The Daily Biotech Pulse: MEI Pharma Wilts On Adverse Regulatory Development, Decision Day For Zogenix, AN2 Therapeutics IPO
Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus
MEI Pharma Says FDA Recommends Additional Phase 3 Study For Facilitating Regulatory Filing For Zandelisib As Blood Cancer Treatment Option
MEI Pharma, Inc. (NASDAQ:MEIP) and Japanese pharma company Kyowa Kirin said the FDA had r required a randomized trial to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib.
The companies were hoping to get marketing authorization for zandelisib via the accelerated approval pathway under 21 CFR Part 314.500, Subpart H, based on data generated by the single arm Phase 2 TIDAL study. Zandelisib is being developed as a treatment option for patients with B-cell malignancies.
MEI Pharma was slumping 45.43% to 98.77 cents in premarket trading.
Novocure Announces Positive Mid-Stage Data For Tumor Treating Fields As Part of Triple Combo Treatment Option For Cancer of Brian Or Spinal Cord
NovoCure Limited(NASDAQ:NVCR) said it will present at the 6th Quadrennial Meeting of the World Federation of Neuro-oncology Societies, to be held in Seoul, updated results from his investigator-initiated phase 2 pilot clinical trial testing the safety and preliminary efficacy of tumor treating fields, together with Merck & Co., Inc.'s (NYSE:MRK) Keytruda and Temodar for the treatment of adult patients with newly diagnosed glioblastoma.
Patients in the trial had median progression-free survival of 12.1 months compared with 7.9 months for matched-control patients from EF-14, the company said.
The stock was gaining 1.05% to $83.01 in premarket trading.
Click here to access Benzinga's FDA Calendar
Bristol-Myers Squibb's Reblozyl Review Period Extended By 3 Months
Bristol Myers Squibb Company (NYSE:BMY) said the U.S. FDA has extended the review of the supplemental biologics license application for Reblozyl for the treatment of anemia in adults with non-transfusion-dependent beta thalassemia to June 27. Reblozyl is being developed and commercialized through a global collaboration with Merck, following Merck's acquisition of Acceleron Pharma, Inc. in November 2021.
A written response to an information request was determined by the FDA to constitute a major amendment, leading the agency to extend the review period by three months to provide time for a full review of the submission.
Jazz Announces Commencement Of Construction of UK Facility to Manufacture Cannabis-Based Medicines
Jazz Pharmaceuticals, Inc. (NASDAQ:JAZZ) and its GW Pharmaceuticals subsidiary announced the official initiation of construction of a new, state-of-the-art manufacturing facility at Kent Science Park in Sittingbourne, U.K.
The new facility will be approximately 60,000 sq. ft, with an investment of over $100 million. Due to open in 2024, the facility is designed to support the company's two regulatory-approved cannabis-based medicines and support future capacity for new medicines under development.
The stock was up 1.20% at $161.52 in premarket trading.
Roche, Bristol-Myers Squibb Announces Collaboration For Deploying Pathology Algorithms To Aid In Cancer Diagnosis And Personalized Treatment Options
Roche Holding AG (OTC:RHHBY) announced that it has entered into a collaboration with Bristol Myers Squibb to support the advancement of two assays for use in clinical trials with the development and deployment of two new digital pathology algorithms. Data from both projects will be used to aid in cancer diagnosis and to advance personalized healthcare treatment options, with the aim of improving outcomes for patients.
Check out other stocks making big moves in the premarket.
Earnings
Athira Pharma, Inc. (NASDAQ:ATHA) (after the close)
Co-Diagnostics, Inc. (NASDAQ:CODX) (after the close)
Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) (after the close)
Panbela Therapeutics, Inc. (NASDAQ:PBLA) (after the close)
TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) (after the close)
On The Radar
PDUFA Dates
Zogenix, Inc.'s (NASDAQ:ZGNX) supplemental new drug application seeking approval for Fintepla as a treatment for seizures associated Lennox-Gastaut syndrome, has a PDUFA goal date of Friday, March 25.
Earnings
POINT Biopharma Global Inc. (NASDAQ:PNT) (before the market open)
IPOs
AN2 Therapeutics, Inc., (NASDAQ:ANTX), a clinical-stage biopharma focused on developing treatments for rare, chronic, and serious infectious diseases, priced its upsized initial public offering of 4.6 million shares of its common stock at $15 per share. The gross proceeds to AN2 Therapeutics from the offering are expected to be $69 million. The shares are expected to begin trading on the Nasdaq under the symbol "ANTX."