Latest news with #LosAltos
Associated Press
3 days ago
- Business
- Associated Press
Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
--Complete Response Letter (CRL) cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate (OLC) --No other concerns stated, including pre-clinical, clinical, or safety data --The Company identified a second manufacturing vendor that has already produced OLC drug product, which could also be used to support the resolution of the Clinical Manufacturing and Controls (CMC) issues identified in the CRL --The Company plans to immediately request a Type A meeting with the FDA to align on next steps --Unicycive currently has an unaudited cash balance of approximately $20.7 million, with cash runway currently expected into the second half of 2026 LOS ALTOS, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. ('Unicycive' or the 'Company') (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a CRL for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. 'We plan to immediately seek a Type A meeting with the Agency to gain alignment on the best strategy to ensure rapid resolution of the CRL,' said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. 'With a second manufacturing vendor identified that has produced OLC drug product, we remain optimistic about our ability to bring this promising new treatment option to patients with CKD on dialysis who are managing hyperphosphatemia, and we plan to provide an update as soon as we have additional clarity on next steps from the FDA.' After submitting the NDA, and as a part of the application review and routine information requests, the FDA notified Unicycive that a third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) was cited for deficiencies following a cGMP inspection. This citation is unrelated to OLC. Unicycive also notes that as part of the NDA review, the Agency has not highlighted any other technical concerns related to the submitted CMC documentation or testing of OLC itself. As part of its overall manufacturing strategy, the Company had previously identified a back-up third-party manufacturing vendor to build redundancy into its supply chain. The second vendor has a long history of successful FDA and international regulatory inspections and has already produced OLC drug product, which could also be used to support the resolution of the CMC issues identified in the CRL. About Oxylanthanum Carbonate (OLC) OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035. About Hyperphosphatemia Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive's second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit and follow us on LinkedIn and X. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as 'anticipate,' 'believe,' 'forecast,' 'estimated' and 'intend' or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Unicycive's Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. 1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145. Epub 2023 Jun 29. PMID: 37229723; PMCID: PMC10371371. Investor Contact: Kevin Gardner LifeSci Advisors [email protected] Media Contact: Rachel Visi Real Chemistry [email protected]
Forbes
19-06-2025
- Business
- Forbes
Clase Azul's New Blanco Ahumado Brings Jalisco To Life
Clase Azul Mexico's new Blanco Ahumado. Clase Azul México As a longtime tequila lover, Clase Azul Mexico is among my go-to brands. I've long admired the company's beautiful spirits and the gorgeous, collectible handmade decanters they come in. The Clase Azul Tequila Plata is my favorite expression, but the new Clase Azul Tequila Blanco Ahumado has me at a full stop—with a distinct smoky profile reminiscent of mezcal, it is a stunner, to say the least. Blanco Ahumado marries the methods of mezcal making with the traditions of tequila. The brand's Master Artisan, Viridiana Tinoco, explains that it is made by cooking blue weber agave in a pit dug into the ground and lit with firewood and volcanic rocks. Shredding and fermenting the agave comes next. The final step is double distilling the liquid in custom-made copper stills. The release about the tequila says that the spirit "is imbued with the essence of Los Altos de Jalisco, Mexico, where Clase Azul Mexico is based. Tequila may be famous, but the region itself, save for a few areas, is largely untraversed and begging to be explored. I've been lucky enough to visit Mexico numerous times and have been to parts of Jalisco, but there is so much more I have yet to touch. In celebration of her new tequila, Viridiana shared why she loves Jalisco so much and what visitors can see and do when they come Our interview follows. The press release for Blanco Ahumado says that the tequila is 'imbued with the essence of Los Altos de Jalisco.' What exactly does this mean, and how and why does Jalisco play such an important role in Blanco Ahumado's identity? The Altos de Jalisco, or the Jaliscan Highlands, are a geographic and cultural region in the eastern part of Jalisco, known for tequila production but also as a bastion of Mexican culture rich in tradition and heritage. Jalisco is also the home of Clase Azul Mexico. While most tequilas are now cooked above ground, the method of underground baking dates back to the beginning of tequila production in Jalisco. Tell us your inspiration for rescuing the ancestral tequila-making methods of the past. How does this method affect the flavor profile of Blanco Ahumado? Everything we do at Clase Azul Mexico is aimed at sharing the magic of Mexico with the world - old and new, traditional, and