Target to $51 from $70
Friday, April 1, 2022
Spero update on FDA review of NDA
The U.S. Food and Drug Administration (FDA) has notified Spero that, as part of its ongoing review of Spero’s New Drug Application (NDA) for tebipenem HBr, it has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review. Spero intends to work with the FDA to seek to resolve the deficiencies expeditiously.
The FDA previously assigned a Prescription Drug User Fee Act (PDUFA) goal action date of June 27, 2022, for completion of its review of the NDA, and initially targeted the midpoint of that review period to communicate proposed labeling and, if necessary, any post-marketing requirement and/or commitment requests to Spero. The Company noted that there are three months remaining before the PDUFA goal action date. Spero also has a late cycle review meeting scheduled with the FDA and expects to provide an update on or before its next earnings call in May 2022.
Longeveron Publishes Peer Reviewed Study of Phase 1 Trial Results of Lomecel-B for Alzheimer’s
Results Support Further Exploration of Therapeutic Potential of Lomecel-B to Slow Cognitive Decline, Improve Quality of Life for Alzheimer’s Patients
Phase 2 Trial Recently Launched With First Patient Treated
https://finance.yahoo.com/news/longeveron-publishes-peer-reviewed-study-120000534.html
Y-mAbs Submits Omburtamab Biologics License Application to FDA
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that on March 31, 2022, the Company completed the resubmission of its Biologics License Application (“BLA”) for 131I-omburtamab (“omburtamab”) to the FDA.
Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to publish later this year.
Lilly updates Phase 1/2 lung cancer data
Eli Lilly and Company (NYSE: LLY) today announced updated data from the Phase 1/2 LIBRETTO-001 trial of Retevmo® (selpercatinib 40 mg & 80 mg capsules) in patients with RET fusion-positive non-small cell lung cancer (NSCLC). Retevmo (marketed as Retsevmo® outside of the U.S.) is a selective and potent RET kinase inhibitor that is approved in multiple countries including the United States for treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive NSCLC, and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). These data were presented at the European Lung Cancer (ELCC) 2022 (poster 27p).
"The LIBRETTO trial provides the largest set of clinical data for a RET inhibitor and these results continue to demonstrate evidence of meaningful clinical outcomes for patients with metastatic RET fusion-positive NSCLC treated with Retevmo, including those with difficult-to-treat brain metastases," said David Hyman, M.D. chief medical officer, oncology at Lilly. "We are continuing to build on the robust body of evidence supporting Retevmo, including through an ongoing randomized Phase 3 confirmatory study, with a planned readout in 2023."
The updated analysis utilized a June 15, 2021, data cut-off and included 355 patients who were eligible for efficacy analysis, 247 of which were previously treated with at least one line of platinum chemotherapy and 69 of which were treatment-naïve. Patients who were previously treated with at least one line of platinum chemotherapy received a median of two prior treatment regimens (range: 1-15), with 58% having received anti-PD-1 or anti-PD-L1 therapy. Responses are based on independent review committee (IRC) assessment.
Ukraine rushing to evacuate Mariupol after Red Cross warnings
The Red Cross and Ukrainian Deputy Prime Minister Iryna Vereshchuk said that efforts are underway to evacuate civilians from the Ukrainian city of Mariupol as officials heed the humanitarian organization’s warnings, which have underscored the necessity to get Ukrainians out of the besieged city.
Vereshchuk and the International Committee of the Red Cross (ICRC) said that 45 buses were in transit to the city, with evacuations slated to begin on Friday, The Guardian reported.
The ICRC Ukraine posted a video on Twitter on Friday with a woman from the organization saying they were in transit to Mariupol “in order to ensure safe passage for the civilians who desperately want to flee the city.”
A safe corridor had been agreed to by Russia, the ICRC and Vereshchuk confirmed, but the ICRC signaled that the exact terms may not be fully agreed upon and urged both sides to come to a mutual accord on it, Reuters reported.
Mariupol has seen some of the worst devastation since Russia began its invasion into the neighboring country weeks ago, and the ICRC warned that the evacuation of its civilians was “hugely important.”
“Time is running out to help these people. This evacuation is hugely important,” Alyona Synenko, a spokesperson for the ICRC, said, according to The Guardian. “It is essential we get concrete and precise agreements from both sides on times and routes tomorrow. These instructions need to be conveyed to military units on the ground and they must be respected.”
The ICRC said last month that unless life-saving aid and evacuation routes are agreed upon, Mariupol residents could see a “worse-case scenario.”
“Hundreds of thousands of the city’s residents are now facing extreme or total shortages of basic necessities like food, water and medicine,” the ICRC said in a statement.
“People of all ages, including our staff, are sheltering in unheated basements, risking their lives to make short runs outside for food and water. Dead bodies, of civilians and combatants, remain trapped under the rubble or lying in the open where they fell.”
https://thehill.com/news/3256090-ukraine-rushing-to-evacuate-mariupol-after-red-cross-warnings/
Merck, Ridgeback: Molnupiravir Associated With More Rapid Elimination of Infectious SARS-CoV-2
Additional Exploratory Patient Subgroup and Virology Data from MOVe-OUT Presented at ECCMID
Among Patients With Infectious Virus at Baseline, No Patients Who Received LAGEVRIO Had Infectious Virus at Days 3, 5 or 10
https://finance.yahoo.com/news/merck-ridgeback-present-data-demonstrating-104000870.html
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