Takeda Will Be Protagonist's Co-Development, U.S. Co-Commercialization Partner With 50:50 Profit Share, and With Exclusive Ex-U.S. Global Rights to Commercialize Rusfertide, Protagonist's InvestigationalInjectable Hepcidin Mimetic Currently in Development for the Treatment of Polycythemia Vera (PV)
Takeda Will Make an Upfront Payment of $300 Million at Closing
Partnership Combines Protagonist's Leadership in Pharmaceutical Peptide Drug Development With Takeda's Commercial Expertise and 70-Plus Year Legacy of Driving Innovation Within the Rare Hematology Community
Protagonist to Host Conference Call and Webcast Today at 4:30 PM ET
Protagonist management will host a conference call and webcast today at 4:30 p.m. ET to provide a brief overview of the co-commercialization agreement.
Wednesday, January 31 at 4:30 PM ET
Domestic: (877) 704-4390 (U.S./Canada)
International: (201) 389-0920
Conference ID: 13744228
Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. Call me™ link will be made active 15 minutes prior to scheduled start time.
Relmada Therapeutics, Inc. (NASDAQ:RLMD - Free Report) - Investment analysts at Leerink Partnrs issued their FY2028 earnings estimates for shares of Relmada Therapeutics in a research report issued on Monday, January 29th. Leerink Partnrs analyst M. Goodman anticipates that the company will post earnings of ($0.90) per share for the year. The consensus estimate for Relmada Therapeutics' current full-year earnings is ($3.33) per share.
Investing.com - CONMED (NYSE:CNMD) reported fourth quarter EPS of $1.06, $0.05 worse than the analyst estimate of $1.11. Revenue for the quarter came in at $327M versus the consensus estimate of $332.22M.
Guidance
CONMED sees FY 2024 EPS of $4.30-$4.40 versus the analyst consensus of $4.40.
CONMED sees FY 2024 revenue of $1.34B-$1.37B versus the analyst consensus of $1.36B.
CONMED's stock price closed at $95.64. It is down -6.43% in the last 3 months and down -3.68% in the last 12 months.
Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced it has determined 100mg/kg is the recommended Phase 2 dose (RP2D) for NT219 in combination with cetuximab in the treatment of head and neck cancer based on its Phase 1/2 dose escalation study (NCT04474470). NT219 is a first-in-class small molecule dual inhibitor of IRS1/2 and STAT3.
The RP2D was determined based on data from the open-label dose escalation study designed to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of NT219 in combination with Erbitux® (cetuximab), in previously treated recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) patients. The Company recently reported that NT219, in combination with cetuximab, demonstrated a dose dependent anti-tumor activity with confirmed partial responses. No dose-limiting toxicities were reported. The additional supporting data used for this determination was pharmacokinetics of NT219 across all dose levels. Further dose optimization is planned for future studies.
The Phase 1 dose escalation study is being concluded and the remaining patients' data are expected to be reported during the first half of 2024. The Company is now advancing its upcoming Phase 2 Proof of Concept study of NT219 for the treatment of R/M SCCHN.
Detailed clinical results from the dose escalation portion of the study are intended to be presented at the European Society of Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2024 in Paris on February 26, 2024, in an Oral Presentation titled “Interim results of a Phase 1/2 trial of NT219 in combination with cetuximab in patients with advanced/metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).”
Cadrenal Therapeutics, Inc., (Nasdaq:CVKD), a biopharmaceutical company developing tecarfarin, a novel Vitamin K Antagonist (VKA) for unmet needs in anticoagulation (blood thinning) therapy, cited today a recent peer-reviewed article in the Journal of the American College of Cardiology (JACC) titled, "When Direct Oral Anticoagulants Should Not Be Standard Treatment" byAntoine Bejjani, MD, et.al. The article examines the numerous medical conditions where direct oral anticoagulants (DOACs), such as Eliquis, Xarelto, Pradaxa, and Savaysa, should not be prescribed.
Consistent with the evolving evidence documenting the need for VKA-based anticoagulant therapy, while simultaneously recognizing the deficiencies of the available VKA anticoagulants (such as warfarin), this latest peer-reviewed journal publication highlights:
For most patients, DOACs are preferred over existing Vitamin K Antagonists [warfarin] for stroke prevention in atrial fibrillation (AFib) and venous thromboembolism treatment.
However, randomized controlled trials indicate that DOACs may not be as efficacious or as safe in conditions such as mechanical heart valves, thrombotic antiphospholipid syndrome (APS), and AFib associated with end-stage kidney disease (ESKD).
Their [DOACs] efficacy is uncertain for conditions such as left ventricular thrombus, and for patients with AFib or venous thrombosis who have ESKD.
