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

Stocks In Focus

EMA's Advisory Committee Backs Approval For AstraZeneca's Targeted Breast Cancer Therapies

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Enhertu (trastuzumab deruxtecan) and Lynparza (olaparib) for breast cancer settings.

Enhertu is being jointly developed and commercialized by AstraZeneca Plc (NASDAQ:AZN) and Daiichi Sankyo (OTC:DSNKY).

Lynparza is jointly developed and commercialized by AstraZeneca and Merck & Co Inc (NYSE:MRK).

Ipsen Buys Epizyme To Bolster Cancer Portfolio

Each CVR entitles deferred cash payments of 30 cents payable upon the first achievement of $250 million in sales of Tazverik in any period of four consecutive quarters by 2026.

An additional 70 cents per CVR is payable upon FDA approval for Tazverik and R2 combo in second-line follicular lymphoma by Jan. 1, 2028.

Pfizer/BioNTech's Updated Omicron-Based COVID-19 Shots Show Improved Response

The companies said that 30 µg and 60 µg doses of a shot targeting just the BA.1 omicron subvariant elicited a 13.5- and 19.6-fold increase in neutralizing geometric titers against that subvariant.

Axsome Gains On Proposed FDA Labeling For Depression Candidate

The company is reviewing the proposed labeling and will reply to the FDA to secure a final labeling agreement.

Shares are up 39.8% at $34.19 during the premarket session.

FDA Institutes Partial Hold On Nuvation Bio's Early Stage Solid Tumor Trial

Following the emergence of uveitis, a form of inflammation in the eye, in certain patients receiving NUV-422, the company paused the enrollment of new patients to assess these adverse events further. 

Astellas's Pompe Disease Gene Therapy Trial Put On FDA Clinical Hold

FORTIS trial is evaluating AT845, an investigational adeno-associated virus gene replacement therapy in adults with Late-Onset Pompe Disease.

Stealth BioTherapeutics Receives Preliminary Buyout Proposal

GSK Shares Encouraging Data From Chronic Hepatitis B Candidate

The data showed that bepirovirsen reduced hepatitis B surface antigen levels and hepatitis B virus DNA after 24 weeks of treatment.

Hillstream BioPharma Collaborates With Sapien Biosciences For Cancer Treatments