Latest news with #Savara
Business Upturn
02-06-2025
- Business
- Business Upturn
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Savara Inc.
NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating claims on behalf of investors of Savara Inc. ('Savara' or the 'Company') (NASDAQ: SVRA). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether Savara and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On May 27, 2025, Savara issued a press release 'announc[ing] that the Company received [a refusal to file] letter from the FDA for the [Biologics License Application] of MOLBREEVI as a therapy to treat patients with autoimmune PAP.' On this news, Savara's stock price fell $0.90 per share, or 31.69%, to close at $1.94 per share on May 27, 2025. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle PeytonPomerantz LLP [email protected] 646-581-9980 ext. 7980
Associated Press
27-05-2025
- Business
- Associated Press
Savara Receives Refusal to File (RTF) Letter From the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for MOLBREEVI* to Treat Patients With Autoimmune Pulmonary Alveolar Proteinosis (autoimmune PAP)
LANGHORNE, Pa.--(BUSINESS WIRE)--May 27, 2025-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that the Company received an RTF letter from the FDA for the BLA of MOLBREEVI as a therapy to treat patients with autoimmune PAP. Upon preliminary review, the FDA determined that the BLA submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC). The RTF was not the result of safety concerns, and the FDA did not request or recommend additional efficacy studies. Within the next 30 days, the Company intends to request a Type A meeting with the Agency. Typically, Type A meetings are granted by the FDA within 30 days of the request. 'The requested CMC data outlined in the RTF letter are currently being generated, and we look forward to meeting with the FDA to align on next steps,' said Matt Pauls, Chair and Chief Executive Officer, Savara. 'Based on our understanding of the letter, we are confident we can thoroughly address the Agency's request and expect to resubmit our BLA in the fourth quarter of 2025. We remain highly confident in our program for autoimmune PAP and believe that our clinical data demonstrate that MOLBREEVI improves pulmonary gas transfer and respiratory health-related quality of life in this rare disease.' Pauls continued, 'As outlined in our Annual Report, we are working to establish a redundant supply chain. Pursuant to that strategy, we remain on track to complete the technology transfer with our second-source drug substance contract manufacturer in the fall. We have completed three upstream process performance qualification (PPQ) batches, are in the process of completing our downstream PPQ campaign and have begun our analytical comparability analysis.' The RTF does not impact previous designations granted by regulators for MOLBREEVI in autoimmune PAP. MOLBREEVI in autoimmune PAP has been granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and the European Medicines Agency (EMA), as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). About Autoimmune Pulmonary Alveolar Proteinosis (autoimmune PAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow ® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at and LinkedIn. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as 'expect,' 'intend,' 'plan,' 'anticipate,' 'believe,' and 'will,' among others. Such statements include, but are not limited to, statements related to the Company's intention to request a Type A meeting with the FDA, our confidence in our ability to thoroughly address the Agency's request, our expectations regarding the resubmission of the BLA and the timing of the resubmission, our belief that our clinical data demonstrate that MOLBREEVI improves pulmonary gas transfer and respiratory health-related quality of life in autoimmune PAP, and that we remain on track to complete the technology transfer with our second-source contract manufacturer in the fall. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; the occurrence and outcome of the planned Type A meeting with the FDA; our ability to address the FDA's request and successfully meet the requirements for resubmission; our ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara's operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K, and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. View source version on CONTACT: Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs [email protected] KEYWORD: PENNSYLVANIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: BIOTECHNOLOGY FDA HEALTH PHARMACEUTICAL CLINICAL TRIALS SOURCE: Savara Inc. Copyright Business Wire 2025. PUB: 05/27/2025 08:05 AM/DISC: 05/27/2025 08:05 AM
The Hindu
23-05-2025
- General
- The Hindu
Akshara Brahma: Where every word is a prayer for A.P.'s Savara tribals
