Tavapadon

Neuroscience R&D News Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's disease spectrum Positive results across all three Phase 3 TEMPO trials reinforce the potential of tavapadon, a novel selective dopamine D1/D5 receptor partial agonist, in Parkinson's disease If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option NORTH CHICAGO, Ill., Sept. 26, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist that was studied as a once daily oral treatment for Parkinson's disease. The submission is based on results from the TEMPO clinical development program that evaluated the efficacy, safety and tolerability of tavapadon across a broad Parkinson's disease population. This includes two Phase 3 trials (TEMPO-1 and TEMPO-2) in early Parkinson's disease, and one Phase 3 trial (TEMPO-3) with tavapadon as adjunctive to levodopa in patients experiencing motor fluctuations. TEMPO-1 and TEMPO-2 demonstrated that patients experienced a statistically significant improvement from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.1 TEMPO-3 demonstrated that patients experienced more "on" time, referring to the period when symptoms were well controlled without dyskinesia or involuntary movements.1 The submission is also based on an interim data cut from TEMPO-4, an open-label extension (OLE) trial to assess the long-term clinical benefit of tavapadon.1 "For many people living with Parkinson's disease, today's oral standard of care isn't effective enough to manage symptoms," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We recognize the physical and mental impact that Parkinson's disease can cause and are committed to providing next-generation treatment options that will help individuals regain motor control and independence at all stages of this challenging disease." About the TEMPO Clinical Development Program The submission is supported by results from three placebo-controlled studies: TEMPO-1 and -2 enrolled patients with early Parkinson's disease (with or without an MAO-B inhibitor) and TEMPO-3 enrolled patients who are on fixed-dose levodopa and had motor fluctuations. An open-label extension study (TEMPO-4) is ongoing to assess the long-term safety and efficacy of tavapadon through 58 weeks of treatment. TEMPO-4 enrolled patients who completed participation in TEMPO-1 through 3, as well as patients on stable doses of levodopa who had not been in prior TEMPO trials. TEMPO-1 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, 27-week trial to evaluate the efficacy, safety and tolerability of two fixed doses of tavapadon in early Parkinson's disease. The primary endpoint was the change from baseline in the MDS-UPDRS Parts II and III combined score. Key secondary endpoints included change from baseline in the MDS-UPDRS Parts II score and percentage of responders with "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC). A total of 529 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson's disease and had disease duration (from time of diagnosis) of less than three years. Patients were randomized to receive tavapadon titrated to 5 milligrams, tavapadon titrated to 15 milligrams or placebo, orally and once daily. TEMPO-2 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, 27-week trial to evaluate the efficacy, safety and tolerability of flexible doses of tavapadon (5-15 mg QD) in early Parkinson's disease. The primary endpoint was the change from baseline in the MDS-UPDRS Parts II and III combined score. Key secondary endpoints included change from baseline in the MDS-UPDRS Parts II score and percentage of responders with "much improved" or "very much improved" on the PGIC. A total of 304 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson's disease and had disease duration (from time of diagnosis) of less than three years. Patients were randomized to receive tavapadon 5-15 mg QD or placebo, orally and once daily. TEMPO-3 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, flexible-dose, 27-week trial to evaluate the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to LD for advanced Parkinson's disease. Patients were provided with a home diary to assess their motor function status (Hauser diary). The primary endpoint was change from baseline in the total "on" time without troublesome dyskinesia based on the two-day average of the self-completed Hauser diary. Secondary endpoints included change from baseline in total daily "off" time, change from baseline in total "on" and "off" time at earlier timepoints in the trial, and change from baseline in the MDS-UPDRS Part I, II and III scores. A total of 507 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson's disease, were experiencing motor fluctuations and were on a stable dose of LD for at least four weeks prior to screening. Patients were randomized to receive either tavapadon adjunctive to LD, tavapadon titrated to 5-15 milligrams, or placebo and LD, orally and once daily. The majority of adverse events were non-serious and mild or moderate in severity across TEMPO-1 through 3.1 The incidence of SAEs and deaths were low and comparable between placebo and tavapadon groups.1 