fda-and-biotech News

Kura Oncology Secures $30M Payment Advancing Key Leukemia Drug
FDA & Biotech
3mo ago

Kura Oncology Secures $30M Payment Advancing Key Leukemia Drug

Milestone from partner Kyowa Kirin triggered by start of pivotal Phase 3 trial for ziftomenib in frontline acute myeloid leukemia, bolstering the company's finances.

iBio Secures $15M Financing, Granting Key Investor a Board Seat
FDA & Biotech
3mo ago

iBio Secures $15M Financing, Granting Key Investor a Board Seat

The deal gives Lynx1 Capital Management the right to nominate a director, signaling a significant vote of confidence in the biotech's strategy.

Viking Therapeutics Surges Over 10% on Oral Obesity Drug Trial Results
FDA & Biotech
3mo ago

Viking Therapeutics Surges Over 10% on Oral Obesity Drug Trial Results

Positive Phase 2 data for its GLP-1 drug candidate VK2735 overshadows a wider-than-expected quarterly loss, fueling investor optimism.

Harmony Biosciences Reaffirms Guidance on WAKIX Strength
FDA & Biotech
3mo ago

Harmony Biosciences Reaffirms Guidance on WAKIX Strength

Strong sales of the company's flagship narcolepsy drug are offsetting recent pipeline disappointments, keeping its 2025 outlook intact.

Tango Therapeutics Secures $225M to Advance Cancer Drugs
FDA & Biotech
3mo ago

Tango Therapeutics Secures $225M to Advance Cancer Drugs

Financing led by major institutional investors strengthens the company's balance sheet and extends its operational runway for its precision oncology pipeline.

Moderna Shares Tumble as CMV Vaccine Trial Fails Key Endpoint
FDA & Biotech
3mo ago

Moderna Shares Tumble as CMV Vaccine Trial Fails Key Endpoint

The company is discontinuing its development program for the congenital CMV vaccine, a significant setback for its non-COVID product pipeline.

Arcturus Stock Collapses 52% After Cystic Fibrosis Drug Disappoints
FDA & Biotech
3mo ago

Arcturus Stock Collapses 52% After Cystic Fibrosis Drug Disappoints

The mRNA-based therapy failed to meet its primary lung function endpoint in a Phase 2 trial, erasing over $650 million in market value despite some encouraging secondary data.

Novartis Drug Cosentyx Succeeds in New Phase 3 Trial
FDA & Biotech
3mo ago

Novartis Drug Cosentyx Succeeds in New Phase 3 Trial

Success in treating polymyalgia rheumatica could expand the label for the blockbuster immunology drug, targeting an underserved elderly patient population.