Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Pfizer Acquires Biohaven For $11B
The deal includes the acquisition of rimegepant (NURTEC ODT), a dual-acting migraine therapy approved for acute treatment and episodic prevention of migraine in adults, Zavegepant, and a portfolio of five preclinical CGRP assets.
BHVN shares are up 74.4% at $144.98 during the premarket session.
Praxis' PRAX-944 Shows Promising Action In Essential Tremor Patients
Treatment with PRAX-944 resulted in clinically meaningful improvements in function, supported by improvements in tremor amplitude.
PRAX-944 was generally well tolerated in Part B of the Phase 2a study, with no new safety findings.
Eisai, Biogen Seek Accelerated Approval For Their Second Alzheimer's Drug
Eisai Co Ltd (OTC:ESALY) has completed the rolling submission of the FDA marketing application under the accelerated approval for lecanemab (BAN2401) for mild cognitive impairment due to Alzheimer's disease (AD) and mild AD.
Eisai is collaborating with Biogen Inc (NASDAQ:BIIB) for drug development.
Eisai has requested a Priority Review, while the lecanemab Phase 3 Clarity AD trial conducted with 1,795 patients will report out in the fall of 2022.
Arcus Posts Encouraging Data For Domvanalimab-Based Regimes In Lung Cancer Settings
Arcus Biosciences Inc (NYSE:RCUS) announced results from the third interim analysis of the ongoing Phase 2 ARC-7 study of zimberelimab vs. domvanalimab plus zimberelimab (doublet) vs. domvanalimab plus zimberelimab and etrumadenant (triplet) as a first-line treatment for metastatic non-small cell lung cancer.
In this interim analysis, both domvanalimab-containing arms continued to show meaningful differentiation compared to zimberelimab alone across multiple efficacy measures, including overall response rate and duration of response.
Longeveron CEO Steps Down
The company has appointed current Chief Medical Officer Chris Min as interim CEO to succeed Green.
The board has formed a search committee and retained an executive search firm to assist in identifying a permanent CEO.
Shares closed 6.65% lower at $7.44 during after-hours trading on Monday.
Zealand Pharma Amends Financing Agreement With Oberland Capital
Zealand Pharma A/S (NASDAQ:ZEAL) has amended its existing financing agreement with Oberland Capital Management LLC, under which Zealand will repurchase $50 million of note principal with a 1.2x prepayment premium.
Oberland Capital will provide Zealand with up to $75 million in incremental capital, of which $50 million is to be reserved for M&A and $12.5 million following positive glepaglutide data.
The updated financial agreement provides a runway extended beyond significant pipeline milestones and into 2023.
Compugen CFO Resigns
He will continue to support the company until his departure in his current roles.
Immatics Initiates Phase 1 Trial Of Lead TCR Bispecific IMA401 In Advanced Solid Tumors
TCER IMA401 will be developed in collaboration with Bristol Myers Squibb Co (NYSE:BMY). Immatics is responsible for conducting the Phase 1 clinical trial.
Verve Therapeutics's First VERVE-101 Clinical Trial Application Cleared In New Zealand
Verve Therapeutics Inc (NASDAQ:VERV) has received clearance of its first clinical trial application for VERVE-101 in New Zealand and plans to initiate a first-in-human Phase 1 trial in patients with HeFH in mid-2022.
The company plans to submit trial applications in the U.K. and the U.S. in 2H of 2022.
Initial data from the VERVE-101 Phase 1 trial is expected in 2023.
Evaxion Biotech Completes Production of Personalized Cancer Immunotherapies For Melanoma Trial
Evaxion Biotech A/S (NASDAQ:EVAX) announced that it has produced all batches of personalized cancer immunotherapies for all patients enrolled in the Phase 1/2a clinical trial of EVX-02 in adjuvant melanoma.
This is the second time Evaxion has conducted a clinical trial with personalized cancer immunotherapy, having previously used a peptide-based treatment.
EVAX shares are up 44.4% at $3.45 during the premarket session.
Synthetic Biologics Posts Encouraging Safety Data On SYN-020 In Healthy Volunteers
Analyses of preliminary data demonstrated that SYN-020 maintained a favorable safety profile and was well-tolerated across all dose levels.
There were a few treatment-related adverse events, and all were mild and resolved without medical intervention.
Cortexyme To Buy Novosteo
Cortexyme Inc (NASDAQ:CRTX) has agreed to acquire privately held Novosteo, which is focused on targeted therapeutics to treat rare skeletal diseases, bone cancer and injury. Deal terms were not disclosed.
The company also plans to operate under a new name, Quince Therapeutics Inc, and begin trading under the "QNCX" symbol in the coming months.
Upon completing the transaction, Novosteo stockholders will own approximately 15.5% of the combined company.
On The Radar
Veru Inc (NASDAQ:VERU): FDA pre-Emergency Use Authorization meeting for the positive Phase 3 COVID-19 study for sabizabulin.
- Bayer AG (OTC:BAYRY): Before the market open
- Immunic Inc (NASDAQ:IMUX): Before the market open
- Epizyme Inc (NASDAQ: EPZM: Before the market open
- Cerevel Therapeutics Holdings Inc (NASDAQ:CERE): Before the market open
- Myovant Sciences Ltd (NYSE:MYOV): Before the market open
- Gamida Cell Ltd (NASDAQ:GMDA): Before the market open
- Agenus Inc (NASDAQ:AGEN): Before the market open
- Reata Pharmaceuticals Inc (NASDAQ:RETA): Before the market open
- Atea Pharmaceuticals Inc (NASDAQ:AVIR): Before the market open
- Urogen Pharma Ltd (NASDAQ:URGN): Before the market open
- Rubius Therapeutics Inc (NASDAQ:RUBY): Before the market open
- Intra-Cellular Therapies Inc (NASDAQ:ITCI): Before the market open
- Athenex Inc (NASDAQ:ATNX): Before the market open
- Calithera Biosciences Inc (NASDAQ:CALA): After the market close
- Opiant Pharmaceuticals Inc (NASDAQ:OPNT): After the market close
- Xenon Pharmaceuticals Inc (NASDAQ:XENE): After the market close
- Revance Therapeutics Inc (NASDAQ:RVNC): After the market close
- Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR): After the market close
- Catalyst Pharmaceuticals Inc (NASDAQ:CPRX): After the market close
- Avinger Inc (NASDAQ:AVGR): After the market close
- Exelixis Inc (NASDAQ:EXEL): After the market close
- Zai Lab Ltd (NASDAQ:ZLAB): After the market close