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Results for " Phase 2 " 26 found 🔀 AI-powered Shuffle

Tritec holds groundbreaking for newest phase at Station Yards

Tritec Real Estate breaks ground on Phase 2C of Station Yards in Ronkonkoma, adding 285 apartments and medical office space.

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Oct 6 • 1:51 PM EDT • Business • libn.com
$1 million state grant awarded to SFM Skatepark in Rome

The SFM Memorial Skatepark in Rome has been awarded a $1 million grant through the Dormitory Authority of the State of New York, which will help push forward Phase 2 of the project to include more amenities such as seating, landscaping and a modified access road, according to Governor Kathy Hochul.

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Oct 2 • 11:00 AM EDT • Entertainment • romesentinel.com
Pioneer of China NewCo model sued in US over trade secret misuse, double-dealing

A legal feud unfolding in New York is putting a spotlight on the work of a business development veteran who is credited for pioneering one of biopharma’s hottest dealmaking mechanism: the China “NewCo” model. In a lawsuit originally filed in New York state court and recently moved to federal court, China’s Lepu Medical Technology has alleged that biopharma business development consultant Su Zhang, who was hired to help shop its GLP-1 weight-loss candidates to Western partners, engaged in corporate double-dealing and trade secret leaks. According to the complaint, while acting as Lepu’s primary dealmaking liaison for a group of obesity and metabolic disease drug candidates, Zhang was secretly double-dipping as the acting chief business officer for a direct competitor, BrightGene Pharmaceutical. “She never adequately disclosed the role, never sought Lepu’s consent, and never proposed any safeguard,” Lepu alleged in its complaint, which was filed in July after Zhang’s consulting firm, CoDevCo, sought certain transaction-based success fees from its angry customer through an arbitration process in Singapore. Lepu, the parent company of Lepu Biopharma, has asked Zhang to pay back its $500,000 retainer and disgorge all benefits she received during the alleged breaches of fiduciary duty, plus other damages and relief. The company has also requested the court grant injunctions to protect Lepu’s trade secrets. The ill-fated partnership officially kicked off in December 2024, when Lepu tapped CoDevCo as its “exclusive business development mechanism” to identify collaborators for the company’s drug candidates. According to Lepu’s complaint, Zhang personally negotiated and signed the agreement as managing director for CoDevCo, which used her home address. Before the Lepu deal, Zhang made a name following a short stint as the global head of business development for Hengrui Pharmaceuticals. It was during her tenure that Hengrui signed a landmark deal granting exclusive rights for a portfolio of GLP-1 assets to Hercules, which was at that time newly established by a group of private equity and venture capital firms. In addition to the regular upfront and milestone payments, Hengrui also gained an equity stake in Hercules, which later became Kailera Therapeutics. The Hengrui-Hercules deal opened a new paradigm, where a Chinese biopharma company spins off certain early-stage assets to investors for further development through the creation of a new company abroad. The “NewCo” model quickly came into vogue as it allows Western investors to access high-potential assets originating from China at an early stage while giving the Chinese licensors an opportunity to reap long-term benefits through equity stakes in the new firms. The NewCo model proved its value when Kailera staged a record-breaking $625 million IPO on Nasdaq this April, merely two years into the Hengrui deal. Related Kailera CEO 'knew we were in a good spot' before obesity biotech's record-breaking $625M IPO On her LinkedIn page, Zhang described her work at Hengrui as “[b]uilding team and capability from the ground up,” forming NewCo and major pharma partnerships worth billions of dollars. Lepu clearly wanted that kind of track record to help boost its own cardiometabolic portfolio, which includes a range of assets for obesity, Type 2 diabetes, fatty liver disease and muscle preservation during weight loss treatment. “Lepu’s pipeline is very valuable, but only if Lepu could secure the right international partner to expand into the overseas market during the available commercial window,” the company argued in its complaint. The Chinese biotech said it had little knowledge of U.S. laws, customs or business practices in the business development field, and therefore “needed to rely entirely” on the expertise of Zhang and her team as the firm’s first engagement of a U.S.