Rani Therapeutics Holdings (NSDQ:RANI), developer of a robotic drug-delivery pill system, generated $73.3 million in its underwritten initial public offering (IPO) of Class A common stock. The San Jose, Calif.–based company’s IPO of 6.7 million shares priced at $11 a share, generating gross proceeds of $73.3 million. The company initially targeted an IPO worth approximately…
Cyclo Therapeutics announces positive Niemann-Pick disease from small study
Cyclo Therapeutics (NSDQ:CYTH) has announced new safety and efficacy data from the its ongoing Phase 1 open-label extension study of Trappsol Cyclo to treat Niemann-Pick disease type C (NPC). NPC is a rare, progressive genetic disorder that involves abnormal cellular cholesterol accumulation. Initial results from the study demonstrated disease stabilization with considerable clinical improvements in…
Pfizer highlights COVID-19 and flu vaccine strategy in Q2 earnings call
With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call. While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during…
Satsuma launches Phase 3 trial for acute migraine drug
Satsuma Pharmaceuticals (NSDQ:STSA) has announced that it has enrolled the first patient in its SUMMIT Phase 3 efficacy trial of STS101, a drug-device product that is a potential acute treatment of migraine. STS101 is a nasal powder containing dihydroergotamine (DHE), an analgesic already available to treat migraines and cluster headaches. In fact, migraine patients have…
FDA grants breakthrough therapy designation to Takeda narcolepsy drug candidate
Takeda (NYSE:TAK) has won breakthrough therapy designation from FDA for TAK-994, an experimental oral orexin agonist. Now in a Phase 2 trial, TAK-994 is formulated to selectively target orexin 2 receptors. Orexin is a neuropeptide that supports normal wakefulness. Orexin deficiency is associated with narcolepsy. Takeda is testing the potential of TAK-994 to treat excessive…
Preprint shows strong but fading efficacy of Pfizer vaccine at six months
An ongoing study involving the BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) could potentially underscore the need for boosters. But more data are needed to understand vaccine performance over time, according to a preprint published on MedRxiv. Pfizer CEO Dr. Albert Bourla has previously predicted that booster doses of the vaccine would be needed. Still,…
Aducanumab continues to face scrutiny as Biogen aims to woo neurologists and Alzheimer’s patients
Given the demand for a potential disease-modifying therapy for the disease, early demand for Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) is considerable from patients. Many neurologists, however, continue to view the drug with skepticism. Fewer than half of neurologists expect they will prescribe the drug in the first six months of availability, according…
FDA grants orphan drug designation to investigational Novartis drug NIS793
FDA has granted orphan drug designation for Novartis’s (SWX:NOVN) NIS793, an anti-TGF-β IgG2 monoclonal antibody. Specifically, the designation covers the use of NIS793 in conjunction with standard-of-care chemotherapy to treat pancreatic cancer. NIS793 has been the subject of eight clinical trials for indications ranging from solid tumors to myelofibrosis. NIS793 would be a first-in-class antibody specific…
FDA approves Merck’s Keytruda to treat certain types of breast cancer
Merck (NYSE:MRK) announced today that it received FDA approval for Keytruda for treating high-risk, early-stage, triple-negative breast cancer (TNBC). Kenilworth, N.J.-based Merck’s Keytruda anti-PD-1 therapy received approval for use in combination with chemotherapy as neoadjuvant treatment, then continued as a single agent as adjuvant treatment after surgery, according to a news release. Approval was based…
Pfizer and Moderna to expand clinical trials for school-aged children
As a result, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have agreed to expand clinical trials of their vaccines in children aged five to 11 before seeking emergency use authorization. In April, Israel first reported suspected cases of heart inflammation in recipients of the COVID-19 vaccine from Pfizer and its partner BioNTech. Since then, FDA has substantiated the risk of myocarditis,…
FDA approves GSK’s Shingrix to prevent shingles in immunocompromised adults
GlaxoSmithKline (NYSE:GSK) received permission from FDA to expand the use of its Shingrinx shingles vaccine to include immunocompromised and immunosuppressed adults 18 years old or older. Having won initial FDA approval in 2017 for individuals 50 and older, the shingles (herpes zoster) vaccine is a non-live, recombinant subunit adjuvanted vaccine. Shingrix is the first shingles…
Why Tryp Therapeutics is exploring the use of psilocybin to treat chronic pain
Many researchers are exploring the potential of the psychedelic compound psilocybin to treat conditions such as depression and post-traumatic stress disorder. But psilocybin offers broader therapeutic promise as it appears to spur neuroplasticity, according to Greg McKee, CEO of Tryp Therapeutics (San Diego). The company is exploring the use of psilocybin-based drugs for treating eating disorders…
Reyvow indicated for treating migraines
