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Avalo Therapeutics, formerly Cerecor, has announced its rebranding to reflect a focus on innovative therapies in immunology and rare diseases. The company boasts a pipeline of six product candidates, with eight clinical programs ongoing. Notably, four of these therapies have received Rare Pediatric Disease Designation, potentially qualifying them for Priority Review Vouchers upon FDA approval. With multiple data readouts expected in the second half of 2021, Avalo aims to address significant unmet medical needs.
Cerecor Inc. (NASDAQ: CERC) reported encouraging results for CERC-002 in Crohn's disease patients who failed multiple biologic therapies. The 1.0 mg/kg cohort showed an 80% reduction in LIGHT levels, with 75% of patients achieving mucosal healing. The company plans to expand CERC-002 to ulcerative colitis. Cerecor also completed a $35 million debt financing, bolstering its cash position to $40.4 million. However, operating expenses surged to $20.5 million, primarily due to increased R&D costs, resulting in a net loss of $17.1 million for Q2 2021.
Cerecor Inc. (CERC) announced positive initial results from its Phase 1b trial of CERC-002 in patients with moderate-to-severe Crohn’s Disease. The company completed a $10 million drawdown from its $35 million debt financing with Horizon Technology Finance Corporation. Cerecor has now drawn a total of $30 million under this agreement, with potential for an additional $5 million based on future milestones. As of June 30, 2021, Cerecor reported $40.4 million in cash, which will support the development of investigational therapies.
Cerecor announced positive results for its investigational drug, CERC-002, in a Phase 1b trial for moderate to severe Crohn's disease. In the low-dose cohort (1.0 mg/kg), 75% of subjects showed clinically meaningful endoscopic improvement, and there was an approximate 80% reduction in LIGHT protein levels. The drug was well-tolerated, with no severe adverse events reported. Following these findings, Cerecor aims to explore expanding CERC-002 to treat ulcerative colitis patients. Complete data for the higher dose cohort is expected in the second half of 2021.
Cerecor Inc. (NASDAQ: CERC) has divested its non-core neurology pipeline assets and entered into a license agreement with Sanford Burnham Prebys for an immune checkpoint program. This strategic move enhances the company's focus on immunology, immuno-oncology, and rare genetic disorders. Cerecor will make an up-front payment and is eligible for further milestone-related payments and royalties. The divestiture of neurology assets allows Cerecor to concentrate on high unmet needs in its core therapeutic areas.
Cerecor Inc. (NASDAQ: CERC) announced a debt financing agreement for up to $35 million with Horizon Technology Finance Corporation. An initial tranche of $20 million has been drawn to support the ongoing clinical development of investigational product candidates targeting rare diseases. The financing increases Cerecor's financial resources and allows for further clinical catalysts through 2021. The remaining $15 million will be available upon achieving specific milestones. Interest payments are structured over 42 months, with certain conditions extending the interest-only period.
Cerecor Inc. (NASDAQ: CERC) has announced participation in three upcoming virtual investor conferences. The 2021 RBC Capital Markets Global Healthcare Virtual Conference is set for May 18, 2021, at 8:35 AM ET, followed by Oppenheimer Rare & Orphan Disease Summit on May 21, 2021, which includes 1x1 meetings only. Finally, the Jefferies Virtual Healthcare Conference will take place on June 2, 2021, at 1:00 PM ET. Live webcasts will be available on the company's website, featuring their developmental focus on treatments for rare diseases.
Cerecor Inc. (NASDAQ: CERC) recently announced significant advancements in its business, highlighted by the FDA granting Fast Track designation to CERC-002 for treating COVID-19 ARDS following encouraging Phase 2 trial results. The company secured exclusive rights to develop and commercialize CERC-002 globally. Cerecor also initiated a Phase 1b trial for CERC-007 in adult onset Still’s disease. Financially, as of March 31, 2021, the company reported $38.3 million in cash, a notable increase from $18.9 million in December 2020, driven by a public offering. However, net product revenue dropped by $2.3 million.
Cerecor Inc. (NASDAQ: CERC) has received Fast Track designation from the FDA for its monoclonal antibody CERC-002 aimed at treating hospitalized COVID-19 patients. This designation allows expedited drug development and review processes, addressing unmet medical needs. CERC-002 targets LIGHT, a cytokine linked to immune response, and is also being developed for pediatric onset Crohn’s disease. The company is advancing multiple treatments for rare diseases, with additional assets in their pipeline having received Orphan Drug Designation.
Cerecor Inc. (NASDAQ: CERC) announced the dosing of its first patient in a Phase 1b clinical trial for CERC-007, targeting adult onset Still’s disease (AOSD). The trial aims to evaluate the safety and tolerability of this high-affinity, fully human anti-IL-18 monoclonal antibody. Initial data is expected in Q3 2021, with top-line results from a related trial in relapsed or refractory multiple myeloma patients anticipated in H2 2021. AOSD is a rare inflammatory disease affecting approximately 3,500 - 7,000 patients in the U.S. and has significant unmet medical needs.