The most common adverse reactions reported in ≥10% of patients were nausea, headache and dizziness for Parkinson's disease patients without levodopa, and nausea and dyskinesia for patients on adjunctive therapy with levodopa.1 More information on the studies can be found on www.clinicaltrials.gov: TEMPO-1: NCT04201093 TEMPO-2: NCT04223193 TEMPO-3: NCT04542499 TEMPO-4: NCT04760769 About Parkinson's Disease More than 11 million people worldwide are living with Parkinson's disease,2 a progressive and chronic neurological disorder characterized by tremor, muscle rigidity, slowness of movement and difficulty with balance.3 The motor symptoms of Parkinson's disease begin when approximately 60-80 percent of the dopamine-producing cells in the brain are lost, and symptoms continue to worsen slowly over the course of time.4 As Parkinson's disease progresses, patients experience complications, including motor and non-motor fluctuations and dyskinesia. Patients report switching from an "on" state (when symptoms are generally well controlled) to an "off" state, during which symptoms such as tremor and stiffness may reappear and patients have more difficulty moving.5 Patients with advanced Parkinson's disease may also experience dyskinesia (involuntary movements) which can significantly hinder daily activities.5 While there is no known cure for the disease, there are treatments available to help reduce symptoms.4 About Tavapadon Tavapadon is an investigational, novel selective D1/D5 receptor partial agonist that was studied as a once-daily oral medicine for Parkinson's disease for use both with and without levodopa. Tavapadon is not approved by any health regulatory authority. About AbbVie in Neuroscience At AbbVie, our commitment to preserving personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders, and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners, and clinicians. For more information, visit www.abbvie.com. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care — and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Contact(s): U.S. Media: Kayla Azzato +1 (224) 355-5243 Kayla.azzato@abbvie.com Global Media: Amber Landis +1 (231) 557-6596 Amber.landis@abbvie.com Investors: Liz Shea +1 (847) 935-2211 Liz.shea@abbvie.com References 1 AbbVie. Data on file ABVRRTI79943. 2 Statistics. Parkinson's Foundation. Available at: https://www.parkinson.org/understanding-parkinsons/statistics. Accessed August 27, 2025. 3 About Parkinson's: Parkinson's 101. The Michael J. Fox Foundation for Parkinson's Research. Available at: https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php. Accessed August 27, 2025. 4 Parkinson's Disease: Hope Through Research. National Institute of Neurological Disorders and Stroke. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research. Accessed August 27, 2025. 5 "Off" Time in Parkinson's Disease. The Michael J. Fox Foundation for Parkinson's Research. Available at: https://www.michaeljfox.org/time-parkinsons-disease. Accessed August 27, 2025. US-TAV-250006 SOURCE AbbVie

iStock, juliannafunk Some of the biggest SPACs from the industry’s pandemic-fueled heyday are no longer on the market. 2021 was a wild year for the biotech public stock market. Across the U.S. and Europe, more than 100 startups went for their initial public offerings while another large batch took a different track—merging with a special purpose acquisition company, also known as the SPAC track. Also called blank-check companies, SPACs work by raising capital via an IPO that they then let sit in trust accounts. Eventually, SPACs can leverage this funding to merge with a promising private company in a deal that not only brings the target company to the public stock market but infuses it with a hefty sum of money. During the heyday of 2021—when the industry was flush with pandemic-driven investments—SPACs presented a quick and comparatively easy way to raise money and go public. SPACs typically come with lower upfront costs than traditional initial public offerings (IPOs) and allow companies to collect even more capital through private investment in public equity (PIPE) placements. IPOs, on the other hand, take longer to complete and are burdened by upfront underwriting and legal fees. But the market has since cooled and contracted . With investors driven away by macro-level uncertainties, dozens of companies have already closed shop while many more are in a precarious position . In this piece, BioSpace checks in on some standout SPACs of 2021, looking at how they’ve fared over the years, and how they’re weathering the current market turbulence. Roivant SPAC Date: October 2021 Value: $611 million Roivant debuted on Nasdaq on Oct. 1, 2021 , via a merger with Montes Archimedes Acquisition Corp. The deal gave the burgeoning biotech access to the blank-check company’s $411 million trust fund and $200 million in a PIPE placement. All told, the SPAC deal put Roivant’s cash position at around $2.5 billion . Roivant has used this money to step-up its subsidiary strategy—forming nimble and focused “ Vants ” dedicated to developing novel therapies. Months after completing its