trailblazing. The cooking process used to create Blanco Ahumado is a way to pay tribute to the history, but also the future, of the tequila category. By using methods from the past, we also create something newer for the future, which is the perfect blend of time-honored tradition and innovation. Although the agave used to make Blanco Ahumado is cooked underground, like mezcal, what keeps it a tequila is the use of Blue Weber Agave. Mezcals can be made from a variety of agaves, but tequila must be made with Blue Weber - what actually gives mezcal a large part of its flavor profile is the method of cooking the agaves in a pit dug into the ground. Agaves used for tequila are not often baked this way, so the final result is a tequila with a delicately smoky profile. Besides the delicious tequilas from the region, what are some other wondrous things Jalisco is known for? What makes Jalisco so special? Jalisco is a stunning state in Mexico, renowned for its rich cultural heritage. It's the cradle of mariachi music, our iconic Jarabe Tapatío (Mexican hat dance) dance, charrería (Mexican rodeo), and exquisite handicrafts. Our cuisine is also a highlight, featuring specialties like tortas ahogadas, pozole, and carnes en su jugo. Guadalajara, the state capital, is Mexico's second-largest city in terms of population and commerce, and a leader in development and growth. Jalisco is also home to numerous breathtaking tourist destinations, including Puerto Vallarta's beautiful beaches, the luxurious Careyes, Chapala's vast lake, Tapalpa's setting in the Sierra Madre, and much more. When you're not making tequilas and mezcals, where are your favorite places to visit in Jalisco? What are some of your favorite restaurants? What are the best hotels for travelers? I'm a foodie and Jalisco's cuisine is amazing. I frequent restaurants like Xocol. Bruna, and one of my absolute favorites is Hueso - Alfonso Cadena's restaurant which surprises guests with its spectacular design and a fusion of French and American cuisine, as well as its use of exotic flavors. For more traditional eats, I love La Birria de la 30 in downtown Guadalajara for the birria, and the torta ahogadas at Las Tortas del Profe Jiménez can't be beat. Tortas ahogadas, for example, are exclusive to Guadalajara, since you cannot find this type of bread anywhere else in Mexico - so this is highly recommended when in town. If you are in the mood for out of this world tacos, Juan's famous barbacoa tacos is a culinary gem born in the heart of Santa Tere. With numerous locations, their barbecue tacos, whether soft or crunchy, offer an explosion of flavor. I'm also a fan of having drinks at Alexa's or El Gallo Altanero, and for a "Guadalatiki" experience, head to De la O Cantina which offers a fusion of traditional Guadalajaran flavors and food offerings with the vibrant and tropical concept of a tiki bar. It's the best place to try local tequilas and so much fun! And if you're in the mood for dessert, try Churros La Bombilla – they sell churros and hot chocolate beloved by Tapatios (Guadalajara locals) or for you're looking for something cold, go enjoy Raspados Jalisco, the first ice cream shop to open in the center of Guadalajara in 1926. When it comes to hotels, I prefer boutique options like Casa Habita and Demetria, but if you're looking for luxury, the Hyatt, Marriott, and Hilton are also great choices. I love Casa Habita's unbeatable location and design in the trendiest area of Guadalajara, Colonia Lafayette. It's a house designed in the '40s with a newly built contemporary tower offering 37 rooms and suites. Demetria has a breathtaking glass and metal design and is also located in Lafayette - the property offers hotel rooms, but you can also rent one of their 6 private apartments. I'm also passionate about exploring Jalisco's beautiful destinations. In Jalisco, you can get a little bit of everything, different aspects of our culture that appeal to everyone. Puerto Vallarta, for example, is known for exciting nightlife, a bustling downtown and I could spend hours walking up and down the Malecon - the beach-side boardwalk where street performers keep you entertained and there's an abundance of shopping and food options to keep you full and happy. Visit the ChocoMuseo Puerto Vallarta, where you can also make your own chocolate. If you want something a bit more private and luxurious, Careyes offers gorgeous architecture, hidden beaches with swimmable coves and offers a stunning mix of Mediterranean and Mexican styles. It's the perfect getaway if you want to immerse yourself in nature, while also ejoying art, culture and community. In your opinion, what's the best way for travelers to experience Jalisco's tequila culture? If you come to learn about the history and process of tequila, you have to visit Tequila, a town in the state of Jalisco about an hour from Guadalajara. It's known as the birthplace of tequila and is famous for its tequila production. The city is situated near the Tequila volcano and is surrounded by fields of the main ingredient, the blue agave plant. The production process can be observed in various distilleries and haciendas. The National Tequila Museum and the Los Abuelos Museum have exhibits on the history of this drink. You can also visit the Altos region, which is one of the best regions for producing tequila in Jalisco, located about an hour and a half from Guadalajara. To enjoy tequila-based drinks like the Paloma or Batanga, head to La Capilla - one of the oldest cantinas in town.
