Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease (AD) and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced that it will present topline data for its randomized, double-blind, phase 1b/2 SIGNAL-AD study of pepinemab treatment for Alzheimer’s disease at the Alzheimer’s Association International Conference in Philadelphia, July 28- Aug 1, 2024. Eric Siemers, MD, Principal Investigator, will present results of the study in a Featured Research Session.
Wednesday, July 17, 2024
Longeveron Fast Track Designation for Lomecel-B™ for Mild Alzheimer’s
FDA designation enables expedited clinical development and regulatory review timelines for Lomecel-B™ –
– Second designation received for Lomecel-B™ for the treatment of mild Alzheimer’s Disease after Regenerative Medicine Advanced Therapeutics (RMAT) Designation announced on July 9, 2024 –
– Phase 2a Lomecel-B™ data in mild Alzheimer’s Disease selected for Featured Research Session oral presentation and poster presentation at upcoming Alzheimer’s Association International Conference® (AAIC) –
Aditxt, Evofem Amend, Restate Merger Targeting September 30 Close
Aditxt, Inc. (“Aditxt”) (NASDAQ: ADTX), a company dedicated to discovering, developing, and deploying promising health innovations, announces this past Friday, July 12th, Aditxt, its wholly owned subsidiary Adifem, Inc., and Evofem Biosciences, Inc.’s (“Evofem”) (OTCQB: EVFM) amended and restated their Merger Agreement. This amended and restated Merger Agreement, among others, addresses pre-closing issues critical for Evofem’s future success, including interim financing needs. The other revisions to the Merger Agreement, alongside additional interim financing for Evofem, include substituting cash for Aditxt’s common stock as the consideration for Evofem’s common stock in the merger and additional changes relating to it. Aditxt and Evofem are diligently working to close the contemplated transaction in the second half of 2024.
Anti-Biden Dems Rush To Block DNC's 'Virtual Nomination' Scheme
Saturday's near-assassination of Donald Trump likely boosted the former president's chances of winning the November election -- and also forced a pause in what had been a steadily-boiling controversy over President Biden's fitness to finish the race and start a new term.
While Biden's mental deterioration was nudged out of media spotlight, his campaign was quietly scheming with the Democratic National Committee to orchestrate a "virtual nomination" held weeks before the party convention kicks off on August 19. Now, indignant anti-Biden Democrats on Capitol Hill are organizing a counter-strike.
"I just think it's a terrible idea for the DNC to do this. I just think people see right through it," said progressive California Rep. Jared Huffman. "At a time when we have this huge enthusiasm gap with the Republicans, to do a stunt like this is just going to make it worse." Separately, he told CNN, “If the election were held today, he would get crushed. We have got to do something about it.”
The DNC, which rigged the primary process for Biden by refusing to host debates and by rearranging the sequences of state balloting, is now working to hold a "virtual roll call" where delegates would vote online between July 29 and Aug. 5, Axios reports. However, the New York Times reported voting could start as early as Monday, July 22.
Either way, the extraordinary advance vote would serve two DNC goals: icing the contest for Biden and avoiding a tumultuous, contested convention next month in Chicago. Democratic "insiders" told the Times that upwards of 80% of delegates would back Biden in a virtual vote.
Congressional Democrats who see Biden as a doomed candidate -- who threatens to carry down-ballot candidates with him -- are now racing against the clock to keep their drive to replace him alive. At the moment, they're channeling their energy into drafting and circulating a joint letter from House Democrats to the DNC, urging party headquarters to cancel its plan. Here's a passage from a draft obtained by the Financial Times:
“Stifling debate and prematurely shutting down any possible change in the Democratic ticket through an unnecessary and unprecedented ‘virtual roll call’ in the days ahead is a terrible idea. It could deeply undermine the morale and unity of Democrats — from delegates, volunteers, grassroots organisers and donors to ordinary voters — at the worst possible time.”
"People are back to being angry at Biden and a push to sign on to this letter is going around ... the 'replace Biden' movement is back," said an unnamed Democratic representative.
Texas Rep. Lloyd Doggett, the first congressional Democrat to urge Biden to quit the race, said the virtual-nomination scheme was inconsistent with Biden's own comments: "Such misguided DNC action would be contrary to President Biden's own recommendation that those seeking an alternative nominee come to the convention."
A key milestone in the intrigue will come at 11am this Friday, when the convention's rules committee conducts a video call. "A majority of its members have deep ties to Mr. Biden and were vetted for their loyalty to him," reports the Times. Contrary to Axios, the Times reported that virtual nomination balloting could start as early as Monday, July 22.
One House representative used creative imagery to describe dissidents' view of the situation, telling CNN, “The disbelief that they’d expedite the nomination is as widespread as the recognition the DNC is leading Democrats into a house fire with water bottles.”
Word of the behind-the-scenes maneuvering comes as new polling by YouGov shows Trump leading in all seven battleground states. His lead is narrowest in Michigan (+2) and Pennsylvania (+3), and largest in Arizona (+7). Notably, the poll was taken after Biden's alarmingly poor June 27 debate with Trump, but before Trump survived the assassination attempt at a rally in western Pennsylvania.