As dawn breaks over Addangi, a hamlet nestled in the folds of the Eastern Ghats in Srikakulam district, 23-year-old Savara Kalavathi steps barefoot into a modest building with an asbestos roof. She cleans the floor and sprinkles cow dung water on the front yard before lighting a small brass lamp in a wall niche. She folds her hands and closes her eyes in reverence as the slender flame flickers to life. Kalavathi has been performing this daily ritual for the past four years, ever since she became a daasibo (servant of god), spiritual custodian of a unique religious order that worships not idols but something more fundamental to a people's existence: their language. Lying between Chaaradi and Lalaada hills on Andhra-Odisha border in Kothuru mandal, Addangi is home to 56 families of the Particularly Vulnerable Tribal Group of Savara, 38 families of whom are adherents of 'Akshara Brahma'. 'We worship our language as god,' says Kalavathi, running a hand over the temple's wall, adorned with the names of days, months and a few other basic words in Savara. In the wall niche, bathed in a warm glow, is a portrait of the 24 letters of the Savara alphabet arranged in a distinct pattern. For half a day every Thursday, followers of the sect gather at the temple to engage in sessions of writing, reading and singing Savara songs as a mark of devotion to their mother tongue. For the rest of the week, lighting the lamp by one of the three daasibos in the village is the sole ritual. 'A daasibo can withdraw from service any time, leaving the task of finding a successor to the community,' says Kalavathi. For Savaras like her, language worship has become a vehicle to ensure the continuity of their lifestyle, culture and memories of their ancient community. A living god Renowned for the intricate wall art of Edisinge and the lively Thongseng folk dance, the Savara tribespeople predominantly reside in Andhra Pradesh and Odisha, with smaller populations scattered across other States. Of a population of around 1.1 lakh (2011 Census) in A.P., 84,585 reside in the erstwhile Srikakulam district and 25,903 in the erstwhile Vizianagaram district, according to the State Tribal Welfare Department. Most are farmers, with a small percentage depending on forest produce for livelihood. Savara belongs to the Kol Munda group of the Austro-Asiatic family of languages. It existed as an oral language until 1936, when Mangei Gomango, a polyglot from Odisha, developed a script for it— Soran Sompen (Akshara Brahma). The 24 characters (18 consonants and six vowels) are the initial letters of the names of the 24 Savara deities, making the alphabet a representation of their pantheon, according to a 2012 special issue of the Journal of Scheduled Castes and Scheduled Tribes Research and Training Institute, Odisha. The religious order asks its followers to shun animal sacrifice, popularise the Savara script and language and pass on the tribal wisdom to the next generation. Arrival in Andhra Akshara Brahma arrived in Andhra Pradesh in the 1990s. And by the turn of the century, a number of Savara families in North Andhra to adopt it. Today, around 950 families in 80 Savara tribal villages in the erstwhile Srikakulam and Vizianagaram districts follow Akshara Brahma, says Savara Kameswara Rao, a 46-year-old government schoolteacher from Seethampeta who, as a teenager, spearheaded the campaign back then. Akshara Brahma has effected a fundamental shift in the tribespeople's way of life. Traditionally, the Savara festivals of Puli Panduga and Maamidi Panduga (harvest festival) mandated animal sacrifice for the community feast. 'In the Akshara Brahma order, animal sacrifice during festivals is prohibited, replaced instead by breaking of coconuts,' says Sandhya, an elderly resident in Addangi. All community festivals are celebrated at the Akshara Brahma temple in the village, making it a common venue for cultural bonding. 'Under Akshara Brahma, the Savaras have joined hands to protect our culture and language. Our objective is to promote it academically too, not just worship it,' says Kameswara Rao. Irrespective of formal education, most followers of Akshara Brahma can either read or write the 24 letters of the language, owing mostly to their acquaintance with them at the temple. In 2014, the Savaras formed a 12-member village committee, Akshara Brahma Youth Society (AYS), to run the cultural and academic activities. An important member on the panel is a vidhya volunteer, who is willing to teach the language to the villagers. The volunteer holds classes for schoolchildren throughout the year, with special sessions during Dasara, Pongal and summer holidays. Kalavathi, a graduate in biology and zoology, has also been volunteering to teach the language to the village children. She is the eighth volunteer in the village, and her two immediate predecessors were also women. Moreover, she is the first to receive a monthly honorarium of ₹1,000, raised by the community. The youngest among five sisters, Kalavathi works under MGNREGS and as a farmhand to support her family. 