SPAC, for instance, the biotech teamed up with Pfizer and in June 2022 launched Priovant Therapeutics to advance brepocitinib, an orally available and selective TYK2 and JAK1 inhibitor for the treatment of autoimmune disorders such as systemic lupus erythematosus and dermatomyositis. Later that year, Roivant and Pfizer debuted another Vant , this time to work on an anti-TL1A antibody for ulcerative colitis. The subsidiary, dubbed Telavant, was acquired by Roche in October 2023 for $7.1 billion upfront . Also in 2022, Roivant scored its first FDA approval for Dermavant’s VTAMA cream, indicated for plaque psoriasis in adults. Two years later, in September 2024, Organon acquired Dermavant in a potential $1.2 billion agreement. That same month, Roivant launched another subsidiary , called Pulmovant, tasked with working on mosliciguat, an inhalable therapy for pulmonary hypertension associated with interstitial lung disease. Since debuting, Roivant’s shares have increased 28% with a market cap of $8.36 billion. EQRx SPAC Date: August 2021 Value: $1.8 billion EQRx launched in 2020 with $200 million in series A money and a lofty goal: change the drug discovery process to develop medicines that are more affordable. In August 2021, CM Life Sciences III, Inc threw its weight behind this mission with a hefty SPAC deal , not only carrying EQRx to the public stock exchange but also providing a $1.8 billion cash infusion. The problems started over a year later, in November 2022, when development plans for the PD-L1 blocker sugemalimab hit a rough patch. In talks with the FDA, EQRx was told that interim findings from its Phase III GEMSTONE-302 trial, conducted in China, would not be enough to support a regulatory filing for U.S. approval. The company at the time decided that there was “no commercially viable path” for sugemalimab in the U.S. EQRx was forced to abandon plans for a test in stage IV non-small cell lung cancer. A few months later, in February 2023, in an effort to “increase . . . operational efficiencies and streamline expenses,” EQRx downsized by 18% , a move that the company expected to generate $18 million in annualized savings. The company ramped up the restructuring process in May that same year with a sweeping business reset , laying off half its headcount and junking another cancer asset. Most notably, EQRx shifted focus to become a more cookie-cutter drug development company, “developing clinically differentiated, high-value medicines,” then-CEO Melanie Nallicheri said in a statement at the time. But even this pivot failed to turn EQRx’s business around. In August 2023, EQRx was absorbed by Revolution Medicines and is no longer trading on Nasdaq. 23andMe SPAC Date: June 2021 Value: $592 million The last few months have been difficult for DNA testing company 23andMe. In March, the company filed for Chapter 11 bankruptcy , seeking for court supervision as it sells its business. This is a far cry from four years earlier, when 23andMe debuted on the public stock market in a SPAC deal with VG Acquisition Corp in June 2021. The agreement raised a gross of $592 million for the consumer genetics company and bumped up its value to $3.5 billion . Shortly after landing on Nasdaq, 23andMe hit its peak market value of approximately $6 billion . Things soon went south, however, as 23andMe struggled to cope with rising interest rates and sales slumps. By the end of fiscal year 2022, the company hit a $184 million net loss , which ballooned to $312 million in 2023 . To stanch the cash bleed, 23andMe in November 2024 put in motion a sweeping restructuring initiative , involving a 40% layoff and a pivot away from drug development efforts. The company at the time expected these measures to generate $35 million in savings annually. Aside from a capital crunch, 23andMe was beset with privacy problems. In October 2023, hackers breached the company’s system and were able to access data of some 6.9 million people. In June this year, 23andMe and its sale were at the heart of a Senate Oversight Committee hearing that highlighted “serious national security” concerns over Americans’ genetic data. That same month, the company was finally acquired for $305 million by the nonprofit TTAM Research Institute, owned by Anne Wojcicki, 23andMe’s former CEO. Wojcicki has pledged to comply with 23andMe’s privacy policies and has made “binding commitments” to add certain safeguards to further protect customers and their genetic data. After being bought by TTAM, 23andMe is no longer on the public stock market. Tango Therapeutics SPAC Date: August 2021 Value: $342 million Tango Therapeutics danced into the public stock market almost four years ago when it merged with BCTG Acquisition Corp. The deal gave the Massachusetts-based biotech $342 million, including $156 million from BCTG’s trust account and roughly $186 million from a PIPE placement. At the time of its Nasdaq debut, Tango’s cash position was at $515 million. In the years since, the biotech has worked on its pipeline of precision cancer therapies, though this effort has not been without its stumbles. In May 2024, Tango shelved the USP1 inhibitor