Brings more than 25 years of biopharma business development and corporate strategy expertiseBOTHELL, Wash., Feb. 03, 2026 (GLOBE NEWSWIRE) -- LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, today announced the appointment of Mark F. Kubik as Chief Business Officer. In this role, Mr. Kubik will lead LeonaBio’s business development strategy and execution, with responsibility for licensing, ...

Core Viewpoint - Athira Pharma, Inc. has rebranded as LeonaBio, Inc. to reflect its strategic focus on developing lasofoxifene for metastatic breast cancer treatment, currently in Phase 3 trials [1][2] Company Overview - LeonaBio is a clinical-stage biopharmaceutical company focused on innovative therapeutics for diseases with high unmet medical needs, including metastatic breast cancer and amyotrophic lateral sclerosis (ALS) [10] - The company aims to advance a pipeline of late-stage assets to maximize clinical and commercial impact [2] Name and Ticker Change - The name change to LeonaBio symbolizes strength and resilience, aligning with the company's mission to support patients facing serious diseases [2] - The new ticker symbol "LONA" will be effective on January 12, 2026, on The Nasdaq Capital Market [1] Lead Drug Candidates - Lasofoxifene and ATH-1105 are the lead drug candidates, targeting treatment-resistant metastatic breast cancer and ALS, respectively [3][10] - Lasofoxifene is in a Phase 3 trial (ELAINE-3) with over 50% enrollment, and data is expected in mid-2027 [3][6] Licensing and Financing - LeonaBio secured an exclusive global license for lasofoxifene from Sermonix Pharmaceuticals, excluding Asia and certain Middle Eastern countries [4] - The company raised $90 million through a private placement, with potential additional funding of up to $146 million from warrants, to support lasofoxifene's development [4] Drug Candidate Details - Lasofoxifene is a selective estrogen receptor modulator (SERM) designed to target both wild-type and mutant estrogen receptors, addressing a critical unmet need in metastatic breast cancer [5] - ATH-1105 is a next-generation small molecule aimed at treating neurodegenerative diseases, currently in Phase 1 trials with plans for a Phase 2 trial in ALS patients in early 2026 [7][8]

Core Viewpoint - Athira Pharma, Inc. has rebranded as LeonaBio, Inc. following the acquisition of rights to develop and commercialize lasofoxifene for metastatic breast cancer, reflecting the company's commitment to innovation and leadership in addressing unmet medical needs [1][2] Group 1: Company Name Change and Strategy - The name change to LeonaBio symbolizes strength and resilience, aligning with the company's mission to deliver transformative therapies for serious diseases [2] - The new ticker symbol "LONA" will be used on The Nasdaq Capital Market starting January 12, 2026, without affecting the company's legal structure or operations [1][2] Group 2: Drug Development Focus - LeonaBio's lead drug candidates include lasofoxifene and ATH-1105, targeting treatment-resistant metastatic breast cancer and amyotrophic lateral sclerosis (ALS) [3][9] - Lasofoxifene is currently in a Phase 3 clinical trial (ELAINE-3), with over 50% enrollment and data expected in mid-2027 [3][6] Group 3: Licensing and Financing - The company secured an exclusive global license for lasofoxifene from Sermonix Pharmaceuticals, with an upfront financing of $90 million and potential additional funding of up to $146 million through warrants [4] - This financing is expected to support lasofoxifene's development through key clinical and regulatory milestones, with sufficient capital for operations into 2028 [4] Group 4: Drug Candidate Details - Lasofoxifene is a selective estrogen receptor modulator (SERM) designed to target both wild-type and mutant estrogen receptors, addressing critical unmet needs in metastatic breast cancer [5] - ATH-1105 is a next-generation small molecule drug candidate aimed at treating neurodegenerative diseases, currently in clinical development for ALS [7][8]