'Nonetheless, I set aside two hours a day for my tribe by serving as a Daasibo and as a vidhya volunteer. I am privileged to be part of a movement promoting our language and serving our community through education,' she says. At her summer camp, she teaches over 20 schoolchildren of various ages. Future plans On May 17 this year, 40 government teachers, representing the Savara tribespeople in Srikakulam and Vizianagaram districts, held a round-table conference, the third of its kind, at Gopalapuram village in Srikakulam district to discuss ways to promote the script. There, they passed a resolution to come up with books in Savara. 'Our next move is to launch more books in Savara to popularise our language and culture. The Savara tribal teachers will also be taught to read and write the language,' says Kameswara Rao, who presided over all three of the round tables. He claims that because of Akshara Brahma, the tribespeople are more literate and careful with liquor consumption and expenditure. Lockstep with cultural icon According to the sect's followers, the AYS has been laying a special focus on promoting Thongseng, the Savara folk dance performed during weddings and festivals. In this art form, usually performed at night, men and women dance together, with women holding umbrellas. Savara Chinna Rao, an assistant priest in Addangi, says the entire community dance to Savara songs at the Akshara Brahma temple during the winter. 'This festival lasts for 30 nights during Karthika Pournima. It symbolises our unity in celebrating our tradition and language.' Support from outside Impressed by the cultural and linguistic activities of the Savaras, the Tirumala Tirupati Devasthanam (TTD) has reportedly begun funding the construction of Akshara Brahma temples in Savara tribal villages. 'The TTD has pledged ₹10 lakh for the construction of an Akshara Brahma temple in our village and has so far released ₹6 lakh, without any condition on the architecture,' says Addangi AYS president Anand Savara. Villagers in Naugada in the neighbouring Parvathipuram Manyam district also claimed that the TTD is funding a ₹10-lakh temple, which is under construction. Naugada is one of the first villages that embraced Akshara Brahma in Andhra Pradesh in the 1990s. Currently, all 70 families are adherents of the sect. Savara Venu Gopal, son of village priest Ananda Rao, says his family dedicated their entire 80 cents on the hill to Akshara Brahma activities. 'Our village is building a two-story temple on this hill,' says Venu Gopal, a farmer. Savara Rajesh, Naugada's tribal physician (Tey-Re-Marin), says the village temple has emerged as a destination for Savara weddings. 'Wedding fees are spent on village development,' he adds. The next wedding is on May 25. Art nearing extinction Despite its influence on Savara culture, Akshara Brahma is yet to find a way to conserve the tribe's most remarkable art: Edisinge, a form of wall art that uses vermilion and colours made of rice, charcoal and ash from coconut shells. These detailed paintings, which honour ancestors and depict agriculture, hunting and the region's biodiversity, used to decorate the inner walls of mud houses. As modern buildings replace traditional dwellings, this ancient art form is fast disappearing in North Andhra. Savara Lakhsmana Rao (28),an Edisinge artist from Seethampeta in Parvathipuram Manyam district, says he hasn't had a house to paint in four years. 'The art is on the verge of extinction in Andhra Pradesh,' he says, adding that elders who mastered Edisinge in most Savara villages are long gone. Addangi's last professional Edisinge artist, Savara Chinna Appanna (65), concurs: 'There is no more space.' Vice-Chancellor of Adikavi Nannaya University-Rajamahendravaram Sattupati Prasanna Sree, an authority on the Savara language and script, observes that the Savara tribespeople celebrate life and nature through the Edisinge. Notably, Prasanna Sree is also trying to bring out a Telugu-Savara dictionary, but but her efforts have hit a hurdle after the death of her source in Seethampeta Agency. According to officials in the School Education Department, the script has not been officially used in any academic activity in Andhra Pradesh. However, proponents of Akshara Brahma have been demanding that the government bring out primary school textbooks in the Savara Language. Back in Addangi, Kalavathi balances her duties in the spiritual and practical realms. She is not just servant of god, but also a guardian of her culture and language, preserving them and ensuring its continuity. Completing her morning rituals at the temple and summer classes for students by 8.30 a.m., she races to join fellow tribeswomen heading to the MGNREGS worksite. And as she walks past a village board displaying 'Addangi' in the Savara script, pride paints a light smile on her lips.