-based BD consultant. “Zhang’s dominating influence on the business development strategy is further evidenced by the fact that she personally controlled the business-development communications on behalf of Lepu with potential partners,” Lepu said in its complaint. After entering the deal, Zhang introduced Lepu to her four associates. According to Lepu’s version of events, all of them were allegedly employed at different time points to perform similar jobs at other Chinese companies that Lepu described as its competitors, while having access to Lepu’s confidential information. As such, Lepu described Zhang’s team as “a roster of individuals whose primary professional loyalty, by virtue of their concurrent full-time employment, ran to Lepu’s competitors.” As well as the specific examples set out in the case, a look at Lepu’s deals over the period suggests Zhang may have been involved in at least one transaction. During their partnership, Lepu, through its subsidiary Shanghai Minwei Biotechnology, also out-licensed its GLP-1/GIP/FGF21 agonist MWN105 to a NewCo called Sidera Bio in the fall of 2025. The deal included an upfront and near-term payment of $35 million, up to $1.01 billion in milestones, and a 9.99% stake in the Danish startup. It seems likely that Zhang facilitated the Minwei deal given that Lepu is on record as having used CoDevCo as its “exclusive business development mechanism.” The big shock for Lepu came in the form of a news article on June 25, 2025. The article, reporting on phase 2 data for BrightGene’s GLP-1/GIP receptor agonist BGM0504, identified Zhang as acting chief business officer of the Lepu rival. Blindsided by her association with BrightGene, Lepu confronted Zhang in July 2025. “Lepu was given assurances that there was nothing to be concerned about and told that Zhang would explain the matter to Lepu,” Lepu alleged in its complaint. “Zhang never did.” Lepu claimed that Zhang had the motive and opportunity to steer potential prospective partners toward BrightGene or other competitors. Later, in February 2026, one of Zhang’s associates joined BrightGene as the vice president for global business development, according to the complaint. Around the same time, Lepu sent written demand letters asking Zhang to account for her BrightGene role, identify what confidential data were shared with the rival firm, and provide any conflict-of-interest or firewall policies during the engagement. According to Lepu, neither CoDevCo nor Zhang answered the questions in their responses. Related Novo vs. KBP: How a $1.3B deal turned into a fraud accusation and an international legal fight In a motion to dismiss filed with the U.S. District Court in the Eastern District of New York on Sept. 4, Zhang’s legal team argued that Lepu’s agreement was signed with CoDevCo, and that an employee of the contractor does not owe fiduciary duties to the client. In its complaint, Lepu said: “That CoDevCo was the contracting entity does not insulate Zhang from personal liability for duties she personally undertook and personally breached.” Taking the argument one step further, the defending party argued that the consulting agreement “does not create a fiduciary relationship even between CoDevCo and Lepu; instead, it identifies CoDevCo as an independent contractor retained to market Lepu’s business to potential western partners.” Although CoDevCo was Lepu’s exclusive business-development contractor, there were no terms stipulating that the consulting firm should serve only Lepu, Zhang’s lawyer noted. As to Lepu’s claims that Zhang misappropriated trade secrets, the defendant argued that Lepu authorized the use of the information so Zhang’s team could perform their service per the agreement. In a rebuttal filed on Sept. 11, Lepu’s lawyer set out why they believe the Chinese biotech satisfied New York law’s misappropriation definition by alleging that the defendant used a trade secret “in breach of a duty or through improper means.” As an alternative to dismissing the suit, the defendant suggested the action should be stayed pending outcomes from the arbitration of a separate case in Singapore. While NewCo pioneer Zhang is defending her business arrangements, momentum behind the NewCo trend has continued unabated into 2026. Through August, Chinese biotech assets have spurred 15 NewCo deals this year, according to local trade publication PharmaDJ.