Forbes
10-06-2025
- Entertainment
- Forbes
The World's Best Tequila, According To America's Top Bartenders
Assorted Tequila shots with lime and salt and with orange and cinnamon. getty A Tequila and a mezcal were selected as the top spirits in their respective categories at the 2025 Bartender Spirits Awards. Below is a brief description and tasting notes for the two agave spirits. Don Nacho Tributo Reposado Tequila is crafted by the Hernandez Gutierrez family in Jalisco's Los Altos region, paying homage to the rich traditions of Jalisco's Highlands. The Tequila undergoes a traditional production process that includes slow-cooking the agave in stone ovens, roller mill extraction, and fermentation in stainless steel tanks without fibers. The spirit is then double-distilled in stainless steel pot stills and aged for 10 months in new American white oak barrels, developing a harmonious balance of agave character and oak influence. The Tequila presents a bright straw-yellow hue with golden highlights, reflecting its extended maturation in oak barrels. On the nose, it exhibits fresh and baked agave notes, while subtle hints of vanilla, maple syrup, citrus zest, and a hint of anise/licorice add complexity. On the palate, the Tequila is robust and aromatic. It reflects an agave and oak-forward profile, showcasing seasoned wood, spice notes of pepper and cinnamon, and a subtle caramel sweetness. The finish is long, slightly sweet, and smooth, with lingering notes of cooked agave, wood spices, and caramel. Don Nacho Tributo Reposado is a testament to the heritage and craftsmanship of Jalisco's Tequila producers. Its balanced profile, marked by the interplay of agave and oak, offers a refined tasting experience that appeals to both connoisseurs and beginners. Mezcal with chili pepper and slice of orange. A typical Mexican alcoholic beverage, it's made from many different types of agave. getty 400 Conejos Espadín Joven Mezcal is a widely available mezcal expression, crafted in the town of Santiago Matatlán, Oaxaca, the heart of mezcal production. The mezcal is made from 100% Espadín agave from Oaxaca, Mexico. José Cuervo owns the brand. As Mezcal has grown in popularity, its production has increasingly bifurcated between large, industrial-sized producers utilizing Espadin agave, and artisanal producers using a mix of traditional wild and domesticated agaves. The production process involves roasting the agave hearts in traditional underground pits, followed by crushing with a stone wheel 'tahona,' fermentation in wooden vats, and double distillation in copper pot stills. The result is a joven or unaged mezcal that reflects the essence of Oaxaca's mezcal terroir. The mezcal is crystal-clear with silver nuances, showcasing its unaged nature. The nose features aromas of wood smoke and light char, accompanied by subtle hints of ripe fruit and herbal/herbaceous notes. Sweet cooked agave is featured prominently on the palate along with herbaceous and fruity notes, and a persistent cold smoke. The finish is long and smooth, with a subtle yet persistent smokiness and lingering fruity and herbaceous notes. 400 Conejos Espadín Joven Mezcal offers an authentic taste of Oaxaca's mezcal heritage at a reasonable price point. Its balanced, complex flavor profile and smooth finish make it suitable for both sipping and mixing, regardless of whether you're new to mezcal or a seasoned enthusiast. The International Bartender Spirits Awards is a renowned global competition that showcases the world's best spirits. Selection is based on quality, innovation, value, and craftsmanship. Judged by an expert panel of bartenders and industry professionals, the competition is highly regarded in the spirits industry and serves as a benchmark for quality. These two spirits are both readily accessible and reasonably priced. More importantly, according to some of America's top bartenders, they are also among the world's best Tequila and Mezcal. Both are worth trying and, if you like them, adding them to your bar!