Reyvow (lasmiditan) is an FDA-approved treatment from Lilly for the acute treatment of migraine with or without aura in adults. FDA has not approved it as a preventive treatment of migraine. In October, Lilly announced that the drug showed superior pain freedom after two hours of ingestion in two-thirds of migraine attacks in a Phase…
FDA advisory committee recommends not approving FibroGen’s anemia drug candidate roxadustat
The FDA’s independent Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted against approving Roxadustat from FibroGen, which would be a novel treatment of anemia resulting from chronic kidney disease (CKD). Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. FibroGen’s CEO said in a statement that the company believes scientific evidence warrants approval of…
Study estimates Pfizer COVID-19 vaccine is 78% effective in pregnant women
A retrospective study published in JAMA concluded that the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) offered statistically significant protection against SARS-CoV-2 infection. The pivotal trial Pfizer used to win emergency use authorization for the vaccine excluded pregnant women. COVID-19, however, increases the risk of pregnancy-related complications — particularly in the third trimester. To determine how…
Madrigal Pharmaceuticals expands patient access to Resmetirom trial
Last month, Madrigal Pharmaceuticals (NSDQ:MDGL) announced promising preliminary results from an open-label Phase 3 trial from its MAESTRO-NAFLD-1 study focused on Resmetirom. The drug, also known as MGL-3196, appeared to support reducing fat and fibrosis within the liver while also curbing biomarkers associated with inflammation. The data also suggest that the drug reduces LDL cholesterol.…
Why Bioclinica tapped AI in immunotherapy trials early in the pandemic
An AI-based system proved its mettle in screening patients in immunotherapy trials, according to Dan Gebow, chief innovation officer at Bioclinica. Early in the COVID-19 pandemic, developers of cancer immunotherapies worried that the novel coronavirus would interfere with their clinical trial results. In previous years, the scientific community established that immunotherapy can rarely cause interstitial…
Several companies could vie for next-gen COVID-19 vaccine market share
A couple of years ago, mRNA vaccines remained at the research stage. Now, they are among the best-selling pharmaceutical products with Pfizer (NYSE:PFE), BioNTech (NSDQ:BNTX) and Moderna (NSDQ:MRNA) dominating the market. However, that could change in the long run as a growing number of companies develop next-generation mRNA COVID-19 vaccines, which promise to be more effective…
Tryp Therapeutics announces research alliance with the University of Michigan
La Jolla, Calif.–based Tryp (CSE: TRYP) is tapping the University of Michigan to test its TRP-8803 drug formulation against traditional oral formulations of synthetic psilocybin. The psilocybin-based drug developer will also work with the university to compare TRP-8803 with conventional formulations of synthetic psilocybin. In particular, the university will perform pharmacokinetic analysis for blood samples…
APC debuts ‘medicine accelerator’ in collaboration with Enterprise Ireland
The Dublin-based pharmaceutical R&D firm APC Ltd has launched a ‘Global Centre of Excellence for Vaccine and Advanced Therapeutic Research and Manufacturing.’ The result of a €25 million investment, the new facility will staff 120 new employees. The facility will have the capacity to produce hundreds of millions of doses of vaccines (including for COVID-19)…
Novartis refiles paperwork to FDA for novel cholesterol drug inclisiran
Novartis (NYSE: NVS) has resubmitted paperwork to the FDA for inclisiran, a subcutaneously-delivered drug candidate for treating hyperlipidemia in adults whose low-density lipoprotein cholesterol (LDL-C) remains elevated after taking a maximum tolerated dose of statin therapy. In Dec. 2020, FDA issued a complete response letter (CRL) for inclisiran. A CRL indicates that the agency has decided…
Pfizer to seek to expand COVID-19 vaccine EUA to children aged 5 to 11
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the U.S. emergency use authorization (EUA) for their COVID-19 vaccine to include children aged five to 11. The companies plan on filing paperwork for the expanded EUA over the coming months. “We are planning for emergency use authorization submission for [children aged five to 11] in…
Lilly’s donanemab may outclass aducanumab, but questions remain
FDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares. But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist. Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021…
J&J COVID-19 vaccine protects against Delta variant
Johnson & Johnson (NYSE:JNJ) has announced that a single shot of its COVID-19 vaccine offers significant protection against the transmissible Delta variant. The vaccine also provides an immune response lasting at least eight months. The announcement coincides with the company filing two preprint studies to bioRxiv. The first analyzes blood samples from eight patients in…
CureVac aims to rebound after announcing disappointing COVID-19 results
Some two week after announcing that its COVID-19 vaccine had an interim efficacy of 47% in a Phase 2b/3 trial, CureVac (NSDQ:CVAC) appeared to be regaining its footing. After announcing the final results of the trial, however, its stock fell approximately 12% on July 1 in mid-day trading. In the trial, the final vaccine efficacy…