Preclinical Studies Show DA-1726 Elicits Superior Weight Loss Compared to Semaglutide (Wegovy™) and Similar Weight Loss Compared to Tirzepatide (Mounjaro™), While Consuming More Food
Initiation of Phase 1 Clinical Trial Expected to Occur in the First Half of 2024
NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). The company plans to initiate a Phase 1 clinical trial, for the treatment of obesity, in the first half of this year.
The chairman of the Metropolitan Transportation Authority defended its much-mocked new subway gates and emergency-exit timers as the authority estimates losing $690 million to fare jumpers.
Chairman Janno Lieber admitted Wednesday that the easily opened $700,000 gates the MTA tested at the Suptin Boulevard-Archer Avenue station weren’t fool-proof.
“We might, in retrospect, have chosen a different model,” Lieber said.
.”We’re going to to continue to experiment, this is not what we’re putting in, in the whole system and it’s being adjusted to deal with some of its shortcomings.”
He argued the gates were a partial success, with fare collection at the station having jumped 20 percent since they were installed.
He also knocked critics of the subway’s new 15-second timers that aim to discourage straphangers from using the emergency doors to leave the station.
Officials believe that reducing the number of times the emergency doors are opened will reduce the number of chances for fare cheats to sneak in without paying — but lefty political activists and commentators online have compared the changes to the decisions made by the sweatshop owners of the Triangle Waistshirt Factory.
That led to the deadliest infernos in city history and subsequent efforts to impose worker safety regulations in the early 1900s.
No emergency here: Riders who should pay walk through the emergency gate at the Times Square subway station and avoid the fare. The MTA says it expects that farebeating cost it more than $690 million last year.G.N.Miller/NYPost
“It’s not funny and it’s not relevant, you’re making light of a tragedy in New York’s history,” a visibly irritated Lieber told reporters.
“We’ve gotten approval from the code authorities, the fire experts on how to do it, and we’re gonna do it,” he continued, “because we’re not letting New Yorkers who walk up to the turnstile and pay their fare — and look over at somebody who has their Metrocard in their hand or their OMNY open on their phone decide that they’re going to go for the gate because it’s open.”
MTA officials have long pursued sign-offs from state safety regulators to begin testing the timed emergency gates near the turnstiles.
They will be installed at three stations as part of the pilot: 59th-Lexington Avenue (No. 4,5 and 6), 138-Grand Concourse in The Bronx (4/5) and Flushing Avenue (J/M) stop on the Bushwick-South Williamsburg border in Brooklyn.
The modified doors will have signs that inform riders of the timers.
Fare evaders boldly enter the West 23rd St Station in the subway in New York via the emergency exit gate, evading paying the fare, on Wednesday July 12, 2023.Levine-Roberts/Sipa USA
Officials also said Wednesday that the motorized doors equipped with fare readers at wheelchair-accessible subway stations — known as AutoGates — will not have timers installed.
The timers are one of a slew of shorter-term efforts the agency is pursuing to clamp down on fare evasion, which soared post-pandemic.
Just 3 percent of riders hopped the turnstile in the first quarter of 2018: a number that tripled to 12.5 percent in the first quarter of 2022 and rose again to 13.3 percent during the last quarter of 2023.
The problem is even worse on the city bus system, where nearly half of riders board without paying, stats show.
Commuters in Paris pass through fare gates that are difficult to jump or get around thanks to tall plastic doors that quickly open and close.Nolan Hicks/N.Y.Post
Exact figures for the amount lost to fare-beating in 2023 have not yet been released, but Lieber said the toll would likely be higher than the $690 million in 2022.
Officials have announced that they are installing tighter gearing on turnstiles to stop riders from being able to wiggle through and the MTA has installed new locks on the emergency doors in the stations after discovering that copies of the old master keys had become widely available. Officials also hired private security guards to stand near the emergency exits at stations to discourage people from sneaking in.
NY Post reporter Reuven Fenton shows how a well-placed wave in front of a badly placed sensor on a new MTA turnstile can trigger it to open. Officials say they’re trying out new designs to try and curb fare evasion.J. Messerschmidt for NY Post
Ultimately, the MTA officials believe — and transit advocates largely agree — that a redesign of the subway system’s fare gates is necessary to fix the problem.
Fare gates commonly used in Europe feature tall plastic doors that are much more difficult to jump or squeeze through. The doors close quickly to prevent people skipping fares from trailing in behind paying riders, but the mechanism is designed to stay open longer for those with wheelchairs, strollers or riders in wheelchairs.
However, New York’s first attempt at using an imported gate setup was quickly hacked by a social media star who showed in a widely shared video how they could be defeated just by leaning over and waving at an ill-placed sensor, which would open the doors.
MTA chairman Janno Lieber walks through another new fare gate design the MTA says it may experiment with during a demonstration in 2023 at Grand Central.James Messerschmidt for NY Post Officials have said they are working to modify those gates and are actively pursuing other designs from manufacturers that would be harder to beat.