Core Viewpoint - Athira Pharma Inc. is making significant strides in its development pipeline by acquiring rights to lasofoxifene, a drug in a Phase 3 trial for metastatic breast cancer, which is expected to enhance its market position and growth potential [1][2]. Group 1: Acquisition Details - Athira has secured an exclusive global license (excluding Asia and certain Middle Eastern countries) from Sermonix Pharmaceuticals for the development and commercialization of lasofoxifene [2]. - As part of the agreement, Athira will issue a pre-funded warrant to purchase approximately 5.5 million shares at an exercise price of $0.001 per share, along with potential payments of up to $100 million based on commercialization or annual net sales milestones [3]. Group 2: Financing and Development Plans - The company announced a $90 million upfront financing through private placement of common stock and warrants, which could provide an additional $146 million if the warrants are exercised, aimed at supporting the development of lasofoxifene through key clinical and regulatory milestones [4]. - The net proceeds from the financing will be utilized for the development of lasofoxifene for treatment-resistant metastatic breast cancer, other clinical assets, and general corporate purposes [5]. Group 3: Market Performance - Following the announcement, Athira Pharma's stock surged by 74.49% to $7.22, reaching a new 52-week high, indicating strong market confidence in the company's future prospects [5].

Core Viewpoint - Athira Pharma, Inc. announced an agreement to acquire global development and commercialization rights to lasofoxifene, a Phase 3 ready asset for metastatic breast cancer, leading to a significant surge in its stock price [1] Group 1: Stock Performance - Athira Pharma shares surged 69.53 percent, gaining $2.88 to trade at $7.01 on Thursday [1] - The stock opened at $7.22 and fluctuated within a day's range of $6.77 to $8.35 [2] - Trading volume spiked to approximately 53.19 million shares, significantly higher than the average volume of around 30,063 shares [2] Group 2: Market Reaction - Investors reacted positively to the late-stage pipeline expansion, with shares now trading near the top of its 52-week range of $2.20 to $8.35 [2]

Market Performance - U.S. stocks experienced an upward trend, with the Nasdaq Composite gaining over 200 points on Thursday [1] - The Dow increased by 0.44% to 48,097.08, while the NASDAQ rose by 1.08% to 22,938.56, and the S&P 500 climbed 0.76% to 6,772.76 [1] Sector Performance - Consumer discretionary shares rose by 2% on Thursday, indicating strong performance in that sector [1] - Conversely, energy stocks fell by 0.5% during the same trading session [1] Inflation and Economic Indicators - U.S. inflation showed a greater-than-expected decline in November, with the Consumer Price Index rising by 2.7% year over year, down from 3% in September and below the expected 3.1% [2] - The Philadelphia Fed Manufacturing Index dropped by 8.5 points to -10.2 in December, missing market estimates [10] - Initial jobless claims decreased by 13,000 to 224,000 for the week ending December 13 [10] Commodity Prices - Oil prices increased by 1% to $56.47, while gold prices decreased by 0.2% to $4,365.60 [5] - Silver prices fell by 1.9% to $65.640, while copper prices rose by 0.1% to $5.4360 [5] Company-Specific Movements - Athira Pharma Inc shares surged by 84% to $7.62 following an agreement to acquire rights for lasofoxifene [8] - Trump Media & Technology Group Corp shares rose by 29% to $13.47 after signing a merger agreement with TAE Technologies [8] - FuelCell Energy Inc shares increased by 32% to $10.47 after reporting better-than-expected fourth-quarter results [8] - Insmed Inc shares dropped by 16% to $166.17 after failing to meet efficacy endpoints in a clinical study [8] - Pyxis Oncology Inc shares fell by 55% to $1.52 following preliminary data from clinical studies [8] - Actelis Networks Inc shares decreased by 47% to $0.59 after announcing a public offering [8] International Market Performance - European shares were generally higher, with the eurozone's STOXX 600 gaining 0.56% and Spain's IBEX 35 Index rising by 0.60% [6] - Asian markets closed mixed, with Japan's Nikkei falling by 1.03% and Hong Kong's Hang Seng gaining 0.12% [9]

