And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline. We are optimistic on this deal, following the success of gene-therapy company BGNE last week. A year after receiving its first grant from Boston University’s CARB-X partnership, Swiss biotech Polyphor is back for more. A few months after its last big catch — a $192 million Series D and rare unicorn status — Orca Bio has reeled in the FDA’s regenerative medicine advanced therapy (RMAT) designation for its experimental cell therapy to treat blood stem cell transplant patients. A few weeks ago Kite and Allogene founder Arie Belldegrun jumped into the expanded syndicate for a Boston-based biotech called Dewpoint Therapeutics — a Polaris-birthed venture that’s styled itself as a drug development pioneer out to craft a major pipeline. Now we hear that Dewpoint has recruited Ameet Nathwani to the executive suite as the new CEO, who’s taking the helm from Polaris managing partner Amir Nashat, who brought the company into existence. Less than 3 months after launch, the AveXis crew’s Taysha raises $95M Series B. When they launched, Taysha said they planned to clinical studies on a gene therapy for Tay-Sachs disease and then file three more INDs in 2021. Risks include a novel technology, early stage, and intense competition. But underneath those headlines came another piece of news: a grand jury subpoena. This article is exclusive for subscribers. The early stage, European VC firm announced yesterday they led a $9 million seed round for Rappta Therapeutics, a Finnish biotech developing inhibitors for an enzyme called PP2A — protein phosphatase 2 — that Bakker thinks now hold the same kind of drug targeting potential as kinases did two decades ago for cancer. When did AveXis IPO? Lead … Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Illinois-based AveXis is a clinical-stage gene therapy company, developing novel treatments for patients suffering from rare neurological genetic diseases. The idea was to tap into a line of AAV9 vector gene therapies that were being developed at UT Southwestern, particularly from the labs of Steven Gray and Berge Minassian. Based in Bannockburn, Illinois, AveXis (NASDAQ: AVXS) is a clinical-stage gene therapy company that is developing novel treatments for patients suffering from rare, Long/Short Equity, Special Situations, Momentum, event-driven. Unlock this story instantly and join 91,500+ biopharma pros reading Endpoints daily — and it's free. That round — which also added deep-pocket player ARCH to the list of backers — came up with $77 million for the next step in the long journey toward the clinic, a nice add to the A round that launched the company. Last October, the FDA OK’d a semi-controversial new antibiotic from Shionogi. In one of two large studies for the drug, known chemically as cefiderocol and commercially as Fetroja, more patients died in the treatment arm than the control arm. Despite the pandemic, the company said they are still on track for that plan. Goldman Sachs and Jefferies acted as the underwriters for the IPO and BMO Capital Markets and Chardan were co-managers. Illinois-based AveXis is a clinical-stage gene therapy company, developing novel treatments for patients suffering from rare neurological genetic diseases. Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of … In an 8-K filing with the SEC on Wednesday, Vaxart revealed the US Attorney’s Office for the Northern District of California served the company with the subpoena back in July. The company issued 4,300,000 shares at $19.00-$21.00 per share. (AVXS) raised $86 million in an IPO on Thursday, February 11th 2016. Taysha launched in April as the brainchild of former AveXis CEO Sean Nolan and former AveXis corporate strategy chief RA Session II, who now serve as Taysha’s chairman and CEO, respectively. Back in 2017, in the wake of back-to-back setbacks and a reorganization, a struggling little biotech named Endocyte completed a $12 million licensing deal that would ultimately put it on a path toward a $2.1 billion buyout. The old AveXis team is moving quickly in Dallas. Now, they’ve announced an oversubscribed $95 million Series B. It recently bagged a second award of up to $18.44 million for work on what it calls a new class of antibiotics to fight drug-resistant Gram-negative bacteria. Orca, one of this year’s Endpoints 11 startups, was founded by three entrepreneurs who were intrigued by Irv Weissman’s cell purification work while studying at Stanford. The group already had 50 translational scientists at work and a GMP facility. Please note the magic link is one-time use only and expires after 24 hours. The government is probing Vaxart’s participation in a study funded by Operation Warp Speed and the company’s disclosure of the news, as well as grants, warrant transactions, and other financing matters beginning in March 2020, according to the filing. UPDATED: Another safety incident triggers a halt to a pivotal Covid-19 vaccine study as J&J slams on the brakes, UPDATED: Vaxart was served a grand jury