The biotech space this week witnessed significant key milestones, including FDA approvals, NDA path-setting meetings, rejections, licensing agreements, and oncology drug acquisitions. The clinical trial arena achieved positive results in therapeutic areas such as idiopathic nephrotic syndrome, age-related macular degeneration, ulcerative colitis, plaque psoriasis, obesity, autoimmune and inflammatory diseases.Let us unpack the key developments and milestones of this week. FDA Approvals & Rejections NRx Pha ...

NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Disc Medicine, Inc. (“Disc” or the “Company”) (NASDAQ: IRON). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Disc 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 January 15, 2026 ...

Core Viewpoint - The company received a complete response letter from the FDA regarding bitopertin, indicating that while there is evidence of its effectiveness in lowering protoporphyrin IX (PPIX), there is uncertainty about whether this reduction can predict clinical benefits [3]. Group 1: Regulatory Update - The FDA's complete response letter highlights sufficient evidence that bitopertin significantly lowers PPIX levels [3]. - However, the FDA expressed uncertainty regarding the correlation between PPIX reduction and actual clinical benefits [3].

Disc Medicine (NasdaqGM:IRON) Update / briefing February 17, 2026 08:00 AM ET Company ParticipantsDerek Archila - Managing DirectorDouglas Tsao - Managing DirectorJohn Quisel - CEORami Katkhuda - Managing DirectorSean Laaman - Executive DirectorStephen Willey - Managing DirectorWill Savage - Chief Medical OfficerConference Call ParticipantsBulchum Patel - AnalystEvan Seigerman - AnalystKristen Kluska - Equity Research AnalystRoger Song - Senior Equity Research AnalystNone - AnalystNone - AnalystOperatorGood ...

Disc to pursue traditional U.S. approval for bitopertin after FDA rejects new fast-track route | ReutersSkip to main content[Exclusive news, data and analytics for financial market professionalsLearn more aboutRefinitiv]Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly//File Photo [Purchase Licensing Rights, opens new tab]- Companies[Disc Medicine Inc]FollowFeb 17 (Reuters) - Disc Medicine [(IRON.O), opens new t ...

February 2026 Bitopertin Regulatory Update Disclaimer and FLS This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding Disc's expectations with respect to its preclinical studies, clinical trials and research and development programs, in particular with respect to bitopertin, DISC-0974 and DISC-3405, and any developments or results in connection therewith; project ...

Core Viewpoint - The U.S. Food and Drug Administration (FDA) has declined to approve Disc Medicine's experimental drug bitopertin for treating erythropoietic protoporphyria, leading to a significant drop in the company's stock price by 31.6% to $48.90 [1]. Company Summary - Disc Medicine was seeking FDA approval for bitopertin, aimed at treating a rare genetic metabolic disorder caused by a deficiency of the ferrochelatase enzyme [1]. - The primary symptom of erythropoietic protoporphyria is hypersensitivity of the skin to sunlight [1].

Core Viewpoint - Disc Medicine, Inc. announced that the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for bitopertin, delaying its potential approval for treating erythropoietic protoporphyria (EPP) [1] Group 1: FDA Review and Approval Process - The FDA acknowledged that previous trials (AURORA and BEACON) provided sufficient evidence that bitopertin significantly lowers whole blood metal-free PPIX [2][6] - However, the FDA concluded that the trials did not demonstrate a clear association between the change in PPIX levels and clinical benefits related to sunlight exposure, necessitating further evidence from the ongoing APOLLO study for traditional approval [2][6] - The APOLLO study is expected to provide topline data in Q4 2026, which could serve as a basis for traditional approval [6] Group 2: Company Response and Future Plans - The company remains committed to delivering bitopertin to the EPP community and plans to pursue all avenues for FDA approval despite the CRL [3] - Disc Medicine is confident in the ongoing APOLLO trial, which has seen significant enthusiasm from patients and physicians, leading to early completion of trial enrollment in March 2026 [3] - Following the completion of the APOLLO study, the company plans to respond to the CRL and anticipates an updated FDA decision by mid-2027 [3] Group 3: Financial Position - As of December 31, 2025, Disc Medicine reported approximately $791 million in cash, cash equivalents, and marketable securities, providing a financial runway into 2029 [3]

NEW YORK, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Disc Medicine, Inc. (“Disc” or the “Company”) (NASDAQ: IRON).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Disc 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 January 15, 202 ...

Disc Medicine, Inc. (IRON) closed the last trading session at $82.14, gaining 6.8% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $122.08 indicates a 48.6% upside potential.The average comprises 12 short-term price targets ranging from a low of $109.00 to a high of $154.00, with a standard deviation of $15.41. While the lowest estimate indicates an increase of 32.7% from the curre ...