Market Overview - U.S. stocks experienced a positive trading session, with the Dow Jones index increasing by approximately 400 points, up 0.84% to 48,289.58, while the NASDAQ rose 1.53% to 23,040.25 and the S&P 500 gained 1.09% to 6,794.36 [1] - In the commodities market, oil prices increased by 1% to $56.48, while gold decreased by 0.2% to $4,364.50, silver fell by 1.1% to $66.160, and copper rose by 0.1% to $5.4370 [5] Company Performance - Accenture (NYSE:ACN) reported first-quarter 2026 earnings of $3.94 per share, exceeding the analyst consensus estimate of $3.75, and sales of $18.700 billion, slightly above the consensus estimate of $18.523 billion [2] - Athira Pharma Inc (NASDAQ:ATHA) shares surged 88% to $7.76 following the announcement of an agreement to acquire rights for the development and commercialization of lasofoxifene [9] - FuelCell Energy Inc (NASDAQ:FCEL) shares increased by 32% to $10.39 after reporting better-than-expected fourth-quarter financial results [9] Sector Performance - Consumer discretionary shares rose by 1.6% on Thursday, indicating a positive trend in this sector [1] - Energy stocks, however, saw a decline of 0.8% during the same trading session [1] International Markets - European shares showed gains, with the eurozone's STOXX 600 up 0.5%, Spain's IBEX 35 Index rising 0.7%, London's FTSE 100 gaining 0.1%, Germany's DAX 40 increasing by 0.5%, and France's CAC 40 up 0.4% [6] - Asian markets closed mixed, with Japan's Nikkei falling 1.03%, while Hong Kong's Hang Seng gained 0.12%, China's Shanghai Composite rose 0.16%, and India's BSE Sensex fell 0.09% [7]

Lasofoxifene (Metastatic Breast Cancer) - The global metastatic ER+/HER2- breast cancer market is expected to grow from approximately $10.9 billion in 2025 to roughly $15.9 billion by 2029[23] - Lasofoxifene, combined with abemaciclib, demonstrated a potential best-in-class median Progression-Free Survival (PFS) of 13 months in a heavily pre-treated mESR1 population in the Phase 2 ELAINE-2 trial[26, 27, 50] - In the ELAINE-1 Phase 2 study, lasofoxifene delivered a median PFS of 24.2 weeks compared to 16.2 weeks with fulvestrant in ESR1-mutant breast cancer[48] - Approximately 70% of all breast cancers are ER+/HER2- subtype[23, 32] - Lasofoxifene reduced new onset breast cancer by 83% in a large prevention trial[30] - The ELAINE-3 registrational Phase 3 trial is ongoing, with topline results expected in mid-2027 and over 50% enrollment[16, 17, 57, 138, 139] - Assuming approximately 10% market penetration, lasofoxifene has a peak market sale potential of over $1 billion in the US market[81] ATH-1105 (ALS) - Approximately 225,000 people globally are affected by ALS, with roughly 33,000 cases in the US[98] - ATH-1105 is a CNS-penetrant positive modulator of HGF as a potential treatment for ALS[103] - A Phase 2 POC study in ALS is planned to start in the first half of 2026, with topline results expected in 2027[18, 19, 140, 141] Financial - A PIPE financing of up to $236 million, including $90 million upfront, provides cash runway through data readout and into 2028[137]

Core Viewpoint - Athira Pharma has acquired the rights to develop and commercialize lasofoxifene, a selective estrogen receptor modulator (SERM), for the treatment of metastatic breast cancer, representing a significant opportunity in a multi-billion dollar market [2][3][4]. Financing and Development - Athira announced a $90 million upfront financing through private placement, co-led by Commodore Capital, Perceptive Advisors, and TCGX, with potential additional funding of up to $146 million through warrants [4][9]. - The financing aims to support the development of lasofoxifene through key clinical and regulatory milestones, with sufficient capital projected to last into 2028 [4][9]. Clinical Trials and Data - The ongoing Phase 3 ELAINE-3 clinical trial is over 50% enrolled, with pivotal data expected in mid-2027 [2][19]. - Previous Phase 2 trials (ELAINE-1 and ELAINE-2) demonstrated lasofoxifene's potential, showing significant progression-free survival and objective response rates in heavily pre-treated patients [17][18]. Market Opportunity - The metastatic breast cancer treatment market is projected to grow from $17.1 billion in 2021 to $41.7 billion by 2030, with a compound annual growth rate (CAGR) of approximately 10.4% [14][15]. - Approximately 40% of breast cancer patients develop ESR1 mutations, creating a substantial market for lasofoxifene as a preferred endocrine therapy [5][14]. License Agreement Details - Athira has entered into a license agreement with Sermonix Pharmaceuticals, which includes a pre-funded warrant for approximately 5.5 million shares and potential milestone payments of up to $100 million based on commercialization success [6][9]. Company Overview - Athira Pharma is focused on developing novel therapeutics for high unmet medical needs, including treatment-resistant metastatic breast cancer and neurodegenerative diseases [23].