Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
GSK Prepares US For Upcoming Flu Season With Over 50M Vaccine Doses
GSK plc (NYSE:GSK) has started shipping doses of its quadrivalent influenza vaccines to U.S. healthcare providers and pharmacies in preparation for the 2022-23 season, following a licensing and lot-release approval from the FDA's Center for Biologics Evaluation and Research.
GSK expects to distribute over 50 million doses of its influenza vaccine to the U.S. market.
Flulaval Quadrivalent and Fluarix Quadrivalent will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for patients six months or older in line with CDC recommendations.
FDA Lifts Hold On Greenwich LifeSciences' Breast Cancer Immunotherapy Trial
The FDA has removed the clinical hold on Greenwich LifeSciences Inc's (NASDAQ:GLSI) Flamingo-01 Phase 3 trial of GP2, immunotherapy to prevent breast cancer recurrences.
The FDA placed a clinical hold due to manufacturing and pharmacy processes.
Through discussions with the FDA and testing of GP2 in the pharmacy process, the company has satisfactorily addressed the clinical hold issues. The company has committed to additional testing of GP2 in the pharmacy process.
Shares are up 4.41% at $9.00 during the premarket session.
Connect Biopharma Sees CBP-201 Topline Data From China Atopic Dermatitis Trial This Year
The Center for Drug Evaluation of the National Medical Products Administration in China has signed off Connect Biopharma Holdings Limited's (NASDAQ:CNTB) primary analysis of its ongoing pivotal trial for its lead product candidate CBP-201 in atopic dermatitis.
The company will analyze data from the Stage 1 16-week treatment period based on CBP-201 on 255 patients. As a result, Connect Biopharma plans to report this trial's top-line results by year-end, earlier than initially planned.
Shares are up 2.48% at 91 cents during the premarket session.
New Finance Chief At SQZ Biotechnologies
SQZ Biotechnologies Co (NYSE:SQZ) has appointed Micah Zajic as the company's chief financial officer, effective immediately.
Zajic has served as the company's chief business officer since October 2020 and brings nearly 20 years of biotechnology and capital markets experience to the role.
Read Next - Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates.
Aldeyra's Reproxalap Hits Primary Goals In Dry Eye Disease Chamber Crossover Trial
Aldeyra Therapeutics Inc (NASDAQ:ALDX) achieved the primary endpoints in a crossover clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate for dry eye disease.
Reproxalap was statistically superior to the vehicle for each of the two prespecified primary endpoints, ocular redness in a dry eye chamber and Schirmer test, a measure of tear production, after a single day of dosing.
No safety signals were observed in the trial, and reproxalap was well tolerated.
Shares are up 6.26% at $4.75 during the premarket session.
Aptorum's CFO Resigns
Last week, Sabrina Khan resigned from her position as Aptorum Group Ltd's (NASDAQ:APM) chief financial officer due to personal reasons.
Martin Siu will replace Khan as the company's head of finance.
Darren Lui, currently chief executive officer, will also be taking over as chief accounting officer of the company.
Catalyst Pharma Settles US Litigation Challenging Ruzurgi Approval
Catalyst Pharmaceuticals Inc (NASDAQ:CPRX) has settled its ongoing patent infringement litigation with Jacobus Pharmaceutical Company Inc and PANTHERx Rare LLC.
Catalyst had asserted in its patent litigation that Jacobus and PANTHERx induced infringement by third parties of Firdapse-related patent rights in their marketing and distribution of Ruzurgi.
As part of the settlement, Catalyst will dismiss all claims related to the patent litigation and has acquired certain aspects of Jacobus' intellectual property rights, including the rights to develop and commercialize Ruzurgi in the U.S. and Mexico.
Greenwich LifeSciences Suspends Share Repurchase Program
Greenwich LifeSciences Inc (NASDAQ:GLSI) has suspended its previously announced share repurchase program.
Under the now-suspended share repurchase program, the company repurchased approximately 520,000 shares for an aggregate purchase price of approximately $7.5 million.
Insider Trading
Annexon Inc (NASDAQ:ANNX): Director Muneer A Satter reported purchasing 3.1 million shares at an average of $3.10/share in Form 4 filing.
Offerings
Pliant Therapeutics Inc (NASDAQ:PLRX) commenced an underwritten public offering of $150 million. In addition, Pliant expects to grant the underwriters an option to purchase up to an additional $22.5 million shares.