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Sep 25 • 8:40 AM EDT • Business • fiercebiotech.com
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Optimi Health Appoints Dr. Michael Blough as Chief Clinical Development Officer

Supports Optimi’s planned Phase 2 psilocybin trial in major depressive disorder and Phase 3 MDMA trial in PTSDVANCOUVER, British Columbia, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN) ("Optimi" or the "Company"), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, today announced the appointment of Michael Blough, Ph.D., as Chief Clinical Development Officer. Dr. Blough has significant experience leading Health Ca

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Sep 22 • 9:00 AM EDT • Health • finance.yahoo.com
AbCellera women’s health data top ‘most aggressive upside scenario,’ putting Astellas and Bayer on notice

AbCellera has reported phase 2 results “beyond even the most aggressive upside scenario” that its CEO dared to consider, boosting the biotech’s chances of challenging Astellas and Bayer for a women’s health market. The phase 2 clinical trial compared ABCL635, an antibody targeting NK3R, to placebo in patients with hot flashes caused by menopause. Investigators enrolled 92 postmenopausal women experiencing a mean of about 10 moderate or severe hot flashes per day. By Week 4, the number of moderate or severe hot flashes had fallen by a mean of 8.8 on ABCL635 and by 3.5 on placebo. That statistically significant, placebo-adjusted reduction of 5.3 hit the trial’s primary endpoint. The level of efficacy also cleared the bar set by existing drugs. While cross-trial comparisons can be misleading, AbCellera CEO Carl Hansen, Ph.D., had seen enough to start hyping the program. “We now view ABCL635 as a potential best-in-class non-hormonal therapy with strong differentiation against approved NK3R competitors across all important dimensions, including efficacy, safety, dosing and convenience,” Hansen said on a Monday morning conference call with investors to discuss the data. “We believe ABCL635 is now a highly de-risked program.” Last week, Hansen used AbCellera’s earnings call to set expectations for readout, with the CEO defining success as a clean safety profile and efficacy comparable to the two approved small molecules. The data vaulted over that bar. Astellas linked (PDF) one of the small molecules, Veozah, to placebo-adjusted reductions in hot flash frequency of 2.1 and 2.6 at Week 4 of its two phase 3 trials. Bayer reported (PDF) placebo-adjusted reductions of 3.04 and 3.29 at Week 4 of pivotal studies for its small molecule, Lynkuet. At 5.3, the placebo-adjusted reduction in AbCellera’s trial comfortably cleared the standard set by the incumbents. Veozah and Lynkuet came to market based on evidence of their ability to reduce the frequency and severity of hot flashes. AbCellera’s phase 2 study covered both endpoints, with the Canadian biotech reporting a mean reduction in severity of 1.4 points at Week 4 on ABCL635, compared to 0.3 points for placebo. Again, the placebo-adjusted result compares favorably to data on Veozah and Lynkuet. Analysts shared Hansen’s enthusiasm for the data. The phase 2 results “firmly validate ABCL635 as a potentially best-in-class treatment,” BMO Capital Markets analysts said in a note to investors Monday. ABCL635’s apparent efficacy edge “is likely attributable to the higher dosing/target engagement the asset is able to reach vs. the oral agents due to its wider therapeutic index,” the analysts added. The analysts, who model $2.3 billion in unadjusted peak sales for ABCL635, flagged the safety profile as another positive of the phase 2 readout. While Veozah carries a boxed warning for liver damage, nobody on ABCL635 in the phase 2 trial had elevated liver enzymes or bilirubin values. If replicated in phase 3, the lack of a liver signal could allow approval without the monitoring requirements imposed on Veozah. Investors appeared equally enthused, sending AbCellera's stock up 32% to $9.21 in premarket trading Monday from a Friday closing price of $6.93. Next, AbCellera will collect the Week 12 data and talk to its advisors about further development. The results open up “a wide variety of possibilities of how we might take this forward into phase 3 studies to truly maximize the value of the asset and make sure that ABCL635 is able to demonstrate its differentiation potential,” Sarah Noonberg, M.D., Ph.D., AbCellera’s chief medical officer, told investors.

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Aug 10 • 8:24 AM EDT • Health • fiercebiotech.com
Sanofi suspends chronic lung disease phase 2 study, tied to ‘strategic business reasons’

Sanofi halted a phase 2 trial testing a monoclonal antibody, SAR445399, in non-cystic fibrosis bronchiectasis, Fierce Biotech has learned. The trial, which began only back in April, was a randomized, double-blind, placebo-controlled study to measure the reduction in mucus plug score following treatment with SAR445399 compared with placebo in adults aged 18 to 80 years with NCFB, a chronic lung disease. The trial was officially reported as halted on July 29, the day before Sanofi’s second-quarter earnings call. The decision to pause the trial was made “as part of a company-wide portfolio review for strategic business reasons,” and not due to safety concerns, a Sanofi spokesperson told Fierce. The move to pause the NCFB trial comes during a trying time for Sanofi following a year filled with a series of trial fails. In February, the French pharma ousted CEO Paul Hudson and appointed Merck KGaA leader Belén Garijo, M.D., Ph.D., to steer the ship. Since then, Garijo has been doing a deep dive on correcting the company’s strewn R&D and clinical strategies. On July 24, Sanofi scrapped amlitelimab for atopic dermatitis, despite its lore as being a potential $5 billion blockbuster. During its second-quarter report, the company abandoned two more assets, balinatunfib and itepekimab, following failed trial results in psoriasis and chronic obstructive pulmonary disease, respectively. SAR445399, only first revealed by Sanofi in 2023, is an anti-interleukin-1 receptor 3 monoclonal antibody developed to block the interleukin 1, 33, and 36 cytokine pathways. These pathways can be important in chronic immune-related dermatologic diseases, such as atopic dermatitis and hidradenitis suppurativa, as well as respiratory conditions, such as NCFB. Related Sanofi’s new CEO ‘looking deeply’ at late-stage pipeline as clinical clearout continues NCFB affects roughly half a million people in the U.S., with a global incidence of greater than one million cases. In August 2025, Insmed received FDA approval for Brinsupri, a DPP1 inhibitor targeting neutrophil activation, for treatment of NCFB in adults and kids ages 12 and older. The British biotech Infex Therapeutics showed promising NCFB phase 2a data using their monoclonal antibody, INFEX702, which acts by disabling Pseudomonas aeruginosa, a bacteria known to be a major pathogen of NCFB. Sanofi is currently running a separate phase 2 study testing SAR445399 as a potential treatment for the inflammatory skin condition hidradenitis suppurativa.