subpoena in July over its controversial role in OWS-funded preclinical study, Novartis bet $6B on the idea — now Versant, venBio have $45M to birth a platform play for radiopharmaceuticals, News briefing: Novo eyes the next kinases in a Finnish startup; Boehringer Ingelheim brings a bispecific to the clinic, Months after achieving unicorn status, Orca steers into the fast lane with an RMAT designation for cell therapy candidate, Pair of Lancet studies give final word on a promising Shionogi antibiotic that turned out to be 'as good' as the other 'suboptimal' options, Polyphor bags second grant in two years for a new class of antibiotics to fight drug-resistant bacteria, Third Rock-backed Cedilla reels in $57.6M for small molecule programs to fight cancer. Cedilla Therapeutics launched just over two years ago with a $56 million Series A and a plan to chart new territory in the protein degradation space. A long-haul biotech with some impressive backers and big goals recruits a major league R&D exec to the helm. The company is currently focused on finding new small molecule binding sites — which may affect protein degradation, inhibition or both — to drug the undruggable. The biotech would take a portfolio approach to gene therapy, akin to the one pursued by BridgeBio (where Session had been CBO of gene therapy). Bioscience & Technology Business CenterThe University of KansasLawrence, Kansas. ENDPOINTS by John Carroll & team — all the news at 11:30a ET, EARLY EDITIONby Arsalan Arif — skimmable links and news at 7:15a ET, New Dewpoint Therapeutics CEO Ameet Nathwani (Sanofi), L to R: Jeroen Bekaert, Ivan Dimov and Nate Fernhoff, Orca Bio (Orca), by Arsalan Arif — skimmable links and news at 7:15a ET. Novartis — then Sandoz — had purchased Weissman’s spinout SyStemix in the ’90s, then scrapped it due to practical challenges. As it turned out, Versant Ventures was also eyeing that very same drug out of Germany: PSMA-617, a radioligand therapeutic for castration-resistant prostate cancer. Please note this link is one-time use only and is valid for only 24 hours. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory. And the company said that it hopes to eventually construct its own commercial scale production site in Dallas – a prospect that perhaps could come sooner rather than later. Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. But Jeroen Bekaert, Ivan Dimov and Nate Fernhoff saw potential there. “But we’ve forgotten that phosphotases are also important.”. The grant includes $2.62 million for Polyphor’s “hit-to-lead” stage and $15.82 million in milestones. “We actually put a term sheet out on that asset because we just thought the efficacy data were so profound there,” managing director Jerel Davis told Endpoints News, referring to a drug that registered a progression-free survival rate of 7.6 months among PSMA-positive patients, with one cohort hitting an overall survival rate of 13.5 months. Is an IPO next? What’s next? In a statement put out Monday evening, the pharma giant said that it had paused further dosing, noting that “the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board as well as our internal clinical and safety physicians.”. They licensed 15 gene therapies in epilepsy, neurodevelopment and neurodegenerative disorders, with an option to license 4 more. Johnson & Johnson has voluntarily ordered a halt to all of its Covid-19 vaccine studies so investigators can probe the unexplained illness of one of the people in their study. Now, CEO Sandra Glucksmann is following up with a $57.6 million Series B round to steer the Cambridge, MA-based biotech in a slightly different direction. Novo Seeds’ Jeroen Bakker thinks he’s found the next kinases. We'll e-mail you a link to set a new password. “Since the introduction of Gleevec, it’s always been about kinases,” Bakker told Endpoints News, referring to the best-selling Novartis drug, first approved in 2001. But it had already cleared another randomized controlled trial and the agency determined the benefits at a time of growing drug resistance outweighed the risk. The company pursued new technologies that can be built on top of AAV9, including bicistronic plasmids (a vector with 2 genes instead of 1), microRNA knockdown (a method to inhibit the tiny strands of RNA that control gene expression), and redosing. Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Lead underwriters for the deal are Goldman Sachs and Jeffries; IPO is set to price this Wed. night, 2.8. Gene therapy trials, of course, can cost a fair bit of cash. We suggest investors consider an allocation. One-time penny stock player Vaxart made market waves Tuesday morning when the company announced it had dosed the first patients in the Phase I study for its oral Covid-19 vaccine candidate. The old AveXis team is moving quickly in Dallas. Unlock this article along with other benefits by subscribing to one of our paid plans. AveXis Incorporated expects to raise $76.5 million in its upcoming IPO. 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