9 million, up approximately 48%-52% year-over-year.
Takeda's Hereditary Angioedema Drug Aces Phase 3 Trial Takeda Pharmaceutical Co Ltd's (NYSE: TAK) Phase 3 SHP643-301 Takhzyro (lanadelumab) study in kids ages 2 to 12 has met its objectives for hereditary angioedema.
The safety profile was consistent with that seen in the clinical program for patients 12 years of age and older.
Actinium Inks Iomab-B Pact For Europe, Middle East, North Africa Actinium Pharmaceuticals Inc (NYSE: ATNM) and Immedica Pharma AB announced a license and supply agreement for Iomab-B under development for targeted conditioning to facilitate bone marrow transplant (BMT) and other cell and gene therapies.
Actinium will receive an upfront payment of $35 million and will be eligible to receive an additional $417 million in milestones.
Stock is trading 34% higher at $7.09 during the premarket session.
Insider Trading Biodesix Inc (NASDAQ: BDSX) shares skyrocketed after a series of filings disclosing stock purchases by its chairman and a couple of its directors.
John Patience bought 279,329 shares at $1.79 per share, while Matthew Strobeck and Jack Schuler purchased 558,659 and 2.79 million shares.
The stock was trading 76.1% higher at $2.80 in premarket trading.
Clinical Readouts/Presentations American Association for Cancer Research Meeting Presentations
C4 Therapeutics Inc (NASDAQ: CCCC): Data from the Phase 1/2 study of CFT7455 in multiple myeloma.
Checkmate Pharmaceuticals Inc (NASDAQ: CMPI): Biomarker signature data from the Phase 1b study of vidutolimod in combination with Keytruda in melanoma
Gracell Biotechnologies Inc (NASDAQ: GRCL): Early results of a safety and efficacy study of allogeneic TruUCAR GC502 in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
Alpine Immune Sciences Inc (NASDAQ: ALPN): Results from the dose-escalation portion of Phase 1 clinical trial of davoceticept (ALPN-202) as monotherapy in advanced malignancies.
HOOKIPA Pharma Inc (NASDAQ: HOOK): Phase 1/2 data for HB- 201 and HB-202 in treatment-refractory HPV16+ cancers.
Schrödinger Inc (NASDAQ: SDGR): New preclinical data from its Wee1 inhibitor program.
Repare Therapeutics Inc (NASDAQ: RPTX): Updated data from its ongoing Phase 1/2 TRESR trial of RP-3500 for solid tumors with specific synthetic-lethal genomic alterations.
Offerings Hoth Therapeutics Inc (NASDAQ: HOTH) priced a public offering of 8.2 million shares at 85 cents per share, for gross proceeds of approximately $7 million.
The company will use the proceeds for general corporate and working capital purposes.
Shares are slipping 19.2% at 85 cents during premarket trading.
On The Radar Zosano Pharma Corp's (NASDAQ: ZSAN) 1-35 reverse split is effective.
Evotec SE (NASDAQ: EVO) (before the market open).
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