This week's biotech roundup features the FDA's path forward for Atara's tab-cel, Arvinas' first-in-class PROTAC approval, and Incyte's Jakafi XR securing a regulatory nod. The week also saw Novartis announcing a site closure, Roche striking a $750 million PathAI deal, and Angelini agreeing to buy Catalyst for $4.1 billion. On the clinical front, Aptevo, Cytokinetics, Viridian, and Mirium all reported positive trial data across oncology, cardiology, ophthalmology, and rare liver disease, respectively.
Let's take a closer look at the details.
FDA Approvals & Rejections
Atara Biotherapeutics Updates FDA Path for Tab-cel Following CRL
Atara Biotherapeutics, Inc. (ATRA) announced that following a Type A meeting with the FDA regarding the Complete Response Letter for its Biologics License Application (BLA) of Tabelecleucel (tab-cel), the agency indicated that a single-arm study using historical controls could provide adequate evidence for resubmission. Pierre Fabre Pharmaceuticals, Atara's partner, plans to submit updated data from the pivotal Phase 3 ALLELE study with longer follow-up. Tab-cel, an allogenic EBV-specific T-cell immunotherapy, is being developed for EBV-driven cancers and autoimmune diseases.
ATRA closed Thursday's trading (May 7, 2026) at $9.93, up 92.82%.
Arvinas Secures FDA Approval for VEPPANU
Arvinas, Inc. (ARVN), together with Pfizer Inc. (PFE), announced that the U.S. FDA has approved VEPPANU for adult patients with estrogen receptor-positive (ER+)/HER2-negative, ESR1-mutated advanced or metastatic breast cancer, following disease progression after at least one line of endocrine therapy.
VEPPANU is the first FDA-approved PROteolysis TArgeting Chimera (PROTAC), representing a milestone in targeted protein degradation technology. The approval was supported by the pivotal Phase 3 VERITAC-2 trial data, where VEPPANU reduced the risk of disease progression or death by 43%, with a median progression-free survival of 5 months versus 2.1 months with fulverstrant.
Arvinas and Pfizer plan to select a third-party partner for commercialization.
ARVN closed Thursday's trading at $10.19, down 0.68%
Incyte Gains FDA Approval for Jakafi XR in Myelofibrosis, Polycythemia Vera, And Graft-Versus-Host Disease
Incyte (INCY) announced that the U.S.FDA has approved Jakafi XR (ruxolitinib), an extended-release formulation for adult patients with intermediate- or high-risk myelofibrosis and for polycythemia vera in patients who have an inadequate response to or are intolerant of hydroxyurea, and for acute and chronic graft-versus-host disease after failure of one or two lines of systemic therapy. The approval provides a once-daily dosing option, expanding treatment flexibility for patients.
The approval was supported by a clinical study showing that a single 55 mg Jakafi XR tablet taken once daily is bioequivalent to a single 25 mg Jakafi immediate-release ablet taken twice daily.
INCY closed Thursday's trading at $97.77, down 2.08%
Layoffs
Novartis Plans Closure of Wehr Manufacturing Site by 2028
Novartis (NVS) is preparing to wind down operations at its Wehr manufacturing site by the end of 2028, as part of a global network modernization strategy. The facility, which produces tablets and capsules for established medicines, is no longer considered competitive, and the closure is expected to impact about 220 jobs. Novartis emphasized that patient supply will not be affected and reaffirmed its commitment to Germany through ongoing R&D investments, including 35 million euros in a new radioligand therapy production facility in Halle slated to open in 2027.
NVS closed Thursday's trading at $145.39, down 2.00%
Deals
Angelina Pharma To Buy Catalyst For $4.1Bln
Angelini Pharma has agreed to acquire Catalyst Pharmaceuticals Inc. (CPRX) for $31.50 per share in cash, valuing the company at approximately $4.1 billion, or 3.5 billion euros. The transaction is expected to close in the third quarter of 2026.
The acquisition includes Catalyst's commercial portfolio focused on rare neuromuscular and neurological diseases, and its marketed products, namely FIRDAPSE (amifampridine), AGAMREE (vamorolone) and FYCOMPA (perampanel).
