Biotech Archives - Page 713 of 795

2 minute read

Lyra Therapeutics Announces First Patient Enrolled In Pivotal ENLIGHTEN II Clinical Trial Of LYR-210 In Chronic Rhinosinusitis Patients

September 8, 7:01 AM

Lyra Therapeutics, Inc. (NASDAQ:LYRA) (the Company or Lyra), a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, and local delivery of medications to

LYRA

2 minute read

Amylyx Pharmaceuticals Announced FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS

By Charles Gross

September 7, 7:46 PM

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) ("Amylyx" or the "Company") announced today that the U.S.

AMLX

1 minute read

Vanda Pharmaceuticals Announced Notice of Opportunity for an FDA Hearing on Supplemental New Drug Application for HETLIOZ to Treat Jet Lag Disorder

By Charles Gross

September 7, 6:50 PM

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the notice of opportunity for an FDA hearing on Vanda's Supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) to treat jet lag disorder.

VNDA

4 minute read

Important Biotech Catalysts For September 7, 2022 – End Of The Day Summary

By Ragothaman Srinivasan

September 7, 5:45 PM

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s (NYSE:PFE) lead drug GBS6…

BCYC

1 minute read

Erasca Presents Preliminary Phase 1/1b Monotherapy Data For ERAS-007 ERK And ERAS-601 SHP2 Inhibitors Supporting Ongoing And Future Combination Trials

By Benzinga Newsdesk

September 7, 4:14 PM

23% (6/26) of patients with RAS/MAPK-altered non-CRC solid tumors and 44% (4/9) with BRAF-driven non-CRC solid tumors responded (confirmed and unconfirmed PR) to single agent ERAS-007 or

ERAS

1 minute read

Mizuho Bolsters Price Target By 55% On This Migraine Stock

By Vandana Singh

September 7, 3:14 PM

Mizuho Securities assumes coverage of Axsome Therapeutics Inc (NASDAQ:AXSM), with a Buy rating and a price target of $76, representing a 25%…

AXSM

1 minute read

FDA
News

Veru Announces Oct. 6 Date For FDA Advisory Committee Meeting To Review Emergency Use Authorization For Sabizabulin For Hospitalized COVID-19 Patients At High Risk For Acute Respiratory Distress Syndrome

By Bill Haddad

September 7, 1:46 PM

MIAMI, Sept. 07, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast

VERU

1 minute read

SpringWorks Shares Pop After Expanded Multiple Myeloma Pact With GSK

By Vandana Singh

September 7, 1:10 PM

SpringWorks Therapeutics Inc (NASDAQ:SWTX) has entered into an expanded global, non-exclusive license and collaboration agreement with GSK plc (NYSE:GSK) for SpringWorks’ nirogacestat with…

GSK

1 minute read

Inspiratm Technologies Performed Hylatm Blood Sensor In-Vivo Study, In Preparation Of Planned Human Studies

By Benzinga Newsdesk

September 7, 9:34 AM

- Reuters

IINN

3 minute read

E-Cigarette Maker To Pay Over $430M To Settle Multi-State Vaping Inquiry, Cannabis Investors Need To Pay Attention

By Jelena Martinovic

September 7, 9:32 AM

E-cigarette producer Juul Labs agreed to pay $438.5 million to 34 states and territories to sort out a two-year bipartisan investigation into its marketing and sales practices.

CGC