TNG348, which was being testing in early-stage studies for solid tumors. The decision to scrap the asset was driven by grade 3 and 4 liver function abnormalities, which Tango detected in patients who had been on the trial for more than eight weeks. Tango planned to assess TNG348 as a monotherapy and as part of a combination regimen with AstraZeneca and Merck’s PARP inhibitor Lynparza, though the company never had the chance . A few months later, in November 2024, Tango was forced to abandon another asset, this time the PRMT5 blocker TNG908. The molecule, designed to get past the blood-brain barrier, was being trialed for glioblastoma, but a Phase I/II study showed that TNG908 “did not meet the pharmacokinetic exposure threshold for clinical efficacy,” according to a company announcement at the time. Discontinuing TNG908 allowed Tango to fully resource its other PRMT5 blocker TNG462, which is now the biotech’s lead asset. The company is developing the asset for pancreatic and lung cancers, as well as other non-CNS malignancies. Phase I/II data are expected later this year, according to Tango’s most recent quarterly report , released last month, after which it expects to launch a registrational trial for pancreatic cancer next year. Since going public, Tango’s stocks have declined 33%. The biotech has a market cap of $745.4 million. Cerevel Therapeutics SPAC Date: July 2020 Value: $440 million Cerevel was a little early to the SPAC party as compared to the other entries on this list, merging in July 2020 with blank-check firm Arya Sciences Acquisition Corp II. The SPAC at the time had $150 million in trust, which Cerevel’s backers—a high-pro including Bain Capital and Pfizer—supplemented with $320 million in a PIPE placement. All told, Cerevel’s public stock debut a few months later was accompanied by a net cash infusion of approximately $440 million . This money helped the Massachusetts biotech establish itself as a leader in the neurology space, anchored by its next-generation antipsychotic schizophrenia drug emraclidine. Phase Ib data published in December 2022 showed that the drug led to “ clinically meaningful and statistically significant improvements ” in positive and negative symptoms after six weeks of treatment, as compared with placebo. These findings, though early, were enough to not only land emraclidine on BioSpace ’s watchlist for neuropsychiatric drugs on August 2023 but also attract the attention of AbbVie. In December that year, the industry giant dropped an eye-watering $8.7 billion to acquire Cerevel, winning emraclidine and the biotech’s rich pipeline of other investigational neuro assets. The bet seemed to pay off quickly, with a Phase III readout in April 2024 showing that its dopamine receptor partial agonist tavapadon elicited significant motor control improvements in patients with Parkinson’s disease. But in November last year, emraclidine returned back-to-back Phase II failures in schizophrenia , delivering a 12% hit to AbbVie’s shares. The pharma has since recalibrated its program for emraclidine and will take the molecule forward as part of an adjunct regimen. AbbVie’s acquisition of Cerevel closed in August 2024 , officially taking the neuro biotech off the public stock exchange just over four years since its debut. Immatics SPAC Date: March 2020 Value: $250 million In two important ways, Immatics’ SPAC journey mirrors that of Cerevel’s: The cancer-focused biotech launched onto the public stock market in 2020, and it did so by merging with an Arya entity. In the case of Immatics, its SPAC was funded by the original Arya Sciences Acquisition Corp., which in March 2020 offered its $148 million trust fund to take the biotech public. The arrangement was completed in July that same year, with Immatics bagging $253 million in total , including proceeds from a PIPE financing. In the years since its Nasdaq debut, Immatics mustered support from many other biopharma companies through partnerships. Chief of these is Bristol Myers Squibb, which in December 2021 paid $150 million upfront and promised up to $770 million in milestones to co-develop the T cell receptor (TCR) bispecific antibody IMA401. Some six months later, in June 2022, BMS doubled down on its commitment to Immatics by paying $60 million to expand their existing arrangement to go after “multiple” off-the-shelf TCR or CAR T programs. Under the expanded contract, Immatics is eligible for up to $700 million per program. In May 2023, BMS exercised its first license option under the Immatics deal, gaining worldwide license to a novel TCR-T product candidate, in turn giving the biotech $15 million in exercise fees. A few months later, the pharma made a $35 million equity investment in Immatics. Aside from BMS, Immatics also struck up an R&D deal with Moderna in September 2023, under which the companies will explore using mRNA technology for the in vivo expression of TCR bispecifics. The collaboration gave Immatics $120 million upfront plus the possibility of more than $1.7 billion in milestones. Since its SPAC, Immatics’ shares have fallen 66%. The company has a market cap of $657 million.