Business Wire
22-05-2025
- Business
- Business Wire
Savara Announces Participation in Jefferies Global Healthcare Conference
LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced members of the management team will host 1x1 meetings and present at the Jefferies Global Healthcare Conference on June 4, 2025, at 9:20am ET/6:20am PT. The live webcast and subsequent replay will be available on the 'Events & Presentations' section of the Company's corporate website and will be archived for 90 days. Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). MOLBREEVI is delivered via an investigational eFlow ® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at and LinkedIn. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.
Yahoo
21-05-2025
- Business
- Yahoo
Savara Inc. (SVRA): Analysts See 212% Upside Potential
We recently published an article titled . Savara Inc. (NASDAQ:SVRA) was one of the stocks that was covered in that article. Wall Street analysts believe SVRA has a 212% upside potential over the next 12 months. Close-up of an inhaler, representing the inhalation of the molgramostim product candidate. Savara Inc. (NASDAQ:SVRA) is a clinical-stage biopharmaceutical company dedicated to addressing the unmet needs of patients suffering from rare respiratory diseases. Founded in 1995, Savara is a key player in this niche field through innovative therapeutic development and a commitment to delivering life-changing solutions to patients worldwide. The company focuses on diseases that have limited treatment options, ensuring its research has a significant impact on improving health outcomes. The cornerstone of Savara Inc. (NASDAQ:SVRA) current pipeline is MOLBREEVI, a promising therapeutic designed to treat autoimmune pulmonary alveolar proteinosis (aPAP), a rare lung disease characterized by the accumulation of surfactant in the alveoli, impeding gas exchange and leading to respiratory distress. MOLBREEVI is currently undergoing Phase 3 clinical trials and has already demonstrated notable improvements in gas exchange, as well as measurable clinical benefits for patients. Savara is actively pursuing regulatory approval through a rolling Biologics License Application (BLA) submission to the FDA, and it is preparing for a Marketing Authorization Application (MAA) to the European Medicines Agency. These efforts reflect Savara's commitment to bringing MOLBREEVI to market as efficiently as possible. Unlike many biopharmaceutical companies, Savara employs a unique business model that emphasizes outsourcing the majority of its clinical development and manufacturing activities to specialized vendors and consultants. This approach enables the company to operate in a capital-efficient manner, maximizing resources while maintaining the highest standards of quality and innovation. Additionally, Savara's leadership team has extensive experience in navigating the complexities of drug development and commercialization, further strengthening its strategic position in the industry. Financially, Savara Inc. (NASDAQ:SVRA) is in a strong position, with approximately $196 million in cash and short-term investments as of its latest financial report. This robust financial reserve ensures the company's operations remain funded through Q2 2027, providing a solid foundation for advancing its pipeline and achieving its goals. Analysts have expressed optimism about Savara's prospects, citing the company's growing momentum, innovative pipeline, and prudent investment strategy as key drivers of its twelve-month average price target of $9.44, which reflects a substantial upside potential of 212.84%. Overall, Savara Inc. (NASDAQ:SVRA) ranks 13th on our list of 13 Best Multibagger Stocks to Invest in Now. While we acknowledge the potential of SVRA to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than SVRA and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: 10 Best Low Volatility Stocks to Buy Now and Starter Stock Portfolio: 12 Safe Stocks to Buy Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