San Francisco Chronicle
01-06-2025
- Sport
- San Francisco Chronicle
How Metro athletes fared at CIF State Track and Field championships
How Metro athletes finish in Saturday's CIF State Track and Field championships in Clovis (Fresno County): METRO MEDALISTS FIRST: Prince Babalola-Buchango (St. Ignatius), 200 (20.79), Kira Gant Hatcher (St. Mary's) triple jump (40-5), Jaden Jefferson (De La Salle), 100 (10.27), Khaliq Muhammad (Pittsburg), pole vault (17-10½), Hanne Thomsen (Montgomery), 3,200 (9:48.98) SECOND: Santia Ali (Clayton Valley), triple jump (39-10¾), Benjamin Bouie (Crystal Springs Uplands), 1,600 (4:04.84), Babalola-Buchango (St. Ignatius), 110 HH (13.59), Maya Ifo Desai (Mitty) girls discus (154-3), El Cerrito boys 4x100 relay (40.72), Landon Pretre (Menlo School), 3,200 (8:54.25), Hannah Rutherford (Mountain View), 400 (54.27), Thomsen (Montgomery), 1,600 (4:35.69) THIRD: St. Francis 4x800 girls relay (8:57.49), Sabrina Zanetto (St. Francis), 800 (2:09.22) More For You Trans athlete embraced as California track and field champion by peers while adult activists duel FOURTH: Avery Boyse (Burlingame) 12-2), Kinga Czajkowska (Palo Alto), 1,600 (4:42.91), De La Salle 4x100 relay (40.80), Jefferson (De La Salle), 200 (20.86), Corinne Jones (St. Mary's), triple jump (38-8½), Ellie McCuskey-Hay (St. Ignatius) long jump (19-3), Rachael Osicka (California), high jump (5-6), Pittsburg girls 4x100 relay (46.42), Kaleb Pleis (San Ramon Valley), long jump (23-9½), Aydon Stefanopoulos (Los Gatos), 1,600 (4:06.68) FIFTH: Babalola-Buchango (St. Ignatius), 100 (10.56), Ben Stout (Amador Valley), high jump (6-7), Evan Usher (Woodside), shot put (58-4¾), discus (179-11) SIXTH: Khairee Baker (American Canyon), 100 (10.61), Bellarmine 4x800 relay (7:44.84), Devon Bertoli (Cardinal Newman), shot put (57-9¼), Emmanuel Fitzgerald (San Mateo), discus (177-10), Joshua Haven (Bellarmine), 300 hurdles (37.87), Kimiko Hirahara (Las Lomas), high jump (5-5), Annalise Horn (Redwood), long jump (18-9½), Tristan Kippes (Palo Alto), 800 (1:52.35), Grady Wachob (Benicia), high jump (6-7) SEVENTH: Anthony Dean (De La Salle), triple jump (47-6½), Daniela Hughes (Los Altos), triple jump (38-5½), McCuskey-Hay (St. Ignatius), 100 (11.63), Joshua Taylor (King's Academy), shot put (56-11½) EIGHTH: Amaya Bharadwaj (Palo Alto), 1,600 (4:48.14), Miles Cook (Sacred Heart Cathedral), 1,600 (4:10.73), Amaya DeFlorimonte (Bishop O'Dowd), triple jump (38-1), Case Jacobson (St. Francis), shot put (56-3½), McCuskey-Hay (St. Ignatius), 200 (24.31), Ryan Shen (Monta Vista), long jump (22-7¼), Lily Symon (Los Altos), 800 (2:10.24) Girls: Long Beach Wilson 46, Long Beach Poly 28, Santiago 28, Jurupa Valley 27, Carlsbad 25
Globe and Mail
30-05-2025
- Business
- Globe and Mail
Top Real Estate in Los Altos, CA Achieves Multiple Overs, Through Strategic Home Prep and Targeted Marketing
Los Altos, CA - In today's highly competitive Silicon Valley housing market, Michael Sutton, a top Los Altos Real Estate Agent, continues to raise the bar. Leveraging smart home preparation, innovative digital marketing, and deep local expertise, Sutton recently secured multiple offers (each above asking price) on a home that, just three weeks prior, was in original condition. This sale demonstrates the powerful impact of focused preparation and strategic exposure. Sutton's approach goes far beyond traditional real estate tactics. His success lies in identifying cost-effective improvements that resonate with today's buyers – maximizing return on investment. Coupled with high-impact photography, home video, and targeted online marketing, Sutton creates the perfect combination that drives buyer interest and results. In this recent case, the home was transformed in just three weeks with a modest investment, generating five strong offers and ultimately selling for $1,500,000 – more than six times the sellers' upgrade budget. Based on Sutton's expert guidance, the sellers walked away with over $200,000 in added value, proving once again that the right strategy pays off. Known throughout the Bay Area for his deep market expertise, contractor background, and strong relationships with fellow agents, Sutton brings a decisive advantage to every transaction. As a seasoned Realtor in Los Altos and surrounding Silicon Valley communities, he provides buyers with early access to off-market properties and data-driven insights that give them the competitive advantage over the competition and guide them to confident, winning outcomes. To learn more about Michael Sutton and how he can help you achieve your Los Altos real estate goals, visit