Beyond the Biden camp, there's another group that's wildly enthusiastic about the idea of a virtual vote that locks in the failing, 81-year-old as the Democrats' standard-bearer: Republicans. When asked what he thought of the DNC's maneuvering, Citizens United president and Trump 2016 deputy campaign manager David Bossie said, "Great idea. I want that hole in the Titanic as soon as possible."
https://www.zerohedge.com/political/anti-biden-dems-rush-block-dncs-virtual-nomination-scheme
Tuesday, July 16, 2024
Cardurion Raises $260M to Advance Cardiovascular Assets
Backed by Bain Capital, Cardurion Pharmaceuticals will use the Series B funds to advance two assets for heart failure and other cardiovascular conditions.
Cardurion Pharmaceuticals has secured $260 million in Series B funds to help progress its cardiovascular assets, the clinical-stage company announced Tuesday.
The funding was led by Ascenta Capital and included many new investors, including Fidelity Management & Research Company, Farallon Capital Management, Delos Capital and Blue Owl Healthcare Opportunities. Bain Capital Life Sciences and Bain Capital Private Equity, which invested up to $300 million in Cardurion in 2021, also participated in this round.
Cardurion will use the funds to advance its two lead drug candidates. The first, a phosphodiesterase-9 (PDE-9) inhibitor to treat two types of heart failure, is in Phase II clinical trials. The second, a calcium/calmodulin-dependent protein kinase II (CaMKII) inhibitor also currently in Phase II, aims to treat a broad range of cardiovascular diseases.
Cardurion is conducting an ongoing Phase II trial for the CaMKII inhibitor in catecholaminergic polymorphic ventricular tachycardia (CPVT), a rare genetic arrhythmia disease. The company plans to pursue additional indications in “major cardiovascular indications,” but specifics were not given.
In May, the PDE-9 inhibitor met its primary endpoint in a Phase IIa heart failure trial, with results showing a median increase in plasma cyclic guanosine monophosphate, a biomarker of clinical benefits in heart failure, after four weeks of treatment versus placebo.
The raise will also enable Cardurion to expand the indications for its portfolio products, advance internal discovery, potentially acquire other therapeutic assets and hire more individuals, according to the announcement.
“Cardiovascular disease remains the leading cause of death in the world, and we are pursuing new therapeutic targets to address unmet needs for patients with these diseases,” Cardurion CEO Peter Lawrence said in a statement.
Evan Rachlin, co-founder and managing partner at Ascenta Capital, said in a statement that the firm is “very impressed with the significant clinical data the Cardurion team has generated for their innovative cardiovascular drug candidates, with strong initial validation for targeting these untapped signaling pathways to address important needs in cardiovascular treatment.”
https://www.biospace.com/business/cardurion-raises-260m-to-advance-cardiovascular-assets
Tempus Launch of AI-enabled, Multimodal Immune Profile Algorithmic Tests
Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, today announced that its multimodal immune profile score (IPS) algorithmic test is now available for research use only (RUO). IPS is the first offering of a larger immunotherapy-based portfolio being developed at Tempus to bring next-generation algorithmic diagnostics to the immuno-oncology space. Additionally, Tempus is collaborating with other partners, like Cleveland Clinic, to bring additional immunotherapy-focused algorithmic tests to this growing portfolio, leveraging clinical, laboratory, genomic, and transcriptomic data to identify patients that may respond to immunotherapy.
AngioDynamics Beats EPS, Beats Revenue for FQ4
“We capped off a transformative 2024 with a solid fourth quarter, largely driven by a second straight quarter of double-digit increases in our Med Tech business as Auryon and NanoKnife, delivered strong revenue growth,” commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. “Within our Mechanical Thrombectomy segment, we achieved key milestones by receiving both FDA 510(k) clearance and CE Marking for AlphaVac in the treatment of pulmonary embolism. These indications open up multiple large, fast-growing markets, and helped to drive a more than 68% sequential increase in AlphaVac revenue during the fourth quarter.”
Mr. Clemmer continued, “Over the last three years, AngioDynamics has undergone a significant transformation to position ourselves for long-term success. We now have an optimized, stable, cash-generating Med Device business, which, in combination with the strength of our balance sheet, allows us to aggressively pursue large, fast-growing global market opportunities with our highly innovative Med Tech portfolio to drive accelerated, profitable growth moving forward.”
“We view 2025 as an inflection point in the trajectory of our business. We expect to continue to deliver strong revenue growth within our Med Tech business as we execute on key commercial initiatives, including multiple significant international expansion opportunities and the broader launch of AlphaVac for PE. The increased scale of our Med Tech business, in combination with the optimization of our Med Device business, will allow us to begin to see increasing leverage as we exit the year. Operationally, we will continue to work through the transition of our manufacturing model to reduce overhead costs and improve margins in 2026 and beyond.”
Subscribe to:
Posts (Atom)