CPRX closed Thursday's trading at $31.17, up 2.11%
Aclarion Signs Agreement with Weill Cornell
Aclarion Inc. (ACON) announced that a second commercial agreement had been established with Weill Cornell Medicine to conduct a study on lumbar surgery to treat degenerative disc disease, using the company's AI-driven platform Nociscan.
Nociscan combines artificial intelligence (AI) with magnetic resonance imaging (MRI) to identify the location of disc pain using specific chemical biomarkers and has shown a 97% surgically verified success rate.
ACON closed Thursday's trading at $3.16, down 3.66%.
Roche Enters $750 Mln Deal to Acquire PathAI
Roche (RHHBY), a healthcare company, announced that it has entered into a definitive merger agreement to acquire PathAI, a digital, AI-powered technology firm, to bolster its position in AI-Driven Diagnostics.
Under the terms of the agreement, Roche will pay an upfront purchase price of $750 million and additional milestone payments of up to $300 million. The transaction is expected to close in the second half of the year, subject to regulatory approvals.
RHHBY closed Thursday's trading at $50.55, down 2.11%
Clinical Trials - Breakthroughs & Setbacks
Aptevo Reports 87% Clinical Benefit And 81% Remission in Frontline AML Trial
Aptevo Therapeutics Inc. (APVO) reported new positive data from its RAINIER frontline acute myeloid leukemia (AML) study showing that Mipletamig, Aptevo's lead proprietary drug candidate in combination with Venetoclax and Azacitidine, achieved an 87% clinical benefit rate and an 81% remission rate in 31 evaluable patients.
No cases of cytokine release syndrome (CRS) have been reported to date, supporting the therapy's favourable safety profile.
APVO closed Thursday's trading at $4.86, down 1.62%.
Cytokinetics' Aficamten Meets Primary Goal in Phase 3 ACACIA-HCM Trial of nHCM
Cytokinetics, Inc. (CYTK) announced positive topline results from ACACIA-HCM, its pivotal Phase 3 clinical trial evaluating Aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). The study met both dual primary endpoints, showing statistically significant improvements in symptoms and exercise capacity compared with placebo.
In addition, the trial met its co-primary endpoints, demonstrating statistically significant improvements from baseline to Week 36 in both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and maximal exercise performance (pVO2) compared with placebo.
CYTK closed Thursday's trading at $74.29, down 0.73%.
Viridian Reports Positive Phase 3 Results for Elegrobart in Thyroid Eye Disease
Viridian Therapeutics, Inc. (VRDN) announced positive topline results from the Phase 3 REVEAL-2 study of Elegrobart in patients with chronic thyroid eye disease. The study met its primary endpoint and also achieved all key secondary endpoints related to proptosis in both the every-four-week(Q4W) and every-eight-week(Q8W) treatment arms, while the Q4W arm demonstrated a statistically significant improvement in diplopia responder rate at week 24.
Elegrobart was generally well tolerated in the study, and a BLA submission is expected in the first quarter of 2027.
VRDN closed Thursday's trading at $17.00, down 3.02%.
Cellectar Biosciences Shares Positive CLOVER WaM Data
Cellectar Biosciences, Inc. (CLRB) announced positive 12-month follow-up data from its Phase 2b CLOVER WaM study evaluating iopofosine I 131 in patients with Waldenström acroglobulinemia, a rare, slow-growing blood cancer.
The trial achieved 83.6% Overall Response Rate and 61.8% Major Response Rate, which is the primary endpoint in a heavily pretreated population with a median duration of response of 17.8 months and the secondary endpoint. Iopofosine I-131 continued to demonstrate a predictable and manageable safety profile according to the firm.
CLRB closed Thursday's trading at $3.30, down 6.52%.
Mirium Pharma's Volixibat Meets Primary Goal in VISTAS Study For PSC
Mirum Pharmaceuticals Inc. (MIRM) announced that the primary endpoint was met in the VISTAS Phase 2b study evaluating Volixibat, an orally administered, minimally absorbed inhibitor of IBAT, for the treatment of primary sclerosing cholangitis (PSC).
In the primary analysis cohort, treatment with Volixibat demonstrated a 2.72-point improvement in Pruritus and a placebo-adjusted difference of 1.64 points in the primary endpoint, as measured by the Adult ItchRO scale. Volixibat's safety profile was generally consistent with the known effects of IBAT inhibition.
MIRM closed Thursday's trading at $102.93, down 6.50%.
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Business News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.