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Aug 5 • 2:50 PM EDT • Business • fiercebiotech.com
Convention Center Launches WIN Phase 2 Series With Construction Services Small Business Workshop

The New Orleans Ernest N. Morial Convention Center (NOENMCC) is continuing its commitment to small and emerging businesses throughout the year with the next installment in its WIN Series. The next phase of workshops, The Procurement Playbook, focuses on construction and vendor service businesses throughout Greater New Orleans. The WIN Series is a part of

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Aug 5 • 9:00 AM EDT • Business • mccno.com
Galveston businesses ask for I-45 construction delay

Concerned about the effect on businesses during the final weeks of Galveston’s peak tourism season, the Galveston Restaurant Group has asked the Texas Department of Transportation to delay Phase 2,

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Jul 27 • 5:10 PM EDT • Business • galvnews.com
Phase 2 of restoration project underway at West Herr Performing Arts Center

Members of the Rochester Broadway Theatre League say this next phase of work includes expanding the theatre's Rothschild Lounge back to its original size.

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Jun 26 • 1:14 PM EDT • Entertainment • spectrumlocalnews.com
PWHL Detroit roster updates: Newest hockey players on expansion squad

Detroit's new team in the Professional Women's Hockey League wrapped up Phase 2 of the expansion process on Monday, June 8 by signing Jesse Compher.

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Jun 8 • 9:20 PM EDT • Sports • sports.yahoo.com
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Los Angeles Rams players participate in offseason workouts for Phase 2 of OTAs

Browse through photos capturing the best moments from this week's offseason workouts at the Los Angeles Rams' training facility.

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May 22 • 1:05 PM EDT • Business • therams.com
Relmada Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update

Positive 12-Month Phase 2 data for NDV-01 demonstrated a 95% complete response (CR) rate at any time and a durable 76% CR rate at 12 months in high-risk non-muscle invasive bladder cancer (NMIBC), and a 94% CR rate at any time and a durable 80% CR rate at 12 months in the BCG-unresponsive subpopulation, reinforcing best-in-class potential in NMIBCOn track to initiate Phase 3 RESCUE registrational program in second line (2L) BCG-unresponsive and adjuvant intermediate-risk NMIBC in mid-2026Filed p

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May 12 • 4:05 PM EDT • Business • finance.yahoo.com
Xenon Reports Q1 2026 Financial Results and Provides Business Update

Reported positive topline data from Phase 3 X-TOLE2 study of azetukalner in FOS in March and anticipate NDA submission in Q3 2026Five additional Phase 3 studies of azetukalner continue to enroll in epilepsy and depression indications with Phase 3 X-NOVA2 MDD topline data expected in H1 2027 Phase 1 studies of novel NaV1.7 (XEN1701) and KV7 (XEN1120) candidates expected to complete H2 2026 to support Phase 2 proof-of-concept studies in pain Cash, cash equivalents and marketable securities of $1.3

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May 7 • 4:01 PM EDT • Business • finance.yahoo.com
IDEAYA Biosciences Reports First Quarter 2026 Financial Results and Provides Business Update

Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint; complete data will be provided in a late-breaking oral...

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May 5 • 6:00 AM EDT • Business • prnewswire.com
Traws Pharma Reports Full Year 2025 Results and Provides Business Highlights

Tivoxavir marboxil advancing towards a human influenza challenge trial as a once-monthly prophylactic agent, building on broad preclinical antiviral activity, Ratutrelvir topline Phase 2a data show a differentiated profile versus PAXLOVID® in COVID patients, with good overall safety; final study analysis underway Private financing of up to $60M (with $10M of such amount upfront) offering of common stock and milestone-based and three-year warrants completed on April 15, 2026 supporting operations

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Apr 15 • 4:01 PM EDT • Business • finance.yahoo.com
XOMA Royalty Reports 2025 Financial Results and Highlights Recent Business Achievements

Portfolio receipts: • Achieved over $50 million of cash receipts, including $33.6 million in royalties and $16.9 million milestones, in full year 2025 • Total receipts increased 9% with royalties up 68% versus full year 2024 Business development: Added 22 assets to portfolio, including five programs in Phase 2 or Phase 3 development Stock buyback program: Repurchased and retired 648,048 shares for an aggregate of $16.0 million Company acquisitions: Completed seven acquisitions, accumulating $11.

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Mar 18 • 6:00 AM EDT • Business • finance.yahoo.com
Vaxart Provides Business Update and Reports Full Year 2025 Financial Results

Topline data from 400-person sentinel cohort of the Phase 2b COVID-19 trial anticipated early Q2 2026 Published positive clinical results in the first quarter of 2026 demonstrating oral norovirus vaccine candidate was safe and immunogenic in lactating women and resulted in passive transfer of antibodies to their infants via breast milk Cash, cash equivalents and investments of $63.8 million as of December 31, 2025; Runway into second quarter of 2027 Conference call today at 4:30 p.m. ET Live sto

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Mar 12 • 4:05 PM EDT • Business • finance.yahoo.com
New plans for Monmouth Park could include more homes, sports complex

Could more houses be in store for Monmouth Park? Developers will return to Oceanport's Planning Board and Council with Phase 2 plans.

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Mar 10 • 5:15 AM EDT • Sports • app.com
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Local business owners share concerns as phase 2 of Penn Avenue project begins

Several blocks of Penn Avenue between Evaline Street and North Graham Street will undergo a major infrastructure makeover starting Monday.

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Mar 9 • 6:31 PM EDT • Business • wtae.com
Cartesian Therapeutics Reports Full Year 2025 Financial Results and Provides Business Update

Enrollment continues to progress in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Phase 2 TRITON trial of Descartes-08 in dermatomyositis and antisynthetase syndrome, expected to initiate in 1H26 Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis actively enrolling Approximately $126.9 million cash, cash equivalents and restricted cash as of December 31, 2025, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AUROR

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Mar 9 • 7:00 AM EDT • Business • finance.yahoo.com
NovaBridge to Host Business Update Call to Review Phase 2a Data for VIS-101 in Wet AMD on Monday, March 9, 2026

VIS-101, purpose-designed to be a best-in-class dual VEGF-A/ANG-2 inhibitor, has the potential to provide more effective and durable treatment than the current standard of care for patients with wet AMD, DME and RVO Visara, a NovaBridge Majority-Owned Subsidiary, Holds Global Rights to VIS-101 Outside of Greater China and Certain Asian Territories ROCKVILLE, Md., March 03, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform co

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Mar 3 • 9:05 AM EST • Business • finance.yahoo.com
Tarsus Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Business Achievements

Generated full-year 2025 net product sales of XDEMVY® of $451.4 million, an increase of more than 150% year-over-year Providing expected XDEMVY peak sales potential of more than $2 billion Extending category-creating leadership with initiation of Phase 2 trial of TP-04 in ocular rosacea (OR) and plans to initiate a Phase 2 trial of TP-05 for Lyme disease prevention in Q2 2026 Management to host conference call today, February 23, 2026, at 1:30 p.m. PT / 4:30 p.m. ET IRVINE, Calif., Feb. 23, 2026

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Feb 23 • 4:05 PM EST • Business • finance.yahoo.com
More naming opportunities planned for Altru Sports Complex; first part of Phase 2 expected to bid in April

The Grand Forks Park District is looking at options for other naming rights in the facility to help fundraise for the project.

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Jan 29 • 8:01 AM EST • Sports • grandforksherald.com
Altru Sports Complex rising along Grand Forks' 42nd Street

Phase 1 is expected to be complete by fall 2027, while Phase 2, if bid by the City Council, would be finished around the summer of 2028.

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Jan 21 • 8:00 AM EST • Sports • grandforksherald.com
MBX Biosciences to Provide 2026 Outlook and Business Update at 44th Annual J.P. Morgan Healthcare Conference

One-year follow-up data from Phase 2 trial of once-weekly canvuparatide, a potential best-in-class therapy for hypoparathyroidism, anticipated in Q2 2026; Phase 3 initiation on track for Q3 2026 12-week data from Phase 1 trial of MBX 4291, a dual GLP-1/GIP co-agonist prodrug with potential for once-monthly dosing and improved tolerability for obesity, anticipated in Q4 2026 Nomination of two additional obesity candidates expected in 2026: an amycretin prodrug and a GLP-1/GIP/GCGR triple agonist,

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Jan 11 • 4:00 PM EST • Business • finance.yahoo.com
Insmed Provides Clinical and Business Update

Insmed Incorporated (Nasdaq:INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, announced today that the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms. Brensocatib was well tolerated, with no new safety signals identified

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Dec 17, 2025 • 4:01 PM EST • Business • finance.yahoo.com