The Daily Biotech Pulse: CHMP Backs AstraZeneca's Breast Cancer Therapies, Ipsen Buys Epizyme, FDA Holds For Nuvation Bio, Astellas Studies

Zinger Key Points
  • Epizyme acquisition to bolster Ipsen's growing oncology presence and leverage its infrastructure
  • Data from updated COVID-19 vaccine candidates to be discussed for rapid introduction of adapted boosters to address the variants

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 AZN and Daiichi Sankyo DSNKY.

Lynparza is jointly developed and commercialized by AstraZeneca and Merck & Co Inc MRK.

Ipsen Buys Epizyme To Bolster Cancer Portfolio

Ipsen SA IPSEY IPSEF has agreed to acquire Epizyme Inc EPZM at $1.45 per share for approximately $247 million plus one contingent value right (CVR) per share. 

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

Pfizer Inc PFE and BioNTech SE BNTX said the modified vaccine against the omicron coronavirus variant generated a higher immune 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

Axsome Therapeutics Inc AXSM received from the FDA proposed labeling for the company's AXS-05 marketing application for major depressive disorder. 

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

The FDA has placed a partial clinical hold on Nuvation Bio Inc's NUVB Phase 1 dose-escalation study of NUV-422 in solid tumors.

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

The FDA has placed a clinical hold on Astellas Pharma Inc's ALPMY FORTIS Phase 1/2 trial following a serious adverse event of peripheral sensory neuropathy in one of the trial participants. 

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

Stealth BioTherapeutics Corp MITO has received a preliminary non-binding proposal letter from Morningside Venture Investments Ltd and J. Wood Capital Advisors LLC to acquire the company for $0.026/share and $0.313/ADS.

GSK Shares Encouraging Data From Chronic Hepatitis B Candidate

GSK plc GSK announced promising interim results from the B-Clear Phase 2b trial of bepirovirsen in people with chronic hepatitis B.

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

Hillstream BioPharma Inc HILS has collaborated with Sapien Biosciences to evaluate the synergy of HSB-1216 with immune checkpoint inhibitors.

"We are excited to extend our collaboration with Hillstream Biopharma to evaluate potential synergy between their HSB-1216 molecule and ICIs using our expertise in establishing patient tissue-derived cell models in oncology, immunology, and Immune-oncology," said Dr. Jugnu Jain, CEO, Sapien Biosciences. "Previously, Sapien demonstrated potent anti-cancer activity of HSB-1216 in primary triple-negative breast cancer cells presented at AACR 2020."

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