Capricor's deramiocel moves ahead without AdCom, says H.C. Wainwright
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HHS spokesperson tells Reuters FDA 'actively re-evaluating' Capricor AdCom
Capricor Therapeutics provides regulatory update on Deramiocel BLA
Roth says 'excessive' Capricor selloff due to 'investor overreaction'
Capricor selloff brings buying opportunity, says H.C. Wainwright
Capricor Therapeutics price target lowered to $22 from $43 at Oppenheimer
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'Legally binding' dye agreement with WK Kellogg lauded by Texas attorney general
WK Kellogg has entered a legally binding agreement to remove 'toxic dyes' from its breakfast cereals, according to Texas Attorney General Ken Paxton. Paxton said in a statement shared by his office yesterday (13 August) that he has 'signed a historic Assurance of Voluntary Compliance' agreement with WK Kellogg, which, he added, 'certifies that the company is legally agreeing to remove artificial food colourings from its cereals by the end of 2027'. Under a transparency commitment on the WK Kellogg website, the company says 85% of its cereals contain no FD&C colours and none contain the Red No. 3 dye. Reformulations to remove all FD&C colours in cereals served in schools will be completed by 2026-27, the company says, adding: 'We will remove FD&C colours from the small percentage of our foods in retail that contain them' by the end of 2027. However, the pledges are not legally binding. Just Food has asked WK Kellogg to comment on the Paxton statement. WK Kellogg responded, repeating the pledges made in the online transparency commitment. However, the company added: 'We appreciate the opportunity to work collaboratively with the Texas AG's office and share their focus on health and wellness. We see the growing focus on health as an opportunity to meet consumer needs in even more meaningful ways.' The attorney general launched an investigation in April into WK Kellogg's claims that its cereals are 'healthy'. Paxton had suggested the products 'are filled with petroleum-based artificial food colourings' that have been linked to health issues such as hyperactivity, obesity, autoimmune disorders, hormonal imbalances, and cancer. And he claimed some of WK Kellogg's products 'specifically contain' artificial food dyes in shades of blue, red, yellow, green and orange. Yesterday, Paxton lauded the development with WK Kellogg as a 'historic legal agreement with a major food company', which, he said, 'represents a significant milestone in the movement to remove toxic dyes from foods and protect the health of all Americans'. He added: 'While other companies have verbally committed to removing food dyes, Kellogg's is the first to officially sign a legally binding agreement confirming that it will remove food colourings.' Since President Trump took office, US Health Secretary Robert F. Kennedy Jr. has launched a campaign – under his Make America Healthy Again (MAHA) initiative - to urge major food manufacturers to phase out the use of artificial dyes. Many have since made pledges to do that but under their own auspices, including Kraft Heinz and General Mills. In January, the US Food and Drug Administration (FDA) said it planned to ban the use of the Red 3 food colouring additive in food, supplements and ingestible drugs. Then in April, the FDA unveiled measures to phase out the use of petroleum-based food dyes by the end of next year, followed by the approval in May for the use of three natural colour additives. Paxton applauded WK Kellogg 'for doing the right thing' and urged 'other food manufacturers to sign similar agreements to demonstrate their commitment to helping Americans live healthier lives'. Meanwhile, markets await news of the progress in Ferrero's takeover of WK Kellogg. The confectionery giant entered an agreement in July to acquire the business for $3.1bn, with the deal expected to close in the current second half of this year. However, it needs to be signed off by regulators and WK Kellogg's shareholders. "'Legally binding' dye agreement with WK Kellogg lauded by Texas attorney general" was originally created and published by Just Food, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
an hour ago
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FDA grants de novo authorisation to Artera's prostate software
The US Food and Drug Administration (FDA) has granted de novo authorisation to Artera's ArteraAI Prostate software. This marks it as an inaugural AI-powered software with the ability to predict long-term results for those with non-metastatic prostate cancer. This regulatory milestone categorises ArteraAI Prostate as a software as a medical device (SaMD) and enables the use of such AI-assisted tools in qualified pathology laboratories across the US. The authorisation also sets a new product code for similar future digital pathology risk-stratification applications. The FDA's decision includes a Predetermined Change Control Plan that allows the company to widen its platform by validating compatibility with more digital pathology scanners with no need for additional 510(k) submissions. The test was previously granted a breakthrough device designation by the US regulator. Artera's broader multimodal artificial intelligence (MMAI) platform is already on the market through ArteraAI as a laboratory-developed test (LDT). The MMAI biomarker test of the company utilises an algorithm that evaluates digital biopsy images and clinical data to forecast the efficacy of hormone therapy and estimate long-term patient outcomes. This algorithm is the product of extensive development, drawing from vast datasets, including various patients and pathology slides, and has been clinically validated through several Phase III randomised studies. Artera's portfolio also includes other MMAI-powered products such as the ArteraAI Prostate Biopsy Assay, ArteraAI Prostate, and ArteraAI Breast Test. Artera co-founder and CEO Andre Esteva said: 'The FDA's decision validates the power of our MMAI platform to deliver on our vision to create AI-guided tools that enable data-backed and tailored treatments for each patient, leading to more confidence throughout the cancer journey, and ultimately, save more lives.' In February 2025, Artera announced a partnership with Tempus to broaden the availability of the AI-based prostate cancer test. "FDA grants de novo authorisation to Artera's prostate software" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
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Coffee sold at Dollar General recalled for 'potential presence' of glass
Instant coffee products sold at Dollar General stores nationwide has been recalled due to the "potential presence of glass," according to the company. Dollar General has voluntarily recalled three lots of its 8-ounce Clover Valley Instant Coffee sold in 48 states, the company said in an announcement posted by the U.S. Food and Drug Administration. "The recall is being initiated after a customer notified Dollar General employees about the potential issue," the statement said. "Ingesting glass fragments may cause injury to the consumer, and these injuries may include damage to teeth, laceration of the mouth and throat, or perforation of the intestine. No illnesses or injuries have been reported to date." The recalled products were sold between July 9-21, 2025, and have the UPC number 876941004069 on the package. There are three specific codes that can be found on the neck of the jar: L-5163 and L-5164 that both have a Best By date of 12/13/2026; and L-5165 with a Best by of 12/14/2026. The Tennessee-based retailer has encouraged any customers who purchased the coffee products to discard it for a full refund. "Contact Dollar General either via email at customercare@ or by phone at 1-888-309-9030 from 6 a.m. to 1 a.m. CST seven days a week to request a full refund of the purchase price (including any tax)," the company stated. "Dollar General is actively investigating the source of the glass contamination and apologizes for any inconvenience caused by this product issue," the recall statement added. Dollar General did not immediately respond to an ABC News request for additional comment. Solve